Authorised Version C2019C00066 registered 22/01/2019
Therapeutic Goods Act 1989
No. 21, 1990
Compilation No. 72
Compilation date: 1 January 2019
Includes amendments up to: Act No. 104, 2018
Registered: 22 January 2019
Prepared by the Office of Parliamentary Counsel, Canberra
About this compilation
This compilation
This is a compilation of the Therapeutic Goods Act 1989 that shows the text of
the law as amended and in force on 1 January 2019 (the compilation date).
The notes at the end of this compilation (the endnotes) include information
about amending laws and the amendment history of provisions of the compiled
law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the
compiled law. Any uncommenced amendments affecting the law are accessible
on the Legislation Register (www.legislation.gov.au). The details of
amendments made up to, but not commenced at, the compilation date are
underlined in the endnotes. For more information on any uncommenced
amendments, see the series page on the Legislation Register for the compiled
law.
Application, saving and transitional provisions for provisions and
amendments
If the operation of a provision or amendment of the compiled law is affected by
an application, saving or transitional provision that is not included in this
compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see
the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as
modified but the modification does not amend the text of the law. Accordingly,
this compilation does not show the text of the compiled law as modified. For
more information on any modifications, see the series page on the Legislation
Register for the compiled law.
Self-repealing provisions
If a provision of the compiled law has been repealed in accordance with a
provision of the law, details are included in the endnotes.
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Contents
Chapter 1—Preliminary 1 Short title...........................................................................1
2 Commencement.................................................................1
3 Interpretation .....................................................................1
3AA Homoeopathic preparations and homoeopathic
standards..........................................................................22
3AB Anthroposophic preparations and anthroposophic
standards..........................................................................23
3A Declaration—member of European Community .............24
3B Declaration—country covered by non-EC/EFTA
MRA................................................................................25
3C Exempting monographs in pharmacopoeias ....................25
4 Objects of Act..................................................................26
5 Act to bind Crown ...........................................................26
5A Application of the Criminal Code—extended
geographical jurisdiction .................................................26
6 Operation of Act..............................................................27
6AAA Commonwealth consent to conferral of functions
etc. on its officers and authorities by
corresponding State laws.................................................27
6AAB When duty imposed.........................................................28
6AAC Imposing duty under State law ........................................29
6AAD Conferral of jurisdiction on federal courts.......................30
6AAE Consequences of State law conferring duty,
function or power on Commonwealth officer or
Commonwealth authority ................................................31
6B Review of certain decisions under State laws..................32
6C Fees payable to Commonwealth under State laws...........32
7 Declaration that goods are/are not therapeutic
goods ...............................................................................33
7AA Excluded goods ...............................................................34
7A Authorised persons..........................................................34
7B Kits ..................................................................................35
7C Secretary may arrange for use of computer
programs to make decisions ............................................36
7D Form for product information for medicine.....................36
8 Power to obtain information with respect to
therapeutic goods.............................................................36
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9 Arrangements with States etc. .........................................37
Chapter 2—Australian Register of Therapeutic Goods 39 9A Australian Register of Therapeutic Goods.......................39
9B When registrations or listings of medical devices
are taken to be cancelled..................................................40
9C Inspection of entries in Register ......................................42
9D Variation of entries in Register........................................43
9E Publication of list of goods on Register...........................48
9F Removal of entries from Register....................................49
9G Criminal offences for false statements in requests
for variation of entries in Register ...................................50
9H Civil penalty for false statements in requests for
variation of entries in Register.........................................51
Chapter 3—Medicines and other therapeutic goods
that are not medical devices 52
Part 3-1—Standards 52 10 Determination of standards..............................................52
10A Application of standards to medical devices ...................53
13 Special provisions relating to Ministerial standards
and default standards .......................................................54
13A Special provisions relating to homoeopathic
standards and anthroposophic standards..........................55
14 Criminal offences for importing, supplying or
exporting goods that do not comply with standards ........56
14A Civil penalties for importing, supplying or
exporting goods that do not comply with standards ........61
14B Application of Customs Act 1901 ....................................63
15 Criminal offences relating to breaching a condition
of a consent .....................................................................63
15AA Civil penalty relating to breaching a condition of a
consent ............................................................................64
15AB Conditions relating to exceptional release of
biologicals .......................................................................65
Part 3-2—Registration and listing of therapeutic goods 66
Division 1—Preliminary 66
15A Application of this Part to medical devices .....................66
15B Application of this Part to a biological ............................68
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16 Therapeutic goods and gazetted groups...........................69
18 Exempt goods..................................................................71
18A Exemption because of emergency ...................................71
19 Exemptions for certain uses.............................................75
19A Exemptions where unavailability etc. of
therapeutic goods.............................................................80
19B Criminal offences relating to registration or listing
etc. of imported, exported, manufactured and
supplied therapeutic goods ..............................................83
19C Notice required to adduce evidence in support of
exception under subsection 19B(6) .................................86
19D Civil penalties relating to registration or listing etc.
of imported, exported, manufactured and supplied
therapeutic goods.............................................................88
20 Criminal offences relating to notifying the
Secretary and to importing goods exempt under
section 18A......................................................................90
20A Civil penalty relating to the importation,
exportation, manufacture or supply of sponsored
goods without proper notification....................................92
21 Offence relating to wholesale supply ..............................94
21A General criminal offences relating to this Part ................94
21B General civil penalties relating to this Part....................102
22 General offences relating to this Part.............................103
22AA Civil penalty for breaching a condition of an
exemption......................................................................106
22A Criminal offences for false statements in
applications for registration...........................................107
22B Civil penalty for false statements in applications
for registration ...............................................................108
Division 1A—Provisional determinations for medicine 109
22C Applications for provisional determination ...................109
22D Provisional determinations ............................................109
22E Period during which provisional determination is
in force ..........................................................................110
22F Revocation of provisional determination.......................112
Division 2—Registration and listing 114
23 Applications generally...................................................114
23AA Applications for provisional registration of
medicine ........................................................................114
23A Classes of therapeutic goods .........................................114
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23B Requirements relating to applications for
registration of therapeutic goods and listing of
medicines under section 26AE ......................................114
23C Requirements relating to applications for listing of
therapeutic goods under section 26 or 26A ...................117
24 Applications for registration..........................................117
24A When evaluation fee due for payment ...........................118
24B Payment of evaluation fee by instalments .....................119
24C Recovery of evaluation fee ............................................119
24D Refund of evaluation fee where evaluation not
completed within prescribed period...............................119
24E Deemed refusal of application.......................................120
25 Evaluation of therapeutic goods ....................................120
25AAA Therapeutic goods (priority applicant)
determinations ...............................................................124
25AA Approved product information for medicine .................126
25AB Registration of therapeutic goods etc. ...........................129
25AC Notice of decision not to register therapeutic goods......130
25A When the Secretary must not use protected
information....................................................................131
25B Registration of therapeutic device to which
EC/EFTA attestation of conformity applies ..................132
26 Listing of therapeutic goods ..........................................132
26AA Listing of therapeutic device to which EC/EFTA
attestation of conformity applies ...................................137
26A Listing of certain medicines ..........................................137
26AB Application for listing of certain medicines
following efficacy evaluation ........................................142
26AC Evaluation fees for listing of medicine under
section 26AE .................................................................146
26AD Lapsing and deemed refusal of applications for
listing of medicine under section 26AE.........................147
26AE Evaluation and listing of certain medicines ...................148
26B Certificates required in relation to patents .....................150
26BA Approved form for notices ............................................151
26BB Permissible ingredients..................................................151
26BC Variation of determination under section 26BB—
Minister’s initiative .......................................................152
26BE Variation of section 26BB determination—
application by person.....................................................153
26BF Permissible indications..................................................156
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26BG Limitations on determination under section 26BF.........157
26BH Variation of determination under section 26BF—
Minister’s initiative .......................................................157
26BJ Variation of determination under section 26BF—
application by person.....................................................157
26C Certificates required in relation to patent
infringement proceedings ..............................................160
26D Requirements for interlocutory injunction.....................163
27 Registration or listing number .......................................165
28 Conditions of registration or listing...............................165
28A Certification of manufacturing steps outside
Australia following application for listing.....................170
29 Duration of registration or listing ..................................170
29A Criminal offence for failing to notify adverse
effects etc. of goods.......................................................173
29AA Civil penalty for failing to notify adverse effects
etc. of goods ..................................................................174
29B Notification of adverse effects etc. where
application withdrawn or lapses ....................................175
29C Civil penalties for failing to notify adverse effects
etc. where application withdrawn or lapses ...................176
29D Suspension of registration or listing ..............................176
29E When suspension takes effect etc. .................................177
29F Revocation of suspension ..............................................178
29G Effect of suspension ......................................................179
30 Cancellation of registration or listing ............................180
30A Revocation of cancellation of registration or listing
upon request ..................................................................184
30AA Revocation of cancellation of registration or
listing—payment of annual registration or listing
charge ............................................................................185
30B Publication of cancellation of registration or listing......185
30C Consultation with Gene Technology Regulator.............186
30D Secretary may seek advice about classes of GM
products or genetically modified organisms ..................186
30E Secretary to take advice into account ............................187
Division 2A—Public notification, and recall, of therapeutic
goods 188
30EA Public notification, and recall, of therapeutic
goods .............................................................................188
30EB Publication of requirements...........................................191
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30EC Criminal offences for non-compliance with
requirements ..................................................................191
30ECA Civil penalty for non-compliance with
requirements ..................................................................192
30ED Powers of suspension and cancellation unaffected ........192
30EE Saving of other laws ......................................................192
Division 2B—Reporting medicine shortages and discontinuation
of supply of medicine 193
30EF Reporting medicine shortages .......................................193
30EG Reporting discontinuation of supply of medicine ..........195
30EH What is a reportable medicine? .....................................197
30EI When is there a medicine shortage? ..............................197
30EJ Medicines Watch List....................................................198
Division 3—General 199
30F Criminal offences for goods exempt under
section 18A not conforming to standards etc.................199
30FA Civil penalty for goods exempt under section 18A
not conforming to standards etc.....................................201
30G Disposal of unused goods exempt under
section 18A....................................................................201
30H Record for goods exempt under section 18A.................202
31 Secretary may require information or documents..........203
31AAA Civil penalty for providing false or misleading
information or documents in relation to therapeutic
goods .............................................................................209
31A Secretary may require information etc. about
goods exempt under section 18 .....................................210
31AA Secretary may require information etc. about
goods exempt under section 18A...................................211
31B Secretary may require information relating to
approvals and authorities under section 19....................212
31BA Secretary may require information about
therapeutic goods approved under section 19A.............214
31C Criminal offences for failing to give information
or documents sought under section 31A, 31AA,
31B or 31BA .................................................................215
31D False or misleading information ....................................215
31E False or misleading documents......................................216
31F Self-incrimination..........................................................217
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Part 3-2A—Biologicals 219
Division 1—Preliminary 219
32 What this Part is about...................................................219
32A Meaning of biological ...................................................219
32AA Biological classes ..........................................................220
32AB When biologicals are separate and distinct from
other biologicals ............................................................221
Division 2—Main criminal offences and civil penalties 222
32B What this Division is about ...........................................222
32BA Criminal offences for importing a biological ................222
32BB Criminal offences for exporting a biological .................225
32BBA Treating biologicals as prohibited imports or
exports ...........................................................................227
32BC Criminal offences for manufacturing a biological .........227
32BD Criminal offences for supplying a biological ................230
32BE Notice required to adduce evidence in support of
exception to offences.....................................................233
32BF Civil penalties for importing, exporting,
manufacturing or supplying a biological .......................235
32BG Criminal offences and civil penalty relating to a
failure to notify the Secretary about manufacturing ......238
32BH Criminal offence relating to wholesale supply ..............241
32BI Criminal offence for using a biological not
included in the Register .................................................242
32BJ General criminal offences relating to this Part ..............244
32BK Civil penalty for making misrepresentations about
biologicals .....................................................................246
32BL Civil penalty for advertising biological for an
indication.......................................................................247
Division 3—Exemptions 248
Subdivision A—Preliminary 248
32C What this Division is about ...........................................248
Subdivision B—Exempting biologicals under the regulations 248
32CA Exempt biologicals ........................................................248
Subdivision C—Exempting biologicals to deal with emergencies 249
32CB Minister may make exemptions.....................................249
32CC Conditions of exemptions..............................................250
32CD Variation or revocation of exemption............................251
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32CE Informing persons of exemption etc. .............................252
32CF Notification and tabling.................................................252
32CG Disposal of unused biologicals ......................................253
32CH Criminal offences for breaching a condition of an
exemption......................................................................253
32CI Civil penalty for breaching a condition of an
exemption......................................................................255
32CJ Criminal offences and civil penalty for biologicals
not conforming to standards etc.....................................255
Subdivision D—Exempting biologicals for certain uses 258
32CK Approvals for importing, exporting or supplying a
biological for special and experimental uses .................258
32CL Conditions of use of biological for experimental
purposes in humans .......................................................260
32CM Exemptions for health practitioners...............................260
32CN Criminal offences relating to the giving of an
authority to a health practitioner....................................263
Subdivision E—Exempting biologicals where substitutes are
unavailable etc. 267
32CO Approvals where substitutes for biologicals are
unavailable etc...............................................................267
Division 4—Including biologicals in the Register 271
Subdivision A—Preliminary 271
32D What this Division is about ...........................................271
Subdivision B—Class 1 biologicals 271
32DA Application for inclusion in the Register .......................271
32DB Inclusion of Class 1 biological in the Register ..............272
32DC Refusal to include Class 1 biological in the
Register .........................................................................273
Subdivision C—Biologicals other than Class 1 biologicals 273
32DD Application for inclusion in the Register .......................273
32DDA Preliminary assessment of applications .........................273
32DE Evaluation of biologicals...............................................275
32DEA Biologicals (priority applicant) determinations .............276
32DF Inclusion of biological in the Register...........................278
32DG Refusal to include biological in the Register .................279
32DH Lapsing of application ...................................................280
32DI Evaluation fee................................................................280
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32DJ When evaluation fee due for payment ...........................281
32DK Payment of evaluation fee by instalments .....................281
32DL Recovery of evaluation fee ............................................281
32DM Reduction of evaluation fee where evaluation not
completed within prescribed period...............................282
Subdivision D—Transitional provisions for existing biologicals 283
32DN Transitional provisions for existing biologicals.............283
Subdivision E—Criminal offences and civil penalties 285
32DO Criminal offences for false statements in
applications for including biologicals in the
Register .........................................................................285
32DP Civil penalty for false statements in applications
for including biologicals in the Register........................286
32DQ Criminal offence and civil penalty for failing to
notify adverse effects etc. of biological while it is
included in the Register .................................................287
32DR Criminal offences and civil penalties for failing to
notify adverse effects etc. of biological where
application withdrawn or lapses ....................................288
Subdivision F—Advice from Gene Technology Regulator 290
32DS Consultation with Gene Technology Regulator.............290
32DT Secretary may seek advice about classes of GM
products or genetically modified organisms ..................291
32DU Secretary to take advice into account ............................291
Division 5—Conditions 293
32E What this Division is about ...........................................293
32EA Conditions applying automatically ................................293
32EB Certification of manufacturing steps outside
Australia ........................................................................296
32EC Imposition of conditions by legislative instrument........296
32ED Imposition of conditions at time biological
included in the Register .................................................297
32EE Imposition or variation or removal of conditions
after biological included in the Register ........................297
32EF Criminal offences for breach of condition.....................298
32EG Civil penalty for breach of condition.............................299
Division 6—Suspension from the Register 300
32F What this Division is about ...........................................300
32FA Suspension of biological from the Register ...................300
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32FB When suspension takes effect etc. .................................301
32FC Revocation of suspension ..............................................302
32FD Effect of suspension ......................................................303
Division 7—Cancellation from the Register 304
32G What this Division is about ...........................................304
32GA Immediate cancellation of biological from the
Register in various circumstances .................................304
32GB Immediate cancellation of biological from the
Register after failure to comply with information
gathering notice .............................................................305
32GC Cancellation of biological from the Register after
notice of proposed cancellation .....................................306
32GD Revocation of cancellation of biological upon
request ...........................................................................308
32GDA Revocation of cancellation of biological upon
request—payment of annual charge ..............................308
32GE Publication of cancellation of entry from Register ........309
32GF Date of effect of cancellation of entries from
Register .........................................................................309
Division 8—Public notification, and recall, of biologicals 310
32H What this Division is about ...........................................310
32HA Public notification, and recall, of biologicals ................310
32HB Publication of requirements...........................................313
32HC Criminal offences for non-compliance with
requirements ..................................................................314
32HD Civil penalty for non-compliance with
requirements ..................................................................314
32HE Powers of suspension and cancellation unaffected ........315
32HF Saving of other laws ......................................................315
Division 9—Obtaining information or documents 316
Subdivision A—Preliminary 316
32J What this Division is about ...........................................316
Subdivision B—Obtaining information or documents for
biologicals included or proposed to be included in
the Register 316
32JA Secretary may require information or documents..........316
32JB Criminal offences for failing to comply with a
notice etc. ......................................................................318
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32JC Civil penalty for giving false or misleading
information or document in compliance with a
notice.............................................................................320
32JD Self-incrimination..........................................................320
Subdivision C—Obtaining information or documents for
biologicals covered by exemptions 321
32JE Secretary may require information etc. about
biologicals exempt under the regulations ......................321
32JF Secretary may require information etc. about
biologicals exempt to deal with emergencies ................322
32JG Secretary may require information etc. about
biologicals exempt for special and experimental
uses................................................................................323
32JH Secretary may require information etc. about
biologicals exempt where substitutes are
unavailable etc...............................................................325
32JI Criminal offences for failing to comply with a
notice etc. ......................................................................326
32JJ Civil penalty for giving false or misleading
information or document in compliance with a
notice.............................................................................327
32JK Self-incrimination..........................................................328
Subdivision D—Inspecting, copying and retaining documents 328
32JL Secretary may inspect and copy documents ..................328
32JM Secretary may retain documents....................................329
Part 3-3—Manufacturing of therapeutic goods 330 33A Application of this Part to medical devices ...................330
33B Application of this Part to biologicals ...........................330
34 Exempt goods and exempt persons ...............................330
35 Criminal offences relating to manufacturing
therapeutic goods...........................................................330
35A Civil penalties relating to manufacturing
therapeutic goods...........................................................333
35B Criminal offences relating to breaching a condition
of a licence ....................................................................334
35C Civil penalty relating to breaching a condition of a
licence ...........................................................................335
36 Manufacturing principles...............................................335
37 Application for licence ..................................................336
38 Grant of licence .............................................................338
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38A Guidelines for multi-site licences ..................................341
38B Splitting multi-site licences ...........................................341
39 Term of licence..............................................................343
40 Conditions of licences ...................................................344
40A Variation of manufacturing site authorisations—
Secretary’s own initiative ..............................................347
40B Variation of licences—application by licence
holder ............................................................................347
41 Revocation and suspension of licences..........................350
41AAAA Withdrawal of revocation of licence upon request ........353
41AA Spent convictions scheme..............................................353
41AB Secretary may require information or documents..........353
41AC Criminal offence for contravening a requirement
in a notice under section 41AB......................................355
41AD False or misleading information—offence ....................355
41AE False or misleading documents—offence......................356
41AF False or misleading information or documents—
civil penalty...................................................................357
41AG Self-incrimination..........................................................358
41AAA Transfer of licences .......................................................358
41A Publication of list of manufacturers etc. ........................359
Chapter 4—Medical devices 360
Part 4-1—Introduction 360
Division 1—Overview of this Chapter 360
41B General ..........................................................................360
41BA Requirements for medical devices (Parts 4-2 and
4-3)................................................................................360
41BB Administrative processes (Parts 4-4 to 4-10).................360
41BC Enforcement (Part 4-11)................................................361
Division 2—Interpretation 362
41BD What is a medical device ...............................................362
41BE Kinds of medical devices...............................................363
41BEA Excluded purposes.........................................................364
41BF System or procedure packs ............................................364
41BG Manufacturers of medical devices .................................365
41BH Meaning of compliance with essential principles ..........366
41BI Meaning of non-application of conformity
assessment procedures...................................................366
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41BIA Meaning of non-application of overseas
requirements comparable to conformity
assessment procedures...................................................367
41BIB Overseas regulators .......................................................367
Division 3—Application provisions 369
41BJ Application of this Chapter to medical devices
covered by Part 3-2........................................................369
41BJA Application of this Chapter to a biological ....................369
41BK Application of the Criminal Code .................................371
Part 4-2—Essential principles and medical device standards 372 41C What this Part is about...................................................372
Division 1—Essential principles 373
41CA Essential principles........................................................373
Division 2—Medical device standards 374
41CB Medical device standards ..............................................374
41CC Content of medical device standards .............................374
41CD Inconsistencies between medical device standards........375
Part 4-3—Conformity assessment procedures 376 41D What this Part is about...................................................376
Division 1—Conformity assessment procedures 377
41DA Conformity assessment procedures ...............................377
41DB Medical device classifications .......................................378
Division 2—Conformity assessment standards 379
41DC Conformity assessment standards..................................379
41DD Content of conformity assessment standards.................379
41DE Inconsistencies between conformity assessment
standards........................................................................380
Part 4-4—Conformity assessment certificates 381 41E What this Part is about...................................................381
Division 1—Issuing conformity assessment certificates 382
41EA When conformity assessment certificates are
required .........................................................................382
41EB Applications ..................................................................382
41EC Considering applications ...............................................383
41ECA Conformity assessment (priority applicant)
determinations ...............................................................385
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41ED Time for making decisions on applications ...................387
41EE Procedure following making a decision whether to
issue certificate ..............................................................387
41EF Duration of certificate ...................................................388
41EG Lapsing of applications .................................................388
41EH Treating applications as having been refused ................389
41EI Criminal offences for making a false statement ............390
41EIA Civil penalty for making a false statement ....................391
Division 2—Conditions 392
41EJ Automatic conditions on conformity assessment
certificates .....................................................................392
41EK Conditions imposed when conformity assessment
certificates are issued.....................................................394
41EL Conditions imposed after issuing a conformity
assessment certificate ....................................................394
Division 3—Suspension of conformity assessment certificates 396
41EM Suspension of conformity assessment certificates .........396
41EN Notice of proposed suspension ......................................396
41EO Duration of suspension..................................................397
41EP Revocation of suspension ..............................................397
41EQ Powers of revocation of conformity assessment
certificates unaffected....................................................398
Division 4—Revocation of conformity assessment certificates 399
41ER Automatic revocation of conformity assessment
certificates .....................................................................399
41ES Immediate revocation of conformity assessment
certificates .....................................................................399
41ET Revocation of conformity assessment certificates
after notice of proposed revocation ...............................400
41EU Limiting revocation of conformity assessment
certificates to some medical devices of a particular
kind................................................................................402
41EV Publication of revocation etc. of conformity
assessment certificates...................................................402
41EW Date of effect of revocation etc. of conformity
assessment certificates...................................................403
Part 4-4A—Australian conformity assessment bodies 404 41EWA Conformity assessment body determinations ................404
41EWB Content of Australian conformity assessment body
certificates .....................................................................407
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41EWC Duration of Australian conformity assessment
body certificates ............................................................407
41EWD Record-keeping .............................................................408
Part 4-5—Including medical devices in the Register 410 41F What this Part is about...................................................410
Division 1—Including medical devices in the Register 411
41FA What this Division is about ...........................................411
Subdivision A—Applications 411
41FC Making an application ...................................................411
41FD Matters to be certified....................................................411
41FDA Basis of certification of conformity assessment
procedures .....................................................................413
41FDB Preliminary assessment of applications .........................413
41FE Criminal offences for making a false statement ............415
41FEA Civil penalty for making a false statement ....................417
Subdivision B—Including kinds of medical devices in the Register 417
41FF Obligation to include kinds of medical devices in
the Register....................................................................417
41FG Notification of unsuccessful applications ......................418
Subdivision C—Auditing of applications 418
41FH Selecting applications for auditing ................................418
41FI Auditing of applications ................................................419
41FIA Certificates issued by Australian conformity
assessment bodies..........................................................420
41FJ Procedure following audits............................................420
41FK Lapsing of applications .................................................421
Subdivision D—Miscellaneous 422
41FKA Medical devices (priority applicant)
determinations ...............................................................422
41FL Device number ..............................................................423
41FM Duration of inclusion in the Register.............................424
Division 2—Conditions 425
41FN Conditions applying automatically ................................425
41FO Conditions imposed when kinds of medical
devices are included in the Register ..............................428
41FP Conditions imposed after kinds of medical devices
are included in the Register ...........................................428
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Part 4-6—Suspension and cancellation from the Register 430
Division 1—Suspension from the Register 430
Subdivision A—General power of suspension 430
41G What this Part is about...................................................430
41GA Suspension of kinds of medical devices from the
Register .........................................................................430
41GB Notice of proposed suspension must be given in
certain cases ..................................................................431
41GC Duration of suspension..................................................431
41GD Revocation of suspension ..............................................432
41GE Treating applications for revocation as having
been refused ..................................................................433
Subdivision B—Suspension as a result of suspension of conformity
assessment document 434
41GF Suspension where conformity assessment
certificate suspended .....................................................434
41GFA Suspension where other certificates or documents
are suspended ................................................................434
41GG Duration of suspension..................................................435
41GH Revocation of suspension ..............................................435
Subdivision C—Effect of suspension 436
41GI Effect of suspension ......................................................436
41GJ Powers of cancellation from Register unaffected ..........436
Division 2—Cancellation of entries from the Register 437
41GK Automatic cancellation of entries of kinds of
medical devices from the Register.................................437
41GL Immediate cancellation of entries of kinds of
medical devices from the Register.................................437
41GLA Revocation of cancellation of entries upon request .......438
41GLB Revocation of cancellation of entries—payment of
annual charge ................................................................439
41GM Cancellation of entries of kinds of medical devices
from the Register after section 41JA notice...................440
41GN Cancellation of entries of kinds of medical devices
from the Register after notice of proposed
cancellation ...................................................................441
41GO Limiting cancellation of entries from Register to
some medical devices of a particular kind.....................442
41GP Publication of cancellation of entry from Register ........443
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41GQ Date of effect of cancellation of entries from
Register .........................................................................443
Part 4-6A—Exempting medical devices to deal with
emergencies 444 41GR What this Part is about...................................................444
41GS Minister may make exemptions.....................................444
41GT Conditions of exemptions..............................................445
41GU Variation or revocation of exemption............................446
41GV Informing persons of exemption etc. .............................447
41GW Notification and tabling.................................................447
41GY Disposal of unused medical devices ..............................448
Part 4-7—Other exemptions from including medical devices in
the Register 449 41H What this Part is about...................................................449
41HA Devices exempted from inclusion in the Register .........449
41HB Exemptions for special and experimental uses ..............450
41HC Exemptions for health practitioners...............................452
41HD Approvals if substitutes for medical devices are
unavailable or in short supply........................................454
Part 4-8—Obtaining information 459 41J What this Part is about...................................................459
Division 1—Information relating to compliance with
requirements and other matters 460
41JA Secretary may require information or documents..........460
41JB Complying with the Secretary’s requirements...............462
41JBA Civil penalty for giving false or misleading
information in purported compliance with a notice .......465
41JC Self-incrimination..........................................................465
Division 2—Information relating to medical devices covered by
exemptions 466
41JCA Secretary may require information etc. about
medical devices exempt under Part 4-6A ......................466
41JD Secretary may require information etc. about
devices exempted under section 41HA from
inclusion in the Register ................................................466
41JE Secretary may require information relating to
approvals under section 41HB.......................................468
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41JF Secretary may require information relating to
health practitioner authorisations...................................469
41JFA Secretary may require information relating to
approvals under section 41HD ......................................470
41JG Criminal offences for failing to give information
or documents sought under this Division ......................471
41JH False or misleading information ....................................471
41JI False or misleading documents......................................472
41JJ Self-incrimination..........................................................473
Part 4-9—Public notification, and recall, of medical devices 475 41K What this Part is about...................................................475
41KA Public notification, and recall, of medical devices ........475
41KB Publication of requirements...........................................478
41KC Criminal offences for failing to comply with
requirements relating to a kind of medical device .........479
41KCA Civil penalty for failing to comply with
requirements relating to a kind of medical device .........480
41KD Powers of suspension and cancellation unaffected ........480
41KE Saving of other laws ......................................................480
Part 4-10—Assessment fees 481 41L What this Part is about...................................................481
41LA Assessment fees.............................................................481
41LB When assessment fee due for payment ..........................482
41LC Payment of assessment fee by instalments ....................482
41LD Recovery of assessment fee...........................................482
41LE Reduction of conformity assessment fee where
decision not made within prescribed period ..................483
Part 4-11—Offences and civil penalty provisions relating to
medical devices 484 41M What this Part is about...................................................484
Division 1—Non-compliance with essential principles 485
41MA Criminal offences for importing, supplying or
exporting a medical device that does not comply
with essential principles ................................................485
41MAA Civil penalties for importing, supplying or
exporting a medical device that does not comply
with essential principles ................................................489
41MB Exceptions .....................................................................490
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41MC Criminal offences relating to breaching a condition
of a consent ...................................................................491
41MCA Civil penalty relating to breaching a condition of a
consent ..........................................................................492
41MD Treating medical devices as prohibited imports or
exports ...........................................................................492
Division 2—Failure to apply conformity assessment procedures 493
41ME Criminal offences for failing to apply conformity
assessment procedures—manufacturers ........................493
41MEA Civil penalties for failing to apply conformity
assessment procedures—manufacturers ........................496
41MF Criminal offences for failing to apply conformity
assessment procedures—sponsors.................................496
41MG Exceptions .....................................................................499
41MH Criminal offence for making false statements in
declarations ...................................................................499
41MHA Civil penalty for making false statements in
declarations ...................................................................500
Division 3—Medical devices not included in the Register and
related matters 501
41MI Criminal offences for importing, exporting,
supplying or manufacturing a medical device not
included in the Register .................................................501
41MIA Notice required to adduce evidence in support of
exception under subsection 41MI(7) .............................504
41MIB Civil penalty for importing, exporting, supplying
or manufacturing a medical device not included in
the Register....................................................................506
41MJ Treating medical devices as prohibited imports or
exports ...........................................................................506
41MK Wholesale supply of medical devices not included
in the Register................................................................507
41ML False advertising about medical devices........................508
41MLA Civil penalty for making misrepresentations about
medical devices .............................................................509
41MLB Civil penalty for false advertising about medical
devices...........................................................................509
41MM Claims about arranging supplies of medical
devices...........................................................................510
41MN Criminal offences relating to breaches of
conditions ......................................................................510
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41MNA Civil penalties for breaching conditions ........................513
Division 3A—Offences and civil penalties related to exemptions
under Part 4-6A
41MNB Criminal offences for breaching a condition of an
exemption......................................................................515
41MNC Civil penalty for breaching a condition of an
exemption......................................................................516
41MND Civil penalty for making misrepresentations about
medical devices .............................................................516
Division 4—Other offences and civil penalty provisions 518
41MO Criminal offences for misusing medical devices
exempted for special or experimental uses ....................518
41MP Criminal offence for failing to notify adverse
events etc. ......................................................................522
41MPA Civil penalty for failing to notify adverse events
etc. .................................................................................523
41MPB Relief from liability for contraventions for failing
to notify adverse events etc. ..........................................525
41MQ Notification of adverse events etc. where
application withdrawn or lapses ....................................526
41MR Civil penalties for failing to notify adverse effects
etc. where application withdrawn or lapses ...................527
Chapter 5—Advertising, counterfeit therapeutic
goods and product tampering 528
Part 5-1—Advertising and generic information 528
Division 1—Preliminary 528
42AA This Part not to apply to advertisements directed at
health professionals etc. ................................................528
42AB This Part not to apply to advertisements for goods
not for human use..........................................................529
42AC This Part not to apply to advertisements for
exported goods ..............................................................529
42B Definitions.....................................................................529
42BAA Therapeutic Goods Advertising Code ...........................531
Division 2—Therapeutic goods advertisements for which an
approval is required 532
42BA Application of Division .................................................532
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42C Offences relating to publication of advertisements .......532
Division 3—General provisions about advertising therapeutic
goods 535
42DA Simplified outline..........................................................535
42DB Definitions.....................................................................535
42DD Restricted representations..............................................535
42DE Applications for approval of use of restricted
representation ................................................................536
42DF Approval of use of restricted representation..................536
42DG Notice of approval or refusal .........................................537
42DH Variation of conditions of approval ...............................537
42DI Withdrawal of approval .................................................537
42DJ Prohibited and required representations ........................538
42DK Permitted use of restricted or prohibited
representations...............................................................539
Division 3A—Therapeutic goods advertisements for which an
approval is not required 540
42DKA Application of Division .................................................540
42DKB Certain representations not to be advertised ..................540
42DL Advertising offences—general ......................................540
42DLA Advertising offences—contravening
section 42DKB notice ...................................................544
42DLB Civil penalty relating to advertisements—general.........545
42DLC Civil penalty relating to advertisements—
contravening section 42DKB notice..............................547
42DM Offences—non-compliance with the Therapeutic
Goods Advertising Code ...............................................548
42DMA Civil penalty—non-compliance with the
Therapeutic Goods Advertising Code ...........................549
Division 4—Generic information about ingredients or
components of therapeutic goods 551
42DN Application of Division .................................................551
42DO Compliance with the Code ............................................551
42DP Offences—dissemination of generic information ..........551
42DQ Civil penalty for dissemination of generic
information....................................................................552
Division 5—Secretary may require information or documents 553
42DR Secretary may require information or documents..........553
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42DS Criminal offences for failing to comply with a
notice etc. ......................................................................554
42DT Civil penalty for giving false or misleading
information or document in compliance with a
notice.............................................................................555
42DU Self-incrimination..........................................................555
Division 6—Directions about advertisements or generic
information 556
42DV Directions about advertisements or generic
information....................................................................556
42DW Offences—contravening direction under
section 42DV.................................................................557
42DX Civil penalty for contravening direction under
section 42DV.................................................................558
Division 7—Public warning notices 560
42DY Secretary may issue a public warning notice.................560
Part 5-2—Counterfeit therapeutic goods 561 42E Offence of dealing with counterfeit therapeutic
goods .............................................................................561
42EA Civil penalty relating to dealing with counterfeit
therapeutic goods...........................................................562
42EB Relief from liability for certain contraventions
relating to dealing with counterfeit therapeutic
goods .............................................................................562
42F Customs treatment of counterfeit therapeutic
goods .............................................................................563
Part 5-3—Product tampering 565 42T Notifying of actual or potential tampering ....................565
42U Meaning of actual or potential tampering etc. ..............566
42V Recall of therapeutic goods because of actual or
potential tampering........................................................567
42VA Civil penalty relating to the recall of therapeutic
goods because of actual or potential tampering.............569
42VB Relief from liability for contraventions relating to
the recall of therapeutic goods because of actual or
potential tampering........................................................569
42W Supply etc. of therapeutic goods that are subject to
recall requirements ........................................................570
42X Saving of other laws ......................................................571
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Chapter 5A—Enforcement 572
Part 5A-1—Civil penalties 572
Division 1—Obtaining an order for a civil penalty 572
42Y Federal Court may order person to pay pecuniary
penalty for contravening civil penalty provision ...........572
42YA What is a civil penalty provision?..................................573
42YC Persons involved in contravening civil penalty
provision........................................................................573
42YCA Continuing contraventions of civil penalty
provisions ......................................................................574
42YD Recovery of a pecuniary penalty ...................................574
42YE Gathering information for application for
pecuniary penalty ..........................................................574
Division 2—Civil penalty proceedings and criminal proceedings 576
42YF Civil proceedings after criminal proceedings ................576
42YG Criminal proceedings during civil proceedings .............576
42YH Criminal proceedings after civil proceedings ................576
42YI Evidence given in proceedings for civil penalty not
admissible in criminal proceedings ...............................576
Part 5A-2—Infringement notices 578 42YJ Simplified outline of this Part........................................578
42YK When an infringement notice may be given ..................578
42YKA Matters to be included in an infringement notice ..........579
42YKB Extension of time to pay amount ...................................581
42YKC Withdrawal of an infringement notice ...........................582
42YKD Effect of payment of amount .........................................583
42YKE Effect of this Part...........................................................584
Part 5A-3—Enforceable undertakings 585 42YL Enforcement of undertakings ........................................585
Part 5A-4—Injunctions 586 42YM Simplified outline of this Part........................................586
42YN Grant of injunctions.......................................................586
42YO Interim injunctions ........................................................587
42YP Discharging or varying injunctions ...............................587
42YQ Certain limits on granting injunctions not to apply .......587
42YR Other powers of court unaffected ..................................588
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Chapter 6—Administration 589
Part 6-1—Payment of charges 589 43 By whom charges payable.............................................589
44 Time for payment of charges.........................................589
44A Exemptions from liability to pay charges ......................590
44B Recovery of unpaid charges ..........................................592
45 Therapeutic Goods Administration Account .................593
Part 6-2—Entry, searches and warrants 595 45A Definitions.....................................................................595
46 Searches to monitor compliance with Act or
regulations .....................................................................596
46A Searches of certain premises to monitor
compliance with Act......................................................596
46B Searches and seizures on public health grounds ............598
47 Searches and seizures related to offences and civil
penalty provisions .........................................................599
48 General powers of authorised persons in relation to
premises ........................................................................600
48A Details of warrant to be given to occupier etc. ..............601
48AA Completing execution of warrant under section 50
after temporary cessation...............................................602
48B Announcement before entry ..........................................603
48BA Use of electronic equipment at premises for
monitoring compliance with Act or regulations ............603
48C Use of electronic equipment at premises relating to
offences and civil penalty provisions ............................605
48D Compensation for damage to electronic equipment.......607
48E Copies of seized things to be provided ..........................607
48F Occupier entitled to be present during search................608
48FA Responsibility to provide facilities and assistance.........608
48G Receipts for things seized under warrant .......................609
48H Retention of seized things .............................................609
48J Magistrate may permit a thing to be retained ................610
49 Monitoring warrants ......................................................610
50 Offence and civil penalty provision related
warrants .........................................................................611
51 Offence and civil penalty provision related
warrants by telephone....................................................612
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51A Inspections for purposes of Mutual Recognition
Convention ....................................................................614
51B Offences relating to warrants.........................................614
52 Identity cards .................................................................615
Part 6-3—Scheduling of substances 616 52AA Overview.......................................................................616
52A Definitions.....................................................................616
52B Advisory Committee on Medicines Scheduling ............617
52C Advisory Committee on Chemicals Scheduling ............618
52CA Joint meetings................................................................619
52D Poisons Standard ...........................................................619
52E Secretary to take certain matters into account in
exercising powers ..........................................................620
52EAA Application for amendment of the Poisons
Standard ........................................................................621
52EB Compensation for acquisition of property .....................622
52EC Review of scheduling regime ........................................622
Chapter 7—Miscellaneous 624 53 Retention of material on withdrawal of application ......624
53A Alternative verdicts for various offences.......................624
54 Offences and forfeiture..................................................627
54AA Offences for contravening conditions or
requirements imposed under the regulations .................627
54AB Criminal offence for damaging etc. documents .............628
54AC Civil penalty for damaging etc. documents ...................628
54A Time for bringing prosecutions .....................................629
54B Personal liability of an executive officer of a body
corporate—general ........................................................629
54BA Personal liability of an executive officer of a body
corporate—offences covered.........................................630
54C Establishing whether an executive officer took
reasonable steps to prevent the commission of an
offence or the contravention of a civil penalty
provision........................................................................633
55 Conduct by directors, employees and agents.................633
56 Judicial notice................................................................635
56A Certificates to provide evidence of certain matters........635
57 Delegation .....................................................................638
58 Export certifications ......................................................640
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59 Fees ...............................................................................641
60 Review of decisions.......................................................641
60A New information on review—discretion to remit ..........646
61 Release of information ..................................................650
61A Immunity from civil actions ..........................................656
63 Regulations....................................................................657
Chapter 8—Repeal and transitional provisions 661 66 Transitional arrangements for goods required to be
registered or listed .........................................................661
67 Transitional provision for therapeutic goods for
export only ....................................................................663
68 Transitional arrangements for Part 3-3 ..........................663
69 Continuation of standards and requirements .................664
Endnotes 665
Endnote 1—About the endnotes 665
Endnote 2—Abbreviation key 667
Endnote 3—Legislation history 668
Endnote 4—Amendment history 679
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Preliminary Chapter 1
Section 1
An Act relating to therapeutic goods
Chapter 1—Preliminary
1 Short title
This Act may be cited as the Therapeutic Goods Act 1989.
2 Commencement
This Act commences on the day after the day on which a House of
the Parliament approves regulations made under this Act in the
same form as approved by the other House, provided that:
(a) not more than 90 days have elapsed; and
(b) the places of Senators have not become vacant under section 13
of the Constitution; and
(c) a dissolution or expiration of the House of Representatives
has not occurred;
between the approval of one House and the approval of the other
House.
3 Interpretation
(1) In this Act, unless the contrary intention appears:
accessory, in relation to a medical device covered by
paragraph 41BD(1)(a), (aa) or (ab), means a thing that the
manufacturer of the thing specifically intended to be used together
with the device to enable the device to be used as the manufacturer
of the device intended.
actual or potential tampering has the meaning given by
section 42U.
advertise, in relation to therapeutic goods, includes make any
statement, pictorial representation or design that is intended,
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whether directly or indirectly, to promote the use or supply of the
goods, including where the statement, pictorial representation or
design:
(a) is on the label of the goods; or
(b) is on the package in which the goods are contained; or
(c) is on any material included with the package in which the
goods are contained.
anthroposophic pharmacopoeia means:
(a) a publication specified under paragraph 3AB(3)(a), as that
publication is in force from time to time; or
(b) a part of a publication specified under paragraph 3AB(3)(b),
as that part is in force from time to time.
anthroposophic preparation has the meaning given by
subsection 3AB(1).
anthroposophic standard has the meaning given by
subsection 3AB(2).
application audit assessment fee means a fee payable under
subsection 41LA(3).
assessment fee means:
(a) a conformity assessment fee; or
(b) an application audit assessment fee;
payable under Part 4-10.
Australian conformity assessment body means an Australian
corporation that is the subject of a conformity assessment body
determination made under the regulations.
Australian conformity assessment body certificate means a
certificate that is issued by an Australian conformity assessment
body and that is of a kind mentioned in section 41FIA.
Australian corporation means a corporation that is registered
under Part 2A.2 of the Corporations Act 2001.
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authorised person means:
(a) in relation to any provision of this Act or the regulations, a
person authorised by the Secretary to exercise powers under
that provision; or
(b) in relation to a provision of Part 6-2, a member of the
Australian Federal Police, or a Customs officer exercising
powers in a Customs place (within the meaning of
section 183UA of the Customs Act 1901).
batch means a quantity of a product that is:
(a) uniform in composition, method of manufacture and
probability of chemical or microbial contamination; and
(b) made in one cycle of manufacture and, in the case of a
product that is sterilised or freeze dried, sterilised or freeze
dried in one cycle.
bioburden, in relation to therapeutic goods, means the quantity and
characteristics of microorganisms present in the goods or to which
the goods may be exposed in a manufacturing environment.
biological has the meaning given by section 32A.
biological number of a biological means:
(a) the number assigned to the biological under
subsection 32DB(2), 32DF(2) or 32DN(5); or
(b) if, in accordance with regulations made for the purposes of
paragraph 9A(4)(ca), a different number is assigned to the
biological—that different number.
British Pharmacopoeia means the edition of the publication of that
name, including any additions or amendments, that was in effect
for the purposes of this Act immediately before the commencement
of Schedule 4 to the Therapeutic Goods Amendment (Medical
Devices and Other Measures) Act 2009 and, if additions or
amendments of that publication are made after that
commencement, or new editions of that publication are published
after that commencement, includes those additions or amendments,
or those new editions, from the effective date published by the
British Pharmacopoeia Commission or any replacement body.
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certification-related activities, when used in relation to an
Australian conformity assessment body, means activities that
consist of, or relate to, the issue of certificates as mentioned in
section 41FIA.
civil penalty provision has the meaning given by section 42YA.
Class 1 biological means a biological included in a class of
biologicals that is:
(a) a class prescribed by the regulations for the purposes of
section 32AA; and
(b) a class referred to in those regulations as Class 1 biologicals.
Commonwealth authority includes:
(a) a body corporate, or an unincorporated body, established for
a public purpose by or under an Act; and
(b) a tribunal or authority established by or in accordance with
an Act.
Commonwealth officer includes:
(a) a Minister; and
(b) a person holding:
(i) an office established by or under an Act; or
(ii) an appointment made under an Act; or
(iii) an appointment made by the Governor-General or a
Minister but not under an Act; and
(c) a person who is a member or officer of a Commonwealth
authority; and
(d) a person who is in the service or employment of the
Commonwealth, or of a Commonwealth authority, or is
employed or engaged under an Act or regulations made
under an Act.
composite pack has the meaning given by subsection 7B(2).
Comptroller-General of Customs means the person who is the
Comptroller-General of Customs in accordance with
subsection 11(3) or 14(2) of the Australian Border Force Act 2015.
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conformity assessment body determination has the meaning given
by section 41EWA.
conformity assessment certificate means a certificate issued under
section 41EE.
conformity assessment document means:
(a) a conformity assessment certificate; or
(b) an Australian conformity assessment body certificate; or
(c) an overseas regulator conformity assessment document.
conformity assessment fee means a fee payable under
subsection 41LA(1).
conformity assessment procedures has the meaning given by
section 41DA.
conformity assessment standard means a conformity assessment
standard specified in an order under section 41DC.
container, in relation to therapeutic goods, means the vessel,
bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack,
wrapper, cover or other similar article that immediately covers the
goods, but does not include an article intended for ingestion.
corporation means a body corporate that is:
(a) a foreign corporation; or
(b) a trading corporation formed within the limits of the
Commonwealth or a financial corporation so formed.
corresponding State law means a State law declared by the
regulations to correspond to this Act or the regulations, including
such a law as amended from time to time.
counterfeit has the meaning given by section 42E.
current Poisons Standard has the meaning given by section 52A.
Customs officer means an officer of Customs within the meaning
of the Customs Act 1901.
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data processing device means any article or material (for example,
a disc) from which information is capable of being reproduced with
or without the aid of any other article or device.
default standard means any of the following:
(a) a standard referred to in paragraph (b) of the definition of
standard in this subsection;
(b) a standard referred to in paragraph (c) of that definition;
(c) a standard referred to in paragraph (d) of that definition.
device number, in relation to a medical device, means any
combination of numbers, symbols and letters assigned to the device
under section 41FL.
directions for use, in relation to therapeutic goods, includes
information on:
(a) appropriate doses of the goods; and
(b) the method of administration or use of the goods; and
(c) the frequency and duration of treatment for each indication of
the goods; and
(d) the use of the goods by persons of particular ages or by
persons having particular medical conditions.
EC/EFTA attestation of conformity means an attestation of
conformity (within the meaning of the EC Mutual Recognition
Agreement or the EFTA Mutual Recognition Agreement) issued by
an EC/EFTA conformity assessment body that is approved by the
Secretary in writing.
EC/EFTA conformity assessment body means a Conformity
Assessment Body designated in one of the following Sectoral
Annexes to the EC Mutual Recognition Agreement or the EFTA
Mutual Recognition Agreement:
(a) Sectoral Annex (Medical Devices);
(b) Sectoral Annex (Medicinal Products GMP Inspection and
Batch Certification).
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EC Mutual Recognition Agreement means the Agreement on
Mutual Recognition in relation to Conformity Assessment,
Certificates and Markings between Australia and the European
Community, as in force from time to time.
EFTA Mutual Recognition Agreement means the Agreement on
Mutual Recognition in relation to Conformity Assessment,
Certificates and Markings between Australia and the European
Free Trade Association, as in force from time to time.
essential principles has the meaning given by section 41CA.
ethics committee means a committee:
(a) constituted and operating as an ethics committee in
accordance with guidelines issued by the CEO of the
National Health and Medical Research Council as in force
from time to time; and
(b) which has notified its existence to the Australian Health
Ethics Committee established under the National Health and
Medical Research Council Act 1992.
European Pharmacopoeia means the English edition of the
publication of that name, including any additions or amendments,
that was in effect immediately before the commencement of this
definition and, if additions or amendments of that publication are
made after that commencement, or new editions of that publication
are published after that commencement, includes those additions or
amendments, or those new editions, from the effective date
published by the Council of Europe or any replacement body.
exempt device means a medical device that is of a kind that is
exempted from Division 3 of Part 4-11 by the regulations.
exempt goods, in relation to a provision of Part 3-2, means
therapeutic goods that are exempted from the operation of that Part
(except section 31A and sections 31C to 31F) by the regulations.
exempt goods, in relation to a provision of Part 3-3, means
therapeutic goods that are exempted from the operation of that Part
by the regulations.
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exempt person, in relation to therapeutic goods, means a person
exempted from the operation of Part 3-3 in relation to those goods
by the regulations.
export only medicine means a medicine that:
(a) is manufactured in Australia for export only, or imported into
Australia for export only; and
(b) is listable goods only because it is so manufactured or
imported (and not for any other reason).
Federal Circuit Court means the Federal Circuit Court of
Australia.
Federal Court means the Federal Court of Australia.
financial corporation means a financial corporation within the
meaning of paragraph 51(xx) of the Constitution.
first Poisons Standard has the meaning given by section 52A.
foreign corporation means a foreign corporation within the
meaning of paragraph 51(xx) of the Constitution.
gazetted kits group means a group of kits identified in an order in
force under subsection 16(3A).
gazetted therapeutic devices group has the meaning given by
subsection 16(3).
gazetted therapeutic goods group has the meaning given by
subsection 16(2).
Gene Technology Regulator has the same meaning as in the Gene
Technology Act 2000.
genetically modified organism has the same meaning as in the
Gene Technology Act 2000.
GM product has the same meaning as in the Gene Technology Act
2000.
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grouped therapeutic goods means therapeutic goods included in:
(a) a gazetted therapeutic goods group; or
(b) a gazetted therapeutic devices group; or
(c) a gazetted kits group.
health practitioner means a person who, under a law of a State or
internal Territory, is registered or licensed to practice in any of the
following health professions:
(a) Aboriginal and Torres Strait Islander health practice;
(b) dental (not including the professions of dental therapist,
dental hygienist, dental prosthetist or oral health therapist);
(c) medical;
(d) medical radiation practice;
(e) nursing;
(f) midwifery;
(g) occupational therapy;
(h) optometry;
(i) pharmacy;
(j) physiotherapy;
(k) podiatry;
(l) psychology.
homoeopathic pharmacopoeia means:
(a) a publication specified under paragraph 3AA(3)(a), as that
publication is in force from time to time; or
(b) a part of a publication specified under paragraph 3AA(3)(b),
as that part is in force from time to time.
homoeopathic preparation has the meaning given by
subsection 3AA(1).
homoeopathic standard has the meaning given by
subsection 3AA(2).
included in the Register:
(a) in relation to a biological—means included in the Register
under Part 3-2A; and
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(b) in relation to a medical device to which Chapter 4 applies—
means included in the Register under Chapter 4.
Note: Section 41BJ deals with the application of Chapter 4 to medical
devices.
indications, in relation to therapeutic goods, means the specific
therapeutic uses of the goods.
international instrument means:
(a) any treaty, convention, protocol, agreement or other
instrument that is binding in international law; and
(b) a part of such a treaty, convention, protocol, agreement or
other instrument.
kind, in relation to a medical device, has the meaning given by
section 41BE.
label, in relation to therapeutic goods, means a display of printed
information:
(a) on or attached to the goods; or
(b) on or attached to a container or primary pack in which the
goods are supplied; or
(c) supplied with such a container or pack.
licence means a licence under Part 3-3.
listable devices means therapeutic devices that are required to be
included in the part of the Register for listed goods.
listable goods means therapeutic goods that are required:
(a) under the regulations; or
(b) by a notice published in the Gazette or on the Department’s
website under subsection 9A(5);
to be included in the part of the Register relating to listed goods.
listed goods means therapeutic goods that are included in the Part
of the Register for goods known as listed goods.
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listing number, in relation to listed goods, means any combination
of numbers, symbols and letters assigned to the goods under
section 27.
major interest holder of a body corporate means a person who:
(a) is in a position to cast, or control the casting of, more than
one-fifth of the maximum number of votes that might be cast
at a general meeting of the body corporate; or
(b) holds more than one-fifth of the issued share capital of the
body corporate (excluding any part of that issued share
capital that carries no right to participate beyond a specified
amount in a distribution of either profits or capital).
manufacture, in relation to therapeutic goods that are not medical
devices, means:
(a) to produce the goods; or
(b) to engage in any part of the process of producing the goods
or of bringing the goods to their final state, including
engaging in the processing, assembling, packaging, labelling,
storage, sterilising, testing or releasing for supply of the
goods or of any component or ingredient of the goods as part
of that process.
manufacturer, of a medical device, has the meaning given by
section 41BG.
manufacturing principles means the principles for the time being
having effect under section 36.
manufacturing site means premises:
(a) that are for use in the manufacture of a particular kind of
therapeutic goods; and
(b) at which the same persons have control of the management of
the production of the goods and the procedures for quality
control.
manufacturing site authorisation means an authorisation referred
to in subsection 38(2B) or 40B(4).
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medical device has the meaning given by section 41BD.
medical device classification means a classification specified in
the regulations made for the purposes of section 41DB.
medical device standard, in relation to a kind of medical device,
means a medical device standard, specified in an order under
section 41CB, that is applicable to that kind of medical device.
medicine means:
(a) therapeutic goods (other than biologicals) that are represented
to achieve, or are likely to achieve, their principal intended
action by pharmacological, chemical, immunological or
metabolic means in or on the body of a human; and
(b) any other therapeutic goods declared by the Secretary, for the
purpose of the definition of therapeutic device, not to be
therapeutic devices.
member of EFTA means a country declared by the Minister under
section 3A to be a member of the European Free Trade
Association.
member of the European Community means a country declared
by the Minister under section 3A to be a member of the European
Community.
mother substance means any of the following:
(a) an animal;
(b) a plant;
(c) an alga;
(d) a fungus;
(e) a micro-organism;
(f) a mineral;
(g) a mineral compound;
(h) a chemical;
(i) a product obtained from any of the things mentioned in
paragraphs (a) to (h).
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Mutual Recognition Convention means the Convention for the
Mutual Recognition of Inspections in respect of the Manufacture of
Pharmaceutical Products done at Geneva on 8 October 1970.
non-EC/EFTA attestation of conformity, for a non-EC/EFTA
MRA, means an attestation of conformity issued, after the
non-EC/EFTA MRA has come into force, by a conformity
assessment body that is designated in the non-EC/EFTA MRA and
approved by the Secretary in writing for the non-EC/EFTA MRA.
non-EC/EFTA MRA means an international instrument that
Australia is bound by, or is a party to, if:
(a) a purpose of the instrument is the recognition of attestations
of conformity; and
(b) the instrument satisfies the requirements (if any) set out in
regulations made for the purposes of this paragraph;
but does not include:
(c) the EC Mutual Recognition Agreement; or
(d) the EFTA Mutual Recognition Agreement.
oath includes affirmation.
overseas regulator has the meaning given by section 41BIB.
overseas regulator conformity assessment document means a
certificate or other document that is issued by an overseas regulator
after that regulator is satisfied that requirements, comparable to the
conformity assessment procedures, have been applied to a medical
device by the manufacturer of the device.
passed preliminary assessment:
(a) when used in relation to a section 23 application for
registration—has the meaning given by subsection 23B(3);
and
(b) when used in relation to a section 23 application for listing
under section 26AE—has the meaning given by
subsection 23B(3); and
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(c) when used in relation to a section 32DD application—has the
meaning given by subsection 32DDA(3); and
(d) when used in relation to a section 41FC application—has the
meaning given by subsection 41FDB(3).
poison means an ingredient, compound, material or preparation
which, or the use of which, may cause death, illness or injury and
includes any ingredient, compound, material or preparation
referred to in a schedule to the current Poisons Standard.
premises includes:
(a) a structure, building, aircraft, vehicle or vessel; and
(b) a place (whether enclosed or built upon or not); and
(c) a part of a thing referred to in paragraph (a) or (b).
presentation, in relation to therapeutic goods, means the way in
which the goods are presented for supply, and includes matters
relating to the name of the goods, the labelling and packaging of
the goods and any advertising or other informational material
associated with the goods.
primary pack, in relation to therapeutic goods, means the complete
pack in which the goods, or the goods and their container, are to be
supplied to consumers.
product information, in relation to therapeutic goods, means
information relating to the safe and effective use of the goods,
including information regarding the usefulness and limitations of
the goods.
protected information, in relation to therapeutic goods, has the
meaning given by section 25A.
quality, in relation to therapeutic goods, includes the composition,
strength, potency, stability, sterility, purity, bioburden, design,
construction and performance characteristics of the goods.
refurbishment has the meaning given by the regulations.
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Register means the Australian Register of Therapeutic Goods
maintained under section 9A.
registered goods means:
(a) therapeutic goods included in the part of the Register for
goods known as registered goods; or
(b) therapeutic goods included in the part of the Register for
goods known as provisionally registered goods.
Note: Subsection (8) provides that a reference in this Act to therapeutic
goods that are registered, or to the registration of therapeutic goods,
includes a reference to a medicine that is provisionally registered
under section 29.
registration number, in relation to registered goods, means any
combination of numbers, symbols and letters assigned to the goods
under section 27.
related body corporate has the same meaning as in the
Corporations Act 2001.
reportable medicine has the meaning given by section 30EH.
restricted medicine means:
(a) a medicine specified in an instrument under subsection (2A);
or
(b) a medicine included in a class of medicine specified in an
instrument under subsection (2B).
scheduling has the meaning given by section 52A.
Secretary means the Secretary of the Department.
shortage of a medicine in Australia has the meaning given by
section 30EI.
sponsor, in relation to therapeutic goods, means:
(a) a person who exports, or arranges the exportation of, the
goods from Australia; or
(b) a person who imports, or arranges the importation of, the
goods into Australia; or
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(c) a person who, in Australia, manufactures the goods, or
arranges for another person to manufacture the goods, for
supply (whether in Australia or elsewhere);
but does not include a person who:
(d) exports, imports or manufactures the goods; or
(e) arranges the exportation, importation or manufacture of the
goods;
on behalf of another person who, at the time of the exportation,
importation, manufacture or arrangements, is a resident of, or is
carrying on business in, Australia.
standard, in relation to therapeutic goods, means any of the
following:
(a) a standard that is constituted by the matters specified in an
order under section 10 that is applicable to the goods;
(b) if the goods are the subject of one or more monographs
(other than a monograph exempt under subsection 3C(1)) in
the British Pharmacopoeia—a standard that is constituted by
the statements (other than statements exempt under
subsection 3C(2)) in those monographs, as interpreted in
accordance with the General Notices section of the British
Pharmacopoeia;
(c) if the goods are the subject of one or more monographs
(other than a monograph exempt under subsection 3C(1)) in
the European Pharmacopoeia—a standard that is constituted
by the statements (other than statements exempt under
subsection 3C(2)) in those monographs, as interpreted in
accordance with the General Notices section of the European
Pharmacopoeia;
(d) if the goods are the subject of one or more monographs
(other than a monograph exempt under subsection 3C(1)) in
the United States Pharmacopeia-National Formulary—a
standard that is constituted by the statements (other than
statements exempt under subsection 3C(2)) in those
monographs, as interpreted in accordance with the General
Notices section of the United States Pharmacopeia-National
Formulary;
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(e) a homoeopathic standard;
(f) an anthroposophic standard.
Note: See also section 13.
State includes the Australian Capital Territory and the Northern
Territory.
State law means a law of a State, of the Australian Capital
Territory or of the Northern Territory.
supply includes:
(a) supply by way of sale, exchange, gift, lease, loan, hire or
hire-purchase; and
(b) supply, whether free of charge or otherwise, by way of
sample or advertisement; and
(c) supply, whether free of charge or otherwise, in the course of
testing the safety or efficacy of therapeutic goods in persons;
and
(d) supply by way of administration to, or application in the
treatment of, a person.
system or procedure pack has the meaning given by section 41BF.
tamper: therapeutic goods are tampered with if:
(a) they are interfered with in a way that affects, or could affect,
the quality, safety or efficacy of the goods; and
(b) the interference has the potential to cause, or is done for the
purpose of causing, injury or harm to any person.
therapeutic device means therapeutic goods (other than
biologicals) consisting of an instrument, apparatus, appliance,
material or other article (whether for use alone or in combination),
together with any accessories or software required for its proper
functioning, which does not achieve its principal intended action
by pharmacological, chemical, immunological or metabolic means
though it may be assisted in its function by such means, but the
expression does not include therapeutic goods declared by the
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Secretary, by order published in the Gazette or on the
Department’s website, not to be therapeutic devices.
therapeutic goods means goods:
(a) that are represented in any way to be, or that are, whether
because of the way in which the goods are presented or for
any other reason, likely to be taken to be:
(i) for therapeutic use; or
(ii) for use as an ingredient or component in the
manufacture of therapeutic goods; or
(iii) for use as a container or part of a container for goods of
the kind referred to in subparagraph (i) or (ii); or
(b) included in a class of goods the sole or principal use of which
is, or ordinarily is, a therapeutic use or a use of a kind
referred to in subparagraph (a)(ii) or (iii);
and includes biologicals, medical devices and goods declared to be
therapeutic goods under an order in force under section 7, but does
not include:
(c) goods declared not to be therapeutic goods under an order in
force under section 7; or
(d) goods in respect of which such an order is in force, being an
order that declares the goods not to be therapeutic goods
when used, advertised, or presented for supply in the way
specified in the order where the goods are used, advertised,
or presented for supply in that way; or
(e) goods (other than goods declared to be therapeutic goods
under an order in force under section 7) for which there is a
standard (within the meaning of subsection 4(1) of the Food
Standards Australia New Zealand Act 1991); or
(f) goods (other than goods declared to be therapeutic goods
under an order in force under section 7) which, in Australia
or New Zealand, have a tradition of use as foods for humans
in the form in which they are presented; or
(g) goods covered by a determination under subsection 7AA(1)
(excluded goods); or
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(h) goods covered by a determination under subsection 7AA(2)
(excluded goods), if the goods are used, advertised, or
presented for supply in the way specified in the
determination.
Therapeutic Goods Advertising Code means the code in force
under section 42BAA.
therapeutic use means use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease,
ailment, defect or injury in persons; or
(b) influencing, inhibiting or modifying a physiological process
in persons; or
(c) testing the susceptibility of persons to a disease or ailment; or
(d) influencing, controlling or preventing conception in persons;
or
(e) testing for pregnancy in persons; or
(f) the replacement or modification of parts of the anatomy in
persons.
trading corporation means a trading corporation within the
meaning of paragraph 51(xx) of the Constitution.
United States Pharmacopeia-National Formulary means the
English edition of the publication of that name, including any
additions or amendments, that was in effect immediately before the
commencement of this definition and, if additions or amendments
of that publication are made after that commencement, or new
editions of that publication are published after that commencement,
includes those additions or amendments, or those new editions,
from the effective date published by the United States
Pharmacopeial Convention or any replacement body.
working day, for a person, means any day except:
(a) Saturday or Sunday; or
(b) a day that is a public holiday in the State or Territory in
which the person is located.
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(2) For the purposes of this Act, therapeutic goods are taken to be for
use in humans if they are not solely for use in animals.
(2A) The Minister may, by legislative instrument, specify medicines for
the purposes of paragraph (a) of the definition of restricted
medicine in subsection (1).
(2B) The Minister may, by legislative instrument, specify classes of
medicine for the purposes of paragraph (b) of the definition of
restricted medicine in subsection (1).
(3) The Secretary must, at least once in each year, cause to be
published in the Gazette or on the Department’s website a list of
the names of all persons, other than members of the Australian
Federal Police, who are, at the time of publication, authorised
persons.
(4) The provisions of this Act are in addition to, and not in substitution
for, the provisions of any other Act that relate to therapeutic goods.
(5) For the purposes of this Act, the presentation of therapeutic goods
is unacceptable if it is capable of being misleading or confusing as
to the content or proper use or identification of the goods and,
without limiting the previous words in this subsection, the
presentation of therapeutic goods is unacceptable:
(a) if it states or suggests that the goods have ingredients,
components or characteristics that they do not have; or
(b) if a name applied to the goods is the same as the name
applied to other therapeutic goods that are supplied in
Australia where those other goods contain additional or
different therapeutically active ingredients; or
(c) if the label of the goods does not declare the presence of a
therapeutically active ingredient; or
(ca) if the therapeutic goods are medicine included in a class of
medicine prescribed by the regulations for the purposes of
this paragraph—if the medicine’s label does not contain the
advisory statements specified under subsection (5A) in
relation to the medicine; or
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(d) if a form of presentation of the goods may lead to unsafe use
of the goods or suggests a purpose that is not in accordance
with conditions applicable to the supply of the goods in
Australia; or
(e) in prescribed cases.
(5A) The Minister may, by legislative instrument, specify advisory
statements in relation to medicine for the purposes of
paragraph (5)(ca).
(5B) For the purposes of subsection (5A), the Minister may specify
different advisory statements for different medicines or different
classes of medicine.
(6) A reference in this Act to an annual registration charge, an annual
listing charge, an annual charge for inclusion in the Register, an
annual licensing charge or an annual conformity assessment body
determination charge is a reference to such a charge imposed under
the Therapeutic Goods (Charges) Act 1989.
(7) A reference to an offence against this Act includes a reference to:
(a) an offence against the regulations; and
(b) an offence against section 6 of the Crimes Act 1914, or
section 11.1, 11.4 or 11.5 of the Criminal Code, in relation to
an offence against this Act or the regulations; and
(c) an offence against section 136.1, 137.1 or 137.2 of the
Criminal Code in relation to this Act or the regulations.
(7A) For the purposes of this Act, a corresponding State law imposes a
duty on a Commonwealth officer or Commonwealth authority if:
(a) the corresponding State law confers a function or power on
the officer or authority; and
(b) the circumstances in which the function or power is
conferred give rise to an obligation on the officer or authority
to perform the function or to exercise the power.
(8) To avoid doubt:
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(a) a reference in this Act to therapeutic goods that are registered
includes a reference to a medicine that is provisionally
registered; and
(b) a reference in this Act to the registration of therapeutic goods
includes a reference to the provisional registration of a
medicine.
Note: Subsection 29(2) deals with the provisional registration of a medicine.
3AA Homoeopathic preparations and homoeopathic standards
Homoeopathic preparation
(1) For the purposes of this Act, a homoeopathic preparation is a
preparation:
(a) manufactured from a mother substance; and
(b) manufactured in accordance with a manufacturing procedure
described in a homoeopathic pharmacopoeia.
Homoeopathic standard
(2) For the purposes of this Act, if:
(a) there are therapeutic goods that are a homoeopathic
preparation; and
(b) the goods are the subject of one or more monographs (other
than a monograph exempt under subsection (4)) in the
homoeopathic pharmacopoeia describing the manufacturing
procedure that the preparation was manufactured in
accordance with;
then there is a homoeopathic standard, in relation to the goods,
that is constituted by the statements (other than statements exempt
under subsection (5)) in those monographs, as interpreted in
accordance with any interpretation sections of that homoeopathic
pharmacopoeia.
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Specifying publications
(3) The Minister may, by legislative instrument, specify either or both
of the following for the purposes of the definition of homoeopathic
pharmacopoeia in subsection 3(1):
(a) publications;
(b) parts of publications.
Exempting entire monographs
(4) The Minister may, by legislative instrument, determine that
specified monographs in a specified homoeopathic pharmacopoeia
are exempt for the purposes of paragraph (2)(b).
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
Exempting parts of monographs
(5) The Minister may, by legislative instrument, determine that
specified statements in specified monographs in a specified
homoeopathic pharmacopoeia are exempt for the purposes of
subsection (2).
3AB Anthroposophic preparations and anthroposophic standards
Anthroposophic preparation
(1) For the purposes of this Act, an anthroposophic preparation is a
preparation:
(a) manufactured from a mother substance; and
(b) manufactured in accordance with a manufacturing procedure
described in an anthroposophic pharmacopoeia.
Anthroposophic standard
(2) For the purposes of this Act, if:
(a) there are therapeutic goods that are an anthroposophic
preparation; and
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(b) the goods are the subject of one or more monographs (other
than a monograph exempt under subsection (4)) in the
anthroposophic pharmacopoeia describing the manufacturing
procedure that the preparation was manufactured in
accordance with;
then there is an anthroposophic standard, in relation to the goods,
that is constituted by the statements (other than statements exempt
under subsection (5)) in those monographs, as interpreted in
accordance with any interpretation sections of that anthroposophic
pharmacopoeia.
Specifying publications
(3) The Minister may, by legislative instrument, specify either or both
of the following for the purposes of the definition of
anthroposophic pharmacopoeia in subsection 3(1):
(a) publications;
(b) parts of publications.
Exempting entire monographs
(4) The Minister may, by legislative instrument, determine that
specified monographs in a specified anthroposophic
pharmacopoeia are exempt for the purposes of paragraph (2)(b).
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
Exempting parts of monographs
(5) The Minister may, by legislative instrument, determine that
specified statements in specified monographs in a specified
anthroposophic pharmacopoeia are exempt for the purposes of
subsection (2).
3A Declaration—member of European Community
(1) The Minister may declare, in writing, that a country specified in
the declaration is a member of:
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(a) the European Community; or
(b) the European Free Trade Association.
(2) A declaration under subsection (1) must be published in the
Gazette or on the Department’s website.
3B Declaration—country covered by non-EC/EFTA MRA
(1) The Minister may declare, in writing, that a country specified in
the declaration is covered by the non-EC/EFTA MRA specified in
the declaration.
(2) A declaration under subsection (1) must be published in the
Gazette or on the Department’s website.
3C Exempting monographs in pharmacopoeias
Exempting entire monographs
(1) The Minister may, by legislative instrument, determine that
specified monographs in the British Pharmacopoeia, the European
Pharmacopoeia or the United States Pharmacopeia-National
Formulary are exempt for the purposes of paragraph (b), (c) or (d)
of the definition of standard in subsection 3(1).
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
Exempting parts of monographs
(2) The Minister may, by legislative instrument, determine that
specified statements in specified monographs in the British
Pharmacopoeia, the European Pharmacopoeia or the United States
Pharmacopeia-National Formulary are exempt for the purposes of
paragraph (b), (c) or (d) of the definition of standard in
subsection 3(1).
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4 Objects of Act
(1) The objects of this Act are to do the following, so far as the
Constitution permits:
(a) provide for the establishment and maintenance of a national
system of controls relating to the quality, safety, efficacy and
timely availability of therapeutic goods that are:
(i) used in Australia, whether produced in Australia or
elsewhere; or
(ii) exported from Australia;
(b) to provide a framework for the States and Territories to adopt
a uniform approach to control the availability and
accessibility, and ensure the safe handling, of poisons in
Australia.
(1A) The reference in paragraph (1)(a) to the efficacy of therapeutic
goods is a reference, if the goods are medical devices, to the
performance of the devices as the manufacturer intended.
(2) This Act is therefore not intended to apply to the exclusion of a law
of a State, of the Australian Capital Territory or of the Northern
Territory to the extent that the law is capable of operating
concurrently with this Act.
5 Act to bind Crown
This Act binds the Crown in right of the Commonwealth, of each
of the States, of the Australian Capital Territory and of the
Northern Territory, but nothing in this Act renders the Crown
liable to be prosecuted for an offence or to be subject to civil
proceedings for a contravention of a civil penalty provision.
5A Application of the Criminal Code—extended geographical
jurisdiction
Section 15.2 of the Criminal Code (extended geographical
jurisdiction—category B) applies to offences against
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subsections 21A(1), (4) and (4A) and sections 22A, 32DO, 41FE,
42E and 42T.
6 Operation of Act
(1) This Act applies to:
(a) things done by corporations; and
(b) things done by natural persons or corporations in so far as
those things are done:
(i) in the course of, or in preparation for, trade or
commerce between Australia and a place outside
Australia, among the States, between a State and a
Territory or between 2 Territories; or
(ii) under a law of the Commonwealth relating to the
provision of pharmaceutical or repatriation benefits; or
(iii) in relation to the Commonwealth or in relation to an
authority of the Commonwealth.
(2) Without limiting the effect of this Act apart from this subsection,
this Act also has the effect it would have if the reference in
paragraph (1)(a) to things done by corporations were confined to
things done by trading corporations for the purposes of their
trading activities.
6AAA Commonwealth consent to conferral of functions etc. on its
officers and authorities by corresponding State laws
(1) A corresponding State law may confer functions or powers, or
impose duties, on:
(a) a Commonwealth officer; or
(b) a Commonwealth authority.
(2) Subsection (1) does not authorise the conferral of a function or
power, or the imposition of a duty, by a corresponding State law to
the extent to which:
(a) the conferral or imposition, or the authorisation, would
contravene any constitutional doctrines restricting the duties
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that may be imposed on Commonwealth officers or
Commonwealth authorities; or
(b) the authorisation would otherwise exceed the legislative
power of the Commonwealth.
(3) Subsection (1) does not extend to a function, power or duty of a
kind specified in regulations made for the purposes of this
subsection.
(4) This Act is not intended to exclude or limit the operation of a
corresponding State law that confers any functions or powers, or
imposes any duties, on a Commonwealth officer or
Commonwealth authority to the extent to which that law:
(a) is consistent with subsections (1) to (3); and
(b) is capable of operating concurrently with this Act.
6AAB When duty imposed
Application
(1) This section applies if a corresponding State law purports to
impose a duty on a Commonwealth officer or Commonwealth
authority.
State legislative power sufficient to support duty
(2) The duty is taken not to be imposed by this Act (or any other law
of the Commonwealth) to the extent to which:
(a) imposing the duty is within the legislative powers of the State
concerned; and
(b) imposing the duty by the corresponding State law is
consistent with the constitutional doctrines restricting the
duties that may be imposed on a Commonwealth officer or
Commonwealth authority.
Note: If this subsection applies, the duty will be taken to be imposed by
force of the corresponding State law (the Commonwealth having
consented under section 6AAA to the imposition of the duty by the
corresponding State law).
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Commonwealth legislative power sufficient to support duty but
State legislative powers are not
(3) If, to ensure the validity of the purported imposition of the duty, it
is necessary that the duty be imposed by a law of the
Commonwealth (rather than by force of the corresponding State
law), the duty is taken to be imposed by this Act to the extent
necessary to ensure that validity.
(4) If, because of subsection (3), this Act is taken to impose the duty, it
is the intention of the Parliament to rely on all powers available to
it under the Constitution to support the imposition of the duty by
this Act.
(5) The duty is taken to be imposed by this Act in accordance with
subsection (3) only to the extent to which imposing the duty:
(a) is within the legislative powers of the Commonwealth; and
(b) is consistent with the constitutional doctrines restricting the
duties that may be imposed on a Commonwealth officer or
Commonwealth authority.
(6) To avoid doubt, neither this Act (nor any other law of the
Commonwealth) imposes a duty on the Commonwealth officer or
Commonwealth authority to the extent to which imposing such a
duty would:
(a) contravene any constitutional doctrine restricting the duties
that may be imposed on a Commonwealth officer or
Commonwealth authority; or
(b) otherwise exceed the legislative power of the
Commonwealth.
(7) Subsections (1) to (6) do not limit section 6AAA.
6AAC Imposing duty under State law
(1) This section:
(a) applies only for the purposes of the application of the
provisions of this Act or another law of the Commonwealth
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(with or without modification) as a law of a State by a
provision of a corresponding State law; and
(b) does not apply for those purposes if the corresponding State
law otherwise provides.
(2) If the corresponding State law purports to impose a duty on a
Commonwealth officer or Commonwealth authority to do a
particular thing, the duty is taken to be imposed by the
corresponding State law to the extent to which imposing the duty:
(a) is within the legislative powers of the State; and
(b) is consistent with the constitutional doctrines restricting the
duties that may be imposed on a Commonwealth officer or
Commonwealth authority.
(3) To avoid doubt, the corresponding State law does not impose the
duty on the Commonwealth officer or Commonwealth authority to
the extent to which imposing the duty would:
(a) contravene any constitutional doctrine restricting the duties
that may be imposed on a Commonwealth officer or
Commonwealth authority; or
(b) otherwise exceed the legislative powers of the State.
(4) If imposing on the Commonwealth officer or Commonwealth
authority the duty to do that thing would:
(a) contravene any constitutional doctrine restricting the duties
that may be imposed on a Commonwealth officer or
Commonwealth authority; or
(b) otherwise exceed the legislative powers of both the State and
the Commonwealth;
the corresponding State law is taken instead to confer on the officer
or authority a power to do that thing at the discretion of the officer
or authority.
6AAD Conferral of jurisdiction on federal courts
If:
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(a) a provision of a corresponding State law purports to apply a
provision of a law of the Commonwealth (the applied
provision) as a law of the State; and
(b) the applied provision purports to confer jurisdiction in
relation to a matter on a federal court;
the jurisdiction in relation to that matter is taken to be conferred on
the court by this section.
6AAE Consequences of State law conferring duty, function or power
on Commonwealth officer or Commonwealth authority
(1) If a corresponding State law confers on a Commonwealth officer or
Commonwealth authority:
(a) the function of including goods in the Register; or
(b) the power to include goods in the Register;
the officer or authority may include the goods in the Register in
accordance with the corresponding State law.
(2) If a corresponding State law authorises or requires a
Commonwealth officer or Commonwealth authority to cancel the
inclusion of goods in the Register, the officer or authority may
cancel the inclusion of the goods in the Register in accordance with
the corresponding State law.
(3) The inclusion of goods in the Register under subsection (1) does
not subject any person to any liability whatever under this Act,
except a liability under Part 6-1.
(4) A Commonwealth officer or Commonwealth authority may make
any notations in the Register that the officer or authority considers
necessary to identify entries that relate to goods included in the
Register under subsection (1).
(5) Goods may be included in the Register under subsection (1) even
though the same goods have already been included in the Register
under another provision of this Act.
(6) A reference in this section to the inclusion of goods in the Register
is a reference to the inclusion of the goods:
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(a) in the part of the Register for goods known as registered
goods; or
(aa) in the part of the Register for goods known as provisionally
registered goods; or
(b) in the part of the Register for goods known as listed goods; or
(ba) in the part of the Register for biologicals included under
Part 3-2A; or
(c) in the part of the Register for medical devices included under
Chapter 4.
6B Review of certain decisions under State laws
(1) Application may be made to the Administrative Appeals Tribunal
for review of a reviewable State decision.
(2) A decision made by the Secretary in the performance of a function,
or the exercise of a power, conferred by a corresponding State law
is a reviewable State decision for the purpose of this section if:
(a) the law under which the decision was made provides for
review by the Administrative Appeals Tribunal; and
(b) the decision is declared by the regulations to be a reviewable
decision for the purposes of this section.
(3) For the purposes of subsection (1), the Administrative Appeals
Tribunal Act 1975 has effect as if a corresponding State law were
an enactment.
6C Fees payable to Commonwealth under State laws
(1) This section applies to fees payable to the Commonwealth under a
State law in respect of the performance or exercise of functions or
powers conferred by that law on the Secretary.
(2) The Secretary may make arrangements with the appropriate
authority of a State, of the Australian Capital Territory or of the
Northern Territory in relation to the payment to the
Commonwealth of fees to which this section applies.
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7 Declaration that goods are/are not therapeutic goods
(1) Where the Secretary is satisfied that particular goods or classes of
goods:
(a) are or are not therapeutic goods; or
(b) when used, advertised, or presented for supply in a particular
way, are or are not therapeutic goods;
the Secretary may, by order published in the Gazette or on the
Department’s website, declare that the goods, or the goods when
used, advertised, or presented for supply in that way, are or are not,
for the purposes of this Act, therapeutic goods.
(1A) In deciding whether particular goods or classes of goods:
(a) are therapeutic goods; or
(b) when used, advertised, or presented for supply in a particular
way, are therapeutic goods;
the Secretary must disregard paragraphs (e) and (f) of the definition
of therapeutic goods in subsection 3(1).
(2) The Secretary may exercise his or her powers under this section of
his or her own motion or following an application made in writing
to the Secretary.
(3) A declaration under this section takes effect on the day on which
the declaration is published in the Gazette or on the Department’s
website or on such later day as is specified in the order.
(4) If a declaration under this section:
(a) is a declaration that particular goods or classes of goods are
not therapeutic goods; and
(b) applies wholly or partly to goods that, apart from this section,
would be medical devices;
the goods are not medical devices, or are not medical devices when
used, advertised, or presented for supply in the way specified in the
declaration.
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7AA Excluded goods
(1) The Minister may, by legislative instrument, determine that
specified goods (other than goods declared to be therapeutic goods
under an order in force under section 7) are excluded goods for the
purposes of this Act.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
(2) The Minister may, by legislative instrument, determine that
specified goods (other than goods declared to be therapeutic goods
under an order in force under section 7), when used, advertised, or
presented for supply in a way specified in the determination, are
excluded goods for the purposes of this Act.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
(3) Before making a determination under this section, the Minister
must have regard to the following matters:
(a) whether it is likely that the specified goods, if not regulated
under this Act, might harm the health of members of the
public;
(b) whether it is appropriate in all the circumstances to apply the
national system of controls relating to the quality, safety,
efficacy and performance of therapeutic goods established by
this Act to regulate the specified goods;
(c) whether the kinds of risks from the specified goods to which
members of the public might be exposed could be more
appropriately dealt with under another regulatory scheme.
(4) The Minister may have regard to any other matter he or she
considers relevant.
7A Authorised persons
The Secretary may, in writing, authorise any of the following
persons to exercise powers under a specified provision of this Act:
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(a) an officer of the Department, of another Department or of an
authority of the Commonwealth;
(b) an officer of:
(i) a Department of State of a State; or
(ii) a Department or administrative unit of the Public
Service of a Territory; or
(iii) an authority of a State or of a Territory;
being a Department, unit or authority that has functions
relating to health matters or law enforcement matters.
7B Kits
(1) If a package contains one or more goods, the package and each of
the goods in the package together constitute a kit for the purposes
of this Act if:
(a) the package and each of the goods are for use as a unit; and
(b) the package and the goods do not constitute a composite pack
or a system or procedure pack; and
(c) at least one of the goods is therapeutic goods; and
(d) each item of the therapeutic goods consists of goods that are:
(i) registered or listed; or
(ii) exempt goods in relation to Part 3-2; or
(iii) included in the Register under Part 3-2A; or
(iv) exempt under subsection 32CA(2) or section 32CB.
(2) A package and therapeutic goods in the package together constitute
a composite pack if:
(a) the therapeutic goods are of 2 or more kinds; and
(b) the package does not contain any medical devices or
therapeutic devices; and
(c) the therapeutic goods are for administration as a single
treatment or as a single course of treatment; and
(d) it is necessary that the therapeutic goods be combined before
administration or that they be administered in a particular
sequence.
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(3) To avoid doubt, it is declared that a kit constitutes therapeutic
goods.
7C Secretary may arrange for use of computer programs to make
decisions
(1) The Secretary may arrange for the use, under the Secretary’s
control, of computer programs for any purposes for which the
Secretary may make decisions under this Act or the regulations.
(2) A decision made by the operation of a computer program under
such an arrangement is taken to be a decision made by the
Secretary.
(3) The Secretary may substitute a decision (the substituted decision)
for a decision (the initial decision) made by the operation of a
computer program under such an arrangement if the Secretary is
satisfied that the initial decision is incorrect.
(4) However, the substituted decision may only be made before the
end of the period of 60 days beginning on the day the initial
decision is made.
7D Form for product information for medicine
(1) The Secretary may, by writing, approve a form for product
information in relation to medicine.
(2) The Secretary may approve different forms for different medicines
or different classes of medicine.
8 Power to obtain information with respect to therapeutic goods
(1) The Secretary may, by notice in writing given to a person who has
imported into Australia or has supplied in Australia:
(a) therapeutic goods; or
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(b) goods in relation to which the Secretary is considering
making a declaration under section 7; or
(c) goods in relation to which the Minister is considering making
a determination under section 7AA (excluded goods);
request the person to give to an officer of the Department identified
in the notice, within such reasonable period as is specified in the
notice, information required by the notice concerning the
composition, indications, directions for use or labelling of the
goods or concerning advertising material relating to the goods.
(1A) A notice under subsection (1) may require the information to be
given:
(a) in writing; or
(b) in accordance with specified software requirements:
(i) on a specified kind of data processing device; or
(ii) by way of a specified kind of electronic transmission.
(2) A person must not fail to comply with a notice given to the person
under this section.
Penalty: 60 penalty units.
(3) Subsection (2) does not apply if the person has a reasonable
excuse.
Note: The defendant bears an evidential burden in relation to the matter in
subsection (3). See subsection 13.3(3) of the Criminal Code.
(4) An offence under subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
9 Arrangements with States etc.
(1) The Minister may make arrangements with the appropriate
Minister of a State, of the Australian Capital Territory or of the
Northern Territory for the carrying out by that State or Territory,
on behalf of the Commonwealth, of:
(a) the evaluation of therapeutic goods for registration; or
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(aa) the evaluation of a biological, other than a Class 1 biological,
for inclusion in the Register under Part 3-2A; or
(b) the inspection of manufacturers of therapeutic goods; or
(c) other functions under this Act or the regulations.
(2) An arrangement under this section may provide for the payment to
a State or Territory of amounts in respect of the performance of
functions under the arrangement.
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Chapter 2—Australian Register of
Therapeutic Goods
9A Australian Register of Therapeutic Goods
(1) The Secretary is to cause to be maintained a register, to be known
as the Australian Register of Therapeutic Goods, for the purpose of
compiling information in relation to, and providing for evaluation
of, therapeutic goods for use in humans.
(2) Subject to subsection (3), the Register is to be kept in such form as
the Secretary determines.
(3) The Register is to contain these 5 parts:
(a) a part for goods to be known as registered goods; and
(aa) a part for goods to be known as provisionally registered
goods; and
(b) a part for goods to be known as listed goods; and
(ba) a part for biologicals included in the Register under
Part 3-2A; and
(c) a part for medical devices included in the Register under
Chapter 4.
(4) The regulations may prescribe:
(a) the therapeutic goods, or the classes of therapeutic goods,
that are required to be included in each part of the Register;
and
(b) the ways in which goods that are included in one part of the
Register may be transferred, or may be required to be
transferred, to another part of the Register; and
(c) the ways in which goods that have been assigned a
registration or listing number may be assigned a different
registration or listing number; and
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(ca) the ways in which a biological that has been assigned a
number under subsection 32DB(2), 32DF(2) or 32DN(5) may
be assigned a different number (which may be any
combination of numbers and either or both of letters and
symbols); and
(d) the ways in which medical devices that have been assigned a
device number may be assigned a different device number.
(5) The Minister may, by notice published in the Gazette or on the
Department’s website:
(a) require that specified therapeutic goods be included in the
part of the Register for listed goods; and
(b) specify the conditions subject to which such goods may be
included in that part of the Register.
(6) If the regulations are amended to require any of those goods to be
included in the part of the Register for listed or registered goods,
then the notice ceases to have effect in respect of the goods
included in the regulations.
9B When registrations or listings of medical devices are taken to be
cancelled
(1) The registration or listing of a medical device to which
subsection 15A(5) applied is taken to be cancelled:
(a) on the second anniversary of the day on which Chapter 4
commences; or
(b) if the medical device is of a kind included in the Register
under Chapter 4 before that second anniversary—when that
inclusion takes effect.
(2) The registration or listing of any other medical device is taken to
be cancelled at the time shown in the table:
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Time of cancellation of registration or listing
Circumstances Time
1 That kind of medical device is When that kind of medical device is included
included in the Register under in the Register under Chapter 4
Chapter 4 before 4 October 2007
because of an application finally
determined before that day
2 An effective application for a The end of 30 days after the application is
conformity assessment finally determined or, if the application
certificate relating to that kind of lapses, the later of the following times (or
medical device is made, but not either of them if they are the same):
finally determined, before
4 October 2007 (a) the time the application lapses;
(b) the start of 4 October 2007
3 An effective application to Whichever one of the following times
include that kind of medical applies, or the earlier of them:
device in the Register under
Chapter 4 is made, but not
finally determined, before
4 October 2007, and item 2 does
(a) the time that kind of medical device is
included in the Register under Chapter 4
(even if that time is before 4 October
2007); not apply (b) the time the application is finally
determined, if the application is
unsuccessful when it is finally
determined;
or, if the application lapses, the later of the
following times (or either of them if they are
the same):
(c) the time the application lapses;
(d) the start of 4 October 2007
None of items 1, 2 and 3 applies The start of 4 October 2007
Note: 4 October 2007 is the fifth anniversary of the day Chapter 4
commenced.
(2A) For the purposes of subsection (2), an application is finally
determined at the first time both the following conditions are met:
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(a) a decision has been made under Part 4-4 or 4-5 whether or
not to grant the conformity assessment certificate or include
the kind of medical device in the Register (as appropriate);
(b) there is no longer any possibility of a change in the outcome
of the decision in terms of the grant (or not) of the
conformity assessment certificate or the inclusion (or not) of
the kind of medical device in the Register.
For the purposes of paragraph (b), ignore any possibility of a
discretion being exercised, after the period has ended, to extend a
period for seeking review by a tribunal or court of the decision or
for starting other proceedings (including appeals) arising out of the
application, the decision or the review.
Note: In certain circumstances a decision may be taken to have been made
under Part 4-4 or Part 4-5. For example, see section 41EH.
(3) This section does not prevent the Secretary from taking action
under section 30.
9C Inspection of entries in Register
(1) A person in relation to whom therapeutic goods are entered on the
Register may make a written request to the Secretary for a copy of
the entry in the Register in relation to the goods.
(2) If the person makes such a request, the Secretary must send to the
person a copy of so much (if any) of that entry as is contained in
any computer database maintained by the Department for purposes
connected with the administration of this Act (other than any part
of that entry that was supplied in confidence by another person).
(3) If the person makes such a request, then, instead of providing a
copy of an entry to the person, the Secretary may, if the request is
for the provision of an electronic copy, provide the information
contained in the entry:
(a) on a data processing device; or
(b) by way of electronic transmission.
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9D Variation of entries in Register
(1) The Secretary may:
(a) following a request by a person in relation to whom
therapeutic goods are entered on the Register; or
(b) on the Secretary’s own initiative;
vary the entry in the Register in relation to the goods if the entry
contains information that is incomplete or incorrect.
(1A) If:
(a) a medicine is included in the part of the Register for goods
known as provisionally registered goods; and
(b) it appears to the Secretary that the quality, safety or efficacy
of the medicine is unacceptable in relation to a class of
persons;
the Secretary may, on the Secretary’s own initiative, vary the entry
in the Register in relation to the medicine:
(c) to reduce the class of persons for whom the medicine is
suitable or to change the directions for use; or
(d) to add a warning, or precaution, that does not include any
comparison of the medicine with any other medicine by
reference to quality, safety or efficacy.
Note: The Secretary may also vary the product information relating to the
medicine: see subsection 25AA(4).
(1B) If:
(a) a medicine is included in the part of the Register for goods
known as provisionally registered goods; and
(b) the Secretary makes a decision under subsection 29(9) to
extend the provisional registration period for the medicine;
the Secretary may, on the Secretary’s own initiative, vary the entry
in the Register in relation to the medicine to reduce the class of
persons for whom the medicine is suitable or to change the
directions for use.
Note: The Secretary may also vary the product information relating to the
medicine: see subsection 25AA(4).
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(1C) If the Secretary proposes to make a variation under subsection (1A)
or (1B), the Secretary must:
(a) give the person in relation to whom the medicine is registered
written notice of the proposed variation and of the reasons for
the proposed variation; and
(b) give the person a reasonable opportunity to make a
submission to the Secretary in relation to the proposed
variation; and
(c) if the person makes a submission in accordance with
paragraph (b)—take the submission into account before
making a decision whether or not to make the variation.
(1D) Subsections (1A) and (1B) apply despite subsection 16(1).
(2) If:
(a) the person in relation to whom therapeutic goods are
registered or listed has requested the Secretary to vary
information included in the entry in the Register that relates
to the goods; and
(b) the only effect of the variation would be:
(i) to reduce the class of persons for whom the goods are
suitable; or
(ii) to add a warning, or precaution, that does not include
any comparison of the goods with any other therapeutic
goods by reference to quality, safety or efficacy;
the Secretary must vary the entry in accordance with the request.
(2A) Subsection (2), to the extent to which it relates to
subparagraph (2)(b)(i), applies despite subsection 16(1).
(2C) If:
(a) the person in relation to whom therapeutic goods are
registered or listed has requested the Secretary to vary the
entry in the Register that relates to the goods; and
(b) the variation is of a kind specified in the regulations; and
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(c) the conditions (if any) specified in the regulations are
satisfied;
the Secretary must vary the entry in accordance with the request.
(2D) Subsection (2C), to the extent that it relates to therapeutic goods
that are registered, applies despite subsection 16(1).
(3) If:
(a) the person in relation to whom therapeutic goods are
registered or listed has requested the Secretary to vary
information included in the entry in the Register that relates
to the goods; and
(b) subsection (2) does not apply to the request; and
(ba) subsection (2C) does not apply to the request; and
(c) the Secretary is satisfied that the variation requested does not
indicate any reduction in the quality, safety or efficacy of the
goods for the purposes for which they are to be used;
the Secretary may vary the entry in accordance with the request.
(3AA) If:
(a) the person in relation to whom a biological is included in the
Register has requested the Secretary to vary information
included in the entry in the Register that relates to the
biological; and
(b) the only effect of the variation would be:
(i) to reduce the class of persons for whom the biological is
suitable; or
(ii) to add a warning, or precaution, that does not include
any comparison of the biological with any other
therapeutic goods by reference to quality, safety or
efficacy;
the Secretary must vary the entry in accordance with the request.
(3AC) If:
(a) the person in relation to whom a biological is included in the
Register has requested the Secretary to vary the entry in the
Register that relates to the biological; and
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(b) the variation is of a kind specified in the regulations; and
(c) the conditions (if any) specified in the regulations are
satisfied;
the Secretary must vary the entry in accordance with the request.
(3A) If:
(a) the person in relation to whom a biological is included in the
Register has requested the Secretary to vary information
included in the entry in the Register that relates to the
biological; and
(aa) subsection (3AA) does not apply to the request; and
(ab) subsection (3AC) does not apply to the request; and
(b) the Secretary is satisfied that the variation requested does not
indicate any reduction in the quality, safety or efficacy of the
biological for the purposes for which it is to be used;
the Secretary may vary the entry in accordance with the request.
(3B) If:
(a) a particular biological ceases to be a biological because of a
determination under subsection 32A(3); and
(b) the biological is included in the Register under Part 3-2A;
the Secretary must move the entry relating to the biological from
the part of the Register for biologicals to whichever other part of
the Register is applicable.
(3C) If:
(a) the person in relation to whom a kind of medical device is
included in the Register has requested the Secretary to vary
information included in the entry in the Register that relates
to the kind of medical device; and
(b) the only effect of the variation would be:
(i) to reduce the class of persons for whom the kind of
medical device is suitable; or
(ii) to add a warning, restriction or precaution, that does not
include any comparison of the kind of medical device
with any other therapeutic goods by reference to quality,
safety or performance;
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the Secretary must vary the entry in accordance with the request.
(3CB) If:
(a) the person in relation to whom a kind of medical device is
included in the Register has requested the Secretary to vary
the entry in the Register that relates to the kind of medical
device; and
(b) the variation is of a kind specified in the regulations; and
(c) the conditions (if any) specified in the regulations are
satisfied;
the Secretary must vary the entry in accordance with the request.
(3D) If:
(a) the person in relation to whom a kind of medical device is
included in the Register has requested the Secretary to vary
information included in the entry in the Register that relates
to the kind of medical device; and
(b) subsection (3C) does not apply to the request; and
(ba) subsection (3CB) does not apply to the request; and
(c) the Secretary is satisfied that the variation requested does not
indicate any reduction in the quality, safety or performance
of the kind of medical device for the purposes for which it is
to be used;
the Secretary may vary the entry in accordance with the request.
(4) If:
(a) particular therapeutic goods cease to be medical devices
because of a declaration under subsection 41BD(3); and
(b) those goods are included in the Register under Chapter 4 as a
kind of medical device;
the Secretary must move the entry relating to the goods from the
part of the Register for medical devices to whichever other part of
the Register is applicable.
Note: Variations to the Register also occur to give effect to limited
cancellations of entries of kinds of medical devices from the Register:
see subsection 41GO(2).
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Section 9E
Form and manner of requests
(6) The Secretary may, by writing:
(a) approve a form for particular kinds of requests under this
section; and
(b) approve the manner of making particular kinds of requests
under this section.
(7) If:
(a) the Secretary has approved a form for, and the manner of
making, a kind of request under this section; and
(b) either:
(i) the kind of request is one under subsection (3) and
which, under the regulations, must be decided within
175 or 255 working days; or
(ii) the kind of request is one prescribed by the regulations
for the purposes of this subparagraph;
then a request of that kind is not effective unless:
(c) the request is in accordance with that form; and
(d) the request contains the information required by that form;
and
(e) the request is made in that manner; and
(f) any prescribed application fee has been paid; and
(g) the request is accompanied by information that is:
(i) of a kind determined under subsection (8); and
(ii) in a form approved, in writing, by the Secretary.
(8) The Secretary may, by legislative instrument, determine a kind of
information for the purposes of subparagraph (7)(g)(i).
Note: See also subsection 33(3A) of the Acts Interpretation Act 1901.
9E Publication of list of goods on Register
The Secretary must, at least once every 12 months, publish a list of
the therapeutic goods included in the Register.
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9F Removal of entries from Register
(1) This section applies if:
(a) there is an entry on the Register in relation to goods; and
(b) the Secretary is satisfied that the goods are not therapeutic
goods.
(2) The Secretary may, by written notice given to the person in relation
to whom the goods are entered on the Register, remove the entry of
the goods from the Register.
(3) Before removing the entry, the Secretary must:
(a) inform the person in writing that the Secretary proposes the
removal and set out the reasons for it; and
(b) invite the person to make written submissions to the
Secretary in relation to the proposed removal within the
period specified in the notice (being not less than 20 working
days after the day the notice is given).
(4) The Secretary must not give the person a notice under
subsection (2) until the Secretary has had regard to any
submissions the person makes under paragraph (3)(b).
(5) A notice under subsection (2) is not a legislative instrument.
(6) If the Secretary removes an entry of goods from the Register under
this section, the removal has effect on the day specified in the
notice under subsection (2) in relation to the goods, being a day not
earlier than 20 working days after the day on which the notice is
given to the person.
(7) If the Secretary removes an entry of goods from the Register under
this section, the Secretary must, as soon as practicable after the
removal, cause to be published in the Gazette, or on the
Department’s website, a notice setting out particulars of the
removal.
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Section 9G
9G Criminal offences for false statements in requests for variation of
entries in Register
(1) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a request
under section 9D for the variation of an entry in the Register
in relation to therapeutic goods; and
(c) the statement is false or misleading in a material particular;
and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
(4) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a request
under section 9D for the variation of an entry in the Register
in relation to therapeutic goods; and
(c) the statement is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a request
under section 9D for the variation of an entry in the Register
in relation to therapeutic goods; and
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(c) the statement is false or misleading in a material particular.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
9H Civil penalty for false statements in requests for variation of
entries in Register
A person contravenes this section if the person in or in connection
with a request under section 9D for the variation of an entry in the
Register in relation to therapeutic goods, makes a statement that is
false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Section 10
Chapter 3—Medicines and other therapeutic
goods that are not medical devices Note: This Chapter still applies to medical devices while they are registered or listed goods.
Section 9B automatically cancels the registration or listing of those goods over time.
Part 3-1—Standards
10 Determination of standards
(1) The Minister may, by legislative instrument, make an order
determining that matters specified in the order constitute a standard
for therapeutic goods or a class of therapeutic goods identified in
the order (whether or not those goods are the subject of a
monograph in the British Pharmacopoeia, the European
Pharmacopoeia, the United States Pharmacopeia-National
Formulary, a homoeopathic pharmacopoeia or an anthroposophic
pharmacopoeia).
Note: Section 12 of the Legislation Act 2003 deals with when a legislative
instrument commences.
(2) Without limiting the generality of subsection (1), an order
establishing a standard for therapeutic goods may:
(a) be specified by reference to:
(i) the quality of the goods; or
(ii) the quantity of the goods when contained in specified
containers; or
(iii) procedures to be carried out in the manufacture of the
goods; or
(iv) a monograph in the British Pharmacopoeia, the
European Pharmacopoeia, the United States
Pharmacopeia-National Formulary, a homoeopathic
pharmacopoeia or an anthroposophic pharmacopoeia; or
(v) a monograph in another publication approved by the
Minister for the purposes of this subsection; or
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(vi) such a monograph as modified in a manner specified in
the order establishing the standard; or
(vii) a standard published by Standards Australia; or
(viii) such other matters as the Minister thinks fit; or
(b) require that a matter relating to the standard be determined in
accordance with a particular test; or
(c) require that therapeutic goods or a class of therapeutic goods
identified in the order be labelled or packaged in a manner, or
kept in containers that comply with requirements, specified
in the order.
(3) Without limiting the generality of paragraph (2)(c), the Minister
may, in an order establishing a standard, direct that there be set out,
in a manner specified in the order, on:
(a) therapeutic goods or a class of therapeutic goods identified in
the order; or
(b) a container or package containing therapeutic goods or a
class of therapeutic goods identified in the order; or
(c) a label of therapeutic goods or a class of therapeutic goods
identified in the order;
such particulars as are required by the order.
(3A) The Minister may, by legislative instrument, vary or revoke an
order made under subsection (1).
Note: Section 12 of the Legislation Act 2003 deals with when a legislative
instrument commences.
(4) Despite subsection 14(2) of the Legislation Act 2003, an order
under subsection (1) of this section, or a variation of such an order,
may make provision in relation to a matter by applying, adopting
or incorporating, with or without modification, any matter
contained in an instrument or other writing as in force or existing
from time to time.
10A Application of standards to medical devices
A standard under section 10 does not apply to a medical device
unless Part 3-2 applies to the device.
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Section 13
Note: Section 15A sets out when Part 3-2 applies to a medical device.
13 Special provisions relating to Ministerial standards and default
standards
(1) For the purposes of this Act, if a statement (the main statement) in
a monograph in the British Pharmacopoeia, the European
Pharmacopoeia or the United States Pharmacopeia-National
Formulary refers to a statement in a monograph in another
publication, the main statement is taken to include the other
statement.
(2) If:
(a) a standard under section 10 (the Ministerial standard)
applies to therapeutic goods; and
(b) requirements applicable to the goods are specified in a
default standard; and
(c) those requirements are inconsistent with the requirements
specified in the Ministerial standard;
the requirements referred to in paragraph (b) are, so far as they are
inconsistent, to be disregarded for the purposes of this Act.
(3) If:
(a) a default standard applies to a class of therapeutic goods; and
(b) another default standard applies to only some of the
therapeutic goods within that class; and
(c) those standards are inconsistent;
the standard referred to in paragraph (a) does not apply in relation
to the goods referred to in paragraph (b).
(4) If:
(a) therapeutic goods consist, or are represented to consist, of a
mixture of ingredients or of a combination of component
parts; and
(b) a default standard is applicable to one or more of the
ingredients or one or more of the component parts; and
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(c) a default standard is applicable to the mixture or
combination;
the standard referred to in paragraph (b) does not apply in relation
to the goods.
(5) If:
(a) therapeutic goods consist, or are represented to consist, of a
mixture of ingredients or of a combination of component
parts; and
(b) there is no standard applicable to the mixture or combination
but a standard is applicable to one or more of the ingredients
or one or more of the component parts;
the Minister may, by order published in the Gazette or on the
Department’s website, determine that the standard does not apply
to the goods. The order has effect accordingly.
(6) An order under subsection (5) is not a legislative instrument.
(7) For the purposes of this Act, in working out at a particular time if
therapeutic goods conform with a default standard applicable to the
goods, if:
(a) after applying subsections (2) to (5), 2 or more default
standards are applicable to the goods at that time; and
(b) at that time, the goods conform with at least one of those
standards but do not conform with at least one of those
standards;
then the default standards that the goods do not conform with are
taken not to apply to the goods at that time.
13A Special provisions relating to homoeopathic standards and
anthroposophic standards
(1) For the purposes of this Act, if a statement (the main statement) in
a monograph in a homoeopathic pharmacopoeia or an
anthroposophic pharmacopoeia refers to a statement in a
monograph in another publication, the main statement is taken to
include the other statement.
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(2) If:
(a) a standard under section 10 (the Ministerial standard)
applies to therapeutic goods; and
(b) requirements applicable to the goods are specified in a
homoeopathic standard or an anthroposophic standard; and
(c) those requirements are inconsistent with the requirements
specified in the Ministerial standard;
the requirements referred to in paragraph (b) are, so far as they are
inconsistent, to be disregarded for the purposes of this Act.
14 Criminal offences for importing, supplying or exporting goods
that do not comply with standards
Offences relating to importing goods into Australia
(1) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
(b) the goods are imported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than by reason of a matter relating to labelling
or packaging); and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the goods
do not conform with the standard.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
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Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
(b) the goods are imported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than by reason of a matter relating to labelling
or packaging).
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
(b) the goods are imported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than by reason of a matter relating to labelling
or packaging).
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Exception
(5A) Subsection (1), (4) or (4A) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person imports the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (5A): see subsection 13.3(3) of the Criminal Code.
Offences relating to supplying goods for use in Australia
(6) A person commits an offence if:
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(a) the person supplies therapeutic goods for use in Australia;
and
(b) the goods are supplied without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods; and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the goods
do not conform with the standard.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (9) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(9) A person commits an offence if:
(a) the person supplies therapeutic goods for use in Australia;
and
(b) the goods are supplied without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(9AA) A person commits an offence if:
(a) the person supplies therapeutic goods for use in Australia;
and
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(b) the goods are supplied without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods.
Penalty: 100 penalty units.
(9AB) An offence against subsection (9AA) is an offence of strict
liability.
Exception
(9A) Subsection (6), (9) or (9AA) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person supplies the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (9A): see subsection 13.3(3) of the Criminal Code.
Offences relating to exporting goods from Australia
(10) A person commits an offence if:
(a) the person exports therapeutic goods from Australia; and
(b) the goods are exported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than a standard relating to the labelling of the
goods for supply in Australia); and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the goods
do not conform with the standard.
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Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (13) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(13) A person commits an offence if:
(a) the person exports therapeutic goods from Australia; and
(b) the goods are exported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than a standard relating to the labelling of the
goods for supply in Australia).
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(13AA) A person commits an offence if:
(a) the person exports therapeutic goods from Australia; and
(b) the goods are exported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than a standard relating to the labelling of the
goods for supply in Australia).
Penalty: 100 penalty units.
(13AB) An offence against subsection (13AA) is an offence of strict
liability.
Exception
(13A) Subsection (10), (13) or (13AA) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person exports the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
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Note: A defendant bears an evidential burden in relation to the matter in
subsection (13A): see subsection 13.3(3) of the Criminal Code.
Decisions on whether to give consent
(14) The Secretary must, as soon as practicable after making a decision
to give a consent, cause particulars of the decision to be published
in the Gazette or on the Department’s website.
(15) The Secretary must, within 28 days after making a decision to
refuse to give a consent, notify the applicant in writing of the
decision and of the reasons for the decision.
14A Civil penalties for importing, supplying or exporting goods that
do not comply with standards
Civil penalty relating to importing goods into Australia
(1) A person contravenes this subsection if:
(a) the person imports therapeutic goods into Australia; and
(b) the person does not have the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than by reason of a matter relating to labelling
or packaging).
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exception
(1A) Subsection (1) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person imports the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
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Civil penalty relating to supplying goods for use in Australia
(2) A person contravenes this subsection if:
(a) the person supplies therapeutic goods for use in Australia;
and
(b) the person does not have the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exception
(2A) Subsection (2) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person supplies the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
Civil penalty relating to exporting goods from Australia
(3) A person contravenes this subsection if:
(a) the person exports therapeutic goods from Australia; and
(b) the person does not have the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than a standard relating to the labelling of the
goods for supply in Australia).
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Exception
(3A) Subsection (3) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person exports the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
Decisions on whether to give consent
(4) The Secretary must, as soon as practicable after making a decision
to give a consent, cause particulars of the decision to be published
in the Gazette or on the Department’s website.
(5) The Secretary must, within 28 days after making a decision to
refuse to give a consent, notify the applicant in writing of the
decision and of the reasons for the decision.
14B Application of Customs Act 1901
Where:
(a) the importation or exportation of goods is an offence under
subsection 14(1), (4), (4A), (10), (13) or (13AA) or a
contravention of subsection 14A(1) or (3); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the goods included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
15 Criminal offences relating to breaching a condition of a consent
(1) The consent of the Secretary under section 14 or 14A may be
given:
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(a) unconditionally or subject to conditions; or
(b) in respect of particular goods or classes of goods.
(2) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent; and
(c) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: 2,000 penalty units.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (5) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(5) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent.
Penalty: 500 penalty units.
(6) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent.
Penalty: 100 penalty units.
(7) An offence against subsection (6) is an offence of strict liability.
15AA Civil penalty relating to breaching a condition of a consent
A person contravenes this section if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent
imposed under section 15.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
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(b) for a body corporate—30,000 penalty units.
15AB Conditions relating to exceptional release of biologicals
(1) Regulations made for the purposes of paragraphs 14(9A)(b) and
14A(2A)(b) may also prescribe conditions that apply in relation to
the supply of a biological that occurs after the circumstances
prescribed for the purposes of those paragraphs have occurred.
(2) The conditions prescribed by those regulations must apply only to
the person supplying the biological.
(3) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of any of the
conditions referred to in subsection (1).
Penalty for contravention of this subsection:60 penalty units.
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Part 3-2—Registration and listing of therapeutic
goods
Division 1—Preliminary
15A Application of this Part to medical devices
The general rule
(1) This Part does not apply to a medical device unless this section
provides otherwise.
Previously registered or listed devices
(2) If a medical device is registered goods or listed goods before the
commencement of this section, this Part continues to apply to the
device unless the registration or listing is cancelled.
Note: A registration or listing can be cancelled under section 30, or can be
taken to be cancelled under section 9B.
Pending applications
(3) This Part continues to apply to a medical device if:
(a) before the commencement of this section, an application was
made under Part 3 for registration or listing of therapeutic
goods that include that medical device; and
(b) immediately before that commencement, the application was
not yet finally determined; and
(c) the application has not been, and is not, withdrawn either
before or after that commencement.
However, this Part ceases to apply to the device if, having been
registered goods or listed goods, the registration or listing is
cancelled.
(4) For the purposes of paragraph (3)(b), an application is finally
determined when the application, and any applications for review
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or appeals arising out of it, have been finally determined or
otherwise disposed of.
Applications made within 2 years relating to certain medical
devices
(5) This Part applies to a medical device if:
(a) regulations made for the purposes of this section specified
either:
(i) the medical device classification applying to the kind of
medical device that includes that device; or
(ii) medical devices of that kind; and
(b) during the period of 2 years after the commencement of this
section, an application was made under Part 3-2 for
registration or listing of therapeutic goods that include that
medical device.
However, this Part ceases to apply to the device if, having been
registered goods or listed goods, the registration or listing is
cancelled.
Note: Medical devices that are registered or listed because of this subsection
are taken to be cancelled 2 years after Chapter 4 commences, or
before then if medical devices of that kind are included in the Register
under Chapter 4: see subsection 9B(1).
Medical devices that are exempt goods
(6) This Part applies to a medical device, during the period of 2 years
after the commencement of this section, if the device is exempt
goods.
Existing approvals under section 19
(7) This Part continues to apply to a medical device if:
(a) an approval or authorisation in force under section 19 applies
to the device; and
(b) that approval or authorisation was in force immediately
before the commencement of this section.
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New approvals under section 19
(8) This Part applies to a medical device if:
(a) subsection (7) does not apply to the device; and
(b) during the period of 2 years after the commencement of this
section, an approval is granted or an authorisation is given
under section 19 that applies to the device.
However, this subsection does not apply after the end of that
period.
15B Application of this Part to a biological
(1) Subject to this section, this Part does not apply to a biological on
and after the commencement of this section.
Biologicals currently included in the Register
(2) If, immediately before the commencement of this section,
therapeutic goods that are a biological were registered goods or
listed goods, this Part continues to apply to the biological on and
after that commencement until the time the biological is included
in the Register under Part 3-2A.
Note: Section 32DN deals with including the biological under Part 3-2A.
Pending applications
(3) If:
(a) before the commencement of this section, an application was
made under this Part for the registration or listing of
therapeutic goods that are a biological; and
(b) immediately before that commencement, the application was
not finally determined; and
(c) the application had not been withdrawn before that
commencement;
this Part continues to apply to the biological on and after that
commencement until the earliest of the following:
(d) the time the biological is included in the Register under
Part 3-2A;
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(e) if the application is unsuccessful when it is finally
determined—the time the application is finally determined;
(f) the time the application is withdrawn;
(g) the time the application lapses.
Note: Section 32DN deals with including the biological under Part 3-2A.
(4) For the purposes of this section, an application is finally
determined when the application, and any applications for review
or appeals arising out of it, have been finally determined or
otherwise disposed of.
Transitional
(5) This Part applies to a biological on and after the commencement of
this section in relation to things done, or omitted to be done, in
relation to the biological before the commencement of this section.
(6) If this Part continues to apply to a biological during a period
described in subsection (2) or (3), then this Part also applies to the
biological after the end of that period in relation to things done, or
omitted to be done, in relation to the biological during that period.
16 Therapeutic goods and gazetted groups
(1) For the purposes of this Part, therapeutic goods (other than
medicine of the kind to which subsection (1A) applies) are to be
taken to be separate and distinct from other therapeutic goods if
they have:
(a) a different formulation, composition or design specification;
or
(b) a different strength or size (disregarding pack size); or
(c) a different dosage form or model; or
(d) a different name; or
(e) different indications; or
(f) different directions for use; or
(g) a different type of container (disregarding container size).
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(1A) Medicines that are listable goods (other than export only
medicines) are taken to be separate and distinct from other
therapeutic goods if the medicines have:
(a) different active ingredients; or
(b) different quantities of active ingredients; or
(c) a different dosage form; or
(d) such other different characteristics as the regulations
prescribe;
from the therapeutic goods.
(2) The Secretary may, by order published in the Gazette, determine
that a group of therapeutic goods (not being medical devices or
therapeutic devices) identified in the order is a gazetted therapeutic
goods group because the goods within the group have common
characteristics.
(3) The Secretary may, by order published in the Gazette, determine
that a group of therapeutic goods (being therapeutic devices)
identified in the order is a gazetted therapeutic devices group
because the goods within the group:
(a) have common characteristics; and
(b) have been produced by the same manufacturer.
(3A) The Secretary may, by order published in the Gazette, determine
that a group of kits identified in the order is a gazetted kits group.
(4) An order under subsection (2), (3) or (3A) may make provision for
or in relation to a matter by applying, adopting or incorporating,
with or without modification, a document as in force from time to
time, if the document is:
(a) published by the Department (whether in electronic form or
otherwise); and
(b) available for sale to the public; and
(c) available for inspection (whether by using a visual display
unit or otherwise) by the public at offices of the Department
specified by the Secretary.
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18 Exempt goods
(1) The regulations may, subject to such conditions (if any) as are
specified in the regulations, exempt:
(a) all therapeutic goods, except those included in a class of
goods prescribed for the purposes of this paragraph; or
(b) specified therapeutic goods; or
(c) a specified class of therapeutic goods;
from the operation of this Part (except section 31A and
sections 31C to 31F).
(2) An exemption in terms of paragraph (1)(a) has effect only in
relation to such classes of persons as are prescribed for the
purposes of this subsection.
(3) Where the regulations revoke an exemption, the revocation takes
effect on the day, not being earlier than 28 days after the day on
which the regulations are made, specified in the regulations.
18A Exemption because of emergency
Minister’s power
(1) The Minister may exempt from the operation of Division 2 of this
Part:
(a) specified therapeutic goods; or
(b) therapeutic goods in a specified class.
The exemption must be made in writing.
(2) The Minister may exempt goods under subsection (1) only if the
Minister is satisfied that, in the national interest:
(a) the exemption should be made so that the goods may be
stockpiled as quickly as possible in order to create a
preparedness to deal with a potential threat to public health
that may be caused by a possible future emergency; or
(b) the exemption should be made so that the goods can be made
available urgently in Australia in order to deal with an actual
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threat to public health caused by an emergency that has
occurred.
When the exemption has effect
(3) The exemption takes effect:
(a) on the day on which the exemption is made; or
(b) on a later day that is specified in the exemption.
(4) The exemption ceases to have effect:
(a) at the end of the period specified by the Minister in the
exemption as the period for which the exemption is to have
effect; or
(b) when the exemption is revoked;
whichever first occurs.
(5) The exemption ceases to have effect in relation to particular
therapeutic goods:
(a) when those goods become registered or listed goods; or
(b) when the Minister varies the exemption by removing those
goods from the exemption;
whichever first occurs.
(6) If the Minister revokes the exemption as mentioned in
paragraph (4)(b), or varies the exemption as mentioned in
paragraph (5)(b), the revocation or variation takes effect:
(a) if the Minister states in the revocation or variation that the
revocation or variation is necessary to prevent imminent risk
of death, serious illness or serious injury—on the day on
which the revocation or variation is made; or
(b) in any other case—on the day specified by the Minister in the
revocation or variation.
The day specified under paragraph (b) of this subsection must not
be earlier than 28 days after the day on which the revocation or
variation is made.
Note: The revocation or variation must be made in writing, see
subsection 33(3) of the Acts Interpretation Act 1901.
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Conditions for the exemption
(7) The exemption is subject to conditions specified in the exemption
about any of the following:
(a) the period for which the exemption is to have effect;
(b) the quantity of goods that are exempt;
(c) the source of those goods;
(d) the persons or class of persons who may import,
manufacture, supply or export those goods;
(e) the supply of those goods (including the persons or class of
persons to whom goods may be supplied for use and the
circumstances under which a stockpile of goods may be
supplied for use);
(f) the storage and security of those goods;
(g) the keeping and disclosure of, and access to, records about
those goods;
(h) the disposal of those goods;
(i) the manner in which any of those goods are to be dealt with
if a condition of the exemption is breached;
(j) any other matters that the Minister thinks appropriate.
Whether or not goods are exempt under this section is not affected
by whether or not there is a breach of a condition of an exemption
under this section in relation to those goods.
Note 1: A person may commit an offence by breaching a condition of an
exemption under this section, see subsections 20(2A) and (2C),
22(7AB) and (7AD), and 30H(1) and (3).
Note 2: A person may also contravene a civil penalty provision, see
section 22AA.
(8) The Minister may revoke or vary the conditions (including by
imposing new conditions) after the exemption is made. The
revocation or variation must be made in writing.
(9) A revocation or variation under subsection (8) takes effect:
(a) if the Minister states in the revocation or variation that the
revocation or variation is necessary to prevent imminent risk
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of death, serious illness or serious injury—on the day on
which the revocation or variation is made; or
(b) in any other case—on the day specified by the Minister in the
revocation or variation.
The day specified under paragraph (b) must not be earlier than 28
days after the day on which the revocation or variation is made.
Exemption not a legislative instrument
(9A) An exemption under subsection (1) is not a legislative instrument.
Informing persons of exemption etc.
(9B) If the Minister makes an exemption under subsection (1), the
Minister must take reasonable steps to give a copy of the following
to each person covered by paragraph (7)(d):
(a) the exemption;
(b) any revocation or variation of the exemption under this
section.
Notification
(10) The Secretary must cause a document setting out particulars of:
(a) an exemption covered by paragraph (2)(b); and
(b) a revocation or variation under this section of an exemption
covered by paragraph (2)(b);
to be published in the Gazette within 5 working days after the day
on which the Minister makes the exemption, revocation or
variation. However, an exemption, or a revocation or variation, is
not invalid merely because of a failure to comply with this
subsection.
Tabling
(11) The Minister must cause a document setting out particulars of:
(a) an exemption covered by paragraph (2)(b); and
(b) a revocation or variation under this section of an exemption
covered by paragraph (2)(b);
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to be tabled before each House of the Parliament within 5 sitting
days of that House after the day on which the Minister makes the
exemption, revocation or variation. However, an exemption, or a
revocation or variation, is not invalid merely because of a failure to
comply with this subsection.
Note: There are other requirements in other parts of this Act about goods
exempt under this section:
(a) sections 20, 22 and 22AA (breach of a condition of the exemption);
(b) sections 30F and 30FA (goods not conforming to standards etc.);
(c) section 30G (disposal of unused goods);
(d) section 30H (record keeping);
(e) section 31AA (providing information to the Secretary);
(f) sections 35, 35A, 39 and 41 (manufacturing goods that are exempt under this section);
(g) section 46A (search of premises).
19 Exemptions for certain uses
(1) The Secretary may, by notice in writing, grant an approval to a
person for the importation into, or the exportation from, Australia
or the supply in Australia of specified therapeutic goods that are
not registered goods, listed goods or exempt goods:
(a) for use in the treatment of another person; or
(b) for use solely for experimental purposes in humans;
and such an approval may be given subject to such conditions as
are specified in the notice of approval.
(1AA) An approval for use of the kind referred to in paragraph (1)(a) must
not be granted to a person unless the person is a health practitioner.
(1A) An approval mentioned in paragraph (1)(a) or (b) is subject to the
conditions (if any) specified in the regulations for the purposes of
that paragraph. Those conditions (if any) are in addition to any
conditions imposed on the approval under subsection (1).
(2) An application for an approval must be made to the Secretary and
must:
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(a) in the case of an application for use of the kind referred to in
paragraph (1)(a)—be in a form (if any) approved, in writing,
by the Secretary and be accompanied by such information
relating to the goods the subject of the application as is
required by the Secretary; and
(b) in the case of an application for use of the kind referred to in
paragraph (1)(b):
(i) be made in writing; and
(ii) be accompanied by such information relating to the
goods the subject of the application as is required by the
Secretary; and
(iii) be accompanied by the prescribed evaluation fee.
(3) Without limiting the conditions to which an approval under
subsection (1) may be made subject, those conditions may include
a condition relating to the charges that may be made for the
therapeutic goods to which the approval relates.
(4) Where an application for an approval is made, the Secretary must,
after having considered the application and, in the case of an
application for the use of therapeutic goods for experimental
purposes in humans, after having evaluated the information
submitted with the application, notify the applicant of the decision
on the application within 28 days of making the decision and, in
the case of a decision not to grant the approval, of the reasons for
the decision.
(4A) The use by a person for experimental purposes in humans of
specified therapeutic goods that are the subject of an approval
granted to someone else under paragraph (1)(b) is subject to the
conditions (if any) specified in the regulations relating to one or
more of the following:
(a) the preconditions on the use of the goods for those purposes;
(b) the principles to be followed in the use of the goods for those
purposes;
(c) the monitoring of the use, and the results of the use, of the
goods for those purposes;
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(d) the circumstances in which the person must cease the use of
the goods for those purposes.
(5) The Secretary may, in writing, authorise a specified medical
practitioner to supply:
(a) specified therapeutic goods for use in the treatment of
humans; or
(b) a specified class of such goods;
to the class or classes of recipients specified in the authority.
(5AA) An application for an authority under subsection (5) must be in a
form (if any) approved, in writing, by the Secretary.
(5A) An authority may be given subject to the conditions (if any)
specified in the authority.
(5B) The Secretary may impose conditions (or further conditions) on an
authority given to a person under subsection (5) by giving to the
person written notice of the conditions (or further conditions).
(6) An authority under subsection (5) may only be given:
(a) to a medical practitioner included in a class of medical
practitioners prescribed by the regulations for the purposes of
this paragraph; and
(aa) to a medical practitioner who has the approval of an ethics
committee to supply the specified therapeutic goods or the
specified class of such goods; and
(b) in relation to a class or classes of recipients prescribed by the
regulations for the purposes of this paragraph.
Paragraph (aa) does not apply in the exceptional circumstances (if
any) prescribed by the regulations for the purposes of this
subsection.
(7) The regulations may prescribe the circumstances in which
therapeutic goods may be supplied under an authority under
subsection (5).
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(7A) The Minister may, by legislative instrument, make rules
authorising any health practitioner who is included in a specified
class of health practitioners to supply:
(a) specified therapeutic goods for use in the treatment of
humans; or
(b) a specified class of such goods;
to the class or classes of recipients specified in those rules, so long
as:
(c) the goods are supplied in the circumstances specified in those
rules; and
(d) the conditions (if any) specified in those rules are satisfied.
(7B) In making rules under subsection (7A), the Minister must comply
with:
(a) such requirements (if any) as are prescribed by the
regulations; and
(b) such restrictions (if any) as are prescribed by the regulations;
and
(c) such limitations (if any) as are prescribed by the regulations.
(7C) If:
(a) a person is authorised, by subsection (7A) rules, to supply
therapeutic goods; and
(b) the person supplies those goods in accordance with those
rules;
the person must:
(c) notify the supply to the Secretary; and
(d) do so within 28 days after the supply.
(7D) A notification under subsection (7C) must:
(a) be in accordance with a form that is approved, in writing, by
the Secretary; and
(b) contain such information as is prescribed by the regulations.
(7E) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
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(b) by way of a specified kind of electronic transmission.
(7F) A person commits an offence if:
(a) the person is subject to a requirement under subsection (7C);
and
(b) the person omits to do an act; and
(c) the omission breaches the requirement.
Penalty: 10 penalty units.
(7G) An offence against subsection (7F) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(7GA) Subsection (7F) does not apply in relation to a person and a
requirement to notify a supply of therapeutic goods if a health
practitioner, on behalf of the person, does the following:
(a) notifies the supply to the Secretary within 28 days after the
supply;
(b) makes the notification in accordance with the requirements
referred to in subsection (7D).
Note: A defendant bears an evidential burden in relation to the matter in
subsection (7GA): see subsection 13.3(3) of the Criminal Code.
(7H) In recommending to the Governor-General that regulations should
be made for the purposes of paragraph (7D)(b), the Minister must
have regard to the principle that information should only be
prescribed for the purposes of that paragraph if the information is
reasonably required for the responsible scrutiny by the Secretary of
the operation of the scheme embodied in subsection (7A).
(8) The regulations may prescribe the circumstances in which an
approval under paragraph (1)(a) must not be given, including but
not limited to, circumstances relating to the following:
(a) therapeutic goods included in a specified class;
(b) therapeutic goods when used in the treatment of a specified
class of persons;
(c) therapeutic goods when used for a particular indication.
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Section 19A
(9) In this section, medical practitioner means a person who is
registered, in a State or internal Territory, as a medical practitioner.
19A Exemptions where unavailability etc. of therapeutic goods
(1) The Secretary may, by notice in writing, grant an approval to a
person for the importation into Australia, or the supply in
Australia, of specified therapeutic goods if the Secretary is satisfied
that:
(a) registered goods that could act as a substitute for the goods
are unavailable or are in short supply; and
(b) either:
(i) the goods that are the subject of the application are
registered or approved for general marketing in at least
one foreign country specified by the Secretary in a
determination under subsection (3); or
(ii) an application under section 23 has been made for
registration of the goods and the application has passed
preliminary assessment; and
(c) the goods are of a kind:
(i) included in Schedule 10 of the Therapeutic Goods
Regulations; or
(ii) specified by the Secretary in a determination under
subsection (4); and
(d) the approval is necessary in the interests of public health.
(1A) The Secretary may, by notice in writing, grant an approval to a
person for the importation into Australia, or the supply in
Australia, of specified therapeutic goods if the Secretary is satisfied
that:
(a) registered goods that could act as a substitute for the goods
are unavailable or are in short supply; and
(b) either:
(i) the goods that are the subject of the application are not
registered or approved for general marketing in any of
the foreign countries specified by the Secretary in a
determination under subsection (3); or
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(ii) the goods that are the subject of the application are
registered or approved for general marketing in at least
one foreign country specified by the Secretary in a
determination under subsection (3), but are not readily
available for importation into, and supply in, Australia;
and
(c) the goods are registered or approved for general marketing in
a foreign country; and
(d) the manufacturing and quality control procedures used in the
manufacture of the goods are acceptable; and
(e) the goods are of a kind:
(i) included in Schedule 10 of the Therapeutic Goods
Regulations; or
(ii) specified by the Secretary in a determination under
subsection (4); and
(f) the approval is necessary in the interests of public health.
(2) The Secretary may, by notice in writing, grant an approval to a
person for the importation into Australia, or the supply in
Australia, of specified therapeutic goods if the Secretary is satisfied
that:
(a) registered goods that could act as a substitute for the goods
do not exist; and
(b) an application under section 23 has been made for
registration of the goods; and
(ba) the application has passed preliminary assessment; and
(c) the goods are of a kind:
(i) included in Schedule 10 of the Therapeutic Goods
Regulations; or
(ii) specified by the Secretary in a determination under
subsection (4); and
(d) the approval is necessary in the interests of public health.
(3) The Secretary may, for the purposes of subparagraph (1)(b)(i),
make written determinations specifying the foreign countries in
which registration or approval for general marketing of the goods
is a prerequisite for approval by the Secretary under subsection (1).
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(4) The Secretary may make written determinations specifying the
kinds of goods that can be the subject of an approval under this
section.
(5) Determinations under subsections (3) and (4) are legislative
instruments.
(6) The Secretary may grant the approval subject to any conditions that
are specified in the notice of approval.
(7) The Secretary may grant the approval for such period as is
specified in the notice of approval.
(8) The approval lapses if:
(a) the period specified in the notice of approval expires; or
(b) a decision has been made under subsection 25(3) in relation
to the goods.
(9) The approval lapses if:
(a) the Secretary is satisfied that paragraph (1)(a), (b), (c) or (d),
paragraph (1A)(a), (b), (c), (d), (e) or (f), or paragraph (2)(a),
(b), (ba), (c) or (d), as the case requires, no longer applies in
relation to the goods, or that a condition of the approval has
been contravened; and
(b) the Secretary has given to the person to whom the approval
was granted a notice stating that the Secretary is so satisfied.
(10) The lapsing of the approval on the expiry of the period specified in
the notice of approval does not prevent another approval being
granted under this section in relation to the goods before the
lapsing of the first-mentioned approval. The other approval may be
expressed to take effect on the expiry of that period.
(11) An approval under subsection (1), (1A) or (2) is not a legislative
instrument.
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19B Criminal offences relating to registration or listing etc. of
imported, exported, manufactured and supplied
therapeutic goods
Offences relating to importing, exporting, manufacturing or
supplying goods for use in humans
(1) A person commits an offence if:
(a) the person:
(i) imports into Australia therapeutic goods for use in
humans; or
(ii) exports from Australia therapeutic goods for use in
humans; or
(iii) manufactures in Australia therapeutic goods for use in
humans; or
(iv) supplies in Australia therapeutic goods for use in
humans; and
(b) none of the following subparagraphs applies in relation to the
goods:
(i) the goods are registered goods or listed goods in relation
to the person;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority
under section 19;
(v) the goods are the subject of an approval under
section 19A; and
(c) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: A person may commit an offence against subsection 20(2A) or (2C),
or may contravene section 22AA (a civil penalty provision), by
importing into Australia therapeutic goods that are exempt under
section 18A.
Note 3: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person:
(i) imports into Australia therapeutic goods for use in
humans; or
(ii) exports from Australia therapeutic goods for use in
humans; or
(iii) manufactures in Australia therapeutic goods for use in
humans; or
(iv) supplies in Australia therapeutic goods for use in
humans; and
(b) none of the following subparagraphs applies in relation to the
goods:
(i) the goods are registered goods or listed goods in relation
to the person;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority
under section 19;
(v) the goods are the subject of an approval under
section 19A.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person:
(i) imports into Australia therapeutic goods for use in
humans; or
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(ii) exports from Australia therapeutic goods for use in
humans; or
(iii) manufactures in Australia therapeutic goods for use in
humans; or
(iv) supplies in Australia therapeutic goods for use in
humans; and
(b) none of the following subparagraphs applies in relation to the
goods:
(i) the goods are registered goods or listed goods in relation
to the person;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority
under section 19;
(v) the goods are the subject of an approval under
section 19A.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Defence if person was not the sponsor of the goods
(5) It is a defence to a prosecution under subsection (1), (4) or (4A) if
the defendant proves that the defendant was not the sponsor of the
goods at the time of the importation, exportation, manufacture or
supply, as the case may be.
Note: The defendant bears a legal burden in relation to the matter in
subsection (5): see section 13.4 of the Criminal Code.
Exception
(6) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or efficacy of the goods; or
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Section 19C
(ii) a matter relating to the labelling or packaging of the
goods; or
(iii) the improper use of the goods; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or efficacy of the goods; or
(ii) a matter relating to the labelling or packaging of the
goods; or
(iii) the improper use of the goods.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (6): see subsection 13.3(3) of the Criminal Code.
Application of Customs Act 1901
(7) Where:
(a) the importation or exportation of goods is an offence under
subsection (1), (4) or (4A); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the goods included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
19C Notice required to adduce evidence in support of exception
under subsection 19B(6)
(1) If:
(a) a defendant is committed for trial for an offence against
subsection 19B(1); or
(b) an offence against subsection 19B(1) is to be heard and
determined by a court of summary jurisdiction;
the committing magistrate or the court must:
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(c) inform the defendant of the requirements of this section; and
(d) cause a copy of this section to be given to the defendant.
(2) A defendant must not, without leave of the court, adduce evidence
in support of the exception under subsection 19B(6) unless:
(a) if paragraph (1)(a) applies—more than 21 days before the
trial begins; or
(b) if paragraph (1)(b) applies—more than 21 days before the
hearing of the offence begins;
he or she gives notice of particulars of the exception.
(3) A defendant must not, without leave of the court, call any other
person to give evidence in support of the exception unless:
(a) the notice under subsection (2) includes the name and
address of the person or, if the name and address is not
known to the defendant at the time he or she gives the notice,
any information in his or her possession that might be of
material assistance in finding the person; and
(b) if the name or the address is not included in the notice—the
court is satisfied that the defendant before giving the notice
took, and after giving the notice continued to take, all
reasonable steps to ascertain the name or address; and
(c) if the name or address is not included in the notice, but the
defendant subsequently ascertains the name or address or
receives information that might be of material assistance in
finding the person—the defendant immediately gives notice
of the name, address or other information, as the case may
be; and
(d) if the defendant is told by or on behalf of the prosecutor that
the person has not been found by the name, or at the address,
given by the defendant:
(i) the defendant immediately gives notice of any
information in the defendant’s possession that might be
of material assistance in finding the person; or
(ii) if the defendant later receives any such information—
the defendant immediately gives notice of the
information.
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Section 19D
(4) A notice purporting to be given under this section on behalf of the
defendant by his or her legal practitioner is, unless the contrary is
proved, taken as having been given with the authority of the
defendant.
(5) Any evidence tendered to disprove that the exception applies may,
subject to direction by the court, be given before or after evidence
is given in support of the exception.
(6) A notice of particulars of the exception must be given, in writing,
to the Director of Public Prosecutions. A notice is taken as having
been given if it is:
(a) delivered to or left at the Office of the Director of Public
Prosecutions; or
(b) sent by certified mail addressed to the Director of Public
Prosecutions at the Office of the Director of Public
Prosecutions.
(7) In this section:
Director of Public Prosecutions means a person holding office as,
or acting as, the Director of Public Prosecutions under the Director
of Public Prosecutions Act 1983.
19D Civil penalties relating to registration or listing etc. of imported,
exported, manufactured and supplied therapeutic goods
Civil penalty relating to importing, exporting, manufacturing or
supplying goods for use in humans
(1) A person contravenes this subsection if:
(a) the person does any of the following:
(i) imports into Australia therapeutic goods for use in
humans;
(ii) exports from Australia therapeutic goods for use in
humans;
(iii) manufactures in Australia therapeutic goods for use in
humans;
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(iv) supplies in Australia therapeutic goods for use in
humans; and
(b) none of the following subparagraphs applies in relation to the
goods:
(i) the goods are registered goods or listed goods in relation
to the person;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority
under section 19;
(v) the goods are the subject of an approval under
section 19A.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Note: A person may commit an offence against subsection 20(2A) or (2C),
or may contravene section 22AA (a civil penalty provision), by
importing into Australia therapeutic goods that are exempt under
section 18A.
Exception if person was not the sponsor of the goods
(2) Subsection (1) does not apply if the person proves that he or she
was not the sponsor of the goods at the time of the importation,
exportation, manufacture or supply, as the case may be.
Civil penalty relating to the importing of registered or listed goods
(3) A person contravenes this subsection if:
(a) therapeutic goods are registered or listed in relation to the
person (other than listed goods that are therapeutic devices);
and
(b) the person imports the goods into Australia; and
(c) the registration number or listing number of the goods is not
set out on the label of the goods in the prescribed manner
before the goods are supplied in Australia.
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Maximum civil penalty:
(a) for an individual—200 penalty units; and
(b) for a body corporate—2,000 penalty units.
Civil penalty relating to the supply of registered or listed goods
(4) A person contravenes this subsection if:
(a) therapeutic goods are registered or listed in relation to the
person (other than listed goods that are therapeutic devices);
and
(b) the person supplies the goods in Australia; and
(c) the registration number or listing number of the goods is not
set out on the label of the goods in the prescribed manner.
Maximum civil penalty:
(a) for an individual—200 penalty units; and
(b) for a body corporate—2,000 penalty units.
Application of Customs Act 1901
(5) Where:
(a) the importation or exportation of goods contravenes
subsection (1); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the goods included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
20 Criminal offences relating to notifying the Secretary and to
importing goods exempt under section 18A
(1B) A person commits an offence if:
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(a) the person is the sponsor of therapeutic goods for use in
humans; and
(b) the person:
(i) imports the goods into Australia; or
(ii) exports the goods from Australia; or
(iii) manufactures the goods in Australia; or
(iv) supplies the goods in Australia; and
(c) the person has not, at the time of the importation, export,
manufacture or supply, properly notified to the Secretary
either or both of the following:
(i) the manufacturer of the goods;
(ii) premises used in the manufacture of the goods.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(1BA) A person commits an offence if:
(a) the person is the sponsor of therapeutic goods for use in
humans; and
(b) the person:
(i) imports the goods into Australia; or
(ii) exports the goods from Australia; or
(iii) manufactures the goods in Australia; or
(iv) supplies the goods in Australia; and
(c) the person has not, at the time of the importation, export,
manufacture or supply, properly notified to the Secretary
either or both of the following:
(i) the manufacturer of the goods;
(ii) premises used in the manufacture of the goods.
Penalty: 100 penalty units.
(1BB) An offence against subsection (1BA) is an offence of strict
liability.
(1C) For the purposes of paragraphs (1B)(c) and (1BA)(c):
(a) a manufacturer is properly notified to the Secretary if:
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(i) the manufacturer was nominated, as a manufacturer of
the goods, in an application for the registration or listing
of the goods; or
(ii) the Secretary was subsequently informed in writing that
the manufacturer is a manufacturer of the goods; and
(b) premises are properly notified to the Secretary if:
(i) the premises were nominated, as premises used in the
manufacture of the goods, in an application for the
registration or listing of the goods; or
(ii) the Secretary was subsequently informed in writing that
the premises are used in the manufacture of the goods.
(2A) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
(b) the goods are exempt under section 18A; and
(c) the importation breaches a condition of the exemption.
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
(2B) Strict liability applies to paragraph (2A)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(2C) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
(b) the goods are exempt under section 18A; and
(c) the importation breaches a condition of the exemption.
Penalty: 60 penalty units.
(2D) An offence under subsection (2C) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
20A Civil penalty relating to the importation, exportation,
manufacture or supply of sponsored goods without
proper notification
(1) A person contravenes this section if:
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(a) the person does any of the following:
(i) imports therapeutic goods into Australia;
(ii) exports therapeutic goods from Australia;
(iii) manufactures therapeutic goods in Australia;
(iv) supplies therapeutic goods in Australia; and
(b) the person is the sponsor of the goods for use in humans; and
(c) the person has not, at or before the time of the importation,
exportation, manufacture or supply, properly notified to the
Secretary either or both of the following:
(i) the manufacturer of the goods;
(ii) premises used in the manufacture of the goods.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Meaning of properly notified
(2) For the purposes of paragraph (1)(c):
(a) a manufacturer is properly notified to the Secretary if:
(i) the manufacturer was nominated, as a manufacturer of
the goods, in an application for the registration or listing
of the goods; or
(ii) the Secretary was subsequently informed in writing that
the manufacturer is a manufacturer of the goods; and
(b) premises are properly notified to the Secretary if:
(i) the premises were nominated, as premises used in the
manufacture of the goods, in an application for the
registration or listing of the goods; or
(ii) the Secretary was subsequently informed in writing that
the premises are used in the manufacture of the goods.
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21 Offence relating to wholesale supply
A person must not supply in Australia therapeutic goods for use in
humans (other than listable devices), being goods of which the
person is not a sponsor, to another person who is not the ultimate
consumer of the goods unless:
(a) the goods are registered goods or listed goods; or
(b) the goods are exempt goods; or
(ba) the goods are exempt under section 18A; or
(c) the goods are the subject of an approval or authority under
section 19; or
(d) the goods are the subject of an approval under section 19A.
Penalty: 120 penalty units.
21A General criminal offences relating to this Part
Offences for making a false or misleading statement
(1) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a certification
of any matter under subsection 26A(2) or 26AB(2); and
(c) the statement is false or misleading in a material particular;
and
(d) either:
(i) the use of the medicine has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the medicine, if the medicine were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
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Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a certification
of any matter under subsection 26A(2) or 26AB(2); and
(c) the statement is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a certification
of any matter under subsection 26A(2) or 26AB(2); and
(c) the statement is false or misleading in a material particular.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Offences relating to breaching a condition of registration or listing
of therapeutic goods
(5) A person commits an offence if:
(a) therapeutic goods are registered or listed in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the registration or
listing of the goods; and
(d) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (8) instead:
see section 53A.
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Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(8) A person commits an offence if:
(a) therapeutic goods are registered or listed in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the registration or
listing of the goods.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(8A) A person commits an offence if:
(a) therapeutic goods are registered or listed in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the registration or
listing of the goods.
Penalty: 100 penalty units.
(8B) An offence against subsection (8A) is an offence of strict liability.
Offences relating to the supply of therapeutic goods in breach of
authority etc.
(9) A person commits an offence if:
(a) the Secretary has authorised, under subsection 19(5), the
person to supply therapeutic goods; and
(b) the person supplies those goods; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority; or
(ii) the supply is not in accordance with the conditions to
which the authority is subject; or
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 19(7); and
(d) either:
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(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because:
(i) the supply is not in accordance with the authority; or
(ii) the supply is not in accordance with the conditions to
which the authority is subject; or
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 19(7).
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(9A) A person commits an offence if:
(a) the Secretary has authorised, under subsection 19(5), the
person to supply therapeutic goods; and
(b) the person supplies those goods; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority;
(ii) the supply is not in accordance with the conditions to
which the authority is subject;
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 19(7).
Penalty: 500 penalty units.
(10) A person commits an offence if:
(a) the Secretary has authorised, under subsection 19(5), the
person to supply therapeutic goods; and
(b) the person supplies those goods; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority;
(ii) the supply is not in accordance with the conditions to
which the authority is subject;
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(iii) the supply is not in accordance with regulations made
for the purpose of subsection 19(7).
Penalty: 100 penalty units.
(11) An offence against subsection (10) is an offence of strict liability.
(11A) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 19(7A) rules; and
(c) the person supplies:
(i) therapeutic goods specified in those rules; or
(ii) therapeutic goods included in a class of therapeutic
goods specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules; and
(e) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(f) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because:
(i) the supply is not in accordance with those rules; or
(ii) the supply is not in the circumstances specified in those
rules; or
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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(11C) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 19(7A) rules; and
(c) the person supplies:
(i) therapeutic goods specified in those rules; or
(ii) therapeutic goods included in a class of therapeutic
goods specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: 500 penalty units.
(11D) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 19(7A) rules; and
(c) the person supplies:
(i) therapeutic goods specified in those rules; or
(ii) therapeutic goods included in a class of therapeutic
goods specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: 100 penalty units.
(11E) An offence against subsection (11D) is an offence of strict liability.
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Offences relating to using therapeutic goods without approval etc.
(12) A person commits an offence if:
(a) the person uses therapeutic goods; and
(b) the goods are used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) the goods are not:
(i) exempt goods; or
(ii) listed goods; or
(iii) registered goods; or
(iv) goods exempt under section 18A; or
(v) goods that are the subject of an approval under
section 19A; and
(d) the goods are not used in accordance with:
(i) an approval or authority under section 19; or
(ii) a condition applicable under regulations made for the
purposes of subsection 19(4A); and
(e) either:
(i) if the person used the goods in the treatment of another
person—the use of the goods has resulted in, will result
in, or is likely to result in, harm or injury to that person;
or
(ii) if the person used the goods solely for experimental
purposes in humans—the use of the goods has resulted
in, will result in, or is likely to result in, harm or injury
to any of those persons.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(12A) A person commits an offence if:
(a) the person uses therapeutic goods; and
(b) the goods are used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) the goods are not:
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(i) exempt goods; or
(ii) listed goods; or
(iii) registered goods; or
(iv) goods exempt under section 18A; or
(v) goods that are the subject of an approval under
section 19A; and
(d) the goods are not used in accordance with:
(i) an approval or authority under section 19; or
(ii) a condition applicable under regulations made for the
purposes of subsection 19(4A).
Penalty: 500 penalty units.
(13) A person commits an offence if:
(a) the person uses therapeutic goods; and
(b) the goods are used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) the goods are not:
(i) exempt goods; or
(ii) listed goods; or
(iii) registered goods; or
(iv) goods exempt under section 18A; or
(v) goods that are the subject of an approval under
section 19A; and
(d) the goods are not used in accordance with:
(i) an approval or authority under section 19; or
(ii) a condition applicable under regulations made for the
purposes of subsection 19(4A).
Penalty: 100 penalty units.
(14) An offence against subsection (13) is an offence of strict liability.
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21B General civil penalties relating to this Part
Civil penalty for making a false or misleading statement
(1) A person contravenes this subsection if the person, in or in
connection with a certification of any matter under
subsection 26A(2) or 26AB(2), makes a statement that is false or
misleading in a material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Civil penalty relating to breaching a condition of registration or
listing of therapeutic goods
(2) A person contravenes this subsection if:
(a) therapeutic goods are registered or listed in relation to the
person; and
(b) the person does an act or omits to do an act that breaches a
condition of the registration or listing of the goods.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Civil penalty for falsely representing therapeutic goods
(3) A person contravenes this subsection if:
(a) the person represents therapeutic goods that are not included
in the Register as being so included; or
(b) the person represents therapeutic goods that are not exempt
goods as being exempt goods; or
(c) the person represents therapeutic goods that are not goods
exempt under section 18A as being goods exempt under that
section; or
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(d) the person represents therapeutic goods that are included in
one part of the Register as being included in another part of
the Register; or
(e) the person represents therapeutic goods that are not the
subject of an approval or authority under section 19 as being
the subject of such an approval or authority; or
(f) the person represents therapeutic goods that are not the
subject of an approval under section 19A as being the subject
of such an approval.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Civil penalty for advertising therapeutic goods for an indication
(4) A person contravenes this subsection if:
(a) the person, by any means, advertises therapeutic goods for an
indication; and
(b) the therapeutic goods are included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
22 General offences relating to this Part
(1) A person must not set out or cause to be set out, on a container or
package that contains therapeutic goods or on a label of goods of
that kind, a number that purports to be the registration number or
listing number of the goods in relation to a particular person if the
number is not that number.
Penalty: 60 penalty units.
(2) A person commits an offence if:
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(a) the person, by any means, advertises therapeutic goods for an
indication; and
(b) the therapeutic goods are included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion; and
(d) either:
(i) the use of the goods for the advertised indication has
resulted in, will result in, or is likely to result in, harm
or injury to any person; or
(ii) the use of the goods for the advertised indication, if the
goods were so used, would result in, or would be likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(3) A person commits an offence if:
(a) the person, by any means, advertises therapeutic goods for an
indication; and
(b) the therapeutic goods are included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person, by any means, advertises therapeutic goods for an
indication; and
(b) the therapeutic goods are included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Penalty: 100 penalty units.
(5A) An offence against subsection (5) is an offence of strict liability.
(6) A person commits an offence if:
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(a) the person claims, by any means, that the person or another
person can arrange the supply of therapeutic goods; and
(b) none of the following subparagraphs applies in relation to the
goods:
(i) the goods are registered goods or listed goods;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority
under section 19 that covers the supply of the goods by
the person or other person;
(v) the goods are the subject of an approval under
section 19A that covers the supply of the goods by the
person or other person.
Penalty: 60 penalty units.
(7) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of:
(i) a condition of an exemption applicable under
regulations made for the purposes of subsection 18(1);
or
(ii) a condition of an approval under section 19; or
(iii) a condition applicable under regulations made for the
purposes of subsection 19(4A); or
(iv) a condition of an approval under section 19A.
(7AA) An offence against subsection (7) is punishable on conviction by a
fine of not more than 60 penalty units.
(7AB) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to
therapeutic goods; and
(b) the goods are exempt under section 18A; and
(c) the act or omission results in the breach of a condition of the
exemption; and
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(d) the act or omission is likely to cause a serious risk to public
health.
Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.
Note 1: A person may commit an offence against subsection 20(2A) or (2C),
or contravene section 22AA (a civil penalty provision), by breaching a
condition of an exemption of therapeutic goods under section 18A that
relates to the importation of the goods.
Note 2: A person may commit an offence against subsection 30H(1) or (3) by
breaching a condition of an exemption of therapeutic goods under
section 18A that relates to records about the goods.
Note 3: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(7AC) Strict liability applies to paragraph (7AB)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(7AD) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to
therapeutic goods; and
(b) the goods are exempt under section 18A; and
(c) the act or omission results in the breach of a condition of the
exemption.
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
(7AE) Strict liability applies to paragraph (7AD)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
22AA Civil penalty for breaching a condition of an exemption
A person contravenes this section if:
(a) the person does an act or omits to do an act in relation to
therapeutic goods; and
(b) the goods are exempt under section 18A; and
(c) the act or omission breaches a condition of the exemption.
Maximum civil penalty:
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(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
22A Criminal offences for false statements in applications for
registration
(1) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with an application
for registration of therapeutic goods; and
(c) the statement is false or misleading in a material particular;
and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with an application
for registration of therapeutic goods; and
(c) the statement is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person makes a statement; and
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(b) the statement is made in or in connection with an application
for registration of therapeutic goods; and
(c) the statement is false or misleading in a material particular.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
22B Civil penalty for false statements in applications for registration
A person contravenes this section if the person in or in connection
with an application for registration of therapeutic goods, makes a
statement that is false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Provisional determinations for medicine Division 1A
Section 22C
Division 1A—Provisional determinations for medicine
22C Applications for provisional determination
(1) A person may make an application to the Secretary for a
provisional determination relating to a medicine of a kind
prescribed by the regulations for the purposes of this subsection.
Note: If the Secretary makes the determination, the person applies under
section 23 for registration of the medicine and that application passes
preliminary assessment, then a different kind of evaluation of the
medicine will occur under section 25.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved, in writing, by
the Secretary; and
(b) be accompanied by the prescribed application fee; and
(c) contain the information that the form requires, and any
further information, statement or document the Secretary
requires, whether in the form or otherwise; and
(d) satisfy any other requirement prescribed by the regulations
for the purposes of this paragraph.
(3) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
22D Provisional determinations
(1) If a person makes an application, in accordance with
subsection 22C(2), for a provisional determination relating to a
medicine, the Secretary must decide to make, or to refuse to make,
the determination.
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Section 22E
Criteria
(2) The Secretary may make the determination if the Secretary is
satisfied that the criteria prescribed by the regulations for the
purposes of this subsection are met in relation to the medicine.
Content of determination
(3) The determination must specify:
(a) the person to whom the determination relates; and
(b) the medicine to which the determination relates; and
(c) the indication of the medicine to which the determination
relates; and
(d) each active ingredient of the medicine to which the
determination relates.
The determination may specify any other matters that the Secretary
considers appropriate.
Notice of decision
(4) As soon as practicable after making the decision, the Secretary
must:
(a) give the person written notice of the decision; and
(b) if the Secretary refuses to make the determination—set out
the reasons for the refusal in the notice.
22E Period during which provisional determination is in force
(1) A provisional determination under section 22D relating to a
medicine:
(a) comes into force on the day on which the Secretary gives the
person notice under subsection 22D(4); and
(b) subject to this section and section 22F, remains in force for
the initial period.
Note: For revocation of the determination, see section 22F.
(2) The initial period is 6 months or another period prescribed by the
regulations for the purposes of this subsection.
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Section 22E
Extensions
(3) The person may make an application to the Secretary to extend the
initial period.
(4) The application must:
(a) be in a form approved, in writing, by the Secretary; and
(b) be made at least 28 days before the determination would
otherwise cease to be in force; and
(c) be accompanied by the prescribed application fee.
(5) On receiving the application, the Secretary must decide to extend,
or to refuse to extend, the initial period.
(6) The Secretary may extend the initial period by 6 months, or
another period prescribed by the regulations for the purposes of
this subsection, if the Secretary:
(a) is still satisfied that the criteria prescribed by the regulations
for the purposes of subsection 22D(2) are met in relation to
the medicine; and
(b) is satisfied that, if the Secretary were to make the extension,
the person would make an application under section 23 for
provisional registration of the medicine before the end of the
extended period.
(7) As soon as practicable after making the decision, the Secretary
must:
(a) give the person written notice of the decision; and
(b) if the Secretary refuses to extend the initial period—set out
the reasons for the refusal in the notice.
(8) Only one extension may be given.
Effect of application under section 23
(9) If the person to whom the provisional determination relates makes
an application under section 23 for provisional registration of the
medicine before the end of the initial period (or that period as
extended), the determination remains in force until:
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Section 22F
(a) the person withdraws the application; or
(b) the application lapses in accordance with subsection 24(2); or
(c) the person gives the Secretary written notice under
subsection 24E(2) that the person wishes to treat the
application as having been refused; or
(d) the application is finally determined.
(10) For the purposes of paragraph (9)(d), an application is finally
determined when the application, and any applications for review
or appeals arising out of it, have been finally determined or
otherwise disposed of.
22F Revocation of provisional determination
Revocation on Secretary’s own initiative
(1) The Secretary may revoke a provisional determination under
section 22D relating to a person and a medicine if the Secretary is
satisfied that the criteria prescribed by the regulations for the
purposes of subsection 22D(2) are no longer met in relation to the
medicine.
Revocation on request
(2) The Secretary must revoke a provisional determination under
section 22D relating to a person and a medicine if the person
requests the Secretary, in writing, to do so.
Notice of revocation
(3) As soon as practicable after making a revocation under this section,
the Secretary must:
(a) give the person written notice of the revocation; and
(b) for a revocation under subsection (1)—set out the reasons for
the revocation in the notice.
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Section 22F
Day revocation takes effect
(4) A revocation under this section takes effect on the day on which
the Secretary gives the person notice of the revocation.
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Section 23
Division 2—Registration and listing
23 Applications generally
A person may make an application to the Secretary for registration
or listing of therapeutic goods.
23AA Applications for provisional registration of medicine
If:
(a) a person makes an application under section 23 for the
registration of a medicine; and
(b) a provisional determination under section 22D relating to the
person, the medicine and the indication to which the
application relates is in force when the application is made;
then, for the purposes of this Act, the application is taken to be an
application for provisional registration of the medicine.
23A Classes of therapeutic goods
The Secretary may, by notifiable instrument, specify different
classes of therapeutic goods for the purposes of section 23B.
23B Requirements relating to applications for registration of
therapeutic goods and listing of medicines under
section 26AE
(1) If an application is made under section 23 for:
(a) registration of therapeutic goods (including an application for
provisional registration of a medicine); or
(b) the listing of a medicine under section 26AE;
the Secretary must carry out an assessment of whether the
requirements set out in subsection (2) have been met in relation to
the application.
(2) The requirements are as follows:
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(a) the application must be made:
(i) in accordance with the form approved, in writing, by the
Secretary for that class of therapeutic goods; or
(ii) in such other manner as is approved, in writing, by the
Secretary for that class of therapeutic goods;
(b) the prescribed application fee for that class of therapeutic
goods must be paid;
(c) the application must be delivered to an office of the
Department specified by the Secretary;
(d) the application must be accompanied by information that is:
(i) of a kind determined under subsection (9) for that class
of therapeutic goods; and
(ii) in a form determined under subsection (10) for that
class of therapeutic goods;
(e) if the application is for the registration of restricted
medicine—the application must be accompanied by product
information, in relation to the medicine, that is in the form
approved under section 7D in relation to the medicine;
(f) if the Secretary so requires—the applicant must:
(i) deliver to the Department a reasonable number of
samples of the goods; and
(ii) do so in a manner approved, in writing, by the
Secretary.
Passing preliminary assessment
(3) An application passes preliminary assessment if the Secretary:
(a) has carried out an assessment, under subsection (1), in
relation to the application; and
(b) is satisfied that the requirements set out in subsection (2)
have been met in relation to the application.
(4) If the application has passed preliminary assessment, the Secretary
must give a written notice to the applicant stating that the
application has passed preliminary assessment.
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(5) Subsection (4) does not apply if the period within which the
Secretary must, under section 25, evaluate the goods to which the
application relates is prescribed by reference to the prescribed
period within which the Secretary is required to consider an
application under subsection 9D(3) to vary an entry in the Register.
(6) If the application has not passed preliminary assessment, the
Secretary must, by written notice given to the applicant, refuse the
application.
Approval of forms etc.
(7) For the purposes of paragraph (2)(a), the Secretary may approve
different forms and different manners for making applications for
different classes of therapeutic goods that are specified under
section 23A.
(8) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Determination of kinds and forms of information
(9) The Secretary may, by legislative instrument, determine a kind of
information for the purposes of the application of
subparagraph (2)(d)(i) to a class of therapeutic goods that is
specified under section 23A.
(10) The Secretary may, by legislative instrument, determine a form of
information for the purposes of the application of
subparagraph (2)(d)(ii) to a class of therapeutic goods that is
specified under section 23A.
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23C Requirements relating to applications for listing of therapeutic
goods under section 26 or 26A
(1) This section applies if an application is made under section 23 for
listing of therapeutic goods under section 26 or 26A.
(2) The application complies with this section if:
(a) the application is made in accordance with a form approved,
in writing, by the Secretary or in such other manner as is
approved, in writing, by the Secretary for the purposes of this
paragraph; and
(b) the application is delivered to an office of the Department
specified by the Secretary; and
(c) the prescribed application fee has been paid; and
(d) the applicant has delivered to the office to which the
application was made such information, in a form approved,
in writing, by the Secretary, as will allow the determination
of the application; and
(e) if the Secretary so requires—the applicant has delivered to
the office to which the application was made a reasonable
number of samples of the goods.
Note: To be listed, an application must comply with this section: see
sections 26, 26AA, 26A and 26AB.
(3) The Secretary may, by legislative instrument, determine forms of
information for the purposes of the application of paragraph (2)(d).
(4) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
24 Applications for registration
(1) This section applies if:
(a) an application is made for the registration of therapeutic
goods under section 23; and
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(b) the goods are goods that are required to be registered; and
(c) the application has passed preliminary assessment.
(1A) A fee specified in, or determined in accordance with, the
regulations is payable by the applicant in respect of the evaluation
of the goods for registration, and the Secretary must notify each
such applicant of the amount of the evaluation fee.
(2) An application for registration of therapeutic goods lapses if:
(a) any part of the evaluation fee payable in respect of those
goods remains unpaid at the end of the period of 2 months
after the day on which the amount became due and payable;
or
(b) the application contains information that is inaccurate or
misleading in a material particular; or
(c) information given to the Secretary by, or on behalf of, the
applicant in connection with the application, including
information given for the purpose of a requirement under
section 31, is inaccurate or misleading in a material
particular; or
(d) the applicant fails to comply with a requirement under
section 31 to give information consisting of individual patient
data in relation to the goods.
(3) In this section, individual patient data, in relation to therapeutic
goods, means information, derived from clinical trials, relating to
individuals before, during and after the administration of the goods
to those individuals, including, but not limited to, demographic,
biochemical and haematological information.
24A When evaluation fee due for payment
Subject to section 24B, an evaluation fee under section 24 payable
by an applicant is due and payable on the day on which the
applicant is notified of the amount of the evaluation fee.
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24B Payment of evaluation fee by instalments
(1) The regulations may provide for the payment of an evaluation fee
under section 24 to be made by such instalments and at such times
as are ascertained in accordance with the regulations, and the
evaluation fee is due and payable accordingly.
(2) Regulations made for the purposes of subsection (1) may provide
that a person is not allowed to pay an evaluation fee under section 24
by instalments if any part of an instalment of:
(a) that or any other evaluation fee under section 24 payable by
the person; or
(b) any assessment fee under section 41LA payable by the
person;
was unpaid immediately after the time when it became due for
payment.
(3) Subsection (2) does not limit the generality of subsection (1).
24C Recovery of evaluation fee
An evaluation fee under section 24 may be recovered by the
Commonwealth as a debt due to the Commonwealth.
24D Refund of evaluation fee where evaluation not completed within
prescribed period
(1) This section applies to an application under section 23 in relation
to therapeutic goods for the evaluation of which a period is
prescribed under paragraph 63(2)(da).
(2) If:
(a) the applicant has paid the whole of the evaluation fee; and
(b) the evaluation is completed, but not within the period
referred to in subsection (1);
then 25% of the evaluation fee must be refunded to the applicant.
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(3) For the purposes of subsection (2), the evaluation is taken to be
completed when the applicant is notified of the Secretary’s
decision under subsection 25(3) in relation to the goods.
24E Deemed refusal of application
(1) This section applies in the case of an application under section 23
in relation to therapeutic goods for the evaluation of which a period
is prescribed under paragraph 63(2)(da).
(2) If, at the end of the period referred to in subsection (1), the
evaluation has not been completed, the applicant may give the
Secretary written notice that the applicant wishes to treat the
application as having been refused.
(3) A notice under subsection (2) may be given at any time before the
evaluation is completed.
(4) Where a notice has been given, this Act (except for subsection 60(5))
has effect as if:
(a) the Secretary had decided not to register the goods the
subject of the application; and
(b) the Minister had made a decision under subsection 60(3)
confirming the decision of the Secretary; and
(c) the Minister’s decision had been made on the day on which
notice was given to the Secretary under subsection (2).
25 Evaluation of therapeutic goods
(1) If:
(a) an application is made for the registration of therapeutic
goods in relation to a person under section 23; and
(b) the application has passed preliminary assessment;
the Secretary must evaluate the goods for registration having
regard to:
(c) unless the application is one referred to in paragraph (d)—
whether the quality, safety and efficacy of the goods for the
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purposes for which they are to be used have been
satisfactorily established; and
(d) for an application for provisional registration of a medicine:
(i) whether, based on preliminary clinical data, the safety
and efficacy of the medicine for the purposes for which
it is to be used have been satisfactorily established; and
(ii) whether the quality of the medicine for the purposes for
which it is to be used has been satisfactorily established;
and
(iii) whether, if the Secretary were to register the medicine,
the Secretary is satisfied with the applicant’s plan to
submit comprehensive clinical data on the safety and
efficacy of the medicine before the end of the 6 years
that would start on the day that registration would
commence; and
(da) if:
(i) the applicant is applying for the registration of restricted
medicine; or
(ii) the applicant is applying for the registration of medicine
(other than restricted medicine) and the applicant has
been given a notice in writing by the Secretary requiring
the applicant to give to the Secretary product
information, in relation to the medicine, that is in the
form approved under section 7D in relation to the
medicine;
the product information given by the applicant in relation to
the medicine; and
(e) whether the presentation of the goods is acceptable; and
(f) whether the goods conform to any standard applicable to the
goods; and
(fa) whether:
(i) the applicable provisions of the Therapeutic Goods
Advertising Code; and
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or the regulations;
are complied with in relation to the goods; and
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(g) if a step in the manufacture of the goods has been carried out
outside Australia—whether the manufacturing and quality
control procedures used in the manufacture of the goods are
acceptable; and
(h) if the goods have been manufactured in Australia—whether
the goods have been manufactured in accordance with
Part 3-3; and
(j) whether the goods contain substances that are prohibited
imports for the purposes of the Customs Act 1901; and
(ja) whether all of the manufacturers of the goods are nominated
as manufacturers of the goods in the application; and
(k) such other matters (if any) as the Secretary considers
relevant.
Note: The Secretary must not use protected information when evaluating
therapeutic goods for registration: see section 25A.
(2) In making a decision for the purposes of paragraph (1)(g), the
matters that may be taken into account include:
(a) whether the applicant has provided:
(i) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a
country that is a member of the European Community
or a member of EFTA—an EC/EFTA attestation of
conformity in relation to the goods; or
(ia) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a
country declared by the Minister under section 3B to be
covered by a non-EC/EFTA MRA—a non-EC/EFTA
attestation of conformity, for the non-EC/EFTA MRA,
in relation to the goods; or
(ii) in any other case—an acceptable form of evidence from
a relevant overseas authority establishing that the
manufacture of the goods is of an acceptable standard;
and
(b) whether the applicant has agreed to provide, where the
Secretary considers inspection of the manufacturing
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procedures used in the manufacture of the goods to be
necessary:
(i) funds for the carrying out of that inspection by the
Department; and
(ii) evidence that the manufacturer has agreed to such an
inspection.
(2A) An evaluation under this section of goods in relation to which a
period has been prescribed under paragraph 63(2)(da) must be
completed within that period.
(2B) If therapeutic goods are exempt from the operation of Part 3-3 or a
person is exempt from the operation of that Part in relation to the
manufacture of the goods, subsection (1) has effect, in relation to
the goods, as if paragraph (h) were omitted.
(2C) If a person is exempt from the operation of Part 3-3 in relation to a
step in the manufacture of therapeutic goods, subsection (1) has
effect, in relation to the goods, as if the reference in paragraph (h)
to Part 3-3 were a reference to that Part to the extent that it applies
to that person in relation to the manufacture of the goods.
(2D) If:
(a) therapeutic goods were made outside Australia; and
(b) had the goods been made in Australia, they would have been
exempt from the operation of Part 3-3;
subsection (1) has effect, in relation to the goods, as if
paragraph (g) were omitted.
(2E) A decision for the purposes of paragraph (1)(g) may also take into
account any information provided to the Secretary by a health
authority of a Convention country and relating to:
(a) the general standards of manufacturing practice of a
particular manufacturer; or
(b) the specific standards of manufacture or control adopted by a
particular manufacturer in relation to particular goods.
(2F) For the purposes of subsection (2E), a Convention country is a
country that is a party to the Mutual Recognition Convention.
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(2G) Information referred to in subsection (2E) and provided in
accordance with the Mutual Recognition Convention is to be
treated as equivalent to information obtained as a result of an
inspection under Part 3-3 of this Act.
(3) After an evaluation under this section of goods has been
completed, the Secretary must decide:
(a) to register the goods; or
(b) not to register the goods.
Note: See also sections 25AA (approved product information for medicine),
25AB (registration of therapeutic goods) and 25AC (notice of decision
not to register therapeutic goods).
25AAA Therapeutic goods (priority applicant) determinations
(1) The regulations may make provision for and in relation to
empowering the Secretary to make therapeutic goods (priority
applicant) determinations.
(2) A therapeutic goods (priority applicant) determination is a
determination that, for the purposes of this Act, a specified person
is a priority applicant in relation to any section 23 application that
may be made by the person for the registration of therapeutic
goods specified in the determination.
(3) The regulations may make provision for and in relation to the
following matters:
(a) applications for therapeutic goods (priority applicant)
determinations;
(b) the approval by the Secretary of a form for such an
application;
(c) information that must accompany such an application;
(d) the application fee for such an application;
(e) empowering the Secretary to give the applicant a written
notice requiring the applicant to give to the Secretary
specified information or documents in connection with the
application within a specified period (which must be at least
10 working days after the notice is given to the applicant).
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(4) The regulations may make provision for and in relation to the
following matters:
(a) empowering the Secretary to revoke a therapeutic goods
(priority applicant) determination;
(b) the consequences of the revocation of a therapeutic goods
(priority applicant) determination.
(5) Subsections (3) and (4) do not limit subsection (1).
(6) A period prescribed under paragraph 63(2)(da) for the evaluation
of therapeutic goods covered by a section 23 application for which
the applicant is a priority applicant may be shorter than the period
prescribed under that paragraph for the evaluation of therapeutic
goods covered by a section 23 application for which the applicant
is not a priority applicant.
(7) The regulations may provide that, if:
(a) a person is a priority applicant in relation to a section 23
application made by the person; and
(b) a decision is made on the application;
a statement setting out the decision may be published on the
Department’s website.
(8) The express references in this section to the Secretary do not, by
implication, prevent the regulations from empowering the
Secretary to delegate any or all of the Secretary’s functions or
powers under regulations made for the purposes of this section.
(9) If a therapeutic goods (priority applicant) determination is in force
under the regulations, the determination may be published on the
Department’s website.
(10) A therapeutic goods (priority applicant) determination made under
the regulations is not a legislative instrument.
(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not
apply to the specification of a person in a therapeutic goods
(priority applicant) determination.
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Note: Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with
specification by class.
25AA Approved product information for medicine
(1) The Secretary must approve product information in relation to
therapeutic goods if:
(a) the Secretary decides, under subsection 25(3), to register the
goods; and
(b) the goods are:
(i) restricted medicine; or
(ii) medicine in respect of which the applicant has been
given a notice of the kind referred to in
subparagraph 25(1)(da)(ii).
Note: Subsection (4) deals with variation of the product information.
(1A) However, the Secretary must not approve product information in
relation to therapeutic goods under subsection (1) unless the
Secretary is satisfied that the product information reflects the basis
on which the Secretary decided under subsection 25(3) to register
the goods.
(1B) If:
(a) there is medicine included in the Register in relation to a
person and there is no product information approved under
this section in relation to the medicine; and
(b) the medicine becomes restricted medicine;
the Secretary may, by written notice given to the person, require
the person to:
(c) give the Secretary product information, in relation to the
medicine, that is in the form approved under section 7D in
relation to the medicine; and
(d) give the Secretary that product information within the period
specified in the notice (which must be at least 30 days after
the notice is given).
(1C) If the person complies with subsection (1B), the Secretary must
approve product information in relation to the medicine that
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reflects the basis on which the medicine is registered at the time of
the approval. The Secretary must, by written notice given to the
person, set out the product information so approved.
Note: Subsection (4) deals with variation of the product information.
Transitional
(2) If:
(a) at the start of the day the first instrument made under
subsection 3(2A) or (2B) takes effect, there is medicine
included in the Register in relation to a person; and
(b) before that day, the Secretary, in a notice given under
subsection 25(4) (as in force on that day) to the person in
relation to the registration of the medicine, specified the
product information that was approved by the Secretary in
relation to the medicine;
then that product information (including as varied before that day)
is, on and after that day, the product information that is approved
under this section in relation to the medicine.
Note: Subsection (4) deals with variation of the product information.
(3) If:
(a) before the day the first instrument made under
subsection 3(2A) or (2B) takes effect, a person made an
application to include medicine in the Register; and
(b) before that day and in relation to that application, the
Secretary, in a notice given under subsection 25(4) (as in
force on that day) to the person, specified the product
information that was approved by the Secretary in relation to
the medicine; and
(c) on or after that day and in relation to that application, the
Secretary includes the medicine in the Register in relation to
the person;
then that product information (including as varied before that
inclusion) is, on and after the day the registration of the medicine
commences, the product information that is approved under this
section in relation to the medicine.
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Note: Subsection (4) deals with variation of the product information.
Variations
(4) If:
(a) there is medicine included in the Register in relation to a
person and there is product information approved under this
section in relation to the medicine; and
(b) either:
(i) under section 9D, the Secretary varies the entry in the
Register in relation to the medicine; or
(ii) there is a change in the conditions to which the
inclusion of the medicine is subject; and
(c) as a result of that variation or change, the Secretary is
satisfied that a variation to that product information is
required;
the Secretary may, by notice in writing given to the person, make
any variations that the Secretary considers appropriate to the
product information that is approved in relation to the medicine.
(4A) Without limiting subsection (4), a variation to the product
information is not appropriate unless:
(a) if subparagraph (4)(b)(i) applies—the product information, as
varied, reflects the basis on which the Secretary decided
under section 9D to vary the entry in the Register in relation
to the medicine; or
(b) if subparagraph (4)(b)(ii) applies—the product information,
as varied, reflects the basis on which the Secretary decided
under section 28 to change the conditions to which the
inclusion of the medicine is subject.
(5) To avoid doubt, if product information that is approved in relation
to medicine is varied under this section, that product information,
as varied, becomes the product information that is approved under
this section in relation to the medicine.
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25AB Registration of therapeutic goods etc.
Therapeutic devices
(1) If:
(a) an application is made under section 23 for the registration of
therapeutic goods in relation to a person; and
(aa) the application has passed preliminary assessment; and
(b) the Secretary decides under subsection 25(3) to register the
goods; and
(c) the goods are therapeutic devices;
the Secretary must:
(d) notify the applicant in writing of the decision within 28 days
of making the decision; and
(e) include the goods in the Register; and
(f) give the applicant a certificate of registration.
Therapeutic goods that are not therapeutic devices
(2) If:
(a) an application is made under section 23 for the registration of
therapeutic goods in relation to a person; and
(aa) the application has passed preliminary assessment; and
(b) the Secretary decides under subsection 25(3) to register the
goods; and
(c) the goods are not therapeutic devices;
the Secretary must, in accordance with subsection (3), notify the
applicant in writing of the decision within 28 days of making the
decision.
(3) The notice must:
(a) set out the decision under subsection 25(3) to register the
goods; and
(b) if the goods are restricted medicine or medicine in respect of
which the applicant has been given a notice of the kind
referred to in subparagraph 25(1)(da)(ii)—set out the product
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information approved under subsection 25AA(1) for the
medicine; and
(c) inform the applicant that the goods will not be included in the
Register unless and until the applicant gives the Secretary:
(i) the certificate required under subsection 26B(1); or
(ii) a notice (in accordance with a form approved, in
writing, by the Secretary) that a certificate under that
subsection is not required in relation to the application.
(4) If the applicant gives the Secretary the certificate referred to in
subparagraph (3)(c)(i) or the notice referred to in
subparagraph (3)(c)(ii), the Secretary must:
(a) include the goods in the Register; and
(b) give the applicant a certificate of registration.
(5) To avoid doubt, if the applicant gives the Secretary the certificate
referred to in subparagraph (3)(c)(i) or the notice referred to in
subparagraph (3)(c)(ii), the Secretary must include the goods in the
Register under paragraph (4)(a) without inquiring into the
correctness of the certificate or the notice.
Date registration commences
(6) The registration of therapeutic goods commences on the day
specified in the certificate of registration.
25AC Notice of decision not to register therapeutic goods
If:
(a) an application is made under section 23 for the registration of
therapeutic goods in relation to a person; and
(aa) the application has passed preliminary assessment; and
(b) the Secretary decides under subsection 25(3) not to register
the goods;
the Secretary must notify the applicant in writing of the decision,
and the reasons for the decision, within 28 days of making the
decision.
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25A When the Secretary must not use protected information
(1) When evaluating therapeutic goods for registration, the Secretary
must not use information about other therapeutic goods that is
protected information.
(2) Information is protected information if:
(a) the information was given to the Secretary in relation to an
application to register therapeutic goods (the new goods):
(i) not being therapeutic devices; and
(ii) consisting of, or containing, an active component; and
(b) the information is about the active component and is not
available to the public; and
(c) when the application to register the new goods was lodged:
(i) no other therapeutic goods consisting of, or containing,
that active component were included in the Register;
and
(ii) no such therapeutic goods had been included in the
Register at any time before then; and
(d) the new goods became registered on or after the
commencement of this subsection; and
(e) 5 years have not passed since the day the new goods became
registered; and
(f) the person in relation to whom the new goods are registered
has not given the Secretary permission in writing for the
Secretary to use the information.
(3) For the purposes of subsection (2), an active component, in
relation to therapeutic goods, is a substance that is, or one of the
substances that together are, primarily responsible for the
biological or other effect identifying the goods as therapeutic
goods.
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25B Registration of therapeutic device to which EC/EFTA
attestation of conformity applies
(1) If:
(a) an application is made under section 23 for the registration of
a therapeutic device in relation to a person; and
(aa) the application has passed preliminary assessment; and
(b) the applicant gives to the Secretary an EC/EFTA attestation
of conformity as to the matters that would require evaluation
under subsection 25(1) if that subsection applied in relation
to the device;
the Secretary must register the device unless the Secretary
considers that the device may compromise the health or safety of
users.
(2) The Secretary must notify the applicant in writing of his or her
decision on the application within 28 days of the making of the
decision. If the Secretary decides not to register the device, the
notice must contain the reasons for that decision.
(3) If the Secretary decides to register the device, the Secretary must:
(a) include the device in the Register; and
(b) give to the applicant a certificate of registration.
(4) The registration of the device commences on the day specified for
the purpose in the certificate of registration.
26 Listing of therapeutic goods
(1) Where:
(a) an application is made for the listing of therapeutic goods in
relation to a person under section 23; and
(aaa) the application complies with section 23C; and
(aa) if goods are not therapeutic devices—the application is
accompanied by either:
(i) the certificate required under subsection 26B(1); or
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(ii) a notice (in accordance with a form approved, in
writing, by the Secretary) that a certificate under that
subsection is not required in relation to the application;
and
(b) the person has complied with any requirements made by the
Secretary under section 31 in relation to the goods; and
(ba) the goods are not goods which may be listed under
section 26A or 26AE;
then, subject to this section and section 26AA, the Secretary is not
to refuse to list the goods in relation to the person except where the
Secretary is satisfied that:
(c) the goods are not eligible for listing; or
(d) the goods are not safe for the purposes for which they are to
be used; or
(e) the presentation of the goods is unacceptable; or
(f) the goods do not conform to a standard applicable to the
goods; or
(fa) either of the following has not been complied with in relation
to the goods:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or the regulations; or
(g) if a step in the manufacture of the goods (not being
therapeutic devices other than devices prescribed for the
purposes of this paragraph) has been carried out outside
Australia—the manufacturing and quality control procedures
used in the manufacture of the goods are not acceptable; or
(h) if the goods have been manufactured in Australia—the goods
have been manufactured contrary to Part 3-3; or
(j) if the goods have been manufactured in Australia, or
imported into Australia, solely for export—a relevant
authority of the country to which the goods are to be
exported has not confirmed its willingness to accept the
goods and:
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(i) the goods have been refused registration or listing for
supply in Australia; or
(ii) the Secretary requires such a confirmation for a reason
other than because the goods have been refused
registration or listing; or
(k) the goods do not comply with prescribed quality or safety
criteria; or
(m) the goods contain substances that are prohibited imports for
the purposes of the Customs Act 1901; or
(n) one or more of the manufacturers of the goods are not
nominated as manufacturers of the goods in the application.
(1AA) If:
(a) a medicine (the original medicine) is included in the Register
in relation to a person; and
(b) the person makes an application under section 23 for the
listing of a medicine (the new medicine) under this section;
and
(ba) the application complies with section 23C; and
(c) the Secretary is satisfied that paragraphs (1)(a) to (ba) are
satisfied in relation to the application; and
(d) the Secretary is satisfied that the new medicine has the same
characteristics as the original medicine apart from the
characteristics specified in an instrument under
subsection (1AB);
the Secretary may list the new medicine in relation to the person.
(1AB) The Minister may, by legislative instrument, specify characteristics
for the purposes of paragraph (1AA)(d).
(1A) To avoid doubt, if:
(a) an application is made for the listing of therapeutic goods in
relation to a person under section 23; and
(aa) the application complies with section 23C; and
(b) the application is accompanied by either:
(i) the certificate required under subsection 26B(1); or
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(ii) a notice that a certificate under that subsection is not
required in relation to the application; and
(c) the other requirements in subsection (1) are met;
the Secretary must list the goods under subsection (1) without
inquiring into the correctness of the certificate or the notice.
(2) In making a decision for the purposes of paragraph (1)(g), the
matters that may be taken into account include:
(a) whether the applicant has provided:
(i) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a
country that is a member of the European Community
or a member of EFTA—an EC/EFTA attestation of
conformity in relation to the goods; or
(ia) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a
country declared by the Minister under section 3B to be
covered by a non-EC/EFTA MRA—a non-EC/EFTA
attestation of conformity, for the non-EC/EFTA MRA,
in relation to the goods; or
(ii) in any other case—an acceptable form of evidence from
a relevant overseas authority establishing that the
manufacture of the goods is of an acceptable standard;
and
(b) whether the applicant has agreed to provide, where the
Secretary considers inspection of the manufacturing
procedures used in the manufacture of the goods to be
necessary:
(i) funds for the carrying out of that inspection by the
Department; and
(ii) evidence that the manufacturer has agreed to such an
inspection.
(2A) If therapeutic goods are exempt from the operation of Part 3-3 or a
person is exempt from the operation of that Part in relation to the
manufacture of the goods, subsection (1) has effect, in relation to
the goods, as if paragraph (h) were omitted.
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(2B) If a person is exempt from the operation of Part 3-3 in relation to a
step in the manufacture of therapeutic goods, subsection (1) has
effect, in relation to the goods, as if the reference in paragraph (h)
to Part 3-3 were a reference to that Part to the extent that it applies
to that person in relation to the manufacture of the goods.
(2C) If:
(a) therapeutic goods were made outside Australia; and
(b) had the goods been made in Australia, they would have been
exempt from the operation of Part 3-3;
subsection (1) has effect, in relation to the goods, as if
paragraph (g) were omitted.
(2D) A decision for the purposes of paragraph (1)(g) may also take into
account any information provided to the Secretary by a health
authority of a Convention country and relating to:
(a) the general standards of manufacturing practice of a
particular manufacturer; or
(b) the specific standards of manufacture or control adopted by a
particular manufacturer in relation to particular goods.
(2E) For the purposes of subsection (2D), a Convention country is a
country that is a party to the Mutual Recognition Convention.
(2F) Information referred to in subsection (2D) and provided in
accordance with the Mutual Recognition Convention is to be
treated as equivalent to information obtained as a result of an
inspection under Part 3-3 of this Act.
(3) Where an application is made, the Secretary must notify the
applicant in writing of his or her decision on the application within
28 days of the making of the decision and, in the case of a decision
not to list the goods, of the reasons for the decision.
(4) As soon as practicable after an applicant has been informed that
therapeutic goods in respect of which an application was made are
acceptable for listing, the Secretary must give to the applicant a
certificate of listing of the goods, and the listing of the goods
commences on the day specified for the purpose in the certificate.
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26AA Listing of therapeutic device to which EC/EFTA attestation of
conformity applies
(1) If:
(a) an application is made under section 23 for the listing of a
therapeutic device in relation to a person; and
(aa) the application complies with section 23C; and
(b) the applicant gives to the Secretary an EC/EFTA attestation
of conformity as to the matters specified in paragraphs
26(1)(c) to (m) in relation to the device;
the Secretary must list the device in relation to the person unless
the Secretary considers that the device may compromise the health
or safety of users.
(2) The Secretary must notify the applicant in writing of his or her
decision within 28 days of the making of the decision. If the
Secretary decides not to list the device, the notice must contain the
reasons for that decision.
(3) If the Secretary decides to list the device, the Secretary must:
(a) include the device in the Register; and
(b) give to the applicant a certificate of listing.
(4) The listing of the device commences on the day specified for the
purpose in the certificate of listing.
26A Listing of certain medicines
(1) If:
(a) an application is made for the listing of medicine in relation
to a person under section 23; and
(aa) the application complies with section 23C; and
(b) the application is accompanied by either:
(i) the certificate required under subsection 26B(1); or
(ii) a notice (in accordance with a form approved, in
writing, by the Secretary) that a certificate under that
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subsection is not required in relation to the application;
and
(c) the requirements of subsection (2) and (where applicable)
subsections (2A), (3) and (4A) have been complied with; and
(d) the medicine is not export only medicine; and
(e) the medicine is not one that has previously had its
registration or listing cancelled;
the Secretary must list the medicine in relation to the person.
(1A) To avoid doubt, if:
(a) an application is made for the listing of a medicine in relation
to a person in accordance with section 23; and
(aa) the application complies with section 23C; and
(b) the application is accompanied by either:
(i) the certificate required under subsection 26B(1); or
(ii) a notice that a certificate under that subsection is not
required in relation to the application; and
(c) the other requirements in subsection (1) are met;
the Secretary must list the medicine under subsection (1) without
inquiring into the correctness of the certificate or the notice.
(2) The applicant must certify that:
(a) the medicine is eligible for listing; and
(b) the medicine is safe for the purposes for which it is to be
used; and
(c) the presentation of the medicine is not unacceptable; and
(ca) the medicine does not contain an ingredient that is not
specified in a determination under paragraph 26BB(1)(a); and
(cb) if a determination under paragraph 26BB(1)(b) specifies
requirements in relation to ingredients being contained in the
medicine—none of the requirements have been contravened;
and
(d) the medicine conforms to every standard (if any) applicable
to the medicine; and
(da) both of the following are complied with in relation to the
medicine:
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(i) the applicable provisions of the Therapeutic Goods
Advertising Code;
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or under the regulations; and
(e) if the medicine has been manufactured in Australia—each
step in the manufacture of the medicine has been carried out
by a person who is the holder of a licence to carry out that
step; and
(f) the medicine complies with all prescribed quality or safety
criteria that are applicable to the medicine; and
(fa) the medicine’s specifications comply with any requirements
that are prescribed by the regulations for the purposes of this
paragraph and that are applicable to the medicine; and
(fb) the medicine’s label:
(i) complies with any requirements that are prescribed by
the regulations for the purposes of this subparagraph
and that are applicable to the medicine; and
(ii) does not make a claim that is inconsistent with any
claim made by the applicant in relation to the medicine
in, or in connection with, the application; and
(fba) if the medicine’s label contains one or more indications—
each indication:
(i) is covered by a determination under
paragraph 26BF(1)(a); and
(ii) is proposed to be accepted in relation to the inclusion of
the medicine in the Register; and
(fc) the applicant holds information or evidence showing the
medicine’s specifications will be maintained under the
conditions set out on the medicine’s label until the
medicine’s expiry date; and
(fd) each indication proposed to be accepted in relation to the
inclusion of the medicine in the Register is covered by a
determination under paragraph 26BF(1)(a); and
(fe) if a determination under paragraph 26BF(1)(b) specifies
requirements in relation to an indication proposed to be
accepted in relation to the inclusion of the medicine in the
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Register—none of the requirements have been contravened;
and
(g) the medicine does not contain substances that are prohibited
imports for the purposes of the Customs Act 1901; and
(h) all the manufacturers of the medicine are nominated as
manufacturers in the application; and
(i) the applicant has, with manufacturers of the medicine who
are manufacturers of the prescribed kind, written agreements
containing such matters as are prescribed; and
(j) both:
(i) the applicant holds information or evidence to support
any claim (other than a claim that is an indication)
proposed to be accepted in relation to the inclusion of
the medicine in the Register; and
(ii) the information or evidence complies with any
requirements specified in a determination under
subsection (2B); and
(ja) both:
(i) the applicant holds information or evidence to support
each indication proposed to be accepted in relation to
the inclusion of the medicine in the Register; and
(ii) the information or evidence complies with any
requirements specified in a determination under
subsection (2B); and
(k) the information included in or with the application is correct.
(2A) The applicant must also certify any other matters prescribed by the
regulations for the purposes of this subsection.
(2B) The Minister may, by legislative instrument, specify requirements
for the purposes of subparagraph (2)(j)(ii) or (2)(ja)(ii).
(3) Subject to subsection (7), if a step in the manufacture of the
medicine has been carried out outside Australia, the Secretary must
have certified, prior to the application being made, that the
manufacturing and quality control procedures used in each such
step are acceptable.
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(4) In deciding whether so to certify for the purposes of subsection (3),
the matters that may be taken into account include:
(a) whether the applicant has provided:
(i) if a step in the manufacture of the medicine has been
carried out in a country that is a member of the
European Community or a member of EFTA—an
EC/EFTA attestation of conformity in relation to the
medicine; or
(ia) if a step in the manufacture of the medicine has been
carried out in a country declared by the Minister under
section 3B to be covered by a non-EC/EFTA MRA—a
non-EC/EFTA attestation of conformity, for the
non-EC/EFTA MRA, in relation to the medicine; or
(ii) in any other case—an acceptable form of evidence from
a relevant overseas authority establishing that the
manufacture of the medicine is of an acceptable
standard; and
(b) whether the applicant has agreed to provide, if the Secretary
considers inspection of the manufacturing procedures used in
the manufacture of the medicine to be necessary:
(i) funds for the carrying out of that inspection by the
Department; and
(ii) evidence that the manufacturer has agreed to such an
inspection; and
(c) whether the applicant has complied with any requirements
made by the Secretary under section 31 in relation to the
manufacture or preparation of the medicine.
(4A) If the medicine includes any ingredient of animal origin, the
Secretary must have certified, prior to the application being made,
that he or she is satisfied of the safety of the ingredient.
(5) If a medicine is exempt from the operation of Part 3-3 or a person
is exempt from the operation of that Part in relation to the
manufacture of the medicine, subsection (2) has effect, in relation
to the medicine, as if paragraph (2)(e) were omitted.
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(6) If a person (the manufacturer) is exempt from the operation of
Part 3-3 in relation to a step in the manufacture of a medicine,
subsection (2) has effect, in relation to the medicine, as if the
reference in paragraph (2)(e) to a person who is the holder of a
licence were a reference to the manufacturer to the extent that
Part 3-3 applies to the manufacturer in relation to the manufacture
of the medicine.
(7) If:
(a) a medicine was made outside Australia; and
(b) had the medicine been made in Australia, it would have been
exempt from the operation of Part 3-3;
subsection (3) does not apply in relation to the medicine.
(9) As soon as practicable after a medicine has been listed under this
section, the Secretary must give to the applicant a certificate of
listing of the medicine. The listing of the medicine commences on
the day specified for the purpose in the certificate.
26AB Application for listing of certain medicines following efficacy
evaluation
(1) If:
(a) an application is made under section 23 for the listing of
medicine in relation to a person; and
(b) the application passes preliminary assessment; and
(c) the requirements of subsections (2), (3), (4) and (6) have
been complied with; and
(d) the medicine is not a medicine which may be listed under
section 26A; and
(e) the medicine is not export only medicine; and
(f) the medicine is not one that has previously had its
registration or listing cancelled;
the Secretary must evaluate the medicine for listing under
section 26AE.
(2) The applicant must certify that:
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(a) the medicine is eligible for listing; and
(b) the medicine is safe for the purposes for which it is to be
used; and
(c) the presentation of the medicine is not unacceptable; and
(d) the medicine does not contain an ingredient that is not
specified in a determination under paragraph 26BB(1)(a); and
(e) if a determination under paragraph 26BB(1)(b) specifies
requirements in relation to ingredients being contained in the
medicine—none of the requirements have been contravened;
and
(f) the medicine conforms to every standard (if any) applicable
to the medicine; and
(g) both of the following are complied with in relation to the
medicine:
(i) the applicable provisions of the Therapeutic Goods
Advertising Code;
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or under the regulations; and
(h) if the medicine has been manufactured in Australia—each
step in the manufacture of the medicine has been carried out
by a person who is the holder of a licence to carry out that
step; and
(i) the medicine complies with all prescribed quality or safety
criteria that are applicable to the medicine; and
(j) the medicine’s specifications comply with any requirements
that are prescribed by the regulations for the purposes of this
paragraph and that are applicable to the medicine; and
(k) the medicine’s label:
(i) complies with any requirements that are prescribed by
the regulations for the purposes of this subparagraph
and that are applicable to the medicine; and
(ii) does not make a claim that is inconsistent with any
claim made by the applicant in relation to the medicine
in, or in connection with, the application; and
(l) the applicant holds information or evidence showing the
medicine’s specifications will be maintained under the
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conditions set out on the medicine’s label until the
medicine’s expiry date; and
(m) the applicant has available sufficient information to
substantiate each claim and each indication proposed to be
accepted in relation to the inclusion of the medicine in the
Register; and
(n) the medicine does not contain substances that are prohibited
imports for the purposes of the Customs Act 1901; and
(o) all the manufacturers of the medicine are nominated as
manufacturers in the application; and
(p) the applicant has, with manufacturers of the medicine who
are manufacturers of the prescribed kind, written agreements
containing such matters as are prescribed; and
(q) the information included in or with the application is
complete and correct.
(3) The applicant must also certify any other matters prescribed by the
regulations for the purposes of this subsection.
(4) Subject to subsection (9), if a step in the manufacture of the
medicine has been carried out outside Australia, the Secretary must
have certified, prior to the application being made, that the
manufacturing and quality control procedures used in each such
step are acceptable.
(5) In deciding whether to certify for the purposes of subsection (4),
the matters that may be taken into account include:
(a) whether the applicant has provided:
(i) if a step in the manufacture of the medicine has been
carried out in a country that is a member of the
European Community or a member of EFTA—an
EC/EFTA attestation of conformity in relation to the
medicine; or
(ii) if a step in the manufacture of the medicine has been
carried out in a country declared by the Minister under
section 3B to be covered by a non-EC/EFTA MRA—a
non-EC/EFTA attestation of conformity, for the
non-EC/EFTA MRA, in relation to the medicine; or
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(iii) in any other case—an acceptable form of evidence from
a relevant overseas authority establishing that the
manufacture of the medicine is of an acceptable
standard; and
(b) whether the applicant has agreed to provide, if the Secretary
considers inspection of the manufacturing procedures used in
the manufacture of the medicine to be necessary:
(i) funds for the carrying out of that inspection by the
Department; and
(ii) evidence that the manufacturer has agreed to such an
inspection; and
(c) whether the applicant has complied with any requirements
made by the Secretary under section 31 in relation to the
manufacture or preparation of the medicine.
(6) If the medicine includes any ingredient of animal origin, the
Secretary must have certified, prior to the application being made,
that he or she is satisfied of the safety of the ingredient.
(7) If a medicine is exempt from the operation of Part 3-3 or a person
is exempt from the operation of that Part in relation to the
manufacture of the medicine, subsection (2) has effect, in relation
to the medicine, as if paragraph (2)(h) were omitted.
(8) If a person (the manufacturer) is exempt from the operation of
Part 3-3 in relation to a step in the manufacture of a medicine,
subsection (2) has effect, in relation to the medicine, as if the
reference in paragraph (2)(h) to a person who is the holder of a
licence were a reference to the manufacturer to the extent that
Part 3-3 applies to the manufacturer in relation to the manufacture
of the medicine.
(9) If:
(a) a medicine was made outside Australia; and
(b) had the medicine been made in Australia, it would have been
exempt from the operation of Part 3-3;
subsection (4) does not apply in relation to the medicine.
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26AC Evaluation fees for listing of medicine under section 26AE
(1) This section applies if:
(a) an application is made under section 23 in relation to a
medicine for listing under section 26AE; and
(b) the application has passed preliminary assessment.
(2) A fee (the evaluation fee) specified in or determined in accordance
with the regulations is payable by the applicant in respect of the
evaluation of a medicine for listing under section 26AE.
(3) The Secretary must notify each applicant of the amount of the
evaluation fee.
(4) The evaluation fee payable by an applicant:
(a) is due and payable on the day on which the applicant is
notified of the amount of the evaluation fee; and
(b) may be recovered by the Commonwealth as a debt due to the
Commonwealth.
(5) If:
(a) an application is made under section 23 in relation to a
medicine for listing under section 26AE; and
(b) the applicant has paid the whole of the evaluation fee; and
(c) regulations made for the purposes of paragraph 63(2)(daaaa)
prescribe a period within which evaluations under
section 26AE in relation to the medicine must be completed;
and
(d) the evaluation is completed, but not within that period;
then 25% of the evaluation fee must be refunded to the applicant.
(6) For the purposes of paragraph (5)(d), the evaluation is taken to be
completed when the applicant is notified of the Secretary’s
decision under subsection 26AE(3) in relation to the medicine.
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Section 26AD
26AD Lapsing and deemed refusal of applications for listing of
medicine under section 26AE
Lapsing of applications
(1) An application for the listing of a medicine under section 26AE
lapses if:
(a) any part of the evaluation fee referred to in section 26AC
remains unpaid at the end of 28 days after the day on which
the amount became due and payable; or
(b) the application contains information that is inaccurate or
misleading in a material particular; or
(c) information given to the Secretary by, or on behalf of, the
applicant in connection with the application is inaccurate or
misleading in a material particular.
Deemed refusal of applications
(2) If:
(a) regulations made for the purposes of paragraph 63(2)(daaaa)
prescribe a period within which evaluations under
section 26AE in relation to the medicine must be completed;
and
(b) at the end of that period, the evaluation has not been
completed;
the applicant may give the Secretary written notice that the
applicant wishes to treat the application as having been refused.
(3) A notice under subsection (2) may be given at any time before the
evaluation is completed.
(4) If a notice has been given, this Act (except subsection 60(5)) has
effect as if:
(a) the Secretary had decided not to list the medicine which is
the subject of the application; and
(b) the Minister had made a decision under subsection 60(3)
confirming the decision of the Secretary; and
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(c) the Minister’s decision had been made on the day on which
notice was given to the Secretary under subsection (2).
26AE Evaluation and listing of certain medicines
Evaluation
(1) If:
(a) an application is made under section 23 for the listing of a
medicine in relation to a person under this section; and
(b) the application has passed preliminary assessment;
the Secretary must evaluate the medicine having regard to:
(c) whether the efficacy of the medicine for the purposes for
which it is to be used has been satisfactorily established; and
(d) such other matters (if any) as the Secretary considers
relevant.
(2) If a period in relation to which an evaluation under this section
must be completed has been prescribed under
paragraph 63(2)(daaaa), the evaluation must be completed within
that period.
Secretary must decide whether to list medicine
(3) After an evaluation under this section of goods has been
completed, the Secretary must decide:
(a) to list the medicine; or
(b) not to list the medicine.
Decision to list
(4) If the Secretary decides under subsection (3) to list the medicine,
the Secretary must, in accordance with subsection (5), notify the
applicant in writing of the decision within 28 days of making the
decision.
(5) The notice must:
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(a) set out the decision under subsection (3) to list the medicine
in relation to the person; and
(b) inform the applicant that the medicine will not be included in
the Register unless and until the applicant gives the
Secretary:
(i) the certificate required under subsection 26B(1); or
(ii) a notice (in accordance with a form approved, in
writing, by the Secretary) that a certificate under that
subsection is not required in relation to the application.
(6) If the applicant gives the Secretary the certificate referred to in
subparagraph (5)(b)(i) or the notice referred to in
subparagraph (5)(b)(ii), the Secretary must:
(a) include the medicine in the Register; and
(b) give the applicant a certificate of listing.
(7) To avoid doubt, if the applicant gives the Secretary the certificate
referred to in subparagraph (5)(b)(i) or the notice referred to in
subparagraph (5)(b)(ii), the Secretary must include the medicine in
the Register under paragraph (3)(a) without inquiring into the
correctness of the certificate or the notice.
Date listing commences
(8) The listing of the medicine commences on the day specified for the
purpose in the certificate.
Refusal to list medicine
(9) If:
(a) an application is made for the listing of medicine in relation
to a person; and
(b) the Secretary decides under subsection (3) not to list the
medicine;
the Secretary must notify the applicant in writing of the decision,
and the reasons for the decision, within 28 days of making the
decision.
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Section 26B
26B Certificates required in relation to patents
(1A) A certificate is required under subsection (1) in relation to an
application for registration or listing of therapeutic goods only if:
(a) the applicant is required to submit evidence or information to
establish the safety or efficacy of the goods as part of the
process of applying for registration or listing; and
(b) in order to satisfy that requirement, the applicant relies (in
whole or in part) on evidence or information that another
person submitted to the Secretary:
(i) to establish the safety or efficacy of other therapeutic
goods that have already been registered or listed; and
(ii) as part of the process of applying for the registration or
listing of those other goods.
(1) The certificate required under this subsection is either:
(a) a certificate to the effect that the applicant, acting in good
faith, believes on reasonable grounds that it is not marketing,
and does not propose to market, the therapeutic goods in a
manner, or in circumstances, that would infringe a valid
claim of a patent that has been granted in relation to the
therapeutic goods; or
(b) a certificate to the effect that:
(i) a patent has been granted in relation to the therapeutic
goods; and
(ii) the applicant proposes to market the therapeutic goods
before the end of the term of the patent; and
(iii) the applicant has given the patentee notice of the
application for registration or listing of the therapeutic
goods under section 23.
The certificate must be signed by, or on behalf of, the applicant and
must be in a form approved by the Secretary.
(2) A person commits an offence if:
(a) the person gives a certificate required under subsection (1);
and
(b) the certificate is false or misleading in a material particular.
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Penalty: 1,000 penalty units.
(3) For the purposes of this section, a patent is taken to have been
granted in relation to therapeutic goods if marketing the goods
without the authority of the patentee would constitute an
infringement of the patent.
(4) In this section:
patent has the same meaning as in the Patents Act 1990.
26BA Approved form for notices
An approval of a form for a notice for the purposes of
subsection 25AB(3), 26(1), 26A(1) or 26AE(5) may require or
permit the notice to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
26BB Permissible ingredients
(1) The Minister may, by legislative instrument, make a determination
specifying either or both of the following:
(a) ingredients;
(b) for some or all of those ingredients—requirements in relation
to those ingredients being contained in medicine.
Note: A person seeking the listing of a medicine under section 26A or 26AB
must certify that:
(a) the medicine does not contain an ingredient that is not specified in the determination; and
(b) none of the requirements specified in the determination in relation to ingredients being contained in the medicine have been contravened.
Requirements
(2) The requirements referred to in paragraph (1)(b) may relate to
particular ingredients not being contained in particular medicine.
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(2A) The requirements referred to in paragraph (1)(b) may relate to a
particular ingredient being contained in particular medicine only in
the circumstances specified in the determination in relation to the
ingredient.
(3) The requirements referred to in paragraph (1)(b) may relate to
permitted concentrations or permitted total amounts of ingredients.
(4) Subsections (2), (2A) and (3) do not limit paragraph (1)(b).
(5) A determination under paragraph (1)(b) may make different
provision for different classes of medicine.
Limitations on determination under subsection (1)
(6) The Minister may, by legislative instrument, make a determination
specifying either or both of the following:
(a) ingredients that must not be specified under paragraph (1)(a);
(b) requirements that must not be specified under
paragraph (1)(b) in relation to ingredients being contained in
medicine.
(7) A determination under paragraph (6)(b) may make different
provision for different classes of medicine.
Incorporation of instruments
(8) Despite subsection 14(2) of the Legislation Act 2003, a
determination under this section may make provision in relation to
a matter by applying, adopting or incorporating any matter
contained in an instrument or other writing as in force or existing
from time to time.
26BC Variation of determination under section 26BB—Minister’s
initiative
The Minister may, on his or her own initiative and by legislative
instrument, vary a determination under section 26BB.
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Section 26BE
26BE Variation of section 26BB determination—application by
person
Making an application for recommendation
(1) A person may apply to the Secretary for a recommendation that the
Minister vary a section 26BB determination.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved, in writing, by
the Secretary; and
(b) set out the recommendation sought; and
(c) be delivered to an office of the Department specified in the
form; and
(d) be accompanied by the prescribed application fee (if any).
Further information about application for recommendation
(2A) The Secretary may, by written notice given to a person who has
made an application under subsection (1), require the person to:
(a) give the Secretary such further information in connection
with the application as is specified in the notice; and
(b) do so within such reasonable period as is specified in the
notice.
Lapsing of application for recommendation
(2B) An application made under subsection (1) lapses if:
(a) the application contains information that is inaccurate or
misleading in a material particular; or
(b) information given to the Secretary by, or on behalf of, the
applicant in connection with the application is inaccurate or
misleading in a material particular.
Decision by Secretary whether to make recommendation
(3) If:
(a) an application is made under subsection (1); and
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(b) any applicable prescribed evaluation fee has been paid; and
(c) if further information is required to be given under
subsection (2A) within a specified period—the information is
given within that period;
the Secretary must carry out an evaluation of whether to make the
recommendation.
(4) After carrying out the evaluation, the Secretary must:
(a) make the recommendation; or
(b) refuse to make the recommendation.
(5) In deciding whether to make the recommendation, the Secretary
must have regard to:
(a) the quality and safety of the ingredients concerned; and
(b) such other matters (if any) as the Secretary considers
relevant.
(5A) If the Secretary refuses to make the recommendation, the Secretary
must:
(a) notify the applicant in writing of his or her decision; and
(b) state in the notice the reasons for the decision.
Partial refund of application fee in certain circumstances
(5B) If:
(a) an application fee is prescribed for the purposes of
paragraph (2)(d); and
(b) regulations made for the purposes of paragraph 63(2)(daaa)
prescribe a period within which recommendations under this
section must be made; and
(c) the Secretary makes a recommendation in relation to an
application under subsection (1), but not within that period;
then 25% of the application fee must be refunded to the applicant.
Deemed refusal of applications in certain circumstances
(5C) If:
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(a) regulations made for the purposes of paragraph 63(2)(daaa)
prescribe a period within which recommendations under this
section must be made; and
(b) at the end of that period, the Secretary has not made a
recommendation in relation to an application under
subsection (1);
the applicant may give the Secretary written notice that the
applicant wishes to treat the application as having been refused.
(5D) A notice under subsection (5C) may be given at any time before
the recommendation in relation to the application is made.
(5E) If a notice has been given under subsection (5C), this Act (except
subsection 60(5)) has effect as if:
(a) the Secretary had decided not to make a recommendation
under this section; and
(b) the Minister had made a decision under subsection 60(3)
confirming the decision of the Secretary; and
(c) the Minister’s decision had been made on the day on which
notice was given to the Secretary under subsection (5C).
Minister may vary determination
(6) If the Secretary makes a recommendation under paragraph (4)(a),
the Minister must:
(a) by legislative instrument, vary the section 26BB
determination; or
(b) refuse to vary the section 26BB determination.
(7) In making a decision under subsection (6), the Minister must have
regard to:
(a) the recommendation made under paragraph (4)(a); and
(b) such other matters (if any) as the Minister considers relevant.
Applications or information may be given electronically
(9) An approval of a form mentioned in paragraph (2)(a), or a notice
mentioned in subsection (2A), may require or permit an application
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Section 26BF
or information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
26BF Permissible indications
(1) The Minister may, by legislative instrument, make a determination
in relation to either or both of the following:
(a) indications;
(b) requirements in relation to indications.
Note: See paragraphs 26A(2)(fba), (fd) and (fe) (which deal with matters
that a person seeking the listing of a medicine under section 26A must
certify).
(2) In deciding whether to make a determination under subsection (1)
in relation to a particular indication, the Minister may have regard
to whether the indication is a therapeutic use that relates to one or
more of the following:
(a) maintaining health;
(b) enhancing health;
(c) preventing a dietary deficiency;
(d) a disease, ailment, defect or injury, other than a serious form
of the disease, ailment, defect or injury.
(3) Subsection (2) does not limit the matters to which the Minister may
have regard in deciding whether to make a determination under
subsection (1) in relation to a particular indication.
(4) Without limiting paragraph (1)(b), the requirements may relate to:
(a) the use of particular indications in specified circumstances;
or
(b) the use of particular indications if certain specified conditions
are met.
(5) A determination under paragraph (1)(b) may make different
provision for different classes of medicines.
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26BG Limitations on determination under section 26BF
(1) The Minister may, by legislative instrument, make a determination
specifying indications that must not be covered by a determination
under paragraph 26BF(1)(a).
(2) The determination may specify an indication either generally or in
relation to specified circumstances.
(3) The Minister may, by legislative instrument, vary or revoke a
determination under subsection (1).
26BH Variation of determination under section 26BF—Minister’s
initiative
The Minister may, on his or her own initiative and by legislative
instrument, vary a determination under section 26BF.
26BJ Variation of determination under section 26BF—application
by person
Application for recommendation to vary section 26BF
determination
(1) A person may apply to the Secretary for a recommendation that the
Minister vary a determination under section 26BF.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved, in writing, by
the Secretary; and
(b) set out the recommendation sought; and
(c) be delivered to an office of the Department specified in the
form; and
(d) be accompanied by the prescribed application fee (if any).
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Limits on kinds of applications that can be made
(3) A person cannot make an application under subsection (1) for a
recommendation the effect of which would be for the
determination to cover any of the following:
(a) an indication specified in a determination under
section 26BG;
(b) an indication that is or contains a restricted representation
(within the meaning of Part 5-1);
(c) unless subsection (4) applies—an indication that is or
contains a prohibited representation (within the meaning of
Part 5-1);
(d) unless subsection (5) applies—an indication that refers to
preventing, curing or alleviating a disease, ailment, defect or
injury.
(4) For the purposes of paragraph (3)(c), this subsection applies if:
(a) the indication is a therapeutic use that relates to sun
protection; and
(b) the prohibited representation relates to the prevention of skin
cancer; and
(c) the use of the prohibited representation is permitted under
section 42DK.
(5) For the purposes of paragraph (3)(d), this subsection applies if the
indication refers to:
(a) the prevention of a dietary deficiency; or
(b) the prevention of skin cancer or sun damage.
Further information about application for recommendation
(6) The Secretary may, by written notice given to a person who has
made an application under subsection (1), require the person to:
(a) give the Secretary such further information in connection
with the application as is specified in the notice; and
(b) do so within such reasonable time as is specified in the
notice.
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Lapsing of application for recommendation
(7) An application made under subsection (1) lapses if:
(a) the application contains information that is inaccurate or
misleading in a material particular; or
(b) information given to the Secretary by, or on behalf of, the
applicant in connection with the application is inaccurate or
misleading in a material particular.
Decision on application for recommendation
(8) If:
(a) an application is made under subsection (1); and
(b) any applicable prescribed application fee has been paid; and
(c) if further information is required to be given under
subsection (6) within a specified time—the information is
given within that time;
the Secretary must decide whether to make the recommendation or
refuse to make the recommendation.
(9) In deciding whether to make the recommendation, the Secretary
may have regard to whether the indication to which the application
relates is a therapeutic use that relates to one or more of the
following:
(a) maintaining health;
(b) enhancing health;
(c) preventing a dietary deficiency;
(d) a disease, ailment, defect or injury, other than a serious form
of the disease, ailment, defect or injury;
(e) sun protection.
(10) If the Secretary refuses to make the recommendation, the Secretary
must:
(a) notify the applicant in writing of his or her decision; and
(b) state in the notice the reasons for the decision.
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Minister may vary section 26BF determination
(11) If the Secretary makes a recommendation under subsection (8), the
Minister must:
(a) by legislative instrument, vary the determination under
subsection 26BF(1); or
(b) refuse to vary the determination.
(12) In deciding whether to vary a determination under
subsection 26BF(1) to include an indication not already covered by
the determination, the Minister may have regard to:
(a) the recommendation made under subsection (8) of this
section; and
(b) whether the indication is a therapeutic use that relates to one
or more of the matters in paragraphs (9)(a) to (e) of this
section.
(13) Subsection (12) does not limit the matters to which the Minister
may have regard in deciding whether to vary the determination.
Applications or information may be given electronically
(14) An approval of a form mentioned in paragraph (2)(a), or a notice
mentioned in subsection (6), may require or permit an application
or information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
26C Certificates required in relation to patent infringement
proceedings
(1) This section applies if:
(a) a person gives a certificate required under subsection 26B(1)
in relation to therapeutic goods; and
(b) another person (the second person) intends to commence
proceedings under the Patents Act 1990 against the person
referred to in paragraph (1)(a) for infringement of a patent
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that has been granted in relation to the therapeutic goods (the
proceedings).
(2) The second person, before the date upon which the proceedings are
commenced, must give to the Secretary and to the person referred
to in paragraph (1)(a) the certificate required by subsection (3).
(3) The certificate required by this subsection is a certificate to the
effect that the proceedings:
(a) are to be commenced in good faith; and
(b) have reasonable prospects of success; and
(c) will be conducted without unreasonable delay.
The certificate must be signed by, or on behalf of, the second
person and must be in a form approved by the Secretary.
(4) For the purpose of paragraph (3)(b), proceedings have reasonable
prospects of success if:
(a) the second person had reasonable grounds in all the
circumstances known to the second person, or which ought
reasonably to have been known to the second person (in
addition to the fact of grant of the patent), for believing that
he or she would be entitled to be granted final relief by the
court against the person referred to in paragraph (1)(a) for
infringement by that person of the patent; and
(b) the second person had reasonable grounds in all the
circumstances known to the second person, or which ought
reasonably to have been known to the second person (in
addition to the fact of grant of the patent), for believing that
each of the claims, in respect of which infringement is
alleged, is valid; and
(c) the proceedings are not otherwise vexatious or unreasonably
pursued.
(5) The person referred to in paragraph (1)(a), with leave of the court,
or the Attorney-General, may apply to a prescribed court for an
order that the second person pay to the Commonwealth a pecuniary
penalty if the second person gives a certificate required under
subsection (3) and:
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(a) the certificate is false or misleading in a material particular;
or
(b) the second person breaches an undertaking given in the
certificate.
(5A) A pecuniary penalty ordered under subsection (5) must not exceed
$10,000,000.
(6) When determining the extent of a pecuniary penalty to be ordered
pursuant to subsection (5), the court must take into account:
(a) any profit obtained by the second person; and
(b) any loss or damage suffered by any person;
by reason of the second person exploiting the patent during the
proceedings.
(7) For the avoidance of doubt, subsection (6) does not limit the
matters the court may take into account when determining a
pecuniary penalty ordered pursuant to subsection (5).
(8) If:
(a) the second person has sought and obtained in the proceedings
an interlocutory injunction restraining the person referred to
in paragraph (1)(a) from infringing a patent; and
(b) section 26D does not apply; and
(c) a prescribed court declares that the second person has given a
certificate required under subsection (3); and
(d) a prescribed court declares that:
(i) the certificate is false or misleading in a material
particular; or
(ii) the second person has breached an undertaking given in
the certificate;
the prescribed court may, pursuant to this section, order that the
second person pay to the Commonwealth, a State or a Territory
compensation for any damages sustained or costs incurred by the
Commonwealth, a State or a Territory as a result of the grant of the
interlocutory injunction.
(9) In this section:
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prescribed court has the same meaning as in the Patents Act 1990.
26D Requirements for interlocutory injunction
(1) This section applies where:
(a) an applicant gives notice to a patentee in accordance with
subparagraph 26B(1)(b)(iii); and
(b) the patentee and/or its exclusive licensee (in this section the
party or parties is or are referred to as the patentee) applies to
a prescribed court for an interlocutory injunction to restrain
the applicant from marketing the therapeutic goods the
subject of the application on the ground that such conduct
will constitute an infringement of its patent.
(2) An application for interlocutory relief in accordance with
subsection (1) may not be instituted unless the patentee has first
notified the Attorney-General of the Commonwealth, or of a State
or of a Territory, in writing of the application.
(3) The Attorney-General of the Commonwealth shall be deemed to be
a party to any proceedings commenced in accordance with
subsection (1) unless the Attorney-General gives written notice to
the prescribed court that he or she does not desire to be a party.
(4) If an interlocutory injunction is granted pursuant to an application
made as described in subsection (1) and:
(a) the patentee subsequently discontinues the principal
proceedings without the consent of the other parties thereto;
or
(b) the principal proceedings are dismissed; and
(c) in either case, the prescribed court declares that:
(i) the patentee did not have reasonable grounds, in all the
circumstances known to the patentee or which ought
reasonably have been known to the patentee:
(A) to believe that it would be granted final relief
by the prescribed court against the applicant
referred to in paragraph (1)(a) for infringement
by that person of the patent; or
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Section 26D
(B) (in addition to the fact of grant of the patent),
for believing that each of the claims, in respect
of which infringement is alleged in the
proceedings, would have a reasonable prospect
of being held to be valid if challenged by the
applicant referred to in paragraph (1)(a); or
(ii) the application for the interlocutory injunction was
otherwise vexatious or not reasonably made or pursued;
the prescribed court may, in addition to any other relief which it
believes should be granted to any person, make any of the orders
described in subsection (5).
(5) If the prescribed court makes a declaration pursuant to
paragraph (4)(c), the prescribed court may, pursuant to the usual
undertaking as to damages given by the patentee to the prescribed
court to obtain the interlocutory injunction:
(a) assess and award compensation to the applicant referred to in
paragraph (1)(a) against whom the interlocutory injunction
was made:
(i) on the basis of an account of the gross profits of the
patentee arising from the sale by it in Australia of the
therapeutic goods the subject of the interlocutory
injunction, during the period of the interlocutory
injunction, without requiring the said applicant to
establish or quantify its actual loss; or
(ii) on such other basis as the court determines to be
appropriate; and
(b) award to the Commonwealth compensation for any damages
sustained, or costs incurred, by it as a result of the grant of
the interlocutory injunction; and
(c) award to a State or a Territory compensation for any damages
sustained, or costs incurred, by it as a result of the grant of
the interlocutory injunction.
(6) In this section:
prescribed court has the same meaning as in the Patents Act 1990.
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27 Registration or listing number
(1) Where the Secretary includes therapeutic goods (other than
grouped therapeutic goods) in the Register, the Secretary is to
assign a unique registration or listing number to the goods.
(2) Where the Secretary includes grouped therapeutic goods in the
Register, the Secretary is to assign a single, unique registration or
listing number to the grouped therapeutic goods.
28 Conditions of registration or listing
(1) The registration or listing of therapeutic goods is subject to the
conditions set out in a determination under subsection (2).
(2) The Minister may, by legislative instrument, make a determination
setting out conditions for the purposes of subsection (1), being
conditions that relate to:
(a) the manufacture of the goods; or
(b) the custody, use, supply, disposal or destruction of the goods;
or
(c) the keeping of records relating to the goods; or
(d) matters dealt with in, or matters additional to matters dealt
with in, standards applicable to the goods; or
(e) such other matters relating to the goods as the Minister thinks
appropriate.
(2A) Without limiting subsection (2), different conditions may be
specified for:
(a) the registration of therapeutic goods; and
(aa) the provisional registration of medicine; and
(b) the listing of therapeutic goods; and
(c) different classes of therapeutic goods.
(2B) If the Secretary includes therapeutic goods in the Register in
relation to a person, the Secretary may, by notice in writing given
to the person, impose conditions on the registration or listing of
those goods.
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(3) The Secretary may, by notice in writing given to the person in
relation to whom therapeutic goods are registered or listed, impose
new conditions on the registration or listing or vary or remove
conditions imposed under subsection (2B) or this subsection.
(3A) The Secretary’s power under subsection (3) may be exercised at
the request of the person concerned or of the Secretary’s own
motion. A request must be accompanied by the prescribed fee.
(4) The imposition or variation or removal of a condition under
subsection (3) takes effect:
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the person; or
(aa) in the case of an imposition or variation requested by the
person, and to which paragraph (a) does not apply—on the
day specified in the notice, which must be at least 28 days
after the notice is given to the person, unless the person has
agreed to an earlier day; or
(ab) in the case of a removal to which paragraph (a) does not
apply—on the day specified in the notice, which must be at
least 28 days after the notice is given to the person, unless the
person has agreed to an earlier day; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 28 days after the notice is
given to the person.
(4A) For the purposes of paragraphs (4)(aa) and (ab), the earlier day
must not be earlier than the day the notice is given to the person.
(5) In addition to any conditions imposed under subsection (1), (2B) or
(3), the registration or listing of therapeutic goods (the subject
goods) is subject to the conditions that the person in relation to
whom the subject goods are registered or listed will:
(aa) not supply a batch of the subject goods in Australia, or export
a batch of the subject goods from Australia, after the expiry
date for the goods; and
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(ab) not, by any means, advertise the subject goods for an
indication other than those accepted in relation to the
inclusion of the goods in the Register; and
(a) allow an authorised person:
(i) to enter, at any reasonable time, premises at which the
person deals with the subject goods, complies with
record-keeping requirements covered by paragraph (c)
or (ca), or keeps documents that relate to the subject
goods; and
(ii) while on those premises, to inspect those premises and
any therapeutic goods on those premises and to
examine, take measurements of, conduct tests on or take
samples of any therapeutic goods on those premises or
any thing on those premises that relates to any
therapeutic goods; and
(iii) while on those premises, to make any still or moving
image or any recording of those premises or any thing
on those premises; and
(iv) while on those premises, to inspect, and make copies of,
any records kept in compliance with paragraph (c) or
(ca); and
(v) while on those premises, to inspect, and make copies of,
any documents that relate to the subject goods; and
(b) if requested to do so by an authorised person, produce to the
person such documents relating to the subject goods as the
person requires and allow the person to copy the documents;
and
(c) in relation to each batch of the subject goods—keep a record,
at least until the end of the period of 12 months after the
expiry date for the goods, of all of the manufacturers
involved in the manufacture of that batch; and
(ca) comply, in relation to the subject goods, with any
record-keeping requirements that are prescribed; and
(d) if requested to do so by an authorised person, make any
record kept in compliance with paragraph (c) or (ca)
available to the authorised person for inspection:
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(i) at or before the time the authorised person requests, or
(if the authorised person requests) immediately; and
(ii) either in electronic form or in paper form, as the
authorised person requests; and
(e) comply, in relation to the subject goods, with any reporting
requirements that are prescribed; and
(f) if a manufacturer who was not nominated as a manufacturer
of the subject goods in the application for the registration or
listing of the goods becomes a manufacturer of the goods—
inform the Secretary in writing of that fact, no later than 10
working days after the manufacturer becomes a manufacturer
of the goods; and
(g) if premises that were not nominated as premises to be used in
the manufacture of the subject goods in the application
become premises used in the manufacture of the goods—
inform the Secretary in writing of that fact, no later than 10
working days after the premises are first used for that
purpose; and
(h) deliver a reasonable number of samples of the subject goods
if the Secretary so requests:
(i) within the period specified in the request (which must
include at least 10 working days); and
(ii) in accordance with any other requirements specified in
the request; and
(i) comply, in relation to the subject goods, with a notice given
to the person under subsection 25AA(1B).
(5B) The listing of a medicine under section 26A or 26AE is subject to a
condition that:
(a) each step in the manufacture of the medicine that is carried
out in Australia is carried out by a person who is the holder
of a licence to carry out that step or who is exempt from the
operation of Part 3-3 in relation to that step; and
(b) each step in the manufacture of the medicine that is carried
out outside Australia is the subject of a certification in force
under subsection 26A(3), 26AB(4) or 28A(2).
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(5C) Subsection (5B) does not apply if the medicine is exempt from the
operation of Part 3-3.
(6) If in, or in connection with, an application for the listing of
therapeutic goods, a claim (other than a claim that is an indication)
is made by the applicant in relation to the goods, the listing of the
goods is subject to the following conditions:
(a) a condition that the sponsor of the goods had, at the time
when the claim was made, information or evidence that
supported the claim and complied with the requirements (if
any) specified in a determination made under
subsection 26A(2B);
(b) a condition that the sponsor retains the information or
evidence at all times while the goods remain listed;
(c) a condition that, at any time while the goods remain listed,
the sponsor will, if asked to do so by the Secretary, give the
information or evidence to the Secretary.
(7) If:
(a) a medicine is listed under section 26A; and
(b) an indication is accepted in relation to the inclusion of the
medicine in the Register;
the listing of the medicine is subject to the following conditions:
(c) a condition that the person in relation to whom the medicine
is listed has, at all times while the medicine remains listed,
information or evidence that supports the indication and
complies with the requirements (if any) specified in a
determination under subsection 26A(2B);
(d) a condition that, at any time while the medicine remains
listed, the person will, if asked to do so by the Secretary, give
the information or evidence to the Secretary.
(8) If:
(a) a medicine is listed under section 26AE; and
(b) an indication is accepted in relation to the inclusion of the
medicine in the Register;
the listing of the medicine is subject to the following conditions:
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(c) a condition that the person in relation to whom the medicine
is listed has, at all times while the medicine remains listed,
information or evidence that supports the indication;
(d) a condition that, at any time while the medicine remains
listed, the person will, if asked to do so by the Secretary, give
the information or evidence to the Secretary.
28A Certification of manufacturing steps outside Australia following
application for listing
(1) The person in relation to whom medicine is listed under
section 26A or 26AE may apply to the Secretary for a certification
under this section of a step in the manufacture of the medicine that
is to be carried out outside Australia.
Note: The listing of medicine is subject to the condition that each step in the
manufacture of the medicine that is carried out outside Australia is the
subject of a certification in force under subsection 26A(3) or
subsection (2) of this section: see subsection 28(5B).
(2) If an application is made to the Secretary under this section, the
Secretary may, by writing, certify that the manufacturing and
quality control procedures used in that step are acceptable. The
Secretary must give the person written notice of the certification.
(3) In deciding whether to give the certification:
(a) subsection 26A(4) applies in a way corresponding to the way
in which it applies for the purposes of subsection 26A(3); and
(b) subsection 26AB(5) applies in a way corresponding to the
way in which it applies for the purposes of
subsection 26AB(4).
29 Duration of registration or listing
(1) Subject to this section, if goods are included in the Register in
relation to a person, the goods remain so included until their
registration or listing is cancelled under this Part.
Note: The goods are taken not to be included in the Register while their
registration or listing is suspended: see section 29G.
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Provisionally registered medicine
(2) If:
(a) a person makes an application for provisional registration of
a medicine; and
(b) in relation to that application, the Secretary decides under
subsection 25(3) to register the medicine; and
(c) the medicine is included in the Register in relation to the
person;
then:
(d) the medicine is provisionally registered; and
(e) the medicine remains included in the Register for the
provisional registration period, unless the medicine’s
registration is cancelled under this Part earlier.
Note: The medicine is taken not to be included in the Register while its
registration is suspended: see section 29G.
(3) Subject to this section, the provisional registration period is the 2
years starting on the day the registration commences.
Note: Subsection 25AB(6) provides that registration commences on the day
specified in the certificate of registration.
Extension of provisional registration upon application
(4) The person in relation to whom the medicine is provisionally
registered may make an application to the Secretary to extend the
provisional registration period.
(5) The application must:
(a) be in a form approved, in writing, by the Secretary; and
(b) contain the information that the form requires, and any
further information, statement or document the Secretary
requires, whether in the form or otherwise; and
(c) be made at least 6 months before the provisional registration
of the medicine is due to end; and
(d) be accompanied by the prescribed application fee.
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(6) On receiving the application, the Secretary must decide to grant, or
to refuse to grant, an extension of the provisional registration
period. In making that decision, the Secretary must have regard to:
(a) whether the Secretary is satisfied with the applicant’s plan to
submit comprehensive clinical data on the safety and efficacy
of the medicine before the end of the 6 years starting on the
day the provisional registration commenced; and
(b) such other matters (if any) as the Secretary considers
relevant.
(7) As soon as practicable after making the decision, the Secretary
must:
(a) give the applicant written notice of the decision; and
(b) if the Secretary decides to extend the provisional registration
period—specify in the notice the period of the extension
(which must not exceed 2 years and may be less than the
period sought by the applicant); and
(c) if the Secretary refuses to extend the provisional registration
period—set out the reasons for the refusal in the notice.
Note: At the time of granting an extension, the Secretary may impose new
conditions on the provisional registration or vary the existing
conditions: see subsection 28(3).
(8) No more than 2 extensions may be granted on applications under
subsection (4).
Note: Under subsection (9) the Secretary may extend the provisional
registration period on his or her own initiative.
Effect on provisional registration of later section 23 application
(9) If:
(a) before the provisional registration period ends, the person in
relation to whom the medicine is provisionally registered
makes an application under section 23 for registration of the
medicine; and
(b) the application is for the medicine to be included in the part
of the Register for goods known as registered goods;
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then the Secretary may, in connection with the application, end or
extend the provisional registration period as the Secretary
considers appropriate.
Note: At the time of granting an extension, the Secretary may impose new
conditions on the provisional registration or vary the existing
conditions: see subsection 28(3).
(10) In ending or extending, under subsection (9), the provisional
registration period:
(a) the Secretary must have regard to any matters prescribed by
the regulations for the purposes of this paragraph; and
(b) the Secretary must ensure the provisional registration period
continues while the Secretary is considering the application,
unless the medicine’s registration is cancelled under this Part;
and
(c) the Secretary must not extend the provisional registration
period so it would end more than 6 years after the provisional
registration commenced, unless the extension is for the
purposes of paragraph (b).
29A Criminal offence for failing to notify adverse effects etc. of
goods
(1) As soon as a person in relation to whom therapeutic goods are
registered or listed becomes aware of information of a kind
mentioned in subsection (2) relating to the goods, the person must
give the information to the Secretary in writing.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) The information with which subsection (1) is concerned is
information of the following kinds:
(a) information that contradicts information already furnished by
the person under this Act;
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(b) information that indicates that the use of the goods in
accordance with the recommendations for their use may have
an unintended harmful effect;
(c) information that indicates that the goods, when used in
accordance with the recommendations for their use, may not
be as effective as the application for registration or listing of
the goods or information already furnished by the person
under this Act suggests;
(d) information that indicates that the quality, safety or efficacy
of the goods is unacceptable.
29AA Civil penalty for failing to notify adverse effects etc. of goods
(1) A person contravenes this section if:
(a) therapeutic goods are registered or listed in relation to a
person; and
(b) the person becomes aware of information of a kind
mentioned in subsection (2) relating to the goods; and
(c) the person does not give the information to the Secretary in
writing as soon as he or she becomes aware of it.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
(2) The information with which subsection (1) is concerned is
information of the following kinds:
(a) information that contradicts information already given by the
person under this Act;
(b) information that indicates that the use of the goods in
accordance with the recommendations for their use may have
an unintended harmful effect;
(c) information that indicates that the goods, when used in
accordance with the recommendations for their use, may not
be as effective as the application for registration or listing of
the goods or information already given by the person under
this Act suggests;
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(d) information that indicates that the quality, safety or efficacy
of the goods is unacceptable.
29B Notification of adverse effects etc. where application withdrawn
or lapses
(1) If an application for registration or listing of goods is withdrawn or
lapses, the Secretary may give the applicant written notice
requiring the applicant:
(a) to inform the Secretary in writing whether the applicant is
aware of any information of a kind mentioned in
subsection 29A(2) or 29AA(2) relating to the goods; and
(b) if the applicant is aware of such information, to give the
information to the Secretary in writing.
(2) Notice under subsection (1) may be given within 14 days after an
application is withdrawn or lapses.
(3) A person must comply with the requirements of a notice under
subsection (1) within 30 days after the notice is given to the
person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person must not, in purported compliance with a notice under
subsection (1), give information that is false or misleading in a
material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
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29C Civil penalties for failing to notify adverse effects etc. where
application withdrawn or lapses
Civil penalty for failing to comply with requirements of a notice
(1) A person contravenes this subsection if the person does not comply
with the requirements of a notice under subsection 29B(1) within
30 days after the day on which the notice is given to the person.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
Civil penalty for giving false or misleading information in
purported compliance with requirements of a notice
(2) A person contravenes this subsection if the person, in purported
compliance with a notice under subsection 29B(1), gives
information that is false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
29D Suspension of registration or listing
(1) The Secretary may, by written notice given to a person in relation
to whom therapeutic goods are included in the Register, suspend
the registration or listing of the goods if:
(a) the Secretary is satisfied that:
(i) there is a potential risk of death, serious illness or
serious injury if the therapeutic goods continue to be
included in the Register; and
(ii) it is likely that the person will, within the period of the
suspension, be able to take the action necessary to
ensure that the therapeutic goods would not cause a
potential risk of death, serious illness or serious injury if
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the therapeutic goods were to continue to be included in
the Register; or
(b) the Secretary is satisfied that it is likely that there are grounds
for cancelling the registration or listing of the goods under
paragraph 30(1)(da), (e), (ea), (f), (fa), (fb) or (g) or
subsection 30(1A), (1C), (1D) or (2).
Notice of proposed suspension in some cases
(2) However, before suspending the registration or listing of the goods
because of paragraph (1)(b), the Secretary must:
(a) inform the person by written notice that the Secretary
proposes the suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
suspension.
(3) The Secretary is not to make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
Period of suspension
(4) A notice under subsection (1) must specify the period of the
suspension. The period must not exceed 6 months.
Note: Section 29E deals with when the suspension takes effect and
extensions of the suspension.
Publication
(5) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
suspension.
29E When suspension takes effect etc.
(1) A suspension under section 29D takes effect:
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(a) if the notice under subsection 29D(1) states that the
suspension is necessary to prevent a potential risk of death,
serious illness or serious injury—on the day on which the
notice is given to the person; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
(2) The suspension has effect until:
(a) the Secretary revokes it under section 29F; or
(b) the end of:
(i) the period specified in the notice under
subsection 29D(4); or
(ii) if the period is extended under subsection (3) of this
section, the period as so extended.
Extension of suspension
(3) The Secretary may, by written notice given to the person, extend
the period specified in the notice under subsection 29D(4) by a
further specified period not exceeding 6 months.
Publication
(4) As soon as practicable after giving a notice under subsection (3),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
extension.
29F Revocation of suspension
(1) The Secretary must revoke a suspension under section 29D, by
written notice given to the person in relation to whom the
therapeutic goods are included in the Register, if the Secretary is
satisfied that:
(a) the ground on which the registration or listing of the
therapeutic goods was suspended no longer applies; and
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(b) there are no other grounds for suspending the registration or
listing of the therapeutic goods.
(2) The Secretary’s power to revoke the suspension may be exercised:
(a) if the person in relation to whom the therapeutic goods are
included in the Register applies in writing to the Secretary; or
(b) on the Secretary’s own initiative.
Publication
(3) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
revocation.
Notice of refusal to revoke suspension
(4) If the Secretary decides, after an application is made under
paragraph (2)(a), not to revoke the suspension, the Secretary must:
(a) notify the applicant in writing of his or her decision; and
(b) state in the notice the reasons for the decision.
29G Effect of suspension
(1) If the registration or listing of therapeutic goods is suspended under
section 29D, the goods are taken, for the purposes of this Act
(other than sections 28, 29A, 29AA, 29E, 29F, 30 and 31), not to
be included in the Register while the suspension has effect.
Note: Dealing in therapeutic goods that are not included in the Register may
be an offence or may contravene a civil penalty provision: see
Division 1.
(2) While the suspension has effect, the Secretary’s power under
section 30 to cancel the registration or listing of the therapeutic
goods is not affected.
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30 Cancellation of registration or listing
(1) The Secretary may, by notice in writing given to a person in
relation to whom therapeutic goods are included in the Register,
cancel the registration or listing of the goods if:
(a) it appears to the Secretary that failure to cancel the
registration or listing would create an imminent risk of death,
serious illness or serious injury; or
(b) the goods become exempt goods; or
(c) the person requests in writing the cancellation of the
registration or listing; or
(d) the goods contain substances that are prohibited imports for
the purposes of the Customs Act 1901; or
(da) the person has refused or failed to comply with the condition
to which the inclusion of the goods is subject under
paragraph 28(5)(d):
(i) if the person was requested under that paragraph to
make the record in question available at or before a
requested time—before the end of the period of 24
hours after that time; or
(ii) if the person was requested under that paragraph to
make the record in question available immediately—
within 24 hours after the request was made; or
(e) in the case of a medicine listed under section 26A, it appears
to the Secretary that any of the certifications under
paragraph 26A(2)(a), (ca), (cb), (e), (fba), (fd), (fe) or (g) are
incorrect or (if applicable) the requirements under
subsection 26A(3) or (4A) are not fulfilled; or
(ea) in the case of a medicine listed under section 26AE, it
appears to the Secretary that any of the certifications under
paragraph 26AB(2)(a), (d), (e), (h) or (n) are incorrect or (if
applicable) the requirements under subsection 26AB(4) or (6)
are not fulfilled; or
(f) the person contravenes a direction, or a condition of a
direction, given to the person under subsection 42DV(1) in
relation to the advertising of the goods and the Secretary is
satisfied that the contravention is significant; or
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(fa) if the person is a body corporate—a related body corporate of
the person contravenes a direction, or a condition of a
direction, given to the related body corporate under
subsection 42DV(1) in relation to the advertising of the
goods and the Secretary is satisfied that the contravention is
significant; or
(fb) there is a breach, involving the goods, of an applicable
provision of the Therapeutic Goods Advertising Code or any
other requirement relating to advertising applicable under
Part 5-1 or under the regulations, and the Secretary is
satisfied that:
(i) the breach is significant; and
(ii) as a result of the breach, the presentation of the goods is
misleading to a significant extent; or
(g) the Secretary is satisfied that a statement made in, or in
connection with, the application for registration or listing of
the goods was false or misleading in a material particular; or
(h) the annual registration or listing charge is not paid within 28
days after it becomes payable.
(1AA) Paragraph (1)(fb) does not apply to medicines that are
manufactured in Australia for export only, or are imported into
Australia for export only.
(1A) The Secretary may, by notice in writing given to a person in
relation to whom a medicine is listed under section 26A or 26AE,
cancel the listing of the medicine if:
(a) the medicine is not eligible for listing; or
(b) the medicine is exempt.
(1C) The Secretary may, by notice in writing given to a person in
relation to whom a medicine is listed under section 26A, cancel the
listing of the medicine if:
(a) the Secretary, under section 31, gives to the person a notice
requiring the person to give to the Secretary information or
documents relating to the medicine; and
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(b) the notice is given for the purposes of ascertaining whether
any of the certifications by the person under
subsection 26A(2) or (2A) in relation to the medicine are
incorrect; and
(c) the person fails to comply with the notice within 20 working
days after the notice is given.
(1D) The Secretary may, by notice in writing given to a person in
relation to whom a medicine is listed under section 26AE, cancel
the listing of the medicine if:
(a) the Secretary, under section 31, gives to the person a notice
requiring the person to give to the Secretary information or
documents relating to the medicine; and
(b) the notice is given for the purposes of ascertaining whether
any of the certifications by the person under
subsection 26AB(2) or (3) in relation to the medicine are
incorrect; and
(c) the person fails to comply with the notice within 20 working
days after the notice is given.
(2) Subject to subsection (3), the Secretary may, by notice in writing
given to a person in relation to whom therapeutic goods are
included in the Register, cancel the registration or listing of the
goods if:
(a) it appears to the Secretary that the quality, safety or efficacy
of the goods is unacceptable; or
(aa) it appears to the Secretary that the presentation of the goods:
(i) in the case of registered goods—is not acceptable; or
(ii) in the case of listed goods—is unacceptable; or
(b) the goods have changed so that they have become separate
and distinct from the goods as so included; or
(ba) in the case of a medicine listed under section 26A, it appears
to the Secretary that any of the certifications under
paragraph 26A(2)(b), (c), (d), (da), (f), (fa), (fb), (fc), (h), (i),
(j), (ja) or (k) or subsection 26A(2A) are incorrect; or
(bab) in the case of a medicine listed under section 26AE, it
appears to the Secretary that any of the certifications under
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paragraph 26AB(2)(b), (c), (f), (g), (i), (j), (k), (l), (m), (o),
(p) or (q) or subsection 26AB(3) are incorrect; or
(c) the sponsor has refused or failed to comply with a condition
to which the inclusion of the goods is subject (other than the
condition under paragraph 28(5)(d)); or
(caa) all of the following subparagraphs apply:
(i) the Secretary gives the person a notice under section 31
that requires the person to give to the Secretary
information, or to produce to the Secretary documents,
relating to the goods;
(ii) subsection (1C) of this section does not apply to the
notice;
(iii) the person fails to comply with that notice within a
further 14 days after the end of the period specified in
that notice; or
(ca) the person has contravened subsection 29A(1) or 29AA(1) in
relation to the goods; or
(d) the goods become required to be included in the other part of
the Register; or
(e) the goods do not conform to a standard applicable to the
goods; or
(eaa) the person contravenes a direction, or a condition of a
direction, given to the person under subsection 42DV(1) in
relation to the advertising of the goods; or
(eab) if the person is a body corporate—a related body corporate of
the person contravenes a direction, or a condition of a
direction, given to the related body corporate under
subsection 42DV(1) in relation to the advertising of the
goods; or
(ea) either of the following has not been complied with in relation
to the goods:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or the regulations.
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(3) Where the Secretary proposes to cancel the registration or listing of
goods in relation to a person under subsection (2), the Secretary
must:
(a) inform the person in writing that the Secretary proposes to
cancel that registration or listing and set out the reasons for
that proposed action; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
action.
(4) Where a person makes submissions in accordance with
paragraph (3)(b), the Secretary is not to make a decision relating to
the cancellation until the Secretary has taken the submissions into
account.
(4A) The Secretary must, by notice in writing given to a person in
relation to whom therapeutic goods are included in the Register,
cancel the registration of the goods if the Secretary becomes aware
that protected information was used when evaluating the goods for
registration.
(5) Where the Secretary cancels the registration or listing of goods in
relation to a person, the goods cease to be registered or listed:
(a) if the cancellation is effected under subsection (1), (1A), (1C)
or (1D)—on the day on which the notice of cancellation is
given to the person; or
(b) in any other case—on the day specified in the notice, which
must be at least 20 working days after the notice is given to
the person.
30A Revocation of cancellation of registration or listing upon
request
(1) If:
(a) the Secretary cancels the registration or listing of therapeutic
goods because of the request of a person made under
paragraph 30(1)(c); and
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(b) before the end of the period of 90 days beginning on the day
the goods ceased to be registered or listed, the person
requests, in writing, the Secretary to revoke the cancellation;
and
(c) the request is accompanied by the prescribed application fee;
the Secretary may, by notice in writing given to the person, revoke
the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to
have occurred.
30AA Revocation of cancellation of registration or listing—payment
of annual registration or listing charge
(1) If:
(a) the Secretary cancels the registration or listing of therapeutic
goods because the annual registration or listing charge was
not paid within 28 days after it became payable (see
paragraph 30(1)(h)); and
(b) before the end of the period of 90 days beginning on the day
the goods ceased to be registered or listed, the person
requests, in writing, the Secretary to revoke the cancellation;
and
(c) the annual registration or listing charge has been paid; and
(d) the request is accompanied by the prescribed application fee;
the Secretary may, by notice in writing given to the person, revoke
the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to
have occurred.
30B Publication of cancellation of registration or listing
If the Secretary cancels the registration or listing of therapeutic
goods under section 30, the Secretary must, as soon as practicable
after the cancellation, cause to be published in the Gazette, or on
the Department’s website, a notice setting out particulars of the
cancellation.
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Section 30C
30C Consultation with Gene Technology Regulator
(1) This section applies to an application for listing or registration of a
therapeutic good under section 23 if:
(a) the therapeutic good is, or contains, a GM product or a
genetically modified organism; and
(b) if the application is for registration—the application has
passed preliminary assessment; and
(c) if the application is for the listing of a medicine under
section 26AE—the application has passed preliminary
assessment.
(2) Subject to subsection (5), the Secretary must give written notice to
the Gene Technology Regulator:
(a) stating that the application has been made; and
(b) requesting the Gene Technology Regulator to give advice
about the application.
(3) If the Secretary gives the Gene Technology Regulator a notice
under subsection (2), the Gene Technology Regulator may give
written advice to the Secretary about the application.
(4) The advice is to be given within the period specified in the notice.
(5) If an advice from the Gene Technology Regulator is in force under
section 30D in relation to a class of therapeutic goods, the
Secretary is not required to notify the Regulator under this section
in relation to an application for listing or registration of a
therapeutic good belonging to that class.
30D Secretary may seek advice about classes of GM products or
genetically modified organisms
(1) The Secretary may request advice from the Gene Technology
Regulator in relation to:
(a) therapeutic goods that consist of, or that contain, a GM
product belonging to a class of GM products specified in the
request; or
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(b) therapeutic goods that consist of, or that contain, a
genetically modified organism belonging to a class of
genetically modified organisms specified in the request.
(2) A request for advice under subsection (1) must specify the matters
to which the advice is to relate.
(3) If the Secretary requests advice from the Gene Technology
Regulator under subsection (1), the Gene Technology Regulator
may provide written advice in relation to the matters specified in
the request.
(4) If the Gene Technology Regulator gives advice to the Secretary
under subsection (3), the advice remains in force until it is
withdrawn by the Gene Technology Regulator by written notice
given to the Secretary.
30E Secretary to take advice into account
If the Secretary receives advice from the Gene Technology
Regulator:
(a) in response to a notice under section 30C within the period
specified in the notice; or
(b) under section 30D;
the Secretary must:
(c) ensure that the advice is taken into account in making a
decision on the application to which the notice relates, or on
an application to which the advice under section 30D relates,
as the case requires; and
(d) inform the Gene Technology Regulator of the decision on the
application.
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Division 2A Public notification, and recall, of therapeutic goods
Section 30EA
Division 2A—Public notification, and recall, of therapeutic
goods
30EA Public notification, and recall, of therapeutic goods
(1) The Secretary may, in writing, impose requirements, relating to
therapeutic goods, on a person if:
(a) any of the circumstances referred to in the second column of
an item in the following table occur in relation to the goods;
and
(b) the person is referred to in the third column of that item.
Circumstances in which requirements may be imposed
Item Circumstance relating to therapeutic goods Person subject to
requirements
1. The goods are supplied while they are
registered goods or listed goods, but the
Secretary is satisfied that they do not conform
with a standard applicable to the goods
The person in relation to
whom the goods are
included in the Register
2. The goods are supplied while they are
registered goods or listed goods, but the
Secretary is satisfied that the manufacturing
principles have not been observed in the
manufacture of the goods
The person in relation to
whom the goods are
included in the Register
3. The goods are supplied while:
(a) they are exempt goods; or
(b) they are exempt under section 18A; or
(c) they are the subject of an approval or
authority under section 19; or
(d) they are the subject of an approval under
section 19A;
but the Secretary is satisfied that they do not
conform with a standard applicable to the goods
The person supplying the
goods
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Circumstances in which requirements may be imposed
Item Circumstance relating to therapeutic goods Person subject to
requirements
4. The goods are supplied while: The person supplying the
(a) they are exempt goods; or goods
(b) they are exempt under section 18A; or
(c) they are the subject of an approval or
authority under section 19; or
(d) they are the subject of an approval under
section 19A;
but the Secretary is satisfied that the
manufacturing principles have not been
observed in the manufacture of the goods
5. The goods are supplied in contravention of The person supplying the
subsection 19B(1), (4) or (4A) or 19D(1) goods
5A. The goods are supplied while they are
registered goods or listed goods, but it appears
to the Secretary that:
(a) the quality, safety or efficacy of the goods is
unacceptable; or
(b) in the case of registered goods—the
presentation of the goods is not acceptable;
or
(c) in the case of listed goods—the presentation
of the goods is unacceptable
The person in relation to
whom the goods are
included in the Register
6. The goods are supplied while they are
registered goods or listed goods, but one or
more steps in the manufacture of the goods has
been carried out by a manufacturer while the
manufacturer did not hold a licence that was in
force
The person in relation to
whom the goods are
included in the Register
6A. The registration or listing of the goods has been
suspended under this Part
The person in relation to
whom the goods were
included in the Register
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Circumstances in which requirements may be imposed
Item Circumstance relating to therapeutic goods Person subject to
requirements
7. The registration or listing of the goods has been The person in relation to
cancelled under this Part whom the goods were
included in the Register
8. The goods are counterfeit (within the meaning The person supplying the
of section 42E) goods
(2) The requirements may be one or more of the following:
(a) to take specified steps, in the specified manner and within
such reasonable period as is specified, to recall therapeutic
goods that have been distributed;
(b) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, to the effect that the circumstances referred to in
paragraph (1)(a) have occurred in relation to therapeutic
goods;
(ba) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, of specified information, or of information of a
specified kind, relating to either or both of the following:
(i) therapeutic goods;
(ii) the circumstances referred to in paragraph (1)(a) in
relation to therapeutic goods;
(c) to publish, in the specified manner and within such
reasonable period as is specified, specified information, or
information of a specified kind, relating to the manufacture
or distribution of therapeutic goods;
(d) to notify the Secretary, in the specified manner and within
such reasonable period as is specified, of specified
information, or of information of a specified kind, relating to
the persons to whom therapeutic goods have been supplied.
(3) If the circumstances referred to in paragraph (1)(a) apply only to a
batch of therapeutic goods, the Secretary may limit the imposition
of the requirements to the therapeutic goods included in that batch.
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Section 30EB
(4) A requirement to recall therapeutic goods under this section does
not apply to therapeutic goods that cannot be recalled because they
have been administered to, or applied in the treatment of, a person.
30EB Publication of requirements
The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after imposing a
requirement under section 30EA, a notice setting out particulars of
the requirement.
30EC Criminal offences for non-compliance with requirements
(1) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 30EA; and
(c) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 30EA.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person does an act or omits to do an act; and
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Section 30ECA
(b) the act or omission breaches a requirement imposed on the
person under section 30EA.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
30ECA Civil penalty for non-compliance with requirements
A person contravenes this section if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 30EA.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
30ED Powers of suspension and cancellation unaffected
Imposition of a requirement under section 30EA does not affect the
Secretary’s power to suspend or cancel the registration or listing of
therapeutic goods under this Part.
30EE Saving of other laws
This Division is not intended to exclude or limit the operation of
any other law of the Commonwealth or any law of a State or
Territory.
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Reporting medicine shortages and discontinuation of supply of medicine Division 2B
Section 30EF
Division 2B—Reporting medicine shortages and
discontinuation of supply of medicine
30EF Reporting medicine shortages
(1) A person in relation to whom a reportable medicine is included in
the Register must notify the Secretary of any shortage of the
medicine in Australia. The person must do so:
(a) for a shortage that has a critical impact—as soon as possible,
but no later than 2 working days, after the first day the person
knows, or ought reasonably to have known, of the shortage;
or
(b) in any other case—before the end of 10 working days
beginning on the first day the person knows, or ought
reasonably to have known, of the shortage.
Note: For reportable medicine, see section 30EH. For shortage of a
medicine in Australia, see section 30EI.
Critical impact
(2) The shortage of a medicine in Australia at a particular time has a
critical impact if, at that time, the medicine is included in an
instrument under section 30EJ.
(3) The shortage of a medicine in Australia at a particular time also has
a critical impact if:
(a) either:
(i) at that time, there are no registered goods that could
reasonably be used as a substitute for the medicine; or
(ii) at that time, there are other registered goods that could
reasonably be used as a substitute for the medicine but
the other registered goods are not likely to be available
in sufficient quantities to meet the demand for the other
registered goods that is likely to arise because of the
shortage; and
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Section 30EF
(b) the shortage has the potential to have a life-threatening
impact on, or a serious impact on the physical or mental
health or functioning of, persons who take, or who may need
to take, the medicine.
Notification requirements
(4) A notification under subsection (1) must:
(a) be in accordance with a form that is approved, in writing, by
the Secretary; and
(b) contain the information required by that form.
(5) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Civil penalty
(6) A person contravenes this subsection if:
(a) the person is subject to a requirement under subsection (1);
and
(b) the person contravenes the requirement.
Maximum civil penalty:
(a) for an individual—100 penalty units; and
(b) for a body corporate—1,000 penalty units.
Exception
(7) Subsection (6) does not apply if:
(a) paragraph (1)(a) and subsection (3) apply in relation to the
shortage but subsection (2) does not; and
(b) as a result of steps taken by the person, it was reasonable for
the person to assume that paragraph (1)(b) applied in relation
to the shortage; and
(c) the person complied with paragraph (1)(b) in relation to the
shortage.
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Section 30EG
30EG Reporting discontinuation of supply of medicine
(1) A person in relation to whom a reportable medicine is included in
the Register must notify the Secretary of any decision (the
discontinuation decision) of the person to permanently discontinue
the supply of the medicine in Australia. The person must do so:
(a) if the discontinuation is likely to be of critical impact:
(i) at least 12 months before the discontinuation is
proposed to occur; or
(ii) if the person is unable to comply with
subparagraph (i)—as soon as practicable after the
decision is made; or
(b) in any other case:
(i) at least 6 months before the discontinuation is proposed
to occur; or
(ii) if the person is unable to comply with
subparagraph (i)—as soon as practicable after the
decision is made.
Note: For reportable medicine, see section 30EH.
Critical impact
(2) The discontinuation of the supply of a medicine in Australia is
likely to be of critical impact if, when the discontinuation decision
is made, the medicine is included in an instrument under
section 30EJ.
(3) The discontinuation of the supply of a medicine in Australia is also
likely to be of critical impact if:
(a) either:
(i) when the discontinuation decision is made, there are no
registered goods that could reasonably be used as a
substitute for the medicine; or
(ii) when the discontinuation decision is made, there are
other registered goods that could reasonably be used as
a substitute for the medicine but the other registered
goods are not likely to be available in sufficient
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Section 30EG
quantities to meet the demand for the other registered
goods that is likely to arise because of the
discontinuation; and
(b) the discontinuation has the potential to have a life-threatening
impact on, or a serious impact on the physical or mental
health or functioning of, persons who take, or who may need
to take, the medicine.
Notification requirements
(4) A notification under subsection (1) must:
(a) be in accordance with a form that is approved, in writing, by
the Secretary; and
(b) contain the information required by that form.
(5) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Civil penalty
(6) A person contravenes this subsection if:
(a) the person is subject to a requirement under subsection (1);
and
(b) the person contravenes the requirement.
Maximum civil penalty:
(a) for an individual—100 penalty units; and
(b) for a body corporate—1,000 penalty units.
Exception
(7) Subsection (6) does not apply if:
(a) paragraph (1)(a) and subsection (3) apply in relation to the
discontinuation but subsection (2) does not; and
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(b) as a result of steps taken by the person, it was reasonable for
the person to assume that paragraph (1)(b) applied in relation
to the discontinuation; and
(c) the person complied with paragraph (1)(b) in relation to the
discontinuation.
30EH What is a reportable medicine?
(1) For the purposes of this Act, registered goods are a reportable
medicine if:
(a) the goods are medicine; and
(b) either:
(i) the medicine contains one or more substances included
in Schedule 4 or 8 to the current Poisons Standard; or
(ii) the medicine is determined in an instrument under
subsection (2).
(2) The Minister may, by legislative instrument, determine medicine
for the purposes of subparagraph (1)(b)(ii).
(3) The Minister must not determine a medicine unless the Minister is
satisfied of either or both of the following:
(a) the medicine is critical to the health of patients in Australia;
(b) the notification to the Secretary of any shortage of the
medicine, or of any decision to permanently discontinue the
supply of the medicine, in Australia would be in the interests
of public health.
30EI When is there a medicine shortage?
For the purposes of this Act, there is a shortage of a medicine in
Australia at a particular time if, at any time in the 6 months after
that particular time, the supply of that medicine in Australia will
not, or will not be likely to, meet the demand for the medicine for
all of the patients in Australia who take, or who may need to take,
the medicine.
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Section 30EJ
30EJ Medicines Watch List
(1) The Minister may, by legislative instrument, determine medicine
for the purposes of subsections 30EF(2) and 30EG(2).
(2) The Minister must not determine a medicine unless the Minister is
satisfied that any shortage of the medicine, or any permanent
discontinuation of the supply of the medicine, in Australia has the
potential to result in:
(a) significant morbidity in patients in Australia; or
(b) the death of one or more patients in Australia.
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Division 3—General
30F Criminal offences for goods exempt under section 18A not
conforming to standards etc.
(1) This section applies if:
(a) therapeutic goods of a particular kind are exempt under
section 18A; and
(b) a person supplies a batch of goods of that kind; and
(c) the Secretary is satisfied that the goods included in that
batch:
(i) do not conform to a standard applicable to goods of that
kind; or
(ii) are otherwise not fit to be used for their intended
purposes.
(2) The Secretary may, by written notice given to the person, require
the person to take steps to recall the goods included in that batch
(except any of those goods that cannot be recalled because they
have been administered to, or applied in the treatment of, a person).
(3) The notice may specify one or more of the following requirements:
(a) the steps to be taken to recall the goods;
(b) the manner in which the steps are to be taken;
(c) a reasonable period within which the steps are to be taken.
(4) The Secretary must, as soon as practicable after giving the notice,
cause particulars of it to be published in the Gazette or on the
Department’s website.
Written notice is not a legislative instrument
(4A) A written notice given to a person by the Secretary under this
section is not a legislative instrument.
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Offences
(4B) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement; and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the person
failed to comply with that requirement.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (5) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(5) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(6) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
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(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement.
Penalty: 100 penalty units.
(6A) An offence against subsection (6) is an offence of strict liability.
Saving of other laws
(7) This section is not intended to exclude or limit the operation of any
other law of the Commonwealth or any law of a State or Territory.
30FA Civil penalty for goods exempt under section 18A not
conforming to standards etc.
A person contravenes this section if:
(a) the Secretary gives a notice to the person under
subsection 30F(2); and
(b) the notice specifies a particular requirement mentioned in
subsection 30F(3); and
(c) the person does not comply with the requirement.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
30G Disposal of unused goods exempt under section 18A
(1) This section applies to particular therapeutic goods if:
(a) an exemption in relation to those goods under section 18A
ceases to have effect otherwise than because those goods
have become registered goods or listed goods (see
paragraph 18A(5)(a)); and
(b) those goods have not been used before the exemption so
ceases to have effect.
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(2) The Secretary may arrange for the disposal of any of those goods
in accordance with the regulations.
(3) Regulations made for the purposes of subsection (2) may set out
the methods by which those goods are to be stored, supplied,
destroyed, exported or otherwise disposed of.
(4) A method set out in the regulations under subsection (3) must not
enable or permit any benefit to be conferred on a person (including
the Commonwealth) other than the owner of those goods.
30H Record for goods exempt under section 18A
(1) A person commits an offence if:
(a) there are therapeutic goods that are exempt under
section 18A; and
(b) a condition of the exemption:
(i) requires the person to keep a record about those goods;
or
(ii) specifies the manner in which the person must keep the
record; and
(c) the person does an act or omits to do an act in relation to
those goods; and
(d) the act or omission results in the breach of that condition of
the exemption.
Penalty: 240 penalty units.
(2) Strict liability applies to paragraph (1)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(3) A person commits an offence if:
(a) there are therapeutic goods that are exempt under
section 18A; and
(b) a condition of the exemption:
(i) requires the person to keep a record about those goods;
or
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(ii) specifies the manner in which the person must keep the
record; and
(c) the person does an act or omits to do an act in relation to
those goods; and
(d) the act or omission results in the breach of that condition of
the exemption.
Penalty: 60 penalty units.
(4) An offence under subsection (3) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
31 Secretary may require information or documents
(1) The Secretary may, by notice in writing given to a person:
(aa) who is an applicant for the registration of therapeutic goods;
or
(ab) in relation to whom therapeutic goods are registered; or
(ac) in relation to whom therapeutic goods were, at any time
during the previous 5 years, registered;
require the person to give to the Secretary, within such reasonable
time as is specified in the notice and in such form as is specified in
the notice, information or documents relating to one or more of the
following:
(a) the formulation of the goods;
(b) the composition of the goods;
(c) the design specifications of the goods;
(d) the quality of the goods;
(e) the method and place of manufacture or preparation of the
goods and the procedures employed to ensure that proper
standards are maintained in the manufacture and handling of
the goods;
(f) the presentation of the goods;
(g) the safety and efficacy of the goods for the purposes for
which they are to be used;
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(ga) whether the goods comply with conditions (if any) on the
registration of the goods;
(gb) the conformity of the goods to a standard applicable to the
goods;
(h) whether either of the following has not been complied with in
relation to the goods:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or the regulations;
(ha) if the goods are registered in relation to the person—whether
the goods are being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia;
(j) the regulatory history of the goods in another country;
(ja) if the goods are a reportable medicine and the medicine is
registered in relation to the person:
(i) whether or not there is a shortage of the medicine in
Australia; or
(ii) if there is a shortage of the medicine in Australia—the
shortage; or
(iii) any decision of the person to permanently discontinue
the supply of the medicine in Australia;
(k) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
(1A) If a notice is given under subsection (1) to a person covered by
paragraph (1)(ac), then paragraphs (1)(a) to (k) (to the extent to
which they are relevant) apply in relation to that part of the period
of 5 years before the notice was given during which the therapeutic
goods were registered.
(1B) If:
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(a) a person makes an application under section 23 for the
registration of therapeutic goods in accordance with a form
referred to in paragraph 23B(2)(a); and
(aa) the application has passed preliminary assessment; and
(b) the form is described as a pre-submission planning form; and
(c) the person chooses a number of days specified in the form for
the purposes of giving information or documents to the
Secretary in the event that the person is given a notice under
subsection (1) of this section in relation to the application;
then that number of days must be specified in any such notice as
the time within which the person must give the required
information or documents to the Secretary. The number of days so
specified is taken to be a reasonable time for the purposes of
subsection (1).
(1C) If:
(a) the person in relation to whom therapeutic goods are
registered makes a request under subsection 9D(3) in
accordance with a form referred to in subsection 9D(6); and
(b) the form is described as a pre-submission planning form; and
(c) the person chooses a number of days specified in the form for
the purposes of giving information or documents to the
Secretary in the event that the person is given a notice under
subsection (1) of this section in relation to the request;
then that number of days must be specified in any such notice as
the time within which the person must give the required
information or documents to the Secretary. The number of days so
specified is taken to be a reasonable time for the purposes of
subsection (1).
(2) The Secretary may, by notice in writing given to a person:
(aa) who is an applicant for the listing of therapeutic goods; or
(ab) in relation to whom therapeutic goods are listed; or
(ac) in relation to whom therapeutic goods were, at any time
during the previous 5 years, listed;
require the person to give to the Secretary, within such reasonable
time as is specified in the notice and in such form as is specified in
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the notice, information or documents relating to one or more of the
following:
(a) the formulation of the goods;
(b) the composition of the goods;
(c) the design specifications of the goods;
(ca) the quality of the goods;
(d) the method and place of manufacture or preparation of the
goods and the procedures employed to ensure that proper
standards are maintained in the manufacture and handling of
the goods;
(e) the presentation of the goods;
(f) the safety of the goods for the purposes for which they are to
be used;
(fa) if the goods are listed under section 26A—any of the matters
covered by a certification by the person under
subsection 26A(2) or (2A) in relation to the medicine;
(fab) if the goods are or were listed under section 26AE—any of
the matters covered by a certification by the person under
subsection 26AB(2) or (3) in relation to the medicine;
(fac) if the goods are or were listed under section 26AE—the
efficacy of the goods in relation to the purposes for which
they are to be used;
(fb) whether the goods comply with conditions (if any) on the
listing of the goods;
(g) the conformity of the goods to a standard applicable to the
goods;
(gaa) whether either of the following has not been complied with in
relation to the goods:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or the regulations;
(ga) if the goods are listed in relation to the person—whether the
goods are being:
(i) supplied in Australia; or
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(ii) imported into Australia; or
(iii) exported from Australia;
(h) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
(2A) If a notice is given under subsection (2) to a person covered by
paragraph (2)(ac), then paragraphs (2)(a) to (h) (to the extent to
which they are relevant) apply in relation to that part of the period
of 5 years before the notice was given during which the therapeutic
goods were listed.
(3) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(4) A person commits an offence if:
(a) either:
(i) the person is given a notice under subsection (1) and the
person is covered by paragraph (1)(ab) or (ac); or
(ii) the person is given a notice under subsection (2) and the
person is covered by paragraph (2)(ab) or (ac); and
(b) the person fails to comply with the notice.
Penalty: 500 penalty units.
(4A) Subsection (4) does not apply if the person has a reasonable
excuse.
Note: The defendant bears an evidential burden in relation to the matter in
subsection (4A). See subsection 13.3(3) of the Criminal Code.
(4B) A person commits an offence if:
(a) either:
(i) the person is given a notice under subsection (1) and the
person is covered by paragraph (1)(ab) or (ac); or
(ii) the person is given a notice under subsection (2) and the
person is covered by paragraph (2)(ab) or (ac); and
(b) the person fails to comply with the notice.
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Penalty: 100 penalty units.
(5) An offence against subsection (4B) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(5AA) Subsection (4B) does not apply if the person has a reasonable
excuse.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (5AA): see subsection 13.3(3) of the Criminal Code.
(5A) A person commits an offence if:
(a) the person is given a notice under this section in relation to
therapeutic goods; and
(b) the person gives information or a document in compliance or
purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular; and
(d) either:
(i) the use of the therapeutic goods has resulted in, will
result in, or is likely to result in, harm or injury to any
person; or
(ii) the use of the therapeutic goods, if the therapeutic goods
were used, would result in, or would be likely to result
in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (6) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(6) A person commits an offence if:
(a) the person is given a notice under this section in relation to
therapeutic goods; and
(b) the person gives information or a document in compliance or
purported compliance with the notice; and
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(c) the information or document is false or misleading in a
material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(7) A person commits an offence if:
(a) the person is given a notice under this section in relation to
therapeutic goods; and
(b) the person gives information or a document in compliance or
purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: 100 penalty units.
(8) An offence against subsection (7) is an offence of strict liability.
31AAA Civil penalty for providing false or misleading information
or documents in relation to therapeutic goods
A person contravenes this section if:
(a) the person is given a notice under section 31 in relation to
therapeutic goods; and
(b) the person gives information or a document in compliance or
purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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31A Secretary may require information etc. about goods exempt
under section 18
Exempt goods for use for experimental purposes in humans
(1) If therapeutic goods are exempt under subsection 18(1) from the
operation of this Part (except this section and sections 31C to 31F)
to allow for their use for experimental purposes in humans, the
Secretary may give the sponsor of the goods a written notice
requiring the sponsor to give to the Secretary specified information
or documents relating to one or more of the following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
Statement by medical practitioner about medicine
(2) If a medicine is exempt under subsection 18(1) from the operation
of this Part (except this section and sections 31C to 31F) because a
medical practitioner has signed a statement in accordance with
regulation 12A of the Therapeutic Goods Regulations 1990, the
Secretary may give the medical practitioner a written notice
requiring the medical practitioner to give to the Secretary specified
information or documents relating to one or more of the following:
(a) the condition of the person to whom the medicine is to be
given or is given;
(b) the supply of the medicine;
(c) the handling of the medicine;
(d) the monitoring of the supply of the medicine;
(e) the results of the supply of the medicine;
(f) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to medicines of that
kind.
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Compliance period
(3) A notice under subsection (1) or (2) must specify a reasonable
period within which the person to whom the notice is given must
comply with it. The period must be at least 14 days starting on the
day on which the notice is given.
Information may need to be given in accordance with specified
software requirements
(4) A notice under subsection (1) or (2) may require information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
31AA Secretary may require information etc. about goods exempt
under section 18A
(1) This section applies to a person who is required to comply with a
condition of an exemption of therapeutic goods under section 18A.
(2) The Secretary may, by written notice given to the person, require
the person to give to the Secretary specified information or
documents relating to one or more of the following:
(a) the supply of any of those goods;
(b) the handling of any of those goods;
(c) the monitoring of the supply of any of those goods;
(d) the results of the supply of any of those goods;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph.
Compliance period
(3) The notice must specify a reasonable period within which the
person must comply with it. The period must be at least 14 days
starting on the day on which the notice is given.
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Information may need to be given in accordance with specified
software requirements
(4) The notice may require information to be given in accordance with
specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
31B Secretary may require information relating to approvals and
authorities under section 19
Approval under subsection 19(1)
(1) The Secretary may give to a person who is granted an approval
under subsection 19(1) in relation to specified therapeutic goods a
written notice requiring the person to give to the Secretary
specified information or documents relating to one or more of the
following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
Approval under subsection 19(1)—use by another person
(2) The Secretary may give to a person using specified therapeutic
goods that are the subject of an approval granted to someone else
under paragraph 19(1)(b) a written notice requiring the person to
give to the Secretary specified information or documents relating
to either of both of the following:
(a) the use of the goods;
(b) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
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Authority under subsection 19(5)
(3) The Secretary may give to a person who is granted an authority
under subsection 19(5) in relation to specified therapeutic goods, or
a specified class of therapeutic goods, a written notice requiring the
person to give to the Secretary specified information or documents
relating to one or more of the following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
Authority under subsection 19(7A) rules
(3A) If a person is authorised, by subsection 19(7A) rules, to supply
therapeutic goods, the Secretary may give the person a written
notice requiring the person to give the Secretary specified
information or documents relating to one or more of the following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
Compliance period
(4) A notice under subsection (1), (2), (3) or (3A) must specify a
reasonable period within which the person to whom the notice is
given must comply with it. The period must be at least 14 days
starting on the day on which the notice is given.
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Information may need to be given in accordance with specified
software requirements
(5) A notice under subsection (1), (2), (3) or (3A) may require
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
31BA Secretary may require information about therapeutic goods
approved under section 19A
(1) The Secretary may give to a person who is granted an approval
under subsection 19A(1), (1A) or (2) in relation to specified
therapeutic goods a written notice requiring the person to give to
the Secretary specified information, or to produce to the Secretary
specified documents, relating to one or more of the following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations.
Compliance
(2) A person given a notice under subsection (1) must give the
information, or produce the documents, to the Secretary:
(a) within the period specified in the notice (which must not be
less than 14 days after the day the notice is given); and
(b) in the form specified in the notice.
(3) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
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General Division 3
Section 31C
31C Criminal offences for failing to give information or documents
sought under section 31A, 31AA, 31B or 31BA
(1) A person commits an offence if:
(a) the person is given a notice under section 31A, 31AA, 31B or
31BA; and
(b) the person fails to comply with the notice.
Penalty: 400 penalty units.
(2) A person commits an offence if:
(a) the person is given a notice under section 31A, 31AA, 31B or
31BA; and
(b) the person fails to comply with the notice.
Penalty: 100 penalty units.
(3) An offence against subsection (2) is an offence of strict liability.
31D False or misleading information
(1) A person to whom a notice is given under section 31A, 31AA, 31B
or 31BA commits an offence if:
(a) the person gives information to the Secretary in compliance
or purported compliance with the notice; and
(b) the person does so knowing that the information:
(i) is false or misleading; or
(ii) omits any matter or thing without which the information
is misleading.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(1A) A person to whom a notice is given under section 31A, 31AA, 31B
or 31BA commits an offence if:
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Section 31E
(a) the person gives information to the Secretary in compliance
or purported compliance with the notice; and
(b) the information:
(i) is false or misleading; or
(ii) omits any matter or thing without which the information
is misleading.
Penalty: 100 penalty units.
(1B) An offence against subsection (1A) is an offence of strict liability.
(2) Subsection (1) or (1A) does not apply as a result of
subparagraph (1)(b)(i) or (1A)(b)(i) if the information is not false
or misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (2): see subsection 13.3(3) of the Criminal Code.
(3) Subsection (1) or (1A) does not apply as a result of
subparagraph (1)(b)(ii) or (1A)(b)(ii) if the information did not
omit any matter or thing without which the information is
misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (3): see subsection 13.3(3) of the Criminal Code.
31E False or misleading documents
(1) A person commits an offence if:
(a) the person produces a document to the Secretary; and
(b) the person does so knowing that the document is false or
misleading; and
(c) the document is produced in compliance or purported
compliance with a notice given under section 31A, 31AA,
31B or 31BA.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
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Section 31F
(1A) A person commits an offence if:
(a) the person produces a document to the Secretary; and
(b) the document is false or misleading; and
(c) the document is produced in compliance or purported
compliance with a notice given under section 31A, 31AA,
31B or 31BA.
Penalty: 100 penalty units.
(1B) An offence against subsection (1A) is an offence of strict liability.
(2) Subsection (1) or (1A) does not apply if the document is not false
or misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (2): see subsection 13.3(3) of the Criminal Code.
(3) Subsection (1) or (1A) does not apply to a person who produces a
document if the document is accompanied by a written statement
signed by the person or, in the case of a body corporate, by a
competent officer of the body corporate:
(a) stating that the document is, to the knowledge of the
first-mentioned person, false or misleading in a material
particular; and
(b) setting out, or referring to, the material particular in which
the document is, to the knowledge of the first-mentioned
person, false or misleading.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (3): see subsection 13.3(3) of the Criminal Code.
31F Self-incrimination
(1) A person is not excused from giving information or a document
under a notice given under section 31, 31A, 31AA, 31B or 31BA
on the ground that the giving of the information or document
would tend to incriminate the person or expose the person to a
penalty.
(2) However, in the case of an individual:
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Section 31F
(a) the information given; or
(b) the giving of the document; or
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or document;
is not admissible in evidence in:
(d) criminal proceedings against the individual, except
proceedings under, or arising out of, subsection 31(5A), (6)
or (7) or section 31D or 31E; or
(e) civil proceedings, except proceedings under section 42Y for
a contravention of section 31AAA.
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Biologicals Part 3-2A
Preliminary Division 1
Section 32
Part 3-2A—Biologicals
Division 1—Preliminary
32 What this Part is about
This Part regulates biologicals. It does this by providing a process
for including biologicals in the Register and providing for
enforcement through criminal offences and civil penalties.
This Part provides for the following administrative processes:
(a) exempting biologicals from the requirement to be
included in the Register;
(b) making the inclusion of biologicals in the Register
subject to conditions;
(c) suspending or cancelling entries of biologicals
from the Register;
(d) requiring public notification of problems with
biologicals, and recall of biologicals;
(e) obtaining information or documents about
biologicals.
32A Meaning of biological
(1) Subject to subsection (3), a biological is a thing that:
(a) either:
(i) comprises, contains or is derived from human cells or
human tissues; or
(ii) is specified under subsection (2); and
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Section 32AA
(b) is represented in any way to be, or is, whether because of the
way in which it is presented or for any other reason, likely to
be taken to be:
(i) for use in the treatment or prevention of a disease,
ailment, defect or injury affecting persons; or
(ii) for use in making a medical diagnosis of the condition
of a person; or
(iii) for use in influencing, inhibiting or modifying a
physiological process in persons; or
(iv) for use in testing the susceptibility of persons to a
disease or ailment; or
(v) for use in the replacement or modification of parts of the
anatomy in persons.
(2) The Secretary may, by legislative instrument, specify things for the
purposes of subparagraph (1)(a)(ii).
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
(3) The Secretary may, by legislative instrument, determine that a
specified thing is not a biological for the purposes of this Act.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
32AA Biological classes
The regulations may prescribe different classes of biologicals.
Note 1: The regulations may prescribe the circumstances in which a biological
included in a class of biologicals is separate and distinct from other
biologicals: see section 32AB.
Note 2: The Secretary may approve different application forms for different
classes of biologicals: see section 32DDA.
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Preliminary Division 1
Section 32AB
32AB When biologicals are separate and distinct from other
biologicals
(1) The regulations may prescribe the circumstances in which a
biological included in a specified class of biologicals is separate
and distinct from other biologicals.
(2) The regulations may make different provision in relation to
different classes of biologicals that are prescribed by the
regulations for the purposes of section 32AA.
Note: The Secretary may cancel the entry of a biological from the Register if
the biological has changed so that it has become separate and distinct
from the biological as so included: see subsection 32GC(1).
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Section 32B
Division 2—Main criminal offences and civil penalties
32B What this Division is about
This Division contains criminal offences and civil penalties
relating to the import, export, manufacture, supply and use of
biologicals.
32BA Criminal offences for importing a biological
(1) A person commits an offence if:
(a) the person imports into Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the importation into Australia of the
biological;
(v) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person; and
(c) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Section 32BA
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person imports into Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the importation into Australia of the
biological;
(v) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person imports into Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
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(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the importation into Australia of the
biological;
(v) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Defences
(5) Subsection (1), (4) or (4A) does not apply if the defendant proves
that the defendant was not the sponsor of the biological at the time
of the importation.
Note: A defendant bears a legal burden in relation to the matter in
subsection (5): see section 13.4 of the Criminal Code.
(6) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (6): see subsection 13.3(3) of the Criminal Code.
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Section 32BB
32BB Criminal offences for exporting a biological
(1) A person commits an offence if:
(a) the person exports from Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the exportation from Australia of the
biological; and
(c) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person exports from Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
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(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the exportation from Australia of the
biological.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person exports from Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the exportation from Australia of the
biological.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Defences
(5) Subsection (1), (4) or (4A) does not apply if the defendant proves
that the defendant was not the sponsor of the biological at the time
of the exportation.
Note: A defendant bears a legal burden in relation to the matter in
subsection (5): see section 13.4 of the Criminal Code.
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Section 32BBA
(6) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (6): see subsection 13.3(3) of the Criminal Code.
32BBA Treating biologicals as prohibited imports or exports
If:
(a) the importation or exportation of a biological is an offence
under subsection 32BA(1), (4) or (4A) or 32BB(1), (4) or
(4A); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the biological included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
32BC Criminal offences for manufacturing a biological
(1) A person commits an offence if:
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(a) the person manufactures in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB; and
(c) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person manufactures in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
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Section 32BC
(4A) A person commits an offence if:
(a) the person manufactures in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Defences
(5) Subsection (1), (4) or (4A) does not apply if the defendant proves
that the defendant was not the sponsor of the biological at the time
of the manufacture.
Note: A defendant bears a legal burden in relation to the matter in
subsection (5): see section 13.4 of the Criminal Code.
(6) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological.
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Section 32BD
Note: A defendant bears an evidential burden in relation to the matters in
subsection (6): see subsection 13.3(3) of the Criminal Code.
32BD Criminal offences for supplying a biological
(1) A person commits an offence if:
(a) the person supplies in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person, being an approval covering the supply in
Australia of the biological; and
(c) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
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Section 32BD
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person supplies in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person, being an approval covering the supply in
Australia of the biological.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person supplies in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
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Section 32BD
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person, being an approval covering the supply in
Australia of the biological.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Defences
(5) Subsection (1), (4) or (4A) does not apply if the defendant proves
that the defendant was not the sponsor of the biological at the time
of the supply.
Note: A defendant bears a legal burden in relation to the matter in
subsection (5): see section 13.4 of the Criminal Code.
(6) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
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Section 32BE
(iii) the improper use of the biological.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (6): see subsection 13.3(3) of the Criminal Code.
32BE Notice required to adduce evidence in support of exception to
offences
(1) If:
(a) a defendant is committed for trial for an offence against
subsection 32BA(1), 32BB(1), 32BC(1) or 32BD(1); or
(b) an offence against subsection 32BA(1), 32BB(1), 32BC(1) or
32BD(1) is to be heard and determined by a court of
summary jurisdiction;
the committing magistrate or the court must:
(c) inform the defendant of the requirements of this section; and
(d) cause a copy of this section to be given to the defendant.
(2) A defendant must not, without leave of the court, adduce evidence
in support of the exception under subsection 32BA(6), 32BB(6),
32BC(6) or 32BD(6) unless the defendant gives notice of
particulars of the exception:
(a) if paragraph (1)(a) applies—more than 21 days before the
trial begins; or
(b) if paragraph (1)(b) applies—more than 21 days before the
hearing of the offence begins.
(3) A defendant must not, without leave of the court, call any other
person to give evidence in support of the exception unless:
(a) the notice under subsection (2) includes the name and
address of the person or, if the name and address is not
known to the defendant at the time the defendant gives the
notice, any information in the defendant’s possession that
might be of material assistance in finding the person; and
(b) if the name or the address is not included in the notice—the
court is satisfied that the defendant before giving the notice
took, and after giving the notice continued to take, all
reasonable steps to ascertain the name or address; and
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(c) if the name or address is not included in the notice, but the
defendant subsequently ascertains the name or address or
receives information that might be of material assistance in
finding the person—the defendant immediately gives notice
of the name, address or other information, as the case may
be; and
(d) if the defendant is told by or on behalf of the prosecutor that
the person has not been found by the name, or at the address,
given by the defendant:
(i) the defendant immediately gives notice of any
information in the defendant’s possession that might be
of material assistance in finding the person; and
(ii) if the defendant later receives any such information—
the defendant immediately gives notice of the
information.
(4) A notice purporting to be given under this section on behalf of the
defendant by the defendant’s legal practitioner is, unless the
contrary is proved, taken as having been given with the authority of
the defendant.
(5) Any evidence tendered to disprove that the exception applies may,
subject to direction by the court, be given before or after evidence
is given in support of the exception.
(6) A notice under this section must be given in writing to the Director
of Public Prosecutions. A notice is taken as having been given if it
is:
(a) delivered to or left at an office of the Office of the Director of
Public Prosecutions; or
(b) sent by certified mail addressed to the Director of Public
Prosecutions at an office of the Office of the Director of
Public Prosecutions.
(7) In this section:
Director of Public Prosecutions means a person holding office as,
or acting as, the Director of Public Prosecutions under the Director
of Public Prosecutions Act 1983.
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Section 32BF
32BF Civil penalties for importing, exporting, manufacturing or
supplying a biological
Importing a biological for use in humans
(1) A person contravenes this subsection if:
(a) the person imports into Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the importation into Australia of the
biological;
(v) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exporting a biological for use in humans
(2) A person contravenes this subsection if:
(a) the person exports from Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
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(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the exportation from Australia of the
biological.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Manufacturing a biological for use in humans
(3) A person contravenes this subsection if:
(a) the person manufactures in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Supplying a biological for use in humans
(4) A person contravenes this subsection if:
(a) the person supplies in Australia a biological for use in
humans; and
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(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person, being an approval covering the supply in
Australia of the biological.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exception if person was not the sponsor of the biological
(5) Subsection (1), (2), (3) or (4) does not apply if the person proves
that he or she was not the sponsor of the biological at the time of
the importation, exportation, manufacture or supply, as the case
may be.
Civil penalty relating to the supply of biologicals included in the
Register
(6) A person contravenes this subsection if:
(a) a biological is included in the Register in relation to the
person; and
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Section 32BG
(b) the biological is of a kind prescribed by the regulations for
the purposes of this paragraph; and
(c) the person supplies the biological in Australia; and
(d) the biological number of the biological is not set out on the
label of the biological in the prescribed manner.
Maximum civil penalty:
(a) for an individual—200 penalty units; and
(b) for a body corporate—2,000 penalty units.
Application of the Customs Act 1901
(7) If:
(a) the importation or exportation of a biological contravenes
subsection (1) or (2); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the biological included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
32BG Criminal offences and civil penalty relating to a failure to
notify the Secretary about manufacturing
Criminal offences
(1) A person commits an offence if:
(a) the person:
(i) imports a biological into Australia for use in humans; or
(ii) exports a biological from Australia for use in humans;
or
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(iii) manufactures a biological in Australia for use in
humans; or
(iv) supplies a biological in Australia for use in humans; and
(b) the person is the sponsor of the biological; and
(c) the person is not exempt under subsection 32CA(1) in
relation to the biological and the biological is not exempt
under subsection 32CA(2); and
(d) the person has not, at or before the time of the importation,
exportation, manufacture or supply, properly notified to the
Secretary either or both of the following:
(i) the manufacturer of the biological;
(ii) the premises used in the manufacture of the biological.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(1A) A person commits an offence if:
(a) the person:
(i) imports a biological into Australia for use in humans; or
(ii) exports a biological from Australia for use in humans;
or
(iii) manufactures a biological in Australia for use in
humans; or
(iv) supplies a biological in Australia for use in humans; and
(b) the person is the sponsor of the biological; and
(c) the person is not exempt under subsection 32CA(1) in
relation to the biological and the biological is not exempt
under subsection 32CA(2); and
(d) the person has not, at or before the time of the importation,
exportation, manufacture or supply, properly notified to the
Secretary either or both of the following:
(i) the manufacturer of the biological;
(ii) the premises used in the manufacture of the biological.
Penalty: 100 penalty units.
(1B) An offence against subsection (1A) is an offence of strict liability.
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Division 2 Main criminal offences and civil penalties
Section 32BG
Civil penalty
(2) A person contravenes this subsection if:
(a) the person:
(i) imports a biological into Australia for use in humans; or
(ii) exports a biological from Australia for use in humans;
or
(iii) manufactures a biological in Australia for use in
humans; or
(iv) supplies a biological in Australia for use in humans; and
(b) the person is the sponsor of the biological; and
(c) the person is not exempt under subsection 32CA(1) in
relation to the biological and the biological is not exempt
under subsection 32CA(2); and
(d) the person has not, at or before the time of the importation,
exportation, manufacture or supply, properly notified to the
Secretary either or both of the following:
(i) the manufacturer of the biological;
(ii) the premises used in the manufacture of the biological.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Definition
(3) For the purposes of this section:
(a) a manufacturer is properly notified to the Secretary if:
(i) the manufacturer was nominated, as a manufacturer of
the biological, in an application for inclusion of the
biological in the Register; or
(ii) the Secretary was subsequently informed in writing that
the manufacturer is a manufacturer of the biological;
and
(b) premises are properly notified to the Secretary if:
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Section 32BH
(i) the premises were nominated, as premises used in the
manufacture of the biological, in an application for
inclusion of the biological in the Register; or
(ii) the Secretary was subsequently informed in writing that
the premises are used in the manufacture of the
biological.
32BH Criminal offence relating to wholesale supply
A person commits an offence if:
(a) the person supplies a biological in Australia for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person, being an approval covering the supply in
Australia of the biological; and
(c) the person to whom the biological is supplied is not the
ultimate consumer of the biological.
Penalty: 120 penalty units.
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Part 3-2A Biologicals
Division 2 Main criminal offences and civil penalties
Section 32BI
32BI Criminal offence for using a biological not included in the
Register
(1) A person commits an offence if:
(a) the person uses a biological; and
(b) the biological is used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) none of the following subparagraphs applies:
(i) the biological is included in the Register;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2);
(v) the person uses the biological in accordance with an
approval under subsection 32CK(1);
(vi) the person uses the biological in accordance with a
condition applicable under regulations made for the
purposes of section 32CL;
(vii) the person uses the biological in accordance with an
authority under subsection 32CM(1) or (7A); and
(d) either:
(i) if the person used the biological in the treatment of that
other person—the use of the biological has resulted in,
will result in, or is likely to result in, harm or injury to
that other person; or
(ii) if the person used the biological solely for experimental
purposes in humans—the use of the biological has
resulted in, will result in, or is likely to result in, harm
or injury to any of those humans.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Section 32BI
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
(4) A person commits an offence if:
(a) the person uses a biological; and
(b) the biological is used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) none of the following subparagraphs applies:
(i) the biological is included in the Register;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2);
(v) the person uses the biological in accordance with an
approval under subsection 32CK(1);
(vi) the person uses the biological in accordance with a
condition applicable under regulations made for the
purposes of section 32CL;
(vii) the person uses the biological in accordance with an
authority under subsection 32CM(1) or (7A).
Penalty: 500 penalty units.
(5) A person commits an offence if:
(a) the person uses a biological; and
(b) the biological is used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) none of the following subparagraphs applies:
(i) the biological is included in the Register;
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Section 32BJ
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2);
(v) the person uses the biological in accordance with an
approval under subsection 32CK(1);
(vi) the person uses the biological in accordance with a
condition applicable under regulations made for the
purposes of section 32CL;
(vii) the person uses the biological in accordance with an
authority under subsection 32CM(1) or (7A).
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
32BJ General criminal offences relating to this Part
Including incorrect biological number on containers etc.
(1) A person commits an offence if:
(a) the person sets out or causes to be set out, on a container or
package that contains a biological or on a label of a
biological, a number that purports to be the biological
number of the biological; and
(b) the number is not that biological number.
Penalty: 60 penalty units.
(2) For the purposes of subsection (1), number includes any
combination of one or more of the following:
(a) numbers;
(b) letters;
(c) symbols.
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Section 32BJ
Advertising biological for an indication
(2A) A person commits an offence if:
(a) the person, by any means, advertises a biological for an
indication; and
(b) the biological is included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion; and
(d) either:
(i) the use of the biological for the advertised indication
has resulted in, will result in, or is likely to result in,
harm or injury to any person; or
(ii) the use of the biological for the advertised indication, if
the biological were so used, would result in, or would be
likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(2B) A person commits an offence if:
(a) the person, by any means, advertises a biological for an
indication; and
(b) the biological is included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(3) A person commits an offence if:
(a) the person, by any means, advertises a biological for an
indication; and
(b) the biological is included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Penalty: 100 penalty units.
(3A) An offence against subsection (3) is an offence of strict liability.
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Division 2 Main criminal offences and civil penalties
Section 32BK
Arranging supply of biological not included in Register
(4) A person commits an offence if:
(a) the person claims, by any means, that the person or another
person can arrange the supply of a biological; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register;
(ii) the person or other person is exempt under
subsection 32CA(1) in relation to the biological or the
biological is exempt under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person or other
person, being an approval covering the supply in
Australia of the biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person or other person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person or other person, being an approval covering the
supply in Australia of the biological.
Penalty for contravention of this subsection:60 penalty units.
32BK Civil penalty for making misrepresentations about biologicals
(1) A person contravenes this section if:
(a) the person makes a representation of a kind referred to in
subsection (2); and
(b) the representation is false or misleading.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
(2) Subsection (1) applies to the following representations:
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Section 32BL
(a) representations that a biological is included in the Register;
(b) representations that a person is exempt under
subsection 32CA(1) in relation to a biological or that a
biological is exempt under subsection 32CA(2);
(c) representations that a biological is exempt under
section 32CB;
(d) representations that a biological is the subject of an approval
under subsection 32CK(1);
(e) representations that a biological is the subject of an authority
under subsection 32CM(1) or (7A);
(f) representations that a biological is the subject of an approval
under subsection 32CO(1), (1A) or (2).
32BL Civil penalty for advertising biological for an indication
A person contravenes this section if:
(a) the person, by any means, advertises a biological for an
indication; and
(b) the biological is included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Part 3-2A Biologicals
Division 3 Exemptions
Section 32C
Division 3—Exemptions
Subdivision A—Preliminary
32C What this Division is about
There are 4 kinds of exemptions in relation to biologicals:
(a) exemptions of biologicals under the regulations;
and
(b) exemptions of biologicals to deal with
emergencies; and
(c) exemptions of biologicals for special and
experimental uses; and
(d) exemptions of biologicals where substitutes are
unavailable.
Subdivision B—Exempting biologicals under the regulations
32CA Exempt biologicals
(1) The regulations may exempt specified persons from the operation
of Division 4 in relation to specified biologicals.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
(2) The regulations may exempt specified biologicals from the
operation of Division 4.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
(3) An exemption under this section may be subject to conditions that
are prescribed in the regulations.
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Exemptions Division 3
Section 32CB
(4) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of a condition of an
exemption under this section.
Penalty: 60 penalty units.
(5) If the regulations revoke an exemption, the revocation takes effect
on the day specified in the regulations. The day must not be earlier
than 28 days after the day on which the regulations revoking the
exemption take effect.
Subdivision C—Exempting biologicals to deal with emergencies
32CB Minister may make exemptions
(1) The Minister may, by writing, exempt specified biologicals from
the operation of Division 4.
Note 1: For specification by class, see subsection 33(3AB) of the Acts
Interpretation Act 1901.
Note 2: There are criminal offences and a civil penalty relating to biologicals
exempt under this section not conforming to standards etc.: see
section 32CJ.
(2) The Minister may make an exemption under subsection (1) only if
the Minister is satisfied that, in the national interest, the exemption
should be made so that:
(a) the biologicals may be stockpiled as quickly as possible in
order to create a preparedness to deal with a potential threat
to public health that may be caused by a possible future
emergency; or
(b) the biologicals can be made available urgently in Australia in
order to deal with an actual threat to public health caused by
an emergency that has occurred.
Period of exemption
(3) An exemption under subsection (1) comes into force:
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(a) on the day the exemption is made; or
(b) on a later day specified in the exemption.
(4) An exemption under subsection (1) remains in force for the period
specified in the exemption, unless revoked earlier.
Note: Section 32CD deals with variation and revocation of the exemption.
Effect of inclusion of biological in the Register
(5) An exemption under subsection (1) ceases to have effect in relation
to a particular biological when that biological becomes included in
the Register under Division 4.
Exemption not a legislative instrument
(6) An exemption under subsection (1) is not a legislative instrument.
32CC Conditions of exemptions
An exemption under section 32CB is subject to conditions
specified in the exemption about any of the following:
(a) the quantity of biologicals that are exempt;
(b) the source of those biologicals;
(c) the persons or class of persons who may import, export,
manufacture or supply those biologicals;
(d) the supply of those biologicals (including the persons or class
of persons to whom biologicals may be supplied for use and
the circumstances under which a stockpile of biologicals may
be supplied for use);
(e) the storage and security of those biologicals;
(f) the keeping and disclosure of, and access to, records about
those biologicals;
(g) the disposal of those biologicals;
(h) the manner in which any of those biologicals is to be dealt
with if a condition of the exemption is breached;
(i) any other matters that the Minister thinks appropriate.
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Section 32CD
Whether or not biologicals are exempt under section 32CB is not
affected by whether or not there is a breach of a condition under
this section in relation to those biologicals.
Note 1: There are criminal offences and civil penalties related to the breach of
a condition of an exemption: see sections 32CH and 32CI.
Note 2: Section 32CD deals with variation and revocation of the conditions.
32CD Variation or revocation of exemption
Variation of exemption
(1) The Minister may, by writing, vary an exemption made under
section 32CB by removing specified biologicals from the
exemption.
Note: For specification by class, see subsection 33(3AB) of the Acts
Interpretation Act 1901.
Revocation of exemption
(2) The Minister may, by writing, revoke an exemption made under
section 32CB.
Variation or revocation of conditions
(3) The Minister may, by writing:
(a) vary the conditions of an exemption made under
section 32CB (including by imposing new conditions); or
(b) revoke the conditions of an exemption made under
section 32CB.
When variation or revocation takes effect
(4) A variation or revocation under this section takes effect:
(a) if the Minister states in the variation or revocation that the
variation or revocation is necessary to prevent imminent risk
of death, serious illness or serious injury—on the day the
variation or revocation is made; or
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(b) in any other case—on a later day specified in the variation or
revocation (which must not be earlier than 28 days after the
day the variation or revocation is made).
32CE Informing persons of exemption etc.
If the Minister makes an exemption under section 32CB, the
Minister must take reasonable steps to give a copy of the following
to each person covered by paragraph 32CC(c):
(a) the exemption;
(b) any variation or revocation of the exemption under
section 32CD.
32CF Notification and tabling
Notification
(1) The Secretary must cause a notice setting out particulars of the
following:
(a) an exemption made under section 32CB because of
paragraph 32CB(2)(b);
(b) a variation or revocation under section 32CD, to the extent
that the variation or revocation relates to an exemption made
under section 32CB because of paragraph 32CB(2)(b);
to be published in the Gazette within 7 days after the day on which
the exemption, variation or revocation is made. However, the
exemption, variation or revocation is not invalid merely because of
a failure to comply with this subsection.
Tabling
(2) The Minister must cause a document setting out particulars of the
following:
(a) an exemption made under section 32CB because of
paragraph 32CB(2)(b);
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Section 32CG
(b) a variation or revocation under section 32CD, to the extent
that the variation or revocation relates to an exemption made
under section 32CB because of paragraph 32CB(2)(b);
to be tabled in each House of the Parliament within 5 sitting days
of that House after the day on which the exemption, variation or
revocation is made. However, the exemption, variation or
revocation is not invalid merely because of a failure to comply
with this subsection.
32CG Disposal of unused biologicals
(1) This section applies to a biological if:
(a) an exemption under section 32CB in relation to that
biological ceases to have effect otherwise than because that
biological becomes included in the Register under
Division 4; and
(b) that biological has not been used before the exemption so
ceases to have effect.
(2) The Secretary may arrange for the disposal of the biological in
accordance with the regulations.
(3) Regulations made for the purposes of subsection (2) may set out
the methods by which the biological is to be stored, supplied,
destroyed, exported or otherwise disposed of.
(4) A method set out in the regulations under subsection (3) must not
enable or permit any benefit to be conferred on a person (including
the Commonwealth) other than the owner of the biological.
32CH Criminal offences for breaching a condition of an exemption
(1) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a
biological; and
(b) the biological is covered by an exemption in force under
section 32CB; and
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(c) the act or omission results in the breach of a condition of the
exemption; and
(d) the act or omission is likely to cause a serious risk to public
health.
Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) Strict liability applies to paragraph (1)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(3) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a
biological; and
(b) the biological is covered by an exemption in force under
section 32CB; and
(c) the act or omission results in the breach of a condition of the
exemption.
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
(4) Strict liability applies to paragraph (3)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(5) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a
biological; and
(b) the biological is covered by an exemption in force under
section 32CB; and
(c) the act or omission results in the breach of a condition of the
exemption.
Penalty: 60 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
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Section 32CI
32CI Civil penalty for breaching a condition of an exemption
A person contravenes this section if:
(a) the person does an act or omits to do an act in relation to a
biological; and
(b) the biological is covered by an exemption in force under
section 32CB; and
(c) the act or omission results in the breach of a condition of the
exemption.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
32CJ Criminal offences and civil penalty for biologicals not
conforming to standards etc.
(1) This section applies if:
(a) a biological is exempt under section 32CB; and
(b) a person supplies a batch of the biologicals; and
(c) the Secretary is satisfied that the biologicals included in that
batch:
(i) do not conform to a standard applicable to the
biologicals; or
(ii) are otherwise not fit to be used for their intended
purposes.
(2) The Secretary may, by written notice given to the person, require
the person to take steps to recall the biologicals included in that
batch (except any of those biologicals that cannot be recalled
because they have been administered to, or applied in the treatment
of, a person).
(3) The notice may specify one or more of the following requirements:
(a) the steps to be taken to recall the biologicals;
(b) the manner in which the steps are to be taken;
(c) a reasonable period within which the steps are to be taken.
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(4) The Secretary must, as soon as practicable after giving the notice,
cause particulars of it to be published in the Gazette or on the
Department’s website.
Notice is not a legislative instrument
(5) A notice given under subsection (2) is not a legislative instrument.
Offences
(6) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement; and
(d) either:
(i) the use of any of the biologicals has resulted in, will
result in, or is likely to result in, harm or injury to any
person; or
(ii) the use of any of the biologicals, if any of the
biologicals were used, would result in, or would be
likely to result in, harm or injury to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the person
failed to comply with that requirement.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(7) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement.
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Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(9) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement.
Penalty: 100 penalty units.
(10) An offence against subsection (9) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
Civil penalty
(11) A person contravenes this subsection if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person does not comply with the requirement.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Saving of other laws
(12) This section is not intended to exclude or limit the operation of any
other law of the Commonwealth or any law of a State or Territory.
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Section 32CK
Subdivision D—Exempting biologicals for certain uses
32CK Approvals for importing, exporting or supplying a biological
for special and experimental uses
(1) The Secretary may, by notice in writing, grant an approval to a
person for one or more of the following:
(a) the importation into Australia of a specified biological;
(b) the exportation from Australia of a specified biological;
(c) the supply in Australia of a specified biological;
that is:
(d) for use in the treatment of another person; or
(e) for use solely for experimental purposes in humans.
(1A) An approval for use of the kind referred to in paragraph (1)(d) must
not be granted to a person unless the person is a health practitioner.
(2) Subsection (1) does not apply if the biological is included in the
Register, the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt under
subsection 32CA(2).
Application for approval
(3) An application for an approval for use of the kind referred to in
paragraph (1)(d) must:
(a) be made to the Secretary; and
(aa) be in a form (if any) approved, in writing, by the Secretary;
and
(b) be accompanied by such information relating to the
biological the subject of the application as is required by the
Secretary.
(4) An application for an approval for use of the kind referred to in
paragraph (1)(e) must:
(a) be made to the Secretary; and
(b) be made in writing; and
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(c) be accompanied by such information relating to the
biological the subject of the application as is required by the
Secretary; and
(d) be accompanied by the prescribed evaluation fee.
Secretary’s decision
(5) If an application for an approval is made, the Secretary must:
(a) after having considered the application; and
(b) in the case of an application for an approval for use of the
kind referred to in paragraph (1)(e)—after having evaluated
the information submitted with the application;
notify the applicant of the decision on the application as soon as
practicable after making the decision and, in the case of a decision
not to grant the approval, of the reasons for the decision.
Conditions
(6) The Secretary may grant an approval under subsection (1) subject
to any conditions that are specified in the notice of approval.
(7) Those conditions may include a condition relating to the charges
that may be made for the biological to which the approval relates.
This subsection does not limit subsection (6).
(8) An approval under subsection (1) for use of the kind referred to in
paragraph (1)(e) is subject to the conditions (if any) specified in the
regulations. Those conditions (if any) are in addition to any
conditions imposed under subsection (6).
(9) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of a condition of an
approval under subsection (1).
Penalty: 60 penalty units.
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Section 32CL
Approval not a legislative instrument
(10) An approval under subsection (1) is not a legislative instrument.
32CL Conditions of use of biological for experimental purposes in
humans
(1) The use by a person (the experimenter) for experimental purposes
in humans of a biological that is the subject of an approval:
(a) that is held by another person under subsection 32CK(1); and
(b) that covers the importation into Australia, or the supply in
Australia, of the biological for use solely for experimental
purposes in humans;
is subject to the conditions (if any) specified in the regulations
relating to one or more of the following:
(c) the preconditions on the use of the biological for those
purposes;
(d) the principles to be followed in the use of the biological for
those purposes;
(e) the monitoring of the use, and the results of the use, of the
biological for those purposes;
(f) the circumstances in which the experimenter must cease the
use of the biological for those purposes.
(2) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of a condition
applicable under regulations made for the purposes of this
section.
Penalty for contravention of this subsection:60 penalty units.
32CM Exemptions for health practitioners
(1) The Secretary may, in writing, authorise a specified medical
practitioner to supply a specified biological, for use in the
treatment of humans, to the class or classes of recipients specified
in the authority.
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Section 32CM
Note: Section 32CN contains criminal offences relating to the giving an
authority to a medical practitioner.
(1A) An application for an authority under subsection (1) must be in a
form (if any) approved, in writing, by the Secretary.
(2) The Secretary may give an authority under subsection (1) subject
to any conditions that are specified in the authority.
(3) The Secretary may impose conditions (or further conditions) on an
authority given to a person under subsection (1) by giving to the
person written notice of the conditions (or further conditions).
(4) An authority under subsection (1) may only be given:
(a) to a medical practitioner included in a class of medical
practitioners prescribed by the regulations for the purposes of
this paragraph; or
(b) to a medical practitioner who has the approval of an ethics
committee to supply the specified biological.
Paragraph (b) does not apply in the exceptional circumstances (if
any) prescribed by the regulations for the purposes of this
subsection.
(5) An authority under subsection (1) may only be given in relation to
a class or classes of recipients prescribed by the regulations for the
purposes of this subsection.
(6) The regulations may prescribe the circumstances in which a
biological may be supplied under an authority under subsection (1).
(7) An authority under subsection (1) is not a legislative instrument.
(7A) The Minister may, by legislative instrument, make rules
authorising any health practitioner who is included in a specified
class of health practitioners to supply a specified biological, for use
in the treatment of humans, to the class or classes of recipients
specified in those rules, so long as:
(a) the biological is supplied in the circumstances specified in
those rules; and
(b) the conditions (if any) specified in those rules are satisfied.
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Section 32CM
(7B) In making rules under subsection (7A), the Minister must comply
with:
(a) such requirements (if any) as are prescribed by the
regulations; and
(b) such restrictions (if any) as are prescribed by the regulations;
and
(c) such limitations (if any) as are prescribed by the regulations.
(7C) If:
(a) a person is authorised, by subsection (7A) rules, to supply a
biological; and
(b) the person supplies the biological in accordance with those
rules;
the person must:
(c) notify the supply to the Secretary; and
(d) do so within 28 days after the supply.
(7D) A notification under subsection (7C) must:
(a) be in accordance with a form that is approved, in writing, by
the Secretary; and
(b) contain such information as is prescribed by the regulations.
(7E) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(7F) A person commits an offence if:
(a) the person is subject to a requirement under subsection (7C);
and
(b) the person omits to do an act; and
(c) the omission breaches the requirement.
Penalty: 10 penalty units.
(7G) An offence against subsection (7F) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
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(7GA) Subsection (7F) does not apply in relation to a person and a
requirement to notify a supply of a biological if a health
practitioner, on behalf of the person, does the following:
(a) notifies the supply to the Secretary within 28 days after the
supply;
(b) makes the notification in accordance with the requirements
referred to in subsection (7D).
Note: A defendant bears an evidential burden in relation to the matter in
subsection (7GA): see subsection 13.3(3) of the Criminal Code.
(7H) In recommending to the Governor-General that regulations should
be made for the purposes of paragraph (7D)(b), the Minister must
have regard to the principle that information should only be
prescribed for the purposes of that paragraph if the information is
reasonably required for the responsible scrutiny by the Secretary of
the operation of the scheme embodied in subsection (7A).
(8) In this section:
medical practitioner means a person who is registered, in a State
or internal Territory, as a medical practitioner.
32CN Criminal offences relating to the giving of an authority to a
health practitioner
(1) A person commits an offence if:
(a) the Secretary has authorised, under subsection 32CM(1), the
person to supply a biological; and
(b) the person supplies the biological; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority;
(ii) the supply is not in accordance with the conditions to
which the authority is subject;
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 32CM(6); and
(d) either:
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(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because:
(i) the supply is not in accordance with the authority; or
(ii) the supply is not in accordance with the conditions to
which the authority is subject; or
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 32CM(6).
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
(4) A person commits an offence if:
(a) the Secretary has authorised, under subsection 32CM(1), the
person to supply a biological; and
(b) the person supplies the biological; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority;
(ii) the supply is not in accordance with the conditions to
which the authority is subject;
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 32CM(6).
Penalty: 500 penalty units.
(4A) A person commits an offence if:
(a) the Secretary has authorised, under subsection 32CM(1), the
person to supply a biological; and
(b) the person supplies the biological; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority;
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(ii) the supply is not in accordance with the conditions to
which the authority is subject;
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 32CM(6).
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
(5) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 32CM(7A) rules; and
(c) the person supplies a biological specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules; and
(e) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person; and
(f) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because:
(i) the supply is not in accordance with those rules; or
(ii) the supply is not in the circumstances specified in those
rules; or
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(7) A person commits an offence if:
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Section 32CN
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 32CM(7A) rules; and
(c) the person supplies a biological specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: 500 penalty units.
(8) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 32CM(7A) rules; and
(c) the person supplies a biological specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: 100 penalty units.
(9) An offence against subsection (8) is an offence of strict liability.
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Exemptions Division 3
Section 32CO
Subdivision E—Exempting biologicals where substitutes are
unavailable etc.
32CO Approvals where substitutes for biologicals are unavailable
etc.
(1) The Secretary may, by notice in writing, grant an approval to a
person for:
(a) the importation into Australia of a specified biological; or
(b) the importation into Australia of a specified biological and
the supply in Australia of that biological;
if the Secretary is satisfied that:
(c) therapeutic goods included in the Register that could act as a
substitute for the biological are unavailable or are in short
supply; and
(d) any of the following conditions is satisfied:
(i) the biological that is the subject of the application for
approval is registered or approved for general marketing
in at least one foreign country specified by the Secretary
under subsection (5);
(ii) an application that complies with section 32DA has
been made for inclusion of the biological in the
Register;
(iii) an application under section 32DD has been made for
inclusion of the biological in the Register, and the
application has passed preliminary assessment; and
(e) the biological is of a kind specified by the Secretary in a
determination under subsection (6); and
(f) the approval is necessary in the interests of public health.
(1A) The Secretary may, by notice in writing, grant an approval to a
person for:
(a) the importation into Australia of a specified biological; or
(b) the importation into Australia of a specified biological and
the supply in Australia of that biological;
if the Secretary is satisfied that:
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Section 32CO
(c) therapeutic goods included in the Register that could act as a
substitute for the biological are unavailable or are in short
supply; and
(d) either:
(i) the biological that is the subject of the application for
approval is not registered or approved for general
marketing in any of the foreign countries specified by
the Secretary under subsection (5); or
(ii) the biological that is the subject of the application for
approval is registered or approved for general marketing
in at least one foreign country specified by the Secretary
under subsection (5), but is not readily available for
importation into, and supply in, Australia; and
(e) the biological is registered or approved for general marketing
in a foreign country; and
(f) the manufacturing and quality control procedures used in the
manufacture of the biological are acceptable; and
(g) the biological is of a kind specified by the Secretary in a
determination under subsection (6); and
(h) the approval is necessary in the interests of public health.
(2) The Secretary may, by notice in writing, grant an approval to a
person for:
(a) the importation into Australia of a specified biological; or
(b) the importation into Australia of a specified biological and
the supply in Australia of that biological;
if the Secretary is satisfied that:
(c) there are no therapeutic goods that are included in the
Register that could act as a substitute for the biological; and
(d) either:
(i) an application that complies with section 32DA has
been made for inclusion of the biological in the
Register; or
(ii) an application under section 32DD has been made for
inclusion of the biological in the Register, and the
application has passed preliminary assessment; and
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(e) the biological is of a kind specified by the Secretary in a
determination under subsection (6); and
(f) the approval is necessary in the interests of public health.
Application for approval
(3) An application for an approval must:
(a) be made to the Secretary; and
(b) be accompanied by such information relating to the
biological as is required by the Secretary.
Secretary’s decision
(4) If an application for an approval is made, the Secretary must, after
having considered the application, notify the applicant of the
decision on the application as soon as practicable after making the
decision and, in the case of a decision not to grant the approval, of
the reasons for the decision.
Determinations
(5) The Secretary may, by legislative instrument, make a
determination specifying foreign countries for the purposes of
subparagraph (1)(d)(i).
(6) The Secretary may, by legislative instrument, make a
determination specifying the kinds of biologicals that can be the
subject of an approval under this section.
Conditions
(7) The Secretary may grant an approval subject to any conditions that
are specified in the notice of approval.
(8) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of a condition of an
approval under subsection (1), (1A) or (2).
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Section 32CO
Penalty: 60 penalty units.
Period of approval
(9) The Secretary may grant an approval for such period as is specified
in the notice of approval.
When approval lapses
(10) The approval lapses if:
(a) the period specified in the notice of approval expires; or
(b) a decision has been made on an application that has been
made for inclusion of the biological in the Register.
(11) The approval lapses if:
(a) the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f),
paragraph (1A)(c), (d), (e), (f), (g) or (h), or paragraph (2)(c),
(d), (e) or (f), as the case requires, no longer applies in
relation to the biological, or that a condition of the approval
has been contravened; and
(b) the Secretary has given to the person to whom the approval
was granted a notice stating that the Secretary is so satisfied.
(12) The lapsing of the approval on the expiry of the period specified in
the notice of approval does not prevent another approval being
granted under this section in relation to the biological before that
lapsing. The other approval may be expressed to take effect on the
expiry of that period.
Approval not a legislative instrument
(13) An approval under subsection (1), (1A) or (2) is not a legislative
instrument.
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Section 32D
Division 4—Including biologicals in the Register
Subdivision A—Preliminary
32D What this Division is about
A Class 1 biological can be included in the Register if a proper
application is made and the applicant certifies various matters.
A biological other than a Class 1 biological can be included in the
Register if a proper application is made and the Secretary is
satisfied the biological is suitable for inclusion following an
evaluation of the biological.
Subdivision B—Class 1 biologicals
32DA Application for inclusion in the Register
(1) A person may make an application to the Secretary to include a
Class 1 biological in the Register.
(2) An application must:
(a) be made in accordance with a form that is approved, in
writing, by the Secretary; and
(b) be accompanied by a statement certifying the matters
mentioned in subsection (3); and
(c) be delivered to an office of the Department specified in the
form; and
(d) be accompanied by the prescribed application fee.
(3) The applicant must certify that:
(a) the biological is a Class 1 biological; and
(b) the biological is safe for the purposes for which it is to be
used; and
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(c) the biological conforms to every standard (if any) applicable
to it; and
(d) both of the following are complied with in relation to the
biological:
(i) the applicable provisions of the Therapeutic Goods
Advertising Code;
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or under the regulations; and
(e) the biological complies with all prescribed quality or safety
criteria that are applicable to it; and
(f) the biological does not contain substances that are prohibited
imports for the purposes of the Customs Act 1901.
(4) An approval of a form may require or permit an application to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
32DB Inclusion of Class 1 biological in the Register
(1) If an application is made in accordance with section 32DA for a
Class 1 biological to be included in the Register in relation to a
person, the Secretary must include the biological in the Register in
relation to the person.
Biological number
(2) If the Secretary includes the biological in the Register, the
Secretary must assign a unique number to the biological. The
number assigned may be any combination of numbers and either or
both of letters and symbols.
Note: The number assigned is the biological number of the biological.
Certificate
(3) As soon as practicable after the biological has been included in the
Register, the Secretary must give to the applicant a certificate of
the inclusion of the biological in the Register.
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Section 32DC
(4) The certificate must:
(a) specify the biological number of the biological; and
(b) specify the day on which the inclusion of the biological in the
Register commences.
Duration of inclusion in the Register
(5) The biological remains included in the Register in relation to the
person until the Secretary cancels the entry of the biological from
the Register under this Part.
Note: The biological is taken not to be included in the Register while it is
suspended: see section 32FD.
32DC Refusal to include Class 1 biological in the Register
If:
(a) an application is made under subsection 32DA(1) to include
a Class 1 biological in the Register; and
(b) the Secretary refuses the application;
the Secretary must, as soon as practicable after the refusal, give the
person notice of the refusal and of the reasons for the refusal.
Subdivision C—Biologicals other than Class 1 biologicals
32DD Application for inclusion in the Register
A person may make an application to the Secretary to include a
biological, other than a Class 1 biological, in the Register.
32DDA Preliminary assessment of applications
(1) If an application is made under section 32DD for the inclusion of a
biological in the Register, the Secretary must carry out an
assessment of whether the requirements set out in subsection (2) of
this section have been met in relation to the application.
(2) The requirements are as follows:
(a) the application must be made:
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(i) in accordance with the form approved, in writing, by the
Secretary for that class of biological; or
(ii) in such other manner as is approved, in writing, by the
Secretary for that class of biological;
(b) the prescribed application fee for that class of biological must
be paid;
(c) the application must be delivered to an office of the
Department specified by the Secretary;
(d) the application must be accompanied by information that is:
(i) of a kind determined under subsection (9) for that class
of biological; and
(ii) in a form determined under subsection (10) for that
class of biological;
(e) if the Secretary so requires—the applicant must:
(i) deliver to the Department a reasonable number of
samples of the biological; and
(ii) do so in a manner approved, in writing, by the
Secretary.
Passing preliminary assessment
(3) An application passes preliminary assessment if the Secretary:
(a) has carried out an assessment, under subsection (1), in
relation to the application; and
(b) is satisfied that the requirements set out in subsection (2)
have been met in relation to the application.
(4) If the application has passed preliminary assessment, the Secretary
must give a written notice to the applicant stating that the
application has passed preliminary assessment.
(5) Subsection (4) does not apply if the period within which the
Secretary must, under section 32DE, evaluate the biological to
which the application relates is prescribed by reference to the
prescribed period within which the Secretary is required to
consider an application under subsection 9D(3) to vary an entry in
the Register.
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Section 32DE
(6) If the application has not passed preliminary assessment, the
Secretary must, by written notice given to the applicant, refuse the
application.
Approval of different forms etc.
(7) For the purposes of paragraph (2)(a), the Secretary may approve
different forms and manners for making applications for different
classes of biologicals that are prescribed by the regulations for the
purposes of section 32AA.
(8) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Determination of kinds and forms of information
(9) The Secretary may, by legislative instrument, determine a kind of
information for the purposes of the application of
subparagraph (2)(d)(i) to a class of biological that is prescribed by
the regulations for the purposes of section 32AA.
(10) The Secretary may, by legislative instrument, determine a form of
information for the purposes of the application of
subparagraph (2)(d)(ii) to a class of biological that is prescribed by
the regulations for the purposes of section 32AA.
32DE Evaluation of biologicals
(1) If an application is made under section 32DD for a biological to be
included in the Register in relation to a person, and the application
has passed preliminary assessment, the Secretary must evaluate the
biological for inclusion in the Register, having regard to:
(a) whether the quality, safety and efficacy of the biological for
the purposes for which it is to be used have been
satisfactorily established; and
(b) whether the presentation of the biological is acceptable; and
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Section 32DEA
(c) whether the biological conforms to any standard applicable to
it; and
(d) whether:
(i) the applicable provisions of the Therapeutic Goods
Advertising Code; and
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or the regulations;
are complied with in relation to the biological; and
(e) if a step in the manufacture of the biological has been carried
out outside Australia and the biological is not exempt from
the operation of Part 3-3—whether the manufacturing and
quality control procedures used in the step are acceptable;
and
(f) if a step in the manufacture of the biological has been carried
out in Australia, the biological is not exempt from the
operation of Part 3-3 and the person is not exempt from the
operation of that Part in relation to that step—whether that
step has been carried out in accordance with that Part; and
(g) whether the biological contains substances that are prohibited
imports for the purposes of the Customs Act 1901; and
(h) whether all of the manufacturers of the biological are
nominated as manufacturers of the biological in the
application; and
(i) such other matters (if any) as the Secretary considers
relevant.
(2) For the purposes of paragraph (1)(e), subsections 25(2), (2E), (2F)
and (2G) apply in a way corresponding to the way in which they
apply for the purposes of paragraph 25(1)(g).
32DEA Biologicals (priority applicant) determinations
(1) The regulations may make provision for and in relation to
empowering the Secretary to make biologicals (priority applicant)
determinations.
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(2) A biologicals (priority applicant) determination is a determination
that, for the purposes of this Act, a specified person is a priority
applicant in relation to any section 32DD application that may be
made by the person for the inclusion in the Register of a biological
specified in the determination.
(3) The regulations may make provision for and in relation to the
following matters:
(a) applications for biologicals (priority applicant)
determinations;
(b) the approval by the Secretary of a form for such an
application;
(c) information that must accompany such an application;
(d) the application fee for such an application;
(e) empowering the Secretary to give the applicant a written
notice requiring the applicant to give to the Secretary
specified information or documents in connection with the
application within a specified period (which must be at least
10 working days after the notice is given to the applicant).
(4) The regulations may make provision for and in relation to the
following matters:
(a) empowering the Secretary to revoke a biologicals (priority
applicant) determination;
(b) the consequences of the revocation of a biologicals (priority
applicant) determination.
(5) Subsections (3) and (4) do not limit subsection (1).
(6) A period prescribed under paragraph 63(2)(daa) for the evaluation
of a biological covered by a section 32DD application for which
the applicant is a priority applicant may be shorter than the period
prescribed under that paragraph for the evaluation of a biological
covered by a section 32DD application for which the applicant is
not a priority applicant.
(7) The regulations may provide that, if:
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Section 32DF
(a) a person is a priority applicant in relation to a section 32DD
application made by the person; and
(b) a decision is made on the application;
a statement setting out the decision may be published on the
Department’s website.
(8) The express references in this section to the Secretary do not, by
implication, prevent the regulations from empowering the
Secretary to delegate any or all of the Secretary’s functions or
powers under regulations made for the purposes of this section.
(9) If a biologicals (priority applicant) determination is in force under
the regulations, the determination may be published on the
Department’s website.
(10) A biologicals (priority applicant) determination made under the
regulations is not a legislative instrument.
(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not
apply to the specification of a person in a biologicals (priority
applicant) determination.
Note: Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with
specification by class.
32DF Inclusion of biological in the Register
(1) If:
(a) an application is made under section 32DD for a biological to
be included in the Register in relation to a person; and
(aa) the application has passed preliminary assessment; and
(b) the Secretary decides that it is appropriate to include the
biological in the Register after an evaluation under
section 32DE; and
(c) no part of an evaluation fee under section 32DI that is due
and payable by the person remains unpaid;
the Secretary must include the biological in the Register in relation
to the person.
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Section 32DG
Biological number
(2) If the Secretary includes the biological in the Register, the
Secretary must assign a unique number to the biological. The
number assigned may be any combination of numbers and either or
both of letters and symbols.
Note: The number assigned is the biological number of the biological.
Certificate
(3) As soon as practicable after the biological has been included in the
Register, the Secretary must give to the applicant a certificate of
the inclusion of the biological in the Register.
(4) The certificate must:
(a) specify the biological number of the biological; and
(b) specify the day on which the inclusion of the biological in the
Register commences.
Duration of inclusion in the Register
(5) The biological remains included in the Register in relation to the
person until the Secretary cancels the entry of the biological from
the Register under this Part.
Note: The biological is taken not to be included in the Register while it is
suspended: see section 32FD.
32DG Refusal to include biological in the Register
If:
(a) an application is made under section 32DD to include a
biological in the Register; and
(aa) the application has passed preliminary assessment; and
(b) the Secretary refuses the application;
the Secretary must, as soon as practicable after the refusal, give the
person notice of the refusal and of the reasons for the refusal.
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Section 32DH
32DH Lapsing of application
(1) An application under section 32DD for inclusion of a biological in
the Register lapses if:
(a) any part of the evaluation fee payable in respect of the
biological remains unpaid at the end of the period of 42 days
after the day on which the part became due and payable; or
(b) information given to the Secretary by, or on behalf of, the
applicant in connection with the application, including
information given for the purpose of a requirement under
section 32JA, is false or misleading in a material particular;
or
(c) the applicant fails to comply with a requirement under
section 32JA to give information consisting of patient data in
relation to the biological.
(2) In this section:
patient data, in relation to a biological, means information, derived
from clinical trials, relating to individuals before, during and after
the administration of the biological to those individuals, including,
but not limited to, demographic, biochemical and haematological
information.
32DI Evaluation fee
(1) If an application is made under section 32DD for a biological to be
included in the Register, and the application has passed preliminary
assessment, an evaluation fee specified in, or determined in
accordance with, the regulations is payable by the applicant in
respect of the evaluation of the biological for inclusion in the
Register.
(2) The Secretary must notify the applicant in writing of the amount of
the evaluation fee.
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32DJ When evaluation fee due for payment
(1) Subject to sections 32DK and 32DM, an evaluation fee payable by
an applicant is due and payable on the day on which the applicant
is notified of the amount of the evaluation fee.
(2) The evaluation fee is payable in the manner prescribed by the
regulations.
32DK Payment of evaluation fee by instalments
(1) The regulations may provide for the payment of an evaluation fee
to be made by such instalments and at such times as are ascertained
in accordance with the regulations, and the evaluation fee is due
and payable accordingly.
(2) Regulations made for the purposes of subsection (1) may provide
that a person is not allowed to pay an evaluation fee by instalments if
any part of an instalment of that or any other evaluation fee payable
by the person was unpaid immediately after the time when it became
due for payment.
(3) If:
(a) the regulations make provision as mentioned in
subsection (2); and
(b) an instalment of an evaluation fee under section 32DI was
unpaid immediately after the time when it became due for
payment;
the balance of the evaluation fee becomes due and payable
immediately.
(4) Subsection (2) does not limit subsection (1).
32DL Recovery of evaluation fee
An evaluation fee may be recovered by the Commonwealth as a
debt due to the Commonwealth.
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Section 32DM
32DM Reduction of evaluation fee where evaluation not completed
within prescribed period
(1) Nothing in section 32DI, 32DJ or 32DK requires the applicant to
pay more than 3/4 of the evaluation fee before the completion of the
evaluation if a period is prescribed under paragraph 63(2)(daa) for
completing the evaluation.
(2) The Secretary must notify the applicant in writing of the day the
evaluation is completed.
(3) If the evaluation is not completed within that period, the evaluation
fee is 3/4 of the fee that, apart from this subsection, would have
been the evaluation fee.
(4) If:
(a) the evaluation is completed within that period; and
(b) part of the evaluation fee under section 32DI is unpaid when
the evaluation is completed;
that part becomes due and payable on the completion of the
evaluation.
(5) For the purposes of this section, if a copy of the evaluation report,
or a summary of that report, is given to either or both of the
following:
(a) the applicant;
(b) a committee established under the regulations to advise the
Secretary on applications to include biologicals in the
Register where a period for evaluating the biologicals is
prescribed under paragraph 63(2)(daa);
then the evaluation is taken to be completed immediately before
the first copy or summary is so given.
Note: This subsection has the effect that if the applicant withdraws the
application after being given a copy of the evaluation report, or a
summary of that report, before the end of that period, the full
evaluation fee is due and payable by the applicant.
(6) A notification under subsection (2) is not a legislative instrument.
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Section 32DN
Subdivision D—Transitional provisions for existing biologicals
32DN Transitional provisions for existing biologicals
Biologicals currently included in the Register
(1) If, immediately before the commencement of this section,
therapeutic goods that are a biological were included in relation to
a person:
(a) in the part of the Register for goods known as registered
goods; or
(b) in the part of the Register for goods known as listed goods; or
(c) in the part of the Register for medical devices included in the
Register under Chapter 4;
then, as soon as practicable after the commencement of this
section, the Secretary must:
(d) by writing, cancel the inclusion of the goods in that part; and
(e) include the biological in the Register under this Part in
relation to the person; and
(f) vary the Register as a result of that cancellation and
inclusion.
Pending applications
(2) If:
(a) before the commencement of this section, an application was
made for the registration or listing of therapeutic goods that
are a biological or for the inclusion of such goods in the
Register under Chapter 4; and
(b) immediately before that commencement, the application was
not finally determined; and
(c) the application has not been, and is not, withdrawn either
before or after that commencement; and
(d) the application is successful when it is finally determined;
and
(e) the goods are included:
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(i) in the part of the Register for goods known as registered
goods; or
(ii) in the part of the Register for goods known as listed
goods; or
(iii) in the part of the Register for medical devices included
in the Register under Chapter 4;
then, as soon as practicable after that inclusion, the Secretary must:
(f) by writing, cancel the inclusion of the goods in that part; and
(g) include the biological in the Register under this Part in
relation to the person; and
(h) vary the Register as a result of that cancellation and
inclusion.
(3) For the purposes of this section, an application is finally
determined when the application, and any applications for review
or appeals arising out of it, have been finally determined or
otherwise disposed of.
Notice of decisions
(4) The Secretary must give the person written notice of the
cancellation and inclusion under subsection (1) or (2).
Biological number
(5) If the Secretary includes the biological in the Register under
subsection (1) or (2), the Secretary must assign a unique number to
the biological. The number assigned may be any combination of
numbers and either or both of letters and symbols.
Note: The number assigned is the biological number of the biological.
Certificate
(6) As soon as practicable after the biological has been included in the
Register under this Part, the Secretary must give to the person a
certificate of the inclusion of the biological in the Register.
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Section 32DO
(7) The certificate must:
(a) specify the biological number of the biological; and
(b) specify the day on which the inclusion of the biological in the
Register under this Part commences.
Duration of inclusion in the Register
(8) The biological remains included in the Register in relation to the
person until the Secretary cancels the entry of the biological from
the Register under this Part.
Note: The biological is taken not to be included in the Register while it is
suspended: see section 32FD.
Annual charge
(9) If, during a financial year, the Secretary includes a biological in the
Register under subsection (1) or (2), subsection 4(1AA) of the
Therapeutic Goods (Charges) Act 1989 does not apply in relation
to the biological for that financial year.
No review of decisions
(10) A decision under this section is taken not to be an initial decision
for the purposes of section 60.
Subdivision E—Criminal offences and civil penalties
32DO Criminal offences for false statements in applications for
including biologicals in the Register
(1) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in, or in connection with, an
application for inclusion of a biological in the Register; and
(c) the statement is false or misleading in a material particular;
and
(d) either:
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(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in, or in connection with, an
application for inclusion of a biological in the Register; and
(c) the statement is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in, or in connection with, an
application for inclusion of a biological in the Register; and
(c) the statement is false or misleading in a material particular.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
32DP Civil penalty for false statements in applications for including
biologicals in the Register
A person contravenes this section if the person in, or in connection
with, an application for inclusion of a biological in the Register,
makes a statement that is false or misleading in a material
particular.
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Section 32DQ
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
32DQ Criminal offence and civil penalty for failing to notify adverse
effects etc. of biological while it is included in the Register
Criminal offence
(1) A person commits an offence if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person knows that particular information is information
of a kind to which subsection (3) applies; and
(c) the person fails to give that information to the Secretary
within the period specified in the regulations (whether or not
the person has already given to the Secretary other
information relating to the same matter).
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
Civil penalty
(2) A person contravenes this subsection if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person knows that particular information is information
of a kind to which subsection (3) applies; and
(c) the person fails to give that information to the Secretary
within the period specified in the regulations (whether or not
the person has already given to the Secretary other
information relating to the same matter).
Maximum civil penalty:
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Section 32DR
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
Relevant information
(3) This subsection applies to information of the following kinds:
(a) information that contradicts information already given by the
person under this Act in relation to the biological (including
information given about the quality, safety or efficacy of the
biologican( �
(b) information that indicates that the use of the biological in
accordance with the recommendations for its use may have
an unintended harmful effect;
(c) information that indicates that the biological, when used in
accordance with the recommendations for its use, may not be
as effective as the application for inclusion of the biological
in the Register or information already given by the person
under this Act suggests.
32DR Criminal offences and civil penalties for failing to notify
adverse effects etc. of biological where application
withdrawn or lapses
(1) If an application for inclusion of a biological in the Register is
withdrawn or lapses, the Secretary may, within 14 days after the
application is withdrawn or lapses, give the applicant written notice
requiring the applicant:
(a) to inform the Secretary in writing whether the applicant is
aware of any information of a kind to which subsection (2)
applies; and
(b) if the applicant is aware of such information, to give the
information to the Secretary in writing.
(2) This subsection applies to information of the following kinds:
(a) information that contradicts information already given by the
person under this Act in relation to the biological (including
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information given about the quality, safety or efficacy of the
biologican( �
(b) information that indicates that the use of the biological in
accordance with the recommendations for its use may have
an unintended harmful effect;
(c) information that indicates that the biological, when used in
accordance with the recommendations for its use, may not be
as effective as the application for inclusion of the biological
in the Register or information already given by the person
under this Act suggests.
Offences
(3) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (1); and
(b) the person fails to comply with the notice within 30 days
after the notice is given to the person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person gives information in purported compliance with a
notice under subsection (1); and
(b) the information is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
Civil penalties
(5) A person contravenes this subsection if:
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Section 32DS
(a) the Secretary gives a notice to the person under
subsection (1); and
(b) the person fails to comply with the notice within 30 days
after the notice is given to the person.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
(6) A person contravenes this subsection if:
(a) the person gives information in purported compliance with a
notice under subsection (1); and
(b) the information is false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
Subdivision F—Advice from Gene Technology Regulator
32DS Consultation with Gene Technology Regulator
(1) This section applies to an application for inclusion of a biological
in the Register if the biological is, or contains, a GM product or a
genetically modified organism.
(2) Subject to subsection (5), the Secretary must give written notice to
the Gene Technology Regulator:
(a) stating that the application has been made; and
(b) requesting the Gene Technology Regulator to give advice
about the application.
(3) If the Secretary gives the Gene Technology Regulator a notice
under subsection (2), the Gene Technology Regulator may give
written advice to the Secretary about the application.
(4) The advice is to be given within the period specified in the notice.
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Section 32DT
(5) If an advice from the Gene Technology Regulator is in force under
section 32DT in relation to a class of biologicals, the Secretary is
not required to notify the Gene Technology Regulator under this
section in relation to an application for inclusion in the Register of
a biological belonging to that class.
(6) A notice under subsection (2) is not a legislative instrument.
32DT Secretary may seek advice about classes of GM products or
genetically modified organisms
(1) The Secretary may request advice from the Gene Technology
Regulator in relation to:
(a) biologicals that consist of, or that contain, a GM product
belonging to a class of GM products specified in the request;
or
(b) biologicals that consist of, or that contain, genetically
modified organisms belonging to a class of genetically
modified organisms specified in the request.
(2) A request for advice under subsection (1) must specify the matters
to which the advice is to relate.
(3) If the Secretary requests advice from the Gene Technology
Regulator under subsection (1), the Gene Technology Regulator
may provide written advice in relation to the matters specified in
the request.
(4) If the Gene Technology Regulator gives advice to the Secretary
under subsection (3), the advice remains in force until it is
withdrawn by the Gene Technology Regulator by written notice
given to the Secretary.
32DU Secretary to take advice into account
If the Secretary receives advice from the Gene Technology
Regulator:
(a) in response to a notice under section 32DS within the period
specified in the notice; or
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Section 32DU
(b) under section 32DT;
the Secretary must:
(c) ensure that the advice is taken into account in making a
decision on the application to which the notice relates, or on
an application to which the advice under section 32DT
relates, as the case requires; and
(d) inform the Gene Technology Regulator of the decision on the
application.
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Conditions Division 5
Section 32E
Division 5—Conditions
32E What this Division is about
Inclusions of biologicals in the Register are subject to certain
automatic conditions. The Minister and the Secretary may impose
further conditions.
32EA Conditions applying automatically
Entry and inspection powers
(1) The inclusion of a biological in the Register is subject to a
condition that the person in relation to whom the biological is
included in the Register will:
(a) allow an authorised person:
(i) to enter, at any reasonable time, any premises (including
premises outside Australia) at which that person or any
other person deals with the biological, complies with
record-keeping conditions under paragraph 32EC(2)(c)
or keeps documents that relate to the biological; and
(ii) while on those premises, to inspect those premises and
any biological on those premises and to examine, take
measurements of, conduct tests on or take samples of
any biological on those premises or any thing on those
premises that relates to any biological; and
(iii) while on those premises, to make any still or moving
image or any recording of those premises or any thing
on those premises; and
(iv) while on those premises, to inspect, and make copies of,
any records kept in compliance with a condition under
paragraph 32EC(2)(c); and
(v) while on those premises, to inspect, and make copies of,
any documents that relate to the biological; and
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Section 32EA
(b) if requested to do so by an authorised person, produce to the
person such documents relating to the biological included in
the Register as the person requires and allow the person to
copy the documents; and
(c) if requested to do so by an authorised person, make any
record kept in compliance with a condition under
paragraph 32EC(2)(c) available to the authorised person for
inspection:
(i) if the authorised person requires the record to be made
available immediately—immediately; and
(ii) if the authorised person requires the record to be made
available at or before a time specified by the authorised
person—at or before that time; and
(iii) in the form required by the authorised person.
(2) An authorised person is not authorised to enter premises as
mentioned in subsection (1) unless the person has shown his or her
identity card issued under section 52 if required by the occupier of
the premises. For the purposes of this subsection, occupier, in
relation to premises, includes a person present at the premises who
is in apparent control of the premises.
Delivery of samples
(3) The inclusion of a biological in the Register is subject to a
condition that the person in relation to whom the biological is
included in the Register will deliver a reasonable number of
samples of the biological if the Secretary so requests:
(a) within the period, of not less than 14 days after the day the
request is made, specified in the request; and
(b) in accordance with any other requirements specified in the
request.
Manufacturing
(4) The inclusion of a biological in the Register is subject to a
condition that the person in relation to whom the biological is
included in the Register will:
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Section 32EA
(a) if a manufacturer who was not nominated as a manufacturer
of the biological in the application for inclusion of the
biological in the Register is to become a manufacturer of a
step in the manufacture of the biological—inform the
Secretary in writing of that fact and of the name and address
of that manufacturer before that manufacturer begins to carry
out that step; and
(b) if premises that were not nominated in the application as
premises to be used in the manufacture of the biological are
to become premises used in a step in the manufacture of the
biological—inform the Secretary in writing of that fact and
of the name and address of the new premises before the
premises are first so used.
(5) The inclusion of a biological, other than a Class 1 biological, in the
Register is subject to a condition that:
(a) each step in the manufacture of the biological that is carried
out in Australia is carried out by a person who is the holder
of a licence to carry out that step or who is exempt from the
operation of Part 3-3 in relation to that step; and
(b) each step in the manufacture of the biological that is carried
out outside Australia is the subject of a certification in force
under subsection 32EB(2).
(6) Subsection (5) does not apply if the biological is exempt from the
operation of Part 3-3.
(7) Paragraph (5)(b) does not apply in relation to a step that was the
subject of the evaluation under section 32DE. This subsection
ceases to apply in relation to that step if either or both of the
following occur:
(a) that step begins to be carried out at premises that are different
from the premises in respect of which that evaluation was
conducted;
(b) that step begins to be carried out by a manufacturer that is
different from the manufacturer in respect of which that
evaluation was conducted.
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Division 5 Conditions
Section 32EB
Expiry date
(8) The inclusion of a biological in the Register is subject to a
condition that the person in relation to whom the biological is
included in the Register will not supply a batch of the biological in
Australia, or export a batch of the biological from Australia, after
the expiry date for the biological.
Advertising
(9) The inclusion of a biological in the Register is subject to a
condition that the person in relation to whom the biological is
included in the Register will not, by any means, advertise the
biological for an indication other than an indication accepted in
relation to that inclusion.
32EB Certification of manufacturing steps outside Australia
(1) The person in relation to whom a biological, other than a Class 1
biological, is included in the Register may apply to the Secretary
for a certification under this section of a step in the manufacture of
the biological that is to be carried out outside Australia.
(2) If an application is made to the Secretary under this section, the
Secretary may, by writing, certify that the manufacturing and
quality control procedures used in that step are acceptable. The
Secretary must give the person written notice of the certification.
(3) In deciding whether to give the certification, subsections 25(2),
(2E), (2F) and (2G) apply in a way corresponding to the way in
which they apply for the purposes of paragraph 25(1)(g).
32EC Imposition of conditions by legislative instrument
(1) The inclusion of a biological in the Register is subject to the
conditions set out in a determination under subsection (2).
(2) The Minister may, by legislative instrument, make a determination
setting out conditions for the purposes of subsection (1), being
conditions that relate to:
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Section 32ED
(a) the manufacture of the biological; or
(b) the custody, use, supply, disposal or destruction of the
biological; or
(c) the keeping of records relating to the biological; or
(ca) reporting requirements relating to the biological; or
(d) matters dealt with in, or matters additional to matters dealt
with in, standards applicable to the biological; or
(e) such other matters relating to the biological as the Minister
thinks appropriate.
(3) Without limiting subsection (2), different conditions may be
specified for different classes of biologicals.
32ED Imposition of conditions at time biological included in the
Register
(1) If the Secretary includes a biological in the Register in relation to a
person, the Secretary may, by notice in writing given to the person,
impose conditions on the inclusion of the biological in the
Register.
(2) A notice under subsection (1) is not a legislative instrument.
32EE Imposition or variation or removal of conditions after
biological included in the Register
(1) The Secretary may, by notice in writing given to the person in
relation to whom a biological is included in the Register, impose
new conditions on the inclusion or vary or remove conditions
imposed under section 32ED or this subsection.
(2) The Secretary’s power under subsection (1) may be exercised at
the request of the person concerned or on the Secretary’s own
initiative. A request must be accompanied by the prescribed fee.
(3) The imposition or variation or removal of a condition under
subsection (1) takes effect:
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Section 32EF
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the person; or
(aa) in the case of an imposition or variation requested by the
person, and to which paragraph (a) does not apply—on the
day specified in the notice, which must be at least 28 days
after the notice is given to the person, unless the person has
agreed to an earlier day; or
(ab) in the case of a removal to which paragraph (a) does not
apply—on the day specified in the notice, which must be at
least 28 days after the notice is given to the person, unless the
person has agreed to an earlier day; or
(b) in any other case—on a later day specified in the notice,
being a day not earlier than 28 days after the notice is given
to the person.
(3A) For the purposes of paragraphs (3)(aa) and (ab), the earlier day
must not be earlier than the day the notice is given to the person.
(4) A notice under subsection (1) is not a legislative instrument.
32EF Criminal offences for breach of condition
(1) A person commits an offence if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the biological in the Register; and
(d) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
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Section 32EG
(4) A person commits an offence if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the biological in the Register.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the biological in the Register.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
32EG Civil penalty for breach of condition
A person contravenes this section if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the biological in the Register.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Division 6 Suspension from the Register
Section 32F
Division 6—Suspension from the Register
32F What this Division is about
The Secretary may suspend biologicals from the Register in certain
circumstances. A biological that is suspended is taken not to be
included in the Register for most purposes.
32FA Suspension of biological from the Register
(1) The Secretary may, by written notice given to a person in relation
to whom a biological is included in the Register, suspend the
biological from the Register if:
(a) the Secretary is satisfied that:
(i) there is a potential risk of death, serious illness or
serious injury if the biological continues to be included
in the Register; and
(ii) it is likely that the person will, within the period of the
suspension, be able to take the action necessary to
ensure that the biological would not cause a potential
risk of death, serious illness or serious injury if the
biological were to continue to be included in the
Register; or
(b) the Secretary is satisfied that it is likely that there are grounds
for cancelling the entry of the biological from the Register
under Division 7 (other than because of
paragraph 32GA(1)(a), (d) or (g)).
Notice of proposed suspension in some cases
(2) However, before suspending a biological from the Register
because it is likely that there are grounds for cancelling the entry of
the biological from the Register under section 32GC, the Secretary
must:
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Section 32FB
(a) inform the person by written notice that the Secretary
proposes the suspension and set out the reasons for it; and
(b) invite the person to make written submissions to the
Secretary in relation to the proposed suspension within the
period specified in the notice (being not less than 28 days
after the day the notice is given).
(3) The Secretary must not make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
Period of suspension
(4) A notice under subsection (1) must specify the period of the
suspension (which must not exceed 6 months).
Note: Section 32FB deals with when the suspension takes effect and
extensions of the suspension.
Publication
(5) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
suspension.
Notice not a legislative instrument
(6) A notice under subsection (1) is not a legislative instrument.
32FB When suspension takes effect etc.
(1) A suspension under section 32FA takes effect:
(a) if the notice under subsection 32FA(1) states that the
suspension is necessary to prevent a potential risk of death,
serious illness or serious injury—on the day on which the
notice is given to the person; or
(b) in any other case—on a later day specified in the notice,
being a day not earlier than 28 days after the notice is given
to the person.
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Part 3-2A Biologicals
Division 6 Suspension from the Register
Section 32FC
(2) The suspension has effect until:
(a) the Secretary revokes it under section 32FC; or
(b) the end of:
(i) the period specified under subsection 32FA(4); or
(ii) if the period is extended under subsection (3) of this
section—the period as so extended.
Extension of suspension
(3) The Secretary may, by written notice given to the person, extend
the period specified under subsection 32FA(4) by a further
specified period not exceeding 6 months.
Publication
(4) As soon as practicable after giving a notice under subsection (3),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
extension.
Notice not a legislative instrument
(5) A notice under subsection (3) is not a legislative instrument.
32FC Revocation of suspension
(1) The Secretary must revoke a suspension under section 32FA, by
written notice given to the person in relation to whom the
biological is included in the Register, if the Secretary is satisfied
that:
(a) the ground on which the biological was suspended from the
Register no longer applies; and
(b) there are no other grounds for suspending the biological from
the Register.
(2) The Secretary’s power to revoke the suspension may be exercised:
(a) if the person in relation to whom the biological is included in
the Register applies in writing to the Secretary; or
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Section 32FD
(b) on the Secretary’s own initiative.
Publication
(3) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
revocation.
Notice of refusal to revoke suspension
(4) If the Secretary decides, after an application is made under
paragraph (2)(a), not to revoke the suspension, the Secretary must:
(a) notify the applicant in writing of his or her decision; and
(b) state in the notice the reasons for the decision.
Notice not a legislative instrument
(5) A notice under subsection (1) is not a legislative instrument.
32FD Effect of suspension
(1) If a biological is suspended from the Register under section 32FA,
the biological is taken, for the purposes of this Act (other than
section 32DQ, Division 5, sections 32FB and 32FC and
Divisions 7 and 9), not to be included in the Register while the
suspension has effect.
Note: Dealing in a biological that is not included in the Register may be a
criminal offence or may contravene a civil penalty provision: see
Division 2.
(2) While the suspension has effect, the Secretary’s power under
Division 7 to cancel the entry of the biological from the Register is
not affected.
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Part 3-2A Biologicals
Division 7 Cancellation from the Register
Section 32G
Division 7—Cancellation from the Register
32G What this Division is about
The Secretary may cancel inclusions of biologicals in the Register
in certain circumstances.
32GA Immediate cancellation of biological from the Register in
various circumstances
(1) The Secretary may, by written notice given to the person in relation
to whom a biological is included in the Register, cancel the entry
of the biological from the Register if:
(a) the Secretary is satisfied that there would be an imminent risk
of death, serious illness or serious injury if the biological
continued to be included in the Register; or
(b) the biological ceases to be a biological or the biological
becomes covered by an order under section 7 declaring goods
not to be therapeutic goods; or
(c) the person is exempt under subsection 32CA(1) in relation to
the biological or the biological is exempt under
subsection 32CA(2); or
(d) the person requests in writing the cancellation of the entry of
the biological from the Register; or
(e) the biological contains substances that are prohibited imports
for the purposes of the Customs Act 1901; or
(f) the Secretary is satisfied that a statement made in, or in
connection with, the application for including the biological
in the Register was false or misleading in a material
particular; or
(g) the annual charge payable under the Therapeutic Goods
(Charges) Act 1989 in respect of the inclusion of the
biological in the Register is not paid within 28 days after it
becomes payable; or
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Section 32GB
(h) the person has failed to comply with a condition mentioned
in subsection 32EA(1) or (3); or
(i) the person contravenes a direction, or a condition of a
direction, given to the person under subsection 42DV(1) in
relation to the advertising of the biological and the Secretary
is satisfied that the contravention is significant; or
(j) if the person is a body corporate—a related body corporate of
the person contravenes a direction, or a condition of a
direction, given to the related body corporate under
subsection 42DV(1) in relation to the advertising of the
biological and the Secretary is satisfied that the contravention
is significant; or
(k) there is a breach, involving the biological, of an applicable
provision of the Therapeutic Goods Advertising Code or any
other requirement relating to advertising applicable under
Part 5-1 or under the regulations, and the Secretary is
satisfied that:
(i) the breach is significant; and
(ii) as a result of the breach, the presentation of the
biological is misleading to a significant extent.
(2) A notice under subsection (1) is not a legislative instrument.
32GB Immediate cancellation of biological from the Register after
failure to comply with information gathering notice
(1) The Secretary may, by written notice given to the person in relation
to whom a biological is included in the Register, cancel the entry
of the biological from the Register if:
(a) the Secretary gives to the person a notice under section 32JA
requiring the person to give to the Secretary information, or
to produce to the Secretary documents, relating to the
biological; and
(b) the notice under section 32JA is given for the purposes of
ascertaining whether any of the certifications by the person
under subsection 32DA(3) in relation to the biological are
incorrect; and
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Part 3-2A Biologicals
Division 7 Cancellation from the Register
Section 32GC
(c) the person fails to comply with the notice under section 32JA
within a further 14 days after the end of the period specified
in that notice.
(2) The Secretary may, by written notice given to the person in relation
to whom a biological is included in the Register, cancel the entry
of the biological from the Register if:
(a) the Secretary gives to the person a notice under section 32JA
requiring the person to give to the Secretary information, or
to produce to the Secretary documents, relating to whether
the biological is being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia; and
(b) either:
(i) the information or documents given are to the effect that
the biological is not being supplied in Australia,
imported into Australia or exported from Australia; or
(ii) the person fails to comply with the notice under
section 32JA within a further 14 days after the end of
the period specified in that notice.
(3) A notice under subsection (1) or (2) is not a legislative instrument.
32GC Cancellation of biological from the Register after notice of
proposed cancellation
(1) The Secretary may, by written notice given to the person in relation
to whom a biological is included in the Register, cancel the entry
of the biological from the Register if:
(a) it appears to the Secretary that the quality, safety or efficacy
of the biological is unacceptable or that the presentation of
the biological is not acceptable; or
(b) the biological has changed so that it has become separate and
distinct from the biological as so included; or
Note: Section 32AB deals with when a biological is separate and distinct from other biologicals.
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(c) the person has failed to comply with a condition to which the
inclusion of the biological is subject (except a condition
mentioned in subsection 32EA(1) or (3)); or
(d) the Secretary gives to the person a notice under section 32JA:
(i) that requires the person to give to the Secretary
information, or to produce to the Secretary documents,
relating to the biological; and
(ii) in respect of which section 32GB does not apply;
and the person fails to comply with that notice within a
further 14 days after the end of the period specified in that
notice; or
(e) the person contravenes subsection 32DQ(1) or (2) in relation
to the biological; or
(f) the biological does not conform to a standard applicable to it;
or
(fa) the person contravenes a direction, or a condition of a
direction, given to the person under subsection 42DV(1) in
relation to the advertising of the biological; or
(fb) if the person is a body corporate—a related body corporate of
the person contravenes a direction, or a condition of a
direction, given to the related body corporate under
subsection 42DV(1) in relation to the advertising of the
biological; or
(g) either of the following has not been complied with in relation
to the biological:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or under the regulations.
(2) However, before cancelling the entry of the biological from the
Register, the Secretary must:
(a) inform the person in writing that the Secretary proposes the
cancellation and set out the reasons for it; and
(b) invite the person to make written submissions to the
Secretary in relation to the proposed cancellation within the
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Part 3-2A Biologicals
Division 7 Cancellation from the Register
Section 32GD
period specified in the notice (being not less than 28 days
after the day the notice is given).
(3) The Secretary must not make a decision relating to the proposed
cancellation until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
(4) A notice under subsection (1) is not a legislative instrument.
32GD Revocation of cancellation of biological upon request
(1) If:
(a) the Secretary cancels the entry of a biological from the
Register because of the request of a person made under
paragraph 32GA(1)(d); and
(b) before the end of the period of 90 days beginning on the day
the biological ceased to be included in the Register, the
person requests, in writing, the Secretary to revoke the
cancellation; and
(c) the request is accompanied by the prescribed application fee;
the Secretary may, by notice in writing given to the person, revoke
the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to
have occurred.
32GDA Revocation of cancellation of biological upon request—
payment of annual charge
(1) If:
(a) the Secretary cancels the entry of a biological from the
Register because the annual charge payable under the
Therapeutic Goods (Charges) Act 1989 in respect of the
inclusion of the biological in the Register was not paid within
28 days after it becomes payable; and
(b) before the end of the period of 90 days beginning on the day
the biological ceased to be included in the Register, the
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Section 32GE
person requests, in writing, the Secretary to revoke the
cancellation; and
(c) the annual charge payable under the Therapeutic Goods
(Charges) Act 1989 in respect of the inclusion of the
biological in the Register has been paid; and
(d) the request is accompanied by the prescribed application fee;
the Secretary may, by notice in writing given to the person, revoke
the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to
have occurred.
32GE Publication of cancellation of entry from Register
The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after cancelling an
entry of a biological from the Register, a notice setting out
particulars of the cancellation.
32GF Date of effect of cancellation of entries from Register
If the Secretary cancels an entry of a biological from the Register,
the cancellation has effect on the day on which the notice of
cancellation is given to the person in relation to whom the
biological was included in the Register.
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Division 8 Public notification, and recall, of biologicals
Section 32H
Division 8—Public notification, and recall, of biologicals
32H What this Division is about
The Secretary may require a person to recall biologicals, or to
inform the public about biologicals, that do not comply with
requirements or cannot lawfully be supplied. There are criminal
offences and a civil penalty for breaching such a requirement.
32HA Public notification, and recall, of biologicals
(1) The Secretary may, by notice in writing, impose requirements,
relating to a biological, on a person if:
(a) any of the circumstances referred to in the 2nd column of an
item in the following table occur in relation to the biological;
and
(b) the person is referred to in the 3rd column of that item.
Circumstances in which requirements may be imposed
Item Circumstance relating to biological Person subject to
requirements
1 It is supplied while it is included in the
Register, but the Secretary is satisfied that it
does not conform with a standard applicable to
it
The person in relation to
whom it is included in the
Register
2 It is a biological, other than a Class 1
biological, and it is supplied while it is included
in the Register, but the Secretary is satisfied
that the manufacturing principles have not been
observed in its manufacture
The person in relation to
whom it is included in the
Register
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Circumstances in which requirements may be imposed
Item Circumstance relating to biological Person subject to
requirements
It is supplied while: The person supplying it
(a) the person is exempt under
subsection 32CA(1) in relation to the
biological or the biological is exempt under
subsection 32CA(2); or
(b) it is exempt under section 32CB; or
(c) it is the subject of an approval under
subsection 32CK(1); or
(d) it is the subject of an authority under
subsection 32CM(1) or (7A); or
(e) it is the subject of an approval under
subsection 32CO(1), (1A) or (2);
but the Secretary is satisfied that it does not
conform with a standard applicable to it
It is a biological, other than a Class 1 The person supplying it
biological, and it is supplied while:
(a) the person is exempt under
subsection 32CA(1) in relation to the
biological or the biological is exempt under
subsection 32CA(2); or
(b) it is exempt under section 32CB; or
(c) it is the subject of an approval under
subsection 32CK(1); or
(d) it is the subject of an authority under
subsection 32CM(1) or (7A); or
(e) it is the subject of an approval under
subsection 32CO(1), (1A) or (2);
but the Secretary is satisfied that the
manufacturing principles have not been
observed in its manufacture
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Part 3-2A Biologicals
Division 8 Public notification, and recall, of biologicals
Section 32HA
Circumstances in which requirements may be imposed
Item Circumstance relating to biological Person subject to
requirements
It is supplied while: The person supplying it
(a) it is not included in the Register; and
(b) the person is not exempt under
subsection 32CA(1) in relation to the
biological and the biological is not exempt
under subsection 32CA(2); and
(c) it is not exempt under section 32CB; and
(d) it is not the subject of an approval under
subsection 32CK(1); and
(e) it is not the subject of an authority under
subsection 32CM(1) or (7A); and
(f) it is not the subject of an approval under
subsection 32CO(1), (1A) or (2)
It is supplied while it is exempt under The person supplying it
section 32CB, and the Secretary is satisfied that
it is not fit to be used for its intended purpose
It is counterfeit goods (within the meaning of The person supplying it
section 42E)
8 It is a biological, other than a Class 1 The person in relation to
biological, and it is supplied while it is included whom it is included in the
in the Register, but the Secretary is satisfied Register
that there is a breach of the condition set out in
subsection 32EA(5)
9 It appears to the Secretary that the quality,
safety or efficacy of the biological is
unacceptable or that the presentation of the
biological is not acceptable
The person in relation to
whom the biological is
included in the Register
It has been suspended from the Register The person in relation to
whom it is included in the
Register
Its entry has been cancelled from the Register The person in relation to
whom it is included in the
Register
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Section 32HB
(2) The requirements may be one or more of the following:
(a) to take specified steps, in the specified manner and within
such reasonable period as is specified, to recall the biological
that has been supplied;
(b) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, that the circumstances referred to in
paragraph (1)(a) have occurred in relation to the biological;
(ba) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, of specified information, or of information of a
specified kind, relating to either or both of the following:
(i) the biological;
(ii) the circumstances referred to in paragraph (1)(a);
(c) to publish, in the specified manner and within such
reasonable period as is specified, specified information, or
information of a specified kind, relating to the manufacture
or supply of the biological;
(d) to notify the Secretary, in the specified manner and within
such reasonable period as is specified, of specified
information, or of information of a specified kind, relating to
the persons to whom the biological has been supplied.
(3) If the circumstances referred to in paragraph (1)(a) apply only to a
batch of the biological, the Secretary may limit the imposition of
the requirements to that batch.
(4) A requirement to recall a biological under this section does not
apply to a biological that cannot be recalled because it has been
administered to, or applied in the treatment of, a person.
(5) A notice under subsection (1) is not a legislative instrument.
32HB Publication of requirements
The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after imposing a
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Part 3-2A Biologicals
Division 8 Public notification, and recall, of biologicals
Section 32HC
requirement under section 32HA, a notice setting out particulars of
the requirement.
32HC Criminal offences for non-compliance with requirements
(1) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 32HA; and
(c) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 32HA.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 32HA.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
32HD Civil penalty for non-compliance with requirements
A person contravenes this section if:
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Section 32HE
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 32HA.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
32HE Powers of suspension and cancellation unaffected
Imposition of a requirement under section 32HA does not affect
the Secretary’s power to suspend a biological, or cancel the entry
of a biological, from the Register under this Part.
32HF Saving of other laws
This Division is not intended to exclude or limit the operation of
any other law of the Commonwealth or any law of a State or
Territory.
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Division 9 Obtaining information or documents
Section 32J
Division 9—Obtaining information or documents
Subdivision A—Preliminary
32J What this Division is about
The Secretary may by written notice seek information or
documents relating to:
• applications for inclusion of biologicals in the Register; or
• biologicals included in the Register; or
• the supply of, and other matters relating to, biologicals
covered by exemptions under Division 3.
There are criminal offences for failing to comply with a notice and
for giving false or misleading information or documents and civil
penalties for giving false or misleading information or documents.
Subdivision B—Obtaining information or documents for
biologicals included or proposed to be included in the
Register
32JA Secretary may require information or documents
(1) The Secretary may, by written notice given to a person:
(a) who is an applicant for the inclusion of a biological in the
Register; or
(b) in relation to whom a biological is included in the Register;
or
(c) in relation to whom a biological was, at any time during the
previous 5 years, included in the Register;
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Section 32JA
require the person to give to the Secretary information, or to
produce to the Secretary documents, that are relevant to one or
more of the following:
(d) the formulation of the biological;
(e) the composition of the biological;
(f) the design specifications of the biological;
(g) the quality of the biological;
(h) the method and place of manufacture or preparation of the
biological and the procedures employed to ensure that proper
standards are maintained in the manufacture and handling of
the biological;
(i) the presentation of the biological;
(j) the safety and efficacy of the biological for the purposes for
which it is to be used;
(k) whether the biological conforms with a standard applicable to
it;
(l) whether the biological complies with conditions (if any) on
the inclusion of the biological in the Register;
(m) whether either of the following has not been complied with in
relation to the biological:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or under the regulations;
(n) if the biological is included in the Register in relation to the
person—whether the biological is being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia;
(o) the regulatory history of the biological in another country;
(p) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
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Division 9 Obtaining information or documents
Section 32JB
(2) The person must give the information, or produce the documents,
to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice; and
(b) in the form specified in the notice.
Note: Section 32JB contains criminal offences for failing to comply with the
notice and for giving false or misleading information or documents
and section 32JC contains a civil penalty for giving false or
misleading information or documents.
(3) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(4) If a notice is given under subsection (1) to a person covered by
paragraph (1)(c), then paragraphs (1)(d) to (p) (to the extent to
which they are relevant) apply in relation to that part of the period
of 5 years before the notice was given during which the biological
was included in the Register.
32JB Criminal offences for failing to comply with a notice etc.
(1) A person commits an offence if:
(a) the person is given a notice under section 32JA; and
(aa) the person is covered by paragraph 32JA(1)(b) or (c); and
(b) the person fails to comply with the notice.
Penalty: 500 penalty units.
Note: Failure to comply with the notice might also lead to suspension or
cancellation of the entry of a biological in the Register (see
Divisions 6 and 7).
(1A) Subsection (1) does not apply if the person has a reasonable
excuse.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (1A): see subsection 13.3(3) of the Criminal Code.
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Section 32JB
(1B) A person commits an offence if:
(a) the person is given a notice under section 32JA; and
(b) the person is covered by paragraph 32JA(1)(b) or (c); and
(c) the person fails to comply with the notice.
Penalty: 100 penalty units.
(1C) An offence against subsection (1B) is an offence of strict liability.
(1D) Subsection (1B) does not apply if the person has a reasonable
excuse.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (1D): see subsection 13.3(3) of the Criminal Code.
(2) A person commits an offence if:
(a) the person is given a notice under section 32JA in relation to
a biological; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular; and
(d) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (5) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(5) A person commits an offence if:
(a) the person is given a notice under section 32JA; and
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Section 32JC
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(6) A person commits an offence if:
(a) the person is given a notice under section 32JA; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: 100 penalty units.
(7) An offence against subsection (6) is an offence of strict liability.
32JC Civil penalty for giving false or misleading information or
document in compliance with a notice
A person contravenes this section if:
(a) the person is given a notice under section 32JA; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
32JD Self-incrimination
(1) A person is not excused from giving information or producing a
document under section 32JA on the ground that the information or
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Section 32JE
the production of the document might tend to incriminate the
person or expose the person to a penalty.
(2) However, in the case of an individual:
(a) the information given or the document produced; and
(b) giving the information or producing the document; and
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or producing
the document;
are not admissible in evidence against the individual:
(d) in criminal proceedings, except proceedings for an offence
against subsection 32JB(1), (1B), (2), (5) or (6); or
(e) in civil proceedings, except proceedings under section 42Y
for a contravention of section 32JC.
Subdivision C—Obtaining information or documents for
biologicals covered by exemptions
32JE Secretary may require information etc. about biologicals
exempt under the regulations
(1) If a person is exempt under subsection 32CA(1) in relation to a
biological, the Secretary may give the person a written notice
requiring the person to give to the Secretary specified information,
or to produce to the Secretary specified documents, relating to one
or more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
(2) If a biological is exempt under subsection 32CA(2), the Secretary
may give the sponsor of the biological a written notice requiring
the sponsor to give to the Secretary specified information, or to
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produce to the Secretary specified documents, relating to one or
more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
Compliance
(3) A person given a notice under subsection (1) or (2) must give the
information, or produce the documents, to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice; and
(b) in the form specified in the notice.
Note: Section 32JI contains criminal offences for failing to comply with the
notice and for giving false or misleading information or documents
and section 32JJ contains a civil penalty for giving false or misleading
information or documents.
(4) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
32JF Secretary may require information etc. about biologicals
exempt to deal with emergencies
(1) This section applies to a person who is required to comply with a
condition of an exemption of a biological under section 32CB.
(2) The Secretary may, by written notice given to the person, require
the person to give to the Secretary specified information, or to
produce to the Secretary specified documents, relating to one or
more of the following:
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Section 32JG
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
(3) The person must give the information, or produce the documents,
to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice; and
(b) in the form specified in the notice.
Note: Section 32JI contains criminal offences for failing to comply with the
notice and for giving false or misleading information or documents
and section 32JJ contains a civil penalty for giving false or misleading
information or documents.
(4) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
32JG Secretary may require information etc. about biologicals
exempt for special and experimental uses
Approval under subsection 32CK(1)
(1) The Secretary may give to a person who is granted an approval
under subsection 32CK(1) in relation to a biological a written
notice requiring the person to give to the Secretary specified
information, or to produce to the Secretary specified documents,
relating to one or more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
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(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
Approval under subsection 32CK(1)—use by another person
(2) The Secretary may give to a person (the experimenter) using a
biological that is the subject of an approval:
(a) that is held by another person under subsection 32CK(1); and
(b) that covers the importation into Australia, or the supply in
Australia, of the biological for use solely for experimental
purposes in humans;
a written notice requiring the experimenter to give to the Secretary
specified information, or to produce to the Secretary specified
documents, relating to either or both of the following:
(c) the use of the biological;
(d) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
Authority under subsection 32CM(1)
(3) The Secretary may give to a person who is granted an authority
under subsection 32CM(1) in relation to a biological a written
notice requiring the person to give to the Secretary specified
information, or to produce to the Secretary specified documents,
relating to one or more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
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Section 32JH
Authority under subsection 32CM(7A) rules
(3A) If a person is authorised, by subsection 32CM(7A) rules, to supply
a biological, the Secretary may give the person a written notice
requiring the person to give the Secretary specified information, or
to produce to the Secretary specified documents, relating to one or
more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
Compliance
(4) A person given a notice under subsection (1), (2), (3) or (3A) must
give the information, or produce the documents, to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice; and
(b) in the form specified in the notice.
Note: Section 32JI contains criminal offences for failing to comply with the
notice and for giving false or misleading information or documents
and section 32JJ contains a civil penalty for giving false or misleading
information or documents.
(5) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
32JH Secretary may require information etc. about biologicals
exempt where substitutes are unavailable etc.
(1) The Secretary may give to a person who is granted an approval
under subsection 32CO(1), (1A) or (2) in relation to a biological a
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written notice requiring the person to give to the Secretary
specified information, or to produce to the Secretary specified
documents, relating to one or more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
Compliance
(2) A person given a notice under subsection (1) must give the
information, or produce the documents, to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice; and
(b) in the form specified in the notice.
Note: Section 32JI contains criminal offences for failing to comply with the
notice and for giving false or misleading information or documents
and section 32JJ contains a civil penalty for giving false or misleading
information or documents.
(3) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
32JI Criminal offences for failing to comply with a notice etc.
(1) A person commits an offence if:
(a) the person is given a notice under section 32JE, 32JF, 32JG
or 32JH; and
(b) the person fails to comply with the notice.
Penalty: 500 penalty units.
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Section 32JJ
(1A) A person commits an offence if:
(a) the person is given a notice under section 32JE, 32JF, 32JG
or 32JH; and
(b) the person fails to comply with the notice.
Penalty: 100 penalty units.
(1B) An offence against subsection (1A) is an offence of strict liability.
(2) A person commits an offence if:
(a) the person is given a notice under section 32JE, 32JF, 32JG
or 32JH; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(3) A person commits an offence if:
(a) the person is given a notice under section 32JE, 32JF, 32JG
or 32JH; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: 100 penalty units.
(4) An offence against subsection (3) is an offence of strict liability.
32JJ Civil penalty for giving false or misleading information or
document in compliance with a notice
A person contravenes this section if:
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(a) the person is given a notice under section 32JE, 32JF, 32JG
or 32JH; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
32JK Self-incrimination
(1) A person is not excused from giving information or producing a
document under section 32JE, 32JF, 32JG or 32JH on the ground
that the information or the production of the document might tend
to incriminate the person or expose the person to a penalty.
(2) However, in the case of an individual:
(a) the information given or the document produced; and
(b) giving the information or producing the document; and
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or producing
the document;
are not admissible in evidence against the individual:
(d) in criminal proceedings, except proceedings for an offence
against subsection 32JI(1), (1A), (2) or (3); or
(e) in civil proceedings, except proceedings under section 42Y
for a contravention of section 32JJ.
Subdivision D—Inspecting, copying and retaining documents
32JL Secretary may inspect and copy documents
The Secretary may inspect a document produced under
section 32JA, 32JE, 32JF, 32JG or 32JH and may make and retain
copies of the whole or a part of the document.
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Section 32JM
32JM Secretary may retain documents
(1) The Secretary may take possession of a document produced under
section 32JA, 32JE, 32JF, 32JG or 32JH, and retain it for as long
as is reasonably necessary.
(2) The person otherwise entitled to possession of the document is
entitled to be supplied, as soon as practicable, with a copy certified
by the Secretary to be a true copy.
(3) The certified copy must be received in all courts and tribunals as
evidence as if it were the original.
(4) Until a certified copy is supplied, the Secretary must provide the
person otherwise entitled to possession of the document, or a
person authorised by that person, reasonable access to the
document for the purposes of inspecting and making copies of the
whole or a part of the document.
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Section 33A
Part 3-3—Manufacturing of therapeutic goods
33A Application of this Part to medical devices
This Part does not apply to a medical device unless Part 3-2 applies
to the device.
Note: Section 15A sets out when Part 3-2 applies to a medical device.
33B Application of this Part to biologicals
This Part does not apply to a Class 1 biological.
34 Exempt goods and exempt persons
(1) The regulations may exempt therapeutic goods or a class of
therapeutic goods identified in the regulations from the operation
of this Part.
(2) The regulations may exempt a person identified in the regulations
from the operation of this Part in relation to the manufacture or a
step in the manufacture of therapeutic goods or a class of
therapeutic goods identified in the regulations.
(3) Where the regulations revoke an exemption, the revocation takes
effect on the day, not being earlier than 28 days after the day on
which the regulations are made, as is specified in the regulations.
35 Criminal offences relating to manufacturing therapeutic goods
(1) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods (other than goods exempt
under section 18A or 32CB); and
(b) the goods are for supply for use in humans; and
(c) none of the following applies:
(i) the goods are exempt goods;
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(ii) the person is an exempt person in relation to the
manufacture of the goods;
(iii) the person is the holder of a licence that is in force that
authorises the carrying out of that step in relation to the
goods at those premises; and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the person
carried out the step in the manufacture of the goods.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods (other than goods exempt
under section 18A or 32CB); and
(b) the goods are for supply for use in humans; and
(c) none of the following applies:
(i) the goods are exempt goods;
(ii) the person is an exempt person in relation to the
manufacture of the goods;
(iii) the person is the holder of a licence that is in force that
authorises the carrying out of that step in relation to the
goods at those premises.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
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Section 35
(4A) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods (other than goods exempt
under section 18A or 32CB); and
(b) the goods are for supply for use in humans; and
(c) none of the following applies:
(i) the goods are exempt goods;
(ii) the person is an exempt person in relation to the
manufacture of the goods;
(iii) the person is the holder of a licence that is in force that
authorises the carrying out of that step in relation to the
goods at those premises.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
(5) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods; and
(b) the goods are for supply for use in humans; and
(c) the goods are exempt under section 18A or 32CB; and
(d) the person is not the holder of a licence that:
(i) is in force; and
(ii) authorises the carrying out of that step in relation to the
goods at those premises; and
(e) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(f) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the person
carried out the step in the manufacture of the goods.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Section 35A
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (9) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(9) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods; and
(b) the goods are for supply for use in humans; and
(c) the goods are exempt under section 18A or 32CB; and
(d) the person is not the holder of a licence that:
(i) is in force; and
(ii) authorises the carrying out of that step in relation to the
goods at those premises.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(10) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods; and
(b) the goods are for supply for use in humans; and
(c) the goods are exempt under section 18A or 32CB; and
(d) the person is not the holder of a licence that:
(i) is in force; and
(ii) authorises the carrying out of that step in relation to the
goods at those premises.
Penalty: 100 penalty units.
(11) An offence against subsection (10) is an offence of strict liability.
35A Civil penalties relating to manufacturing therapeutic goods
(1) A person contravenes this subsection if:
(a) the person carries out a step in the manufacture of therapeutic
goods at premises in Australia; and
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Section 35B
(b) the goods are for supply for use in humans; and
(c) the goods are not exempt under section 18A or 32CB; and
(d) none of the following applies:
(i) the goods are exempt goods;
(ii) the person is an exempt person in relation to the
manufacture of the goods;
(iii) the person is the holder of a licence that is in force that
authorises the carrying out of that step in relation to the
goods at those premises.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
(2) A person contravenes this subsection if:
(a) the person carries out a step in the manufacture of therapeutic
goods at premises in Australia; and
(b) the goods are for supply for use in humans; and
(c) the goods are exempt under section 18A or 32CB; and
(d) the person is not the holder of a licence that:
(i) is in force; and
(ii) authorises the carrying out of that step in relation to the
goods at those premises.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
35B Criminal offences relating to breaching a condition of a licence
(1) A person commits an offence if:
(a) the person holds a licence; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the licence; and
(d) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
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Section 35C
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
(4) A person commits an offence if:
(a) the person holds a licence; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the licence.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person holds a licence; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the licence.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
35C Civil penalty relating to breaching a condition of a licence
A person contravenes this section if:
(a) the person holds a licence; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the licence.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
36 Manufacturing principles
(1) The Minister may, from time to time, determine written principles
to be observed in the manufacture of therapeutic goods for use in
humans.
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Section 37
(2) The manufacturing principles may relate to:
(a) the standards to be maintained, and the equipment to be used,
at premises used for the manufacturing of therapeutic goods
for use in humans; or
(b) procedures for quality assurance and quality control to be
employed in the manufacturing of therapeutic goods for use
in humans; or
(c) the qualifications and experience required of persons
employed in the manufacture of therapeutic goods for use in
humans; or
(d) the manufacturing practices to be employed in the
manufacturing of therapeutic goods for use in humans; or
(e) other matters relevant to the quality, safety and efficacy of
therapeutic goods for use in humans that are manufactured in
Australia;
and may include codes of good manufacturing practice.
(4) Manufacturing principles are legislative instruments.
37 Application for licence
(1) An application for a licence must:
(a) be made in accordance with a form approved by the
Secretary; and
(b) identify the therapeutic goods or classes of therapeutic goods
that the applicant proposes to manufacture; and
(c) in accordance with subsections (1A) and (1B), identify one or
more manufacturing sites that will be used in the
manufacture of those goods; and
(d) identify the steps in the manufacture of those goods that the
applicant proposes to carry out under the licence; and
(da) if the applicant proposes to carry out steps in the manufacture
of blood or blood components under the licence—contain
information relating to those steps set out in regulations made
for the purposes of this paragraph; and
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(e) state the names, qualifications and experience of the persons
who are to have control of the production of the goods and of
the quality control measures that are to be employed; and
(f) be delivered to an office of the Department specified in the
form; and
(g) be accompanied by the prescribed application fee.
Manufacturing sites
(1A) Subject to subsection (1B), an application under subsection (1)
must relate to one manufacturing site only. This does not prevent
other applications from relating to other manufacturing sites.
(1B) If an applicant is of the view that, having regard to the guidelines
under section 38A, a licence could be granted covering 2 or more
manufacturing sites, the applicant may:
(a) identify those sites in the application; and
(b) state the applicant’s reasons for the applicant’s view.
Further information
(2) The Secretary may, by notice in writing given to an applicant for a
licence, require the applicant:
(a) to give to the Secretary, within such reasonable time as is
specified in the notice, such further information concerning
the application as is specified in the notice; or
(b) to allow an authorised person, at any reasonable time
specified in the notice, to inspect each manufacturing site
identified in the application and the equipment, processes and
facilities that will be used in the manufacture of the goods, or
other goods at that site.
Applications or information may be given electronically
(3) An approval of a form mentioned in paragraph (1)(a), or a notice
mentioned in subsection (2), may require or permit an application
or information to be given in accordance with specified software
requirements:
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(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
38 Grant of licence
(1) Where:
(a) a person has made an application to carry out steps in the
manufacture of therapeutic goods at one or more
manufacturing sites; and
(b) the prescribed application fee has been paid; and
(c) any applicable prescribed inspection fees have been paid; and
(d) the applicant has complied with any requirements made by
the Secretary under subsection 37(2) in relation to the
application;
the Secretary must grant the applicant a licence covering one or
more manufacturing sites specified in the licence unless the
Secretary is satisfied that:
(e) the applicant will be unable to comply with the
manufacturing principles; or
(f) one or more of the manufacturing sites identified in the
application are not satisfactory for the manufacture of the
goods; or
(g) at least one of the following persons:
(i) the applicant;
(ii) a person (a manager) who makes, or participates in
making, decisions that affect the whole, or a substantial
part, of the applicant’s affairs;
(iii) if the applicant is a body corporate—a major interest
holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against this Act or a
corresponding State law; or
(v) been convicted of an offence against a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
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(vi) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of this Act or
a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
(viii) breached a condition of a manufacturing licence; or
(ix) had a manufacturing licence suspended or revoked; or
(x) been a manager, or a major interest holder, of a body
corporate in respect of which subparagraph (iv), (v),
(vi), (vii), (viii) or (ix) applies in that 10 year period, if
the conduct resulting in that subparagraph applying
occurred when the person was a manager or major
interest holder of the body corporate; or
(h) any other circumstances prescribed by the regulations for the
purposes of this paragraph exist.
Interpretation
(1A) A reference in paragraph (1)(g) to a person convicted of an offence
includes a reference to a person in respect of whom an order has
been made relating to the offence under:
(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found
a person to have committed an offence to take action without
proceeding to record a conviction.
(1AA) Paragraph (1)(g) does not limit paragraph (1)(h).
(1B) In paragraph (1)(g):
manufacturing licence means:
(a) a licence granted under this Part; or
(b) a licence, granted under a law of a State or Territory relating
to therapeutic goods, relating to manufacturing therapeutic
goods.
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Special circumstances justifying grant of licence
(2) Notwithstanding paragraph (1)(g), the Secretary may grant a
licence to an applicant who, apart from this subsection, could not
be granted a licence because of that paragraph if, in the opinion of
the Secretary, special circumstances make it appropriate to do so.
Guidelines
(2A) The Secretary must have regard to the guidelines under
section 38A in granting licences under this section.
What the licence authorises
(2B) For each manufacturing site covered by a licence, the Secretary
must authorise, in the licence, the holder of the licence to carry out
specified steps in the manufacture of specified therapeutic goods at
that manufacturing site.
Note 1: For specification by class, see subsection 33(3AB) of the Acts
Interpretation Act 1901.
Note 2: Sections 40A and 40B deal with variation of authorisations.
Notice of decision
(3) Where the Secretary grants or refuses to grant a licence to an
applicant, the Secretary must:
(a) give the applicant written notice of the decision; and
(b) in the case of a refusal—include in the notice the reasons for
the refusal.
Publication
(4) Where the Secretary grants a licence, the Secretary must cause
particulars of the decision to be published in the Gazette or on the
Department’s website as soon as is practicable after the decision is
made.
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Section 38A
38A Guidelines for multi-site licences
The Secretary must, by legislative instrument, make guidelines
setting out the circumstances in which a licence may cover 2 or
more manufacturing sites.
38B Splitting multi-site licences
(1) This section applies if a licence (the old licence):
(a) either:
(i) was in force under this Part immediately before the
commencement of this section; or
(ii) was suspended under this Part immediately before that
commencement; and
(b) related to premises that comprise 2 or more sites (the old
sites).
(2) As soon as practicable after the commencement of this section, the
Secretary must:
(a) by writing, revoke the old licence; and
(b) on the day that the Secretary revokes the old licence, grant
new licences (each of which is a new licence) to the holder of
the old licence which, when considered together, cover the
old sites.
The Secretary must give the holder written notice of the revocation
and grant.
Note: Subsections (5) and (6) deal with when each new licence commences
and when the old licence ends.
Guidelines
(3) The Secretary must have regard to the guidelines under
section 38A in granting licences under this section.
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Application of this Part
(4) Subject to this section, subsections 38(2B) and (4) and sections 39
to 41A apply to a new licence in the same way as they apply to a
licence granted under section 38.
Note: This means, for example, that:
(a) the Secretary must give a manufacturing site authorisation under subsection 38(2B) in relation to each manufacturing site covered by a new licence; and
(b) the Secretary may impose conditions on a new licence under subsection 40(1) and the statutory conditions under subsection 40(4) will apply to a new licence; and
(c) the Secretary may revoke or suspend a new licence under section 41.
Commencement of new licence
(5) The day specified under subsection 39(1) for the commencement
of each new licence granted to the holder of the old licence must be
the day (the transition day) after the day each new licence is
granted.
Note: Subsection (7) deals with suspending a new licence from the transition
day.
When revocation of old licence takes effect
(6) The revocation of the holder’s old licence takes effect immediately
before the start of the transition day.
Suspension of new licence
(7) If:
(a) subparagraph (1)(a)(ii) applies in relation to an old licence;
and
(b) the period of suspension of the old licence is due to end at the
end of a day (the relevant day) after the transition day;
the Secretary may, on the day that the Secretary grants a new
licence to the holder of the old licence and by notice in writing
given to the holder, suspend the new licence for a period starting
on the transition day and ending at the end of the relevant day.
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(8) Subsection 41(2) does not apply in relation to a suspension under
subsection (7) of this section. However, subsections 41(4) to (6) do
apply in relation to the suspension.
(9) To avoid doubt, subsection (7) does not prevent subsection 41(1)
from applying in relation to a new licence.
Licence charges
(10) Subsection 4(2) of the Therapeutic Goods (Charges) Act 1989 does
not apply in relation to a new licence for the financial year in
which the new licence is granted.
No review of revocation of old licence
(11) The revocation of the old licence is taken not to be an initial
decision for the purposes of section 60.
39 Term of licence
(1) A licence commences on the day specified in the licence and
remains in force until it is revoked or suspended.
(2) If:
(a) the licence covers therapeutic goods that are exempt under
section 18A; and
(b) those goods cease to be exempt under that section before the
licence is revoked;
the licence ceases to be in force in relation to those goods when
those goods cease to be exempt under that section.
Note: An exemption under section 18A may cease to have effect only in
relation to some of the goods covered by the exemption, see
subsection 18A(5).
(3) If:
(a) the licence covers a biological that is exempt under
section 32CB; and
(b) the biological ceases to be exempt under that section before
the licence is revoked;
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the licence ceases to be in force in relation to the biological when
the biological ceases to be exempt under that section.
Note: An exemption under section 32CB may cease to have effect only in
relation to some of the biologicals covered by the exemption: see
subsections 32CB(5) and 32CD(1).
40 Conditions of licences
(1) A licence may be granted subject to such conditions relating to the
manufacture of the goods as the Secretary thinks appropriate.
(2) The Secretary may, by notice in writing given to the holder of a
licence, impose new conditions on the licence or vary or remove
existing conditions.
(3) The imposition, variation or removal of a condition under
subsection (2) takes effect:
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the person; or
(b) in any other case—on the day specified in the notice, which
must be at least 28 days after the notice is given to the
person, unless the person has agreed to an earlier day.
(3A) For the purposes of paragraph (3)(b), the earlier day must not be
earlier than the day the notice is given to the person.
(4) In addition to any conditions imposed under subsection (1) or (2),
each licence is, except as otherwise specified in the licence, subject
to the conditions that the holder of the licence will:
(a) ensure that:
(i) the goods conform to any standard applicable to the
goods; and
(ii) the holder of the licence observes the manufacturing
principles in carrying out any steps in the manufacture
of the goods under the licence;
unless:
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(iii) the goods are a biological and are for supply after the
circumstances prescribed by the regulations for the
purposes of paragraphs 14(9A)(b) and 14A(2A)(b) have
occurred; or
(iv) the goods are a biological and are for export after the
circumstances prescribed by the regulations for the
purposes of paragraphs 14(13A)(b) and 14A(3A)(b)
have occurred; and
(aa) if:
(i) the holder of the licence carries out, or proposes to carry
out, steps in the manufacture of blood or blood
components under the licence; and
(ii) regulations made for the purposes of this paragraph set
out particular information relating to those steps;
comply with a request by the Secretary to provide such
information, in accordance with those regulations; and
(ab) as soon as the holder of the licence becomes aware of
information of a kind mentioned in subsection (5), give the
information to the Secretary in writing; and
(ac) give the Secretary the information specified in a notice under
subsection (6) within the period, and in the manner, specified
in the notice; and
(b) allow an authorised person:
(i) to enter, at any reasonable time, each manufacturing site
covered by the licence; and
(ii) while at such a site, to inspect the site, any therapeutic
goods at the site and the processes relating to the
manufacture of therapeutic goods at the site and to
examine, take measurements of, conduct tests on or take
samples of any therapeutic goods at the site or any thing
at the site that relates to any therapeutic goods; and
(iii) while at such a site, to make any still or moving image
or any recording of that site or those goods or processes;
and
(c) where an authorised person enters a site as mentioned in
subparagraph (b)(i), require the holder or his or her
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employees at that site to answer questions relating to
procedures carried out at that site; and
(d) if requested to do so by an authorised person:
(i) produce to the person such documents relating to the
manufacture of therapeutic goods manufactured at that
site as the person requires and allow the person to copy
the documents; or
(ii) produce to the person for examination any batch
samples kept by the holder; and
(e) comply with such other conditions (if any) as are specified in
the regulations for the purposes of this section.
(5) The information with which paragraph (4)(ab) is concerned is
information of the following kinds:
(a) information that indicates that the use of the goods in
accordance with the recommendations for their use may have
an unintended harmful effect;
(b) information that indicates that the goods, when used in
accordance with the recommendations for their use, may not
be as effective as was suggested by:
(i) the application for registration or listing of the goods; or
(ii) information already furnished by the holder of the
licence under this Act; or
(iii) if the holder of the licence is not the sponsor of the
goods—information already furnished by the sponsor of
the goods under this Act;
(c) information that indicates that the quality, safety or efficacy
of the goods is unacceptable.
(6) The Secretary may, by notice in writing given to the holder of a
licence, require the holder to give the Secretary, within the
specified period and in the specified manner, specified information
to be used by the Secretary in deciding whether to revoke or
suspend the licence under section 41 in the circumstances referred
to in paragraph 41(1)(a).
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(7) The period specified in a notice given under subsection (6) must be
at least 14 days after the notice is given.
40A Variation of manufacturing site authorisations—Secretary’s
own initiative
(1) The Secretary may, on his or her own initiative and by notice in
writing given to the holder of a licence, vary a manufacturing site
authorisation in relation to the licence.
(2) A variation under subsection (1) takes effect:
(a) if the notice states that the variation is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the holder; or
(b) in any other case—on the day specified in the notice (which
must not be earlier than 28 days after the notice is given to
the holder).
40B Variation of licences—application by licence holder
Addition of manufacturing sites
(1) If the holder of a licence is of the view that, having regard to the
guidelines under section 38A, the licence could cover one or more
additional manufacturing sites, the holder may apply to the
Secretary for a variation of the licence so that it covers one or more
additional manufacturing sites specified in the application.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved by the
Secretary; and
(b) identify the therapeutic goods or classes of therapeutic goods
that the holder proposes to manufacture at each additional
manufacturing site specified in the application; and
(c) identify the steps in the manufacture of those goods that the
holder proposes to carry out under the licence; and
(d) if the holder proposes to carry out steps in the manufacture of
blood or blood components under the licence—contain
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information relating to those steps set out in regulations made
for the purposes of paragraph 37(1)(da); and
(e) state the names, qualifications and experience of the persons
who are to have control of the manufacture of the goods and
of the quality control measures that are to be employed; and
(f) be delivered to an office of the Department specified in the
form; and
(g) be accompanied by the prescribed application fee.
(3) If an application is made under subsection (1) and any applicable
prescribed inspection fees have been paid, the Secretary may, by
notice in writing given to the holder of the licence, vary the licence
so that the licence covers each additional manufacturing site
specified in the notice.
(4) For each manufacturing site specified under subsection (3), the
Secretary must, in the notice under that subsection, vary the licence
to authorise the holder of the licence to carry out specified steps in
the manufacture of specified therapeutic goods at that
manufacturing site.
Note 1: For specification by class, see subsection 33(3AB) of the Acts
Interpretation Act 1901.
Note 2: Section 40A and subsections (6) to (9) of this section deal with
variation of authorisations.
(5) A variation under subsection (3) or (4) takes effect on the day on
which the notice is given to the holder.
Variation of manufacturing site authorisations
(6) The holder of a licence may apply to the Secretary for a variation
of a manufacturing site authorisation in relation to the licence.
(7) An application under subsection (6) must:
(a) be made in accordance with a form approved by the
Secretary; and
(b) set out the variation sought; and
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(c) be delivered to an office of the Department specified in the
form; and
(d) be accompanied by the prescribed application fee.
(8) If an application is made under subsection (6) and any applicable
prescribed inspection fees have been paid, the Secretary may, by
notice in writing given to the holder of the licence, vary the
manufacturing site authorisation.
(9) A variation under subsection (8) takes effect on the day on which
the notice is given to the holder.
Removal of manufacturing sites
(9A) The holder of a licence may apply to the Secretary for a variation
of the licence so that it ceases to cover one or more manufacturing
sites specified in the application.
(9B) An application under subsection (9A) must:
(a) be made in accordance with a form approved by the
Secretary; and
(b) be delivered to an office of the Department specified in the
form; and
(c) be accompanied by the prescribed application fee.
(9C) If an application is made under subsection (9A), the Secretary may,
by notice in writing given to the holder of the licence, vary the
licence so that the licence does not cover each manufacturing site
specified in the notice.
(9D) A variation under subsection (9C) takes effect on the day specified
in the notice.
Further information
(10) The Secretary may, by notice in writing given to the holder of a
licence who has made an application under subsection (1), (6) or
(9A), require the holder:
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(a) to give to the Secretary, within such reasonable time as is
specified in the notice, such further information concerning
the application as is specified in the notice; or
(b) for an application under subsection (1) or (6)—to allow an
authorised person, at any reasonable time specified in the
notice, to inspect each manufacturing site identified in the
application and the equipment, processes and facilities that
will be used in the manufacture of therapeutic goods at that
site.
Applications or information may be given electronically
(11) An approval of a form mentioned in paragraph (2)(a), (7)(a) or
(9B)(a), or a notice mentioned in subsection (10), may require or
permit an application or information to be given in accordance with
specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
41 Revocation and suspension of licences
(1) Subject to subsection (2), the Secretary may, by notice in writing
given to the holder of a licence, revoke the licence, or suspend the
licence for a period specified in the notice, if:
(a) at least one of the following persons:
(i) the holder;
(ii) a person (a manager) who makes, or participates in
making, decisions that affect the whole, or a substantial
part, of the holder’s affairs;
(iii) if the holder is a body corporate—a major interest
holder of the body corporate;
has:
(iv) been convicted of an offence against this Act or a
corresponding State law; or
(v) been convicted of an offence against a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
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(vi) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of this Act or
a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
(viii) breached a condition of a manufacturing licence; or
(ix) had a manufacturing licence suspended or revoked; or
(x) been a manager, or a major interest holder, of a body
corporate in respect of which subparagraph (iv), (v),
(vi), (vii), (viii) or (ix) applies, if the conduct resulting
in that subparagraph applying occurred when the person
was a manager or major interest holder of the body
corporate; or
(d) the holder requests in writing that the licence be revoked or
suspended, as the case may be; or
(e) the holder ceases to carry on the business of manufacturing
the goods to which the licence relates; or
(ea) the holder contravenes a manufacturing site authorisation in
relation to the licence; or
(f) the annual licensing charge, or any applicable prescribed
inspection fees, have not been paid within 28 days after they
become payable; or
(g) the goods are exempt under section 18A and the holder has
breached a condition of the exemption in relation to those
goods; or
(ga) the licence covers a biological that is exempt under
section 32CB and the holder has breached a condition of the
exemption in relation to the biological; or
(h) any other circumstances prescribed by the regulations for the
purposes of this paragraph exist.
(1A) A reference in paragraph (1)(a) to a person convicted of an offence
includes a reference to a person in respect of whom an order has
been made relating to the offence under:
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(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found
a person to have committed an offence to take action without
proceeding to record a conviction.
(1B) Paragraph (1)(a) does not limit paragraph (1)(h).
(1C) In paragraph (1)(a):
manufacturing licence means:
(a) a licence granted under this Part; or
(b) a licence, granted under a law of a State or Territory relating
to therapeutic goods, relating to manufacturing therapeutic
goods.
(2) Where the Secretary proposes to revoke a licence or suspend a
licence otherwise than at the request of the holder of the licence,
the Secretary must, unless the Secretary considers that failure to
revoke or suspend the licence immediately would create an
imminent risk of death, serious illness or serious injury:
(a) by notice in writing given to the holder, inform the holder of
the action that the Secretary proposes to take and of the
reasons for that proposed action; and
(b) except where the proposed action is to be taken as a result of
a failure to pay the annual licensing charge or an applicable
prescribed inspection fee—give the holder an opportunity to
make, within such reasonable time as is specified in the
notice, submissions to the Secretary in relation to the
proposed action.
(3) Where the holder makes submissions in accordance with
paragraph (2)(b), the Secretary is not to make a decision relating to
the revocation or suspension of the licence before taking into
account the submissions.
(4) A licence may be revoked notwithstanding that the licence is
suspended.
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(5) Where a licence is suspended, the Secretary may, by notice in
writing given to the holder of the licence, revoke the suspension.
(6) Where the Secretary revokes or suspends a licence, the Secretary
must cause particulars of the decision to be published in the
Gazette or on the Department’s website as soon as is practicable
after the decision is made.
41AAAA Withdrawal of revocation of licence upon request
(1) If:
(a) the Secretary revokes a licence because of the request of a
person made under paragraph 41(1)(d); and
(b) before the end of the period of 90 days beginning on the day
the licence was revoked, the person requests, in writing, the
Secretary to withdraw the revocation; and
(c) the request is accompanied by the prescribed application fee
(if any);
the Secretary may, by notice in writing given to the person,
withdraw the revocation.
(2) If the revocation is withdrawn, the revocation is taken never to
have occurred.
41AA Spent convictions scheme
Nothing in section 40 or 41 affects the operation of Part VIIC of
the Crimes Act 1914 (which includes provisions that, in certain
circumstances, relieve persons from the requirement to disclose
spent convictions and require persons aware of such convictions to
disregard them).
41AB Secretary may require information or documents
(1) If:
(a) a person is the holder of a licence; and
(b) the person has carried out, or is carrying out, one or more
steps in the manufacture of therapeutic goods;
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the Secretary may, by written notice given to the person, require
the person to:
(c) give the Secretary information, or produce to the Secretary
documents, relating to one or more of the following:
(i) the therapeutic goods;
(ii) if the therapeutic goods consist of a mixture of
ingredients—those ingredients;
(iii) if the therapeutic goods consist of a mixture of
ingredients—the suppliers of those ingredients;
(iv) if the therapeutic goods consist of a combination of
component parts—those component parts;
(v) if the therapeutic goods consist of a combination of
component parts—the suppliers of those component
parts;
(vi) the containers or packages used, or proposed to be used,
to contain the therapeutic goods;
(vii) the batch numbers of the therapeutic goods;
(viii) the expiry dates of the therapeutic goods;
(ix) the distribution of the therapeutic goods;
(x) the conformity of the therapeutic goods to a standard
applicable to the goods;
(xi) the step or steps that the person has carried out, or is
carrying out, in the manufacture of the therapeutic
goods;
(xii) the premises used to carry out one or more steps in the
manufacture of the therapeutic goods;
(xiii) the observance of the manufacturing principles;
(xiv) the names, qualifications and experience of individuals
who have control of any of the steps that have been
carried out, or are being carried out, in the manufacture
of the therapeutic goods;
(xv) the measures for quality assurance and quality control
employed in the taking of any of the steps that have
been carried out, or are being carried out, in the
manufacture of the therapeutic goods;
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(xvi) compliance with the conditions of the licence;
(xvii) whether there are grounds for revoking or suspending
the licence;
(xviii) any other matter that is prescribed by the regulations
and that relates to the manufacture of the therapeutic
goods; and
(d) do so:
(i) within such reasonable time as is specified in the notice;
and
(ii) in such form as is specified in the notice.
(2) The time specified in the notice must not be shorter than 14 days
after the notice is given.
(3) The rule in subsection (2) does not apply if the Secretary is
satisfied that, because of circumstances of urgency, the time
specified in the notice should be shorter than 14 days after the
notice is given.
(4) An approval of a form may require or permit the information to be
given, or the documents to be produced, in accordance with
specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
41AC Criminal offence for contravening a requirement in a notice
under section 41AB
A person commits an offence if:
(a) the person has been given a notice under section 41AB; and
(b) the person omits to do an act; and
(c) the omission contravenes a requirement in the notice.
Penalty: 400 penalty units.
41AD False or misleading information—offence
(1) A person commits an offence if:
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(a) the person is given a notice under section 41AB; and
(b) the person gives information to the Secretary in compliance,
or purported compliance, with the notice; and
(c) the person does so knowing that the information:
(i) is false or misleading; or
(ii) omits any matter or thing without which the information
is misleading.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(2) Subsection (1) does not apply as a result of subparagraph (1)(c)(i)
if the information is not false or misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (2).
(3) Subsection (1) does not apply as a result of subparagraph (1)(c)(ii)
if the information did not omit any matter or thing without which
the information is misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (3).
41AE False or misleading documents—offence
(1) A person commits an offence if:
(a) the person produces a document to the Secretary; and
(b) the person does so knowing that the document is false or
misleading; and
(c) the document is produced in compliance, or purported
compliance, with a notice given under section 41AB.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(2) Subsection (1) does not apply if the document is not false or
misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (2).
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(3) Subsection (1) does not apply to a person who produces a
document if the document is accompanied by a written statement
signed by the person or, in the case of a body corporate, by a
competent officer of the body corporate:
(a) stating that the document is, to the knowledge of the
first-mentioned person, false or misleading in a material
particular; and
(b) setting out, or referring to, the material particular in which
the document is, to the knowledge of the first-mentioned
person, false or misleading.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (3).
41AF False or misleading information or documents—civil penalty
(1) A person contravenes this section if:
(a) the person is given a notice under section 41AB; and
(b) the person gives information, or produces a document, in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
(2) Subsection (1) does not apply to a person who produces a
document if the document is accompanied by a written statement
signed by the person or, in the case of a body corporate, by a
competent officer of the body corporate:
(a) stating that the document is, to the knowledge of the
first-mentioned person, false or misleading in a material
particular; and
(b) setting out, or referring to, the material particular in which
the document is, to the knowledge of the first-mentioned
person, false or misleading.
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41AG Self-incrimination
(1) A person is not excused from giving information or a producing a
document under a section 41AB notice on the ground that the
giving of the information or the production of the document would
tend to incriminate the person or expose the person to a penalty.
(2) However, in the case of an individual:
(a) the information given or the document produced; or
(b) the giving of the information or the production of the
document; or
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or producing
the document;
is not admissible in evidence in:
(d) criminal proceedings against the individual, except
proceedings under, or arising out of, section 41AD or 41AE;
or
(e) proceedings for a pecuniary penalty order against the
individual for a contravention of a civil penalty provision.
41AAA Transfer of licences
(1) The regulations may make provision for and in relation to the
transfer of licences.
(2) Regulations made for the purposes of subsection (1) may make
provision for and in relation to:
(a) the making of an application for the transfer of a licence; and
(b) the payment of a fee in respect of an application; and
(c) the assessment of an application; and
(d) the conditions of a licence upon the transfer of the licence;
and
(e) the review of decisions made under the regulations.
(3) Subsection (2) does not limit subsection (1).
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41A Publication of list of manufacturers etc.
The Secretary may, from time to time and in such manner as the
Secretary determines, publish a list of the persons who are licensed
under this Part, the classes of goods to which the licences relate,
the steps of manufacture that the licences authorise and the
addresses of the manufacturing sites to which the licences relate.
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Part 4-1 Introduction
Division 1 Overview of this Chapter
Section 41B
Chapter 4—Medical devices Note: This Chapter does not apply, and Chapter 3 (Medicines and other therapeutic goods that
are not medical devices) still applies, to medical devices that are registered or listed goods. Section 9B automatically cancels the registration or listing of those goods over time.
Part 4-1—Introduction
Division 1—Overview of this Chapter
41B General
The purpose of this Chapter is to ensure the safety and satisfactory
performance of medical devices. It does this by:
(a) setting out particular requirements for medical devices; and
(b) establishing administrative processes principally aimed at
ensuring those requirements are met; and
(c) providing for enforcement through a series of offences and
civil penalty provisions.
41BA Requirements for medical devices (Parts 4-2 and 4-3)
The requirements for medical devices are:
(a) essential principles (that are about the safety and
performance characteristics of medical devices); and
(b) conformity assessment procedures (that are mainly about the
application of quality management systems) or requirements
comparable to conformity assessment procedures.
Note: Medical device standards may be made under Division 2 of Part 4-2,
and conformity assessment standards may be made under Division 2
of Part 4-3, but they are not requirements.
41BB Administrative processes (Parts 4-4 to 4-10)
The administrative processes under this Chapter are:
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(a) issuing conformity assessment certificates for some
manufacturers of medical devices; and
(aa) making conformity assessment body determinations; and
(b) including medical devices in the Register; and
(c) suspending or cancelling entries of medical devices from the
Register; and
(ca) exempting medical devices from various provisions of this
Chapter to deal with emergency situations; and
(d) exempting medical devices from the requirement to be
included in the Register; and
(e) obtaining information about medical devices; and
(f) requiring public notification of problems with medical
devices, and recall of such devices.
Note: Part 4-10 provides for assessment fees to be payable in some
circumstances.
41BC Enforcement (Part 4-11)
Part 4-11 contains offences and civil penalty provisions that are
aimed at ensuring that:
(a) the requirements for medical devices are complied with; and
(b) the administrative processes under this Chapter (particularly
the inclusion of medical devices in the Register) are
followed.
Note: There are some offences and civil penalty provisions in Parts 4-4 to
4-9. They generally relate to matters ancillary to administrative
processes in those Parts (e.g. false or misleading statements in
applications).
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Part 4-1 Introduction
Division 2 Interpretation
Section 41BD
Division 2—Interpretation
41BD What is a medical device
(1) A medical device is:
(a) any instrument, apparatus, appliance, material or other article
(whether used alone or in combination, and including the
software necessary for its proper application) intended, by
the person under whose name it is or is to be supplied, to be
used for human beings for the purpose of one or more of the
following:
(i) diagnosis, prevention, monitoring, treatment or
alleviation of disease;
(ii) diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or disability;
(iii) investigation, replacement or modification of the
anatomy or of a physiological process;
(iv) control of conception;
and that does not achieve its principal intended action in or
on the human body by pharmacological, immunological or
metabolic means, but that may be assisted in its function by
such means; or
(aa) any instrument, apparatus, appliance, material or other article
specified under subsection (2A); or
(ab) any instrument, apparatus, appliance, material or other article
that is included in a class of instruments, apparatus,
appliances, materials or other articles specified under
subsection (2B); or
(b) an accessory to an instrument, apparatus, appliance, material
or other article covered by paragraph (a), (aa) or (ab).
Note: Declarations under subsection (3) exclude articles from the scope of
this definition. Declarations under section 7 can also have this effect:
see subsection 7(4).
(2) For the purposes of paragraph (1)(a), the purpose for which an
instrument, apparatus, appliance, material or other article (the main
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equipment) is to be used is to be ascertained from the information
supplied, by the person under whose name the main equipment is
or is to be supplied, on or in any one or more of the following:
(a) the labelling on the main equipment;
(b) the instructions for using the main equipment;
(c) any advertising material relating to the main equipment;
(d) technical documentation describing the mechanism of action
of the main equipment.
(2A) The Secretary may, by notice published in the Gazette or on the
Department’s website, specify a particular instrument, apparatus,
appliance, material or other article for the purposes of
paragraph (1)(aa). The notice is not a legislative instrument.
(2B) The Secretary may, by legislative instrument, specify a particular
class of instruments, apparatus, appliances, materials or other
articles for the purposes of paragraph (1)(ab).
(3) The Secretary may, by order published in the Gazette or on the
Department’s website, declare that a particular instrument,
apparatus, appliance, material or other article, or that a particular
class of instruments, apparatus, appliances, materials or other
articles, are not, for the purposes of this Act, medical devices.
Note: A declaration under this section does not stop articles from being
therapeutic goods.
(4) A declaration under this section takes effect on the day on which
the declaration is published in the Gazette or on the Department’s
website or on such later day as is specified in the order.
41BE Kinds of medical devices
General
(1) For the purposes of this Chapter, a medical device is taken to be of
the same kind as another medical device if they:
(a) have the same sponsor; and
(b) have the same manufacturer; and
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(c) have the same device nomenclature system code (see
subsection (3)); and
(d) have the same medical device classification; and
(e) are the same in relation to such other characteristics as the
regulations prescribe, either generally or in relation to
medical devices of the kind in question.
Unique medical devices
(2) If a medical device is not of the same kind as any other medical
device:
(a) this Chapter applies in relation to the device as if it were a
kind of medical device; and
(b) references in this Chapter to delivering a reasonable number
of samples of the kind of device are taken to be references to
delivering the device.
Device nomenclature codes
(3) The Minister may, by legislative instrument, determine device
nomenclature codes for medical devices.
41BEA Excluded purposes
The Secretary may, by legislative instrument, specify purposes for
the purposes of paragraph 41FD(ia) and subsection 41FF(1A).
41BF System or procedure packs
(1) A package and therapeutic goods in the package are a system or
procedure pack if:
(a) the package and the therapeutic goods are for use as a unit,
either in combination as a system or in a medical or surgical
procedure; and
(b) the package contains at least one medical device; and
(c) the package and the therapeutic goods do not constitute a
composite pack.
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(2) To avoid doubt, a system or procedure pack is a medical device.
41BG Manufacturers of medical devices
(1) The manufacturer of a medical device is the person who is
responsible for the design, production, packaging and labelling of
the device before it is supplied under the person’s name, whether
or not it is the person, or another person acting on the person’s
behalf, who carries out those operations.
(2) If subsection (1) does not apply to a medical device, the
manufacturer of the device is the person who, with a view to
supplying the device under the person’s name, does one or more of
the following using ready-made products:
(a) assembles the device;
(b) packages the device;
(c) processes the device;
(d) fully refurbishes the device;
(e) labels the device;
(f) assigns to the device its purpose by means of information
supplied, by the person, on or in any one or more of the
following:
(i) the labelling on the device;
(ii) the instructions for using the device;
(iii) any advertising material relating to the device;
(iv) technical documentation describing the mechanism of
action of the device.
(3) However, a person is not the manufacturer of a medical device if:
(a) the person assembles or adapts the device for an individual
patient; and
(b) the device has already been supplied by another person; and
(c) the assembly or adaptation does not change the purpose
intended for the device by means of information supplied by
that other person, on or in any one or more of the following:
(i) the labelling on the device;
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Section 41BH
(ii) the instructions for using the device;
(iii) any advertising material relating to the device;
(iv) technical documentation describing the mechanism of
action of the device.
(4) A person is not the manufacturer of a medical device if the person
is included in a class of persons prescribed by the regulations for
the purposes of this subsection.
41BH Meaning of compliance with essential principles
(1) A medical device complies, for the purposes of this Chapter
(including Part 4-11), with the essential principles if and only if it
does not contravene any of the essential principles.
(2) However, a medical device is also taken, for the purposes of this
Chapter (other than Part 4-11), to comply with the essential
principles if:
(a) the medical device complies with one or more medical device
standards that apply to it; and
(b) the medical device contravenes the essential principles only
in respect of a part or parts of the essential principles to
which that medical device standard, or one or more of those
medical device standards, relate.
(3) For the purposes of this section, a medical device standard relates
to a part or parts of the essential principles only if the standard
specifies that part or parts.
41BI Meaning of non-application of conformity assessment
procedures
(1) A conformity assessment procedure is taken, for the purposes of
this Chapter, not to have been applied to a medical device if:
(a) there has been a contravention of the conformity assessment
procedures; and
(b) the contravention relates, wholly or partly, to that device or
its manufacture.
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(2) However, for the purposes of this Chapter (other than Part 4-11),
subsection (1) does not apply if:
(a) the quality management system applied in the manufacture of
the medical device complies with one or more conformity
assessment standards that apply to it; and
(b) the contravention is only in respect of a part or parts of the
conformity assessment procedures to which that conformity
assessment standard, or one or more of those conformity
assessment standards, relate.
(3) For the purposes of this section, a conformity assessment standard
relates to a part or parts of the conformity assessment procedures
only if the standard specifies that part or parts.
41BIA Meaning of non-application of overseas requirements
comparable to conformity assessment procedures
(1) A requirement that is comparable to a conformity assessment
procedure is taken, for the purposes of this Chapter, not to have
been applied to a medical device by the manufacturer of the device
if:
(a) there has been a contravention of the requirement; and
(b) the contravention relates, wholly or partly, to that device or
its manufacture.
(2) However, for the purposes of this Chapter (other than Part 4-11),
subsection (1) does not apply if:
(a) the quality management system applied in the manufacture of
the medical device complies with one or more conformity
assessment standards that apply to it; and
(b) the contravention is only in respect of a part or parts of the
requirement to which that conformity assessment standard, or
one or more of those conformity assessment standards, relate.
41BIB Overseas regulators
(1) An overseas regulator is a body determined in an instrument under
subsection (2).
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Section 41BIB
(2) The Secretary may, by notifiable instrument, determine a body for
the purposes of subsection (1). The Secretary must be satisfied that
the body:
(a) is established outside Australia; and
(b) is empowered to issue certificates or other documents to the
effect that the body is satisfied that requirements, comparable
to the conformity assessment procedures, have been applied
to medical devices by the manufacturers of the devices.
(3) Without limiting subsection (2), the Secretary may determine a
body by reference to a designation, recognition, approval or
authorisation (however described) of the body:
(a) by one or more countries; or
(b) by another body.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
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Section 41BJ
Division 3—Application provisions
41BJ Application of this Chapter to medical devices covered by
Part 3-2
(1) This Chapter does not apply to a medical device if section 15A
applies to the device, except for purposes connected with:
(a) applications for including the medical device in the Register
under this Chapter; or
(b) including the medical device in the Register under this
Chapter.
Note: Section 15A sets out the circumstances in which Part 3-2 applies or
continues to apply to medical devices.
(2) However, if an exemption under section 34 applied to a medical
device, or the manufacturer of the device, immediately before the
commencement of this Chapter:
(a) Parts 4-3 and 4-4, and Division 2 of Part 4-11, apply in
relation to the device after the end of the period of 2 years
after that commencement; and
(b) Parts 4-8, 4-9 and 4-10, and Divisions 3 and 4 of Part 4-11,
apply in relation to the device, to the extent that they relate to
any of the provisions referred to in paragraph (a), after the
end of that period.
41BJA Application of this Chapter to a biological
(1) Subject to this section, this Chapter does not apply to a biological
on and after the commencement of this section.
Biologicals currently included in the Register
(2) If, immediately before the commencement of this section,
therapeutic goods that are a biological were included in the
Register under this Chapter, this Chapter continues to apply to the
biological on and after that commencement until the time the
biological is included in the Register under Part 3-2A.
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Section 41BJA
Note: Section 32DN deals with including the biological under Part 3-2A.
Pending applications
(3) If:
(a) before the commencement of this section, an application was
made under this Chapter for the inclusion in the Register of
therapeutic goods that are a biological; and
(b) immediately before that commencement, the application was
not finally determined; and
(c) the application had not been withdrawn before that
commencement;
this Chapter continues to apply to the biological on and after that
commencement until the earliest of the following:
(d) the time the biological is included in the Register under
Part 3-2A;
(e) if the application is unsuccessful when it is finally
determined—the time the application is finally determined;
(f) the time the application is withdrawn;
(g) the time the application lapses.
Note: Section 32DN deals with including the biological under Part 3-2A.
(4) For the purposes of this section, an application is finally
determined when the application, and any applications for review
or appeals arising out of it, have been finally determined or
otherwise disposed of.
Transitional
(5) This Chapter applies to a biological on and after the
commencement of this section in relation to things done, or
omitted to be done, in relation to the biological before the
commencement of this section.
(6) If this Chapter continues to apply to a biological during a period
described in subsection (2) or (3), then this Chapter also applies to
the biological after the end of that period in relation to things done,
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Section 41BK
or omitted to be done, in relation to the biological during that
period.
41BK Application of the Criminal Code
Chapter 2 of the Criminal Code applies to all offences against this
Chapter.
Note: Chapter 2 of the Criminal Code sets out the general principles of
criminal responsibility.
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Part 4-2 Essential principles and medical device standards
Section 41C
Part 4-2—Essential principles and medical device
standards
41C What this Part is about
The essential principles set out the requirements relating to the
safety and performance characteristics of medical devices.
Compliance with applicable medical device standards is not
required, but it is one way to establish compliance with essential
principles.
Note: Dealing in medical devices that do not comply with the essential
principles may be an offence or may contravene a civil penalty
provision: see Division 1 of Part 4-11.
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Essential principles Division 1
Section 41CA
Division 1—Essential principles
41CA Essential principles
(1) The regulations may set out requirements for medical devices.
(2) These requirements are to be known as the essential principles.
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Part 4-2 Essential principles and medical device standards
Division 2 Medical device standards
Section 41CB
Division 2—Medical device standards
41CB Medical device standards
(1) The Minister may, by legislative instrument, make an order
determining that:
(a) matters specified in the order constitute a medical device
standard for kinds of medical devices identified in the order;
and
(b) medical devices of those kinds that comply with the standard
are to be treated as complying with those parts of the
essential principles specified in the standard.
Note: Section 12 of the Legislation Act 2003 deals with when a legislative
instrument commences.
(2) The Minister may, by legislative instrument, vary or revoke an
order made under subsection (1).
41CC Content of medical device standards
(1) Without limiting the scope of section 41CB, an order establishing a
medical device standard for kinds of medical devices may be
specified by reference to:
(a) the safety or performance characteristics of the devices; or
(b) a monograph in the British Pharmacopoeia, the European
Pharmacopoeia or the United States Pharmacopeia-National
Formulary; or
(c) a monograph in a publication approved by the Minister for
the purposes of this subsection; or
(d) such a monograph as modified in a manner specified in the
order; or
(e) a standard published by a standards organisation; or
(f) such other matters as the Minister thinks fit.
(2) For the purposes of paragraph (1)(e), these are standards
organisations:
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Section 41CD
(a) Standards Australia;
(b) the International Organisation for Standardization;
(c) the International Electrotechnical Commission;
(d) the European Committee for Standardization;
(e) the European Committee for Electrotechnical
Standardization;
(f) any other organisation declared by the Minister by notice
published in the Gazette or on the Department’s website.
41CD Inconsistencies between medical device standards
(1) A medical device standard that:
(a) applies to a kind of medical device; and
(b) is inconsistent with another medical device standard that
applies only to some of the devices of that kind;
is, to the extent of the inconsistency, of no effect in relation to the
devices referred to in paragraph (b).
(2) A medical device standard that applies to a kind of medical device
that consists of a combination of component parts takes precedence
over any medical device standard that applies to the component
parts.
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Part 4-3 Conformity assessment procedures
Section 41D
Part 4-3—Conformity assessment procedures
41D What this Part is about
The conformity assessment procedures set out the requirements
relating to the application of quality management systems for
medical devices, and other requirements imposed on
manufacturers.
Compliance with applicable conformity assessment standards is
not required, but it is one way to establish that one or more parts of
the conformity assessment procedures have been applied to
medical devices.
Note 1: Dealing in medical devices that have not had the conformity
assessment procedures applied may be an offence or may contravene a
civil penalty provision: see Division 2 of Part 4-11.
Note 2: See section 41BI on applying the conformity assessment procedures.
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Section 41DA
Division 1—Conformity assessment procedures
41DA Conformity assessment procedures
(1) The regulations may set out requirements relating to the
obligations of manufacturers of medical devices.
(2) These requirements are to be known as the conformity assessment
procedures.
(3) The conformity assessment procedures, or any part of the
conformity assessment procedures, may:
(a) be limited in their application to one or more medical device
classifications; or
(b) apply differently to different medical device classifications,
different kinds of medical devices or different manufacturers.
(4) Without limiting subsection (1), the regulations may relate to all or
any of the following:
(a) application of quality management systems for the
manufacture of medical devices;
(b) certification of compliance with the essential principles, or
the quality management systems for the manufacture of
medical devices;
(c) notification of, and assessment of, changes to a
manufacturer’s product range, product design or quality
management systems;
(d) declarations to be made by manufacturers of medical devices
that conformity assessment procedures have been applied to
the devices;
(e) marks to be affixed to medical devices indicating the
application of the conformity assessment procedures to the
devices;
(f) monitoring and inspecting the design of medical devices or
the manufacturing processes for medical devices;
(g) monitoring the performance of medical devices;
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Section 41DB
(h) corrective action required in relation to the design,
manufacture, packaging, labelling and supply of medical
devices;
(i) keeping records of the manufacture of medical devices, the
design of medical devices or the manufacturing processes for
medical devices.
41DB Medical device classifications
The regulations may specify:
(a) classifications, to be known as medical device
classifications, applying to medical devices or kinds of
medical devices; and
(b) matters in relation to the classification of medical devices or
kinds of medical devices.
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Conformity assessment standards Division 2
Section 41DC
Division 2—Conformity assessment standards
41DC Conformity assessment standards
(1) The Minister may, by legislative instrument, make an order
determining that:
(a) matters specified in the order constitute a conformity
assessment standard for quality management systems
identified in the order; and
(b) a quality management system that complies with the standard
is to be treated as having had applied to it those parts of the
conformity assessment procedures specified in the standard.
Note: Section 12 of the Legislation Act 2003 deals with when a legislative
instrument commences.
(2) A conformity assessment standard may be limited to particular
kinds of medical devices.
(3) The Minister may, by legislative instrument, vary or revoke an
order made under subsection (1).
41DD Content of conformity assessment standards
(1) Without limiting the scope of section 41DC, an order establishing a
conformity assessment standard for a kind of medical device may
be specified by reference to:
(a) procedures to be carried out under the quality management
systems for the design, manufacture and final inspection of
the devices; or
(b) a standard published by a standards organisation; or
(c) such other matters as the Minister thinks fit.
(2) For the purposes of paragraph (1)(b), these are standards
organisations:
(a) Standards Australia;
(b) the International Organisation for Standardization;
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Section 41DE
(c) the European Committee for Standardization;
(d) any other organisation declared by the Minister by notice
published in the Gazette or on the Department’s website.
41DE Inconsistencies between conformity assessment standards
A conformity assessment standard that:
(a) identifies quality management systems to which it applies;
and
(b) is inconsistent with another conformity assessment standard
that applies only to particular kinds of medical devices;
is, to the extent of the inconsistency, of no effect in relation to the
devices referred to in paragraph (b).
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Section 41E
Part 4-4—Conformity assessment certificates
41E What this Part is about
The Secretary can issue a conformity assessment certificate (which
may be limited to some medical devices) in respect of a
manufacturer of medical devices, signifying one or more of these:
(a) that relevant quality management systems have
been applied to the device;
(b) the essential principles for the device have been
complied with;
(c) other certification requirements of the conformity
assessment procedures have been met.
Note: A conformity assessment certificate may be required for an
application to include a kind of medical device in the Register to pass
preliminary assessment: see paragraph 41FDB(2)(e).
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Division 1 Issuing conformity assessment certificates
Section 41EA
Division 1—Issuing conformity assessment certificates
41EA When conformity assessment certificates are required
The regulations may prescribe:
(a) kinds of manufacturers in respect of whom a conformity
assessment certificate must be issued before valid
applications can be made for kinds of medical devices,
manufactured by those manufacturers, to be included in the
Register; or
(b) kinds of medical devices in respect of which a conformity
assessment certificate must be issued before valid
applications can be made for those kinds of medical devices
to be included in the Register.
Note: The regulations may prescribe different levels of fees for different
kinds of manufacturers and medical devices: see subsection 41LA(2).
41EB Applications
(1) An application for a conformity assessment certificate must:
(a) be made in accordance with a form approved, in writing, by
the Secretary or in such other manner as is approved, in
writing, by the Secretary; and
(b) be delivered to an office of the Department specified by the
Secretary.
Note: A conformity assessment fee is payable under section 41LA for
consideration of the application.
(2) An application is not effective if:
(a) the prescribed application fee has not been paid; or
(b) the application contains information that is false or
misleading in a material particular.
Note: A person might also commit an offence, or contravene a civil penalty
provision, if the person makes a statement in an application that is
false or misleading in a material particular: see sections 41EI and
41EIA.
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Section 41EC
(3) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(4) The Secretary may, by written notice given to an applicant for a
conformity assessment certificate, require the applicant to allow an
authorised person, at any reasonable time specified in the notice, to
inspect:
(a) the premises (including premises outside Australia) and
equipment, processes and facilities that are being or will be
used to manufacture medical devices of the kind in question;
and
(b) any other kinds of medical devices on those premises.
41EC Considering applications
(1) If the application is made in accordance with section 41EB, the
Secretary must decide whether to issue the conformity assessment
certificate.
(2) In deciding whether to issue the certificate, the Secretary must
consider some or all aspects of whether the conformity assessment
procedures relating to one or more of the following have been
applied to the medical device:
(a) the application of quality management systems for the
manufacture of medical devices;
(b) the certification of compliance with the essential principles;
(c) any other requirement of the conformity assessment
procedures specified in regulations made for the purposes of
this subsection.
(3) In deciding whether to issue the certificate, the Secretary must also
consider:
(a) whether at least one of the following persons:
(i) the applicant;
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Section 41EC
(ii) a person (a manager) who makes, or participates in
making, decisions that affect the whole, or a substantial
part, of the applicant’s affairs;
(iii) if the applicant is a body corporate—a major interest
holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against this Act or a
corresponding State law; or
(v) been convicted of an offence against a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of this Act or
a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
(viii) breached a condition of a conformity assessment
document; or
(ix) had a conformity assessment document suspended or
revoked; or
(x) been a manager, or a major interest holder, of a body
corporate in respect of which subparagraph (iv), (v),
(vi), (vii), (viii) or (ix) applies in that 10 year period, if
the conduct resulting in that subparagraph applying
occurred when the person was a manager or major
interest holder of the body corporate; or
(b) whether any other circumstances prescribed by the
regulations for the purposes of this paragraph exist.
(4) A reference in paragraph (3)(a) to a person convicted of an offence
includes a reference to a person in respect of whom an order has
been made relating to the offence under:
(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
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Section 41ECA
Note: Section 19B of the Crimes Act 1914 empowers a court that has found
a person to have committed an offence to take action without
proceeding to record a conviction.
(5) Paragraph (3)(a) does not limit paragraph (3)(b).
(6) The Secretary may, by written notice given to the applicant, require
the applicant:
(a) to deliver to the office to which the application was made a
reasonable number of samples of the kind of medical device
to which the application relates within the period, of not less
than 14 days after the day the notice is given, specified in the
notice; and
(b) to do so in a manner specified in the notice.
41ECA Conformity assessment (priority applicant) determinations
(1) The regulations may make provision for and in relation to
empowering the Secretary to make conformity assessment (priority
applicant) determinations.
(2) A conformity assessment (priority applicant) determination is a
determination that, for the purposes of this Act, a specified person
is a priority applicant in relation to any section 41EB application
that may be made by the person for a conformity assessment
certificate in relation to medical devices of a kind specified in the
determination.
(3) The regulations may make provision for and in relation to the
following matters:
(a) applications for conformity assessment (priority applicant)
determinations;
(b) the approval by the Secretary of a form for such an
application;
(c) information that must accompany such an application;
(d) the application fee for such an application;
(e) empowering the Secretary to give the applicant a written
notice requiring the applicant to give to the Secretary
specified information or documents in connection with the
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Section 41ECA
application within a specified period (which must be at least
10 working days after the notice is given to the applicant).
(4) The regulations may make provision for and in relation to the
following matters:
(a) empowering the Secretary to revoke a conformity assessment
(priority applicant) determination;
(b) the consequences of the revocation of a conformity
assessment (priority applicant) determination.
(5) Subsections (3) and (4) do not limit subsection (1).
(6) The regulations may make provision for and in relation to the
priority to be given by the Secretary to consideration of a
section 41EB application where the applicant is a priority
applicant.
(7) The regulations may provide that, if:
(a) a person is a priority applicant in relation to a section 41EB
application made by the person; and
(b) a decision is made on the application;
a statement setting out the decision may be published on the
Department’s website.
(8) The express references in this section to the Secretary do not, by
implication, prevent the regulations from empowering the
Secretary to delegate any or all of the Secretary’s functions or
powers under regulations made for the purposes of this section.
(9) If a conformity assessment (priority applicant) determination is in
force under the regulations, the determination may be published on
the Department’s website.
(10) A conformity assessment (priority applicant) determination made
under the regulations is not a legislative instrument.
(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not
apply to the specification of a person in a conformity assessment
(priority applicant) determination.
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Section 41ED
Note: Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with
specification by class.
41ED Time for making decisions on applications
If the application relates to the issuing of a conformity assessment
certificate in relation to which a period has been prescribed under
paragraph 63(2)(dc), a decision on the application must be made
within that period, unless the application lapses under
section 41EG.
41EE Procedure following making a decision whether to issue
certificate
(1) After making a decision whether to issue a conformity assessment
certificate, the Secretary must:
(a) notify the applicant in writing of his or her decision within 20
working days; and
(b) if the decision is not to issue the certificate—state in the
notice the reasons for the decision; and
(c) if the decision is to issue the certificate and all assessment
fees that are due and payable for the application have been
paid:
(i) issue the certificate to the manufacturer in relation to
whom the application was made; and
(ii) give the applicant a copy of the certificate (if the
applicant is not the manufacturer).
(2) A conformity assessment certificate must specify whether it
covers:
(a) all medical devices manufactured by the manufacturer; or
(b) only specified medical devices manufactured by the
manufacturer.
(3) A conformity assessment certificate must contain any other
information prescribed by the regulations for the purposes of this
subsection.
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Section 41EF
41EF Duration of certificate
(1) The conformity assessment certificate commences on the day
specified for the purpose in the certificate. The certificate must
specify the period for which it is to be in force (which must be no
longer than 5 years).
(2) A conformity assessment certificate has effect at all times:
(a) unless the certificate is suspended under Division 3; or
(b) until the end of the period specified in the certificate, or if the
Secretary extends that period, until the end of that extended
period; or
(c) until the certificate is revoked under Division 4.
Extensions
(3) The Secretary may, in writing and on his or her own initiative,
extend the period for which a conformity assessment certificate is
in force.
(4) An extension must be no longer than 12 months.
(5) Only one extension may be given.
(6) The Secretary:
(a) must give notice of an extension to the manufacturer in
relation to whom the certificate was issued; and
(b) may give notice of an extension to the applicant for the
certificate (if the applicant is not the manufacturer).
41EG Lapsing of applications
An application for a conformity assessment certificate lapses if:
(a) the applicant does not deliver to the office to which the
application was made such information (in a form approved
in writing by the Secretary) as will allow the certificate to be
issued; or
(b) the applicant does not comply with a requirement by the
Secretary under subsection 41EC(6) to deliver to the office to
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Section 41EH
which the application was made a reasonable number of
samples of the kind of medical device to which the
application relates; or
(c) the applicant fails to comply with a notice under
section 41JA to give to the Secretary information within a
further 10 working days from the day specified in the notice;
or
(d) information given to the Secretary by, or on behalf of, the
applicant in connection with the application, including
information given for the purpose of a notice under
section 41JA, is false or misleading in a material particular;
or
(e) the applicant fails to allow an authorised person to carry out
any inspection as required under subsection 41EB(4); or
(f) for the whole or a part of the conformity assessment fee for
the application that is due and payable in accordance with
regulations made for the purposes of Part 4-10—the applicant
fails to pay that whole or part in accordance with those
regulations.
41EH Treating applications as having been refused
(1) The applicant for an application for a conformity assessment
certificate may give the Secretary written notice that the applicant
wishes to treat the application as having been refused if:
(a) a period is prescribed under paragraph 63(2)(dc) for making a
decision on the application; and
(b) at the end of the period, the applicant has not been notified of
a decision whether to issue the certificate.
(2) The notice may be given at any time before the applicant is notified
of the decision.
(3) If a notice has been given, this Act (except for subsection 60(5)) has
effect as if:
(a) the Secretary had decided not to issue the certificate; and
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Section 41EI
(b) the Minister had made a decision under subsection 60(3)
confirming the decision of the Secretary; and
(c) the Minister’s decision had been made on the day on which
notice was given to the Secretary.
41EI Criminal offences for making a false statement
(1) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is made in or in connection with an application
for a conformity assessment certificate; and
(c) the person knows that the statement is false or misleading in
a material particular; and
(d) either:
(i) the use of the kind of medical device has resulted in,
will result in, or is likely to result in, harm or injury to
any person; or
(ii) the use of the kind of medical device, if the kind of
medical device were used, would result in, or would be
likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is in or in connection with an application for a
conformity assessment certificate; and
(c) the person knows that the statement is false or misleading in
a material particular.
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Section 41EIA
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is in or in connection with an application for a
conformity assessment certificate; and
(c) the statement is false or misleading in a material particular.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
41EIA Civil penalty for making a false statement
A person contravenes this section if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is false or misleading in a material particular;
and
(c) the statement is in or in connection with an application for a
conformity assessment certificate.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Section 41EJ
Division 2—Conditions
Note: Breaching conditions of the conformity assessment certificate may lead to suspension or revocation of the certificate (see Divisions 3 and 4), may be an offence (see subsections 41MN(5), (8) and (8A)), and may contravene a civil penalty provision (see subsection 41MNA(2)).
41EJ Automatic conditions on conformity assessment certificates
Entry and inspection powers
(1) A conformity assessment certificate is subject to the conditions that
the manufacturer in respect of whom the certificate is issued will:
(a) allow an authorised person:
(i) to enter, at any reasonable time, premises (including
premises outside Australia) at which the person or any
other person deals with medical devices of a kind
covered by the certificate; and
(ii) while on those premises, to inspect those premises and
medical devices of any kind on those premises and to
examine, take measurements of, conduct tests on,
require tests to be conducted on or take samples of
medical devices of any kind on those premises or any
thing on those premises that relates to medical devices
of any kind; and
(iii) while on those premises, to make any still or moving
image or any recording of those premises or any thing
on those premises; and
(b) if requested to do so by an authorised person:
(i) produce to the person such documents relating to
devices of a kind covered by the certificate, or to the
manufacturer’s quality management system, as the
person requires; and
(ii) allow the person to copy the documents.
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Section 41EJ
Review
(2) A conformity assessment certificate is subject to the condition that
the manufacturer in respect of whom the certificate is issued will
cooperate in any review by the Secretary of the certificate to
determine whether the conformity assessment procedures relating
to the following matters have been applied to the kinds of medical
devices covered by the certificate:
(a) the application of quality management systems for the
manufacture of medical devices;
(b) the certification of compliance with the essential principles;
(c) any other requirement of the conformity assessment
procedures specified in the regulations made for the purposes
of subsection 41EC(2).
Notification of substantial changes
(3) A conformity assessment certificate is subject to the condition that
the person in respect of whom the certificate is issued will notify
the Secretary, in writing, of any plan for substantial changes to:
(a) quality management systems; or
(b) the product range covered by those systems; or
(c) the product design of kinds of medical devices;
in respect of which the certificate is issued.
Fees
(4) A conformity assessment certificate is subject to the condition that
the applicant for the certificate will pay a fee, prescribed in the
regulations, for a review under subsection (2), when the fee
becomes due and payable.
(5) The regulations may prescribe different levels of fees for different
kinds of manufacturers and medical devices.
Conditions in regulations
(5A) A conformity assessment certificate is subject to any conditions
prescribed by the regulations for the purposes of this subsection.
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Section 41EK
Conditions do not limit other conditions
(6) A condition imposed under this section is in addition to any
conditions imposed under this Division.
41EK Conditions imposed when conformity assessment certificates
are issued
If the Secretary issues a conformity assessment certificate in
respect of a manufacturer, the Secretary may, in writing, impose
conditions on the certificate in respect of:
(a) one or more kinds of medical devices covered by the
certificate; or
(b) the manufacturer’s quality management system.
41EL Conditions imposed after issuing a conformity assessment
certificate
(1) The Secretary may, by written notice given to a manufacturer in
respect of whom a conformity assessment certificate has been
issued:
(a) impose new conditions on the certificate in respect of:
(i) one or more kinds of medical devices covered by the
certificate; or
(ii) the manufacturer’s quality management system; or
(b) vary or remove existing conditions.
The power may be exercised at the request of the applicant for the
certificate or on the Secretary’s own initiative.
(2) The imposition, variation or removal of a condition under this
section takes effect:
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the person; or
(aa) in the case of an imposition or variation requested by the
person, and to which paragraph (a) does not apply—on the
day specified in the notice, which must be at least 20 working
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Section 41EL
days after the notice is given to the person, unless the person
has agreed to an earlier day; or
(ab) in the case of a removal to which paragraph (a) does not
apply—on the day specified in the notice, which must be at
least 20 working days after the notice is given to the person,
unless the person has agreed to an earlier day; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
(3) For the purposes of paragraphs (2)(aa) and (ab), the earlier day
must not be earlier than the day the notice is given to the person.
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Division 3 Suspension of conformity assessment certificates
Section 41EM
Division 3—Suspension of conformity assessment
certificates
41EM Suspension of conformity assessment certificates
(1) The Secretary may, by written notice given to the person in relation
to whom a conformity assessment certificate is issued, suspend the
certificate if the Secretary is satisfied that it is likely that there are
grounds for revoking the certificate under section 41ET.
(2) The suspension may be limited to some medical devices of that
kind, as specified in the notice.
(3) The notice must specify the period of the suspension. The period
must not exceed 6 months.
Note: The period of the suspension may be extended under section 41EO.
41EN Notice of proposed suspension
(1) However, before suspending a conformity assessment certificate,
the Secretary must:
(a) inform the person in writing that the Secretary proposes the
suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
suspension.
(2) The Secretary is not to make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions
the person makes under paragraph (1)(b).
(3) This section does not apply if the notice under section 41EM states
that the suspension is necessary to prevent imminent risk of death,
serious illness or serious injury.
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Section 41EO
41EO Duration of suspension
(1) The suspension takes effect:
(a) if the notice under section 41EM states that the suspension is
necessary to prevent imminent risk of death, serious illness or
serious injury—on the day on which the notice is given to the
person; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
(2) The suspension has effect until:
(a) the Secretary revokes it under section 41EP; or
(b) the expiry of:
(i) the period specified in the notice under section 41EM;
or
(ii) if the period is extended under subsection (3) of this
section, the period as so extended.
Note: Unless a suspension of a conformity assessment certificate has been
revoked, the certificate is automatically revoked: see section 41ER.
(3) If a person in relation to whom a kind of medical device is
included in the Register shows that he or she has taken steps to
address the grounds for revoking the certificate under
section 41ET, the Secretary may, by written notice given to the
person, extend the period specified in the notice under
section 41EM by a further specified period not exceeding 6
months.
41EP Revocation of suspension
(1) The Secretary must revoke the suspension if the Secretary is
satisfied that:
(a) the ground on which the conformity assessment certificate
was suspended no longer applies; and
(b) there are no other grounds for suspending the certificate.
(2) The Secretary’s power to revoke the suspension may be exercised:
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Section 41EQ
(a) if:
(i) the manufacturer in relation to whom the conformity
assessment certificate was issued; or
(ii) the person who applied for the certificate (if the
applicant was not the manufacturer);
applies in writing to the Secretary; or
(b) on the Secretary’s own initiative.
(3) After revoking the suspension, the Secretary must, within 20
working days after the revocation, give written notice of the
revocation to the person in relation to whom the conformity
assessment certificate was issued.
(4) If the Secretary decides, after an application is made under
paragraph (2)(a), not to revoke the suspension, the Secretary must:
(a) notify the applicant in writing of his or her decision within 20
working days after the decision is made; and
(b) state in the notice the reasons for the decision.
41EQ Powers of revocation of conformity assessment certificates
unaffected
(1) This Division does not affect the Secretary’s powers to revoke a
conformity assessment certificate under Division 4.
(2) To the extent that a suspension under this Division relates to a
conformity assessment certificate to which such a revocation
relates, the suspension ceases to have effect.
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Section 41ER
Division 4—Revocation of conformity assessment
certificates
41ER Automatic revocation of conformity assessment certificates
The Secretary must, by written notice given to the person in
relation to whom a conformity assessment certificate is issued,
revoke the certificate if:
(a) the certificate has been suspended under section 41EM; and
(b) the period applying to the suspension under
subsection 41EM(3) or 41EO(3) (as the case requires)
expires before the suspension is revoked under section 41EP.
41ES Immediate revocation of conformity assessment certificates
(1) The Secretary may, by written notice given to the manufacturer in
relation to whom a conformity assessment certificate is issued,
revoke the certificate if the manufacturer requests in writing the
revocation of the certificate.
(2) If:
(a) the Secretary revokes a certificate under subsection (1); and
(b) before the end of the period of 90 days beginning on the day
the certificate was revoked, the manufacturer requests, in
writing, the Secretary to withdraw the revocation; and
(c) the request is accompanied by the prescribed application fee
(if any);
the Secretary may, by notice in writing given to the manufacturer,
withdraw the revocation.
(3) If the revocation is withdrawn, the revocation is taken never to
have occurred.
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Division 4 Revocation of conformity assessment certificates
Section 41ET
41ET Revocation of conformity assessment certificates after notice
of proposed revocation
(1) The Secretary may, by written notice given to the person in relation
to whom a conformity assessment certificate is issued, revoke the
certificate if:
(a) the conformity assessment procedures have not been applied
to medical devices of a kind to which the certificate applies;
or
(b) the manufacturer in relation to whom the certificate is issued
refuses or fails to comply with a condition to which the
certificate is subject; or
(c) the Secretary gives to the person a notice under section 41JA
that requires the person to give to the Secretary information
or documents and the person fails to comply with that notice
within a further 10 working days from the day specified in
that notice; or
(d) the manufacturer in respect of whom the certificate is issued
no longer manufactures any of the kinds of medical devices
to which the certificate applies; or
(e) at least one of the following persons:
(i) the person (the holder) in relation to whom the
certificate is issued;
(ii) a person (a manager) who makes, or participates in
making, decisions that affect the whole, or a substantial
part, of the holder’s affairs;
(iii) if the holder is a body corporate—a major interest
holder of the body corporate;
has:
(iv) been convicted of an offence against this Act or a
corresponding State law; or
(v) been convicted of an offence against a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
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Section 41ET
(vi) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of this Act or
a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
(viii) breached a condition of a conformity assessment
document; or
(ix) had a conformity assessment document suspended or
revoked; or
(x) been a manager, or a major interest holder, of a body
corporate in respect of which subparagraph (iv), (v),
(vi), (vii), (viii) or (ix) applies, if the conduct resulting
in that subparagraph applying occurred when the person
was a manager or major interest holder of the body
corporate; or
(f) any other circumstances prescribed by the regulations for the
purposes of this paragraph exist.
(1A) A reference in paragraph (1)(e) to a person convicted of an offence
includes a reference to a person in respect of whom an order has
been made relating to the offence under:
(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found
a person to have committed an offence to take action without
proceeding to record a conviction.
(1B) Paragraph (1)(e) does not limit paragraph (1)(f).
(2) However, before revoking the certificate, the Secretary must:
(a) inform the person in writing that the Secretary proposes the
revocation and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
revocation.
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Section 41EU
(3) The Secretary is not to make a decision relating to the proposed
revocation until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
(4) Nothing in this section affects the operation of Part VIIC of the
Crimes Act 1914 (which includes provisions that, in certain
circumstances, relieve persons from the requirement to disclose
spent convictions and require persons aware of such convictions to
disregard them).
41EU Limiting revocation of conformity assessment certificates to
some medical devices of a particular kind
(1) If the Secretary is satisfied that the ground for revoking a
conformity assessment certificate applies only to:
(a) some of the kinds of medical devices to which the certificate
applies; or
(b) some medical devices of the kinds to which the certificate
applies;
the Secretary must limit the revocation to the medical devices to
which that ground or any other ground for revocation applies.
(2) If the revocation of the certificate is so limited, the Secretary must
vary the certificate so that it no longer applies to the medical
devices referred to in subsection (1).
41EV Publication of revocation etc. of conformity assessment
certificates
The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after revoking a
conformity assessment certificate, or varying a conformity
assessment certificate under subsection 41EU(2), a notice setting
out particulars of the revocation or variation.
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Section 41EW
41EW Date of effect of revocation etc. of conformity assessment
certificates
If the Secretary revokes a conformity assessment certificate, or
varies a conformity assessment certificate under
subsection 41EU(2), the revocation or variation has effect:
(a) if the revocation is under section 41ER or 41ES, or the
variation relates to a ground of revocation in section 41ER or
41ES—on the day on which the notice of revocation or
variation is given to the person in relation to whom the
certificate was issued; or
(b) in any other case—on such later day as is specified in the
notice.
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Part 4-4A Australian conformity assessment bodies
Section 41EWA
Part 4-4A—Australian conformity assessment
bodies
41EWA Conformity assessment body determinations
(1) The regulations may make provision for and in relation to
empowering the Secretary to make conformity assessment body
determinations.
(2) A conformity assessment body determination is a determination
that a specified Australian corporation is an Australian conformity
assessment body for the purposes of this Act.
(3) The regulations may make provision for and in relation to the
following matters:
(a) applications for conformity assessment body determinations;
(b) the approval by the Secretary of a form for such an
application;
(c) information that must accompany such an application;
(d) the application fee for such an application;
(e) the lapsing of such an application;
(f) the assessment by the Secretary of whether a conformity
assessment body determination should be made in response
to such an application;
(g) the assessment fee for such an assessment;
(h) the duration of conformity assessment body determinations.
(4) A conformity assessment body determination:
(a) may be of general application; or
(b) may be limited to either or both of the following:
(i) one or more specified medical devices;
(ii) one or more specified conformity assessment
procedures.
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(4A) If under the regulations the Secretary makes a conformity
assessment body determination, the Secretary must assign a unique
identification number to the body.
(4B) The Secretary must publish a list of the Australian conformity
assessment bodies on the Department’s website.
(4C) The Secretary may also publish on the Department’s website any
information relating to Australian conformity assessment bodies
and either to conformity assessment body determinations or to
certification-related activities of Australian conformity assessment
bodies.
(5) The regulations may provide that a conformity assessment body
determination is subject to:
(a) the conditions prescribed by the regulations; and
(b) such other conditions (if any) as are specified in the
determination.
Note: See subsections 41MN(10) to (12) and 41MNA(3) for offences and a
civil penalty for a breach of the conditions.
(6) The following are examples of conditions that may be prescribed:
(a) a condition that the body will allow an authorised person:
(i) to enter, at any reasonable time, premises used by the
body to carry on certification-related activities; and
(ii) while on those premises, to inspect those premises and
anything on those premises that concerns
certification-related activities carried on by the body;
and
(iii) while on those premises, to make any still or moving
image or any recording of those premises or anything on
those premises that concerns certification-related
activities carried on by the body; and
(iv) while on those premises, to inspect, and make copies of,
any documents that concern certification-related
activities carried on by the body;
(b) a condition that the body will, if requested to do so by the
Secretary, give the Secretary information, or produce to the
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Secretary documents, that concern certification-related
activities carried on by the body.
(6A) The regulations may make provision for and in relation to the
effect on an Australian conformity assessment body certificate of
the Australian conformity assessment body ceasing to carry on
certification-related activities.
(6B) Without limiting subsection (6A), regulations made for the
purposes of that subsection may make provision in relation to a
matter by conferring on the Secretary a power to make a decision
of an administrative character.
(7) The regulations may make provision for and in relation to
empowering the Secretary to revoke, suspend or vary a conformity
assessment body determination.
(7A) If under the regulations the Secretary suspends a conformity
assessment body determination, the conditions referred to in
subsection (5) continue during the suspension.
(8) Subsections (3) to (7) do not limit subsection (1).
(9) The express references in this section to the Secretary do not, by
implication, prevent the regulations from empowering the
Secretary to delegate any or all of the Secretary’s functions or
powers under regulations made for the purposes of this section.
(10) If a conformity assessment body determination is in force under the
regulations, the determination must be published on the
Department’s website.
(11) A conformity assessment body determination made under the
regulations is not a legislative instrument.
(12) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not
apply to the specification of an Australian corporation in a
conformity assessment body determination.
Note: Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with
specification by class.
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Section 41EWB
41EWB Content of Australian conformity assessment body
certificates
(1) An Australian conformity assessment body certificate that is issued
to a manufacturer of medical devices must specify whether it
covers:
(a) all medical devices manufactured by the manufacturer; or
(b) only specified medical devices manufactured by the
manufacturer.
(2) An Australian conformity assessment body certificate must contain
any other information prescribed by the regulations for the
purposes of this subsection.
(3) An Australian conformity assessment body certificate may be
subject to conditions specified in the certificate.
41EWC Duration of Australian conformity assessment body
certificates
(1) An Australian conformity assessment body certificate commences
on the day specified for the purpose in the certificate. The
certificate must specify the period for which it is to be in force
(which must be no longer than 5 years).
(2) An Australian conformity assessment body certificate has effect at
all times:
(a) unless the certificate is suspended by the Australian
conformity assessment body; or
(b) until the end of the period specified in the certificate, or if the
Australian conformity assessment body extends that period,
until the end of that extended period; or
(c) until the certificate is revoked by the Australian conformity
assessment body.
Extensions
(3) An Australian conformity assessment body that has issued an
Australian conformity assessment body certificate may, in writing
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and on its own initiative, extend the period for which the certificate
is in force.
(4) An extension must be no longer than 12 months.
(5) Only one extension may be given.
(6) The Australian conformity assessment body must give notice of an
extension to the person to whom the certificate was issued.
41EWD Record-keeping
(1) If an Australian corporation:
(a) is an Australian conformity assessment body; and
(b) is required by a condition referred to in
subsection 41EWA(5) to keep records relating to
certification-related activities carried on by the corporation;
the Australian corporation must keep the records at all times while
the corporation is an Australian conformity assessment body.
(2) If the Australian corporation ceases to be an Australian conformity
assessment body, the corporation must keep the records referred to
in subsection (1) for 15 years after that cessation.
Offences
(3) An Australian corporation commits an offence if:
(a) the corporation is subject to a requirement under this section;
and
(b) the corporation contravenes the requirement.
Penalty: 1,200 penalty units.
(4) An Australian corporation commits an offence if:
(a) the corporation is subject to a requirement under this section;
and
(b) the corporation contravenes the requirement.
Penalty: 300 penalty units.
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(5) An offence against subsection (4) is an offence of strict liability.
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Part 4-5 Including medical devices in the Register
Section 41F
Part 4-5—Including medical devices in the Register
41F What this Part is about
Kinds of medical devices can be included in the Register if they
comply with the essential principles, and conformity assessment
procedures have been applied to the kinds of devices or
requirements, comparable to those procedures, have been applied
to the kinds of devices (and certain other requirements are
complied with).
Inclusions in the Register are subject to certain automatic
conditions and the Secretary may impose further conditions.
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Section 41FA
Division 1—Including medical devices in the Register
41FA What this Division is about
Kinds of medical devices are usually included in the Register once
an application is made, together with the required certification and
the application passes preliminary assessment. However,
applications may be selected for audit, which involves checking
some or all aspects of the application and certification.
Note 1: In some cases, an application relating to a kind of medical device will
not pass preliminary assessment unless that kind of device is covered
by a conformity assessment certificate under Part 4-4: see
paragraph 41FDB(2)(e).
Note 2: Dealing in medical devices of a kind not included in the Register may
be an offence or may contravene a civil penalty provision: see
Division 3 of Part 4-11.
Subdivision A—Applications
41FC Making an application
(1) A person may make an application to the Secretary for a kind of
medical device to be included in the Register.
(2) An application must not contain information that is false or
misleading in a material particular.
Note: A person might also commit an offence, or contravene a civil penalty
provision, if the person makes a statement in an application that is
false or misleading in a material particular: see sections 41FE and
41FEA.
41FD Matters to be certified
The applicant must certify that:
(a) devices of the kind in question are medical devices; and
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(b) devices of that kind are intended for a specified purpose, as
ascertained under subsection 41BD(2); and
(c) the kind of device is correctly classified according to the
medical device classifications; and
(d) devices of that kind comply with the essential principles; and
(e) the applicant:
(i) has available sufficient information to substantiate that
compliance with the essential principles; or
(ii) has procedures in place, including a written agreement
with the manufacturer of the kind of devices setting out
the matters required by the regulations, to ensure that
such information can be obtained from the manufacturer
within the period specified in the regulations; and
(f) either:
(i) appropriate conformity assessment procedures have
been applied to devices of that kind; or
(ii) requirements, comparable to the conformity assessment
procedures, have been applied to devices of that kind;
and
(g) the applicant:
(i) has available sufficient information to substantiate the
application of the procedures referred to in
subparagraph (f)(i) or the requirements referred to in
subparagraph (f)(ii); or
(ii) has procedures in place, including a written agreement
with the manufacturer of the kind of devices setting out
the matters required by the regulations, to ensure that
such information can be obtained from the manufacturer
within the period specified in the regulations; and
(h) both of the following are complied with in relation to devices
of that kind:
(i) the applicable provisions of the Therapeutic Goods
Advertising Code;
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or under the regulations; and
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Section 41FDA
(i) devices of that kind do not contain substances that are
prohibited imports for the purposes of the Customs Act 1901;
and
(ia) devices of that kind are not to be used exclusively for one or
more of the purposes specified under section 41BEA; and
(j) the information included in or with the application is
complete and correct.
Note: See section 41BH for when a medical device complies with the
essential principles, section 41BI for when conformity assessment
procedures are taken not to have been applied to a medical device and
section 41BIA for when requirements comparable to those procedures
are taken not to have been applied to a medical device.
41FDA Basis of certification of conformity assessment procedures
When certifying the matter referred to in paragraph 41FD(f), the
applicant must also state that the certification of the matter is
based:
(a) on a conformity assessment certificate that is in force; or
(b) on an Australian conformity assessment body certificate that
is in force; or
(c) on an overseas regulator conformity assessment document
that is in force.
41FDB Preliminary assessment of applications
(1) If an application is made under section 41FC for a kind of medical
device to be included in the Register in relation to a person, the
Secretary must carry out an assessment of whether the
requirements set out in subsection (2) have been met in relation to
the application.
(2) The requirements are as follows:
(a) the application must be made:
(i) in accordance with the form approved, in writing, by the
Secretary for that classification of medical device; or
(ii) in such other manner as is approved, in writing, by the
Secretary for that classification of medical device;
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Section 41FDB
(b) the prescribed application fee for that classification of
medical device must be paid;
(c) the application must be delivered to an office of the
Department specified by the Secretary;
(d) the application must be accompanied by information that is:
(i) of a kind determined under subsection (7) for that
classification of medical device; and
(ii) in a form determined under subsection (8) for that
classification of medical device;
(e) if regulations made for the purposes of section 41EA require
the manufacturer of the kind of device to have a conformity
assessment certificate relating to the kind of medical device
before an application under section 41FC can be made—such
a certificate is in force;
(f) the applicant has certified the matters in section 41FD.
Passing preliminary assessment
(3) An application passes preliminary assessment if the Secretary:
(a) has carried out an assessment, under subsection (1), in
relation to the application; and
(b) is satisfied that the requirements set out in subsection (2)
have been met in relation to the application.
(4) If the application has not passed preliminary assessment, the
Secretary must refuse the application.
Note: The Secretary is required to give notice of the refusal: see
section 41FG.
Approval of forms etc.
(5) For the purposes of paragraph (2)(a), the Secretary may approve
different forms and different manners for making applications for
different medical device classifications.
(6) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
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(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Determination of kinds and forms of information
(7) The Secretary may, by legislative instrument, determine a kind of
information for the purposes of the application of
subparagraph (2)(d)(i) to medical devices of a particular
classification.
(8) The Secretary may, by legislative instrument, determine a form of
information for the purposes of the application of
subparagraph (2)(d)(ii) to medical devices of a particular
classification.
41FE Criminal offences for making a false statement
(1) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the person knows that the statement is false or misleading in
a material particular; and
(c) the statement is in or in connection with:
(i) an application for including a kind of medical device in
the Register under this Chapter; or
(ii) a certification or purported certification under
section 41FD; and
(d) either:
(i) the use of the kind of medical device has resulted in,
will result in, or is likely to result in, harm or injury to
any person; or
(ii) the use of the kind of medical device, if the kind of
medical device were used, would result in, or would be
likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the person knows that the statement is false or misleading in
a material particular; and
(c) the statement is in or in connection with:
(i) an application for including a kind of medical device in
the Register under this Chapter; or
(ii) a certification or purported certification under
section 41FD.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is false or misleading in a material particular;
and
(c) the statement is in or in connection with:
(i) an application for including a kind of medical device in
the Register under this Chapter; or
(ii) a certification or purported certification under
section 41FD.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
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41FEA Civil penalty for making a false statement
A person contravenes this section if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is false or misleading in a material particular;
and
(c) the statement is in or in connection with:
(i) an application for including a kind of medical device in
the Register under this Chapter; or
(ii) a certification or purported certification under
section 41FD.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Subdivision B—Including kinds of medical devices in the
Register
41FF Obligation to include kinds of medical devices in the Register
(1) If:
(a) an application for a kind of medical device to be included in
the Register in relation to a person has passed preliminary
assessment; and
(b) the application has not been selected for audit under
section 41FH;
the Secretary must include the kind of device in the Register in
relation to the person.
(1A) However, the Secretary must not include the kind of device in the
Register in relation to the person if the Secretary is satisfied that
the kind of device is to be used exclusively for one or more of the
purposes specified under section 41BEA.
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Section 41FG
(2) As soon as practicable after the kind of device has been included in
the Register, the Secretary must make available to the applicant a
certificate of the inclusion of the kind of device in the Register.
(3) The certificate must specify the day on which the inclusion of the
kind of device in the Register commences.
41FG Notification of unsuccessful applications
(1) This section applies if an application under subsection 41FC(1) for
a kind of medical device to be included in the Register:
(a) is refused under subsection 41FDB(4); or
(b) is refused under subsection 41FF(1A).
(2) The Secretary must notify the applicant in writing, of the refusal
within 20 working days after the application has been received and
the prescribed application fee has been paid.
Subdivision C—Auditing of applications
41FH Selecting applications for auditing
(1A) This section applies to applications that have passed preliminary
assessment.
(1) The Secretary:
(a) must select for auditing any application for a kind of medical
device to be included in the Register that is an application of
the kind prescribed by the regulations; and
(b) may select for auditing any other application for a kind of
medical device to be included in the Register.
Note: An application audit assessment fee is payable in respect of any
application that the Secretary must select for auditing: see Part 4-10.
(2) If an application is selected for auditing:
(a) the Secretary must give the applicant a written notice (the
selection notice) that:
(i) informs the applicant of the selection; and
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(ii) requires the applicant to provide, within the period
specified in the notice, information or documents that
the Secretary is satisfied is relevant to the audit; and
(b) the application must be dealt with under this Subdivision and
not under Subdivision B.
(3) The selection notice must be given within:
(a) 20 working days after the application is made and the
prescribed application fee is paid; or
(b) if the regulations prescribe a longer period for that kind of
application—that longer period.
(4) Subparagraph (2)(a)(ii) does not limit section 41JA (Secretary may
require information).
41FI Auditing of applications
(1) In auditing the application, the Secretary may consider all or some
aspects of one or both of the following matters:
(a) whether the application is in accordance with Subdivision A;
(b) whether matters as to which the applicant has certified under
section 41FD are correct.
(1A) In auditing the application, the Secretary may, by written notice
given to the applicant, require the applicant:
(a) to deliver to the office to which the application was made a
reasonable number of samples of the kind of medical device
to which the application relates within the period, of not less
than 14 days after the day the notice is given, specified in the
notice; and
(b) to do so in a manner specified in the notice.
(2) The Secretary must decide to include the kind of device to which
the application relates in the Register, in relation to the person to
whom the application relates, if the Secretary is satisfied as to all
such aspects considered in the audit.
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Section 41FIA
(3) The Secretary must decide not to include the kind of device to
which the application relates in the Register if the Secretary is not
so satisfied.
41FIA Certificates issued by Australian conformity assessment
bodies
(1) If:
(a) a section 41FC application is made for a kind of medical
device to be included in the Register; and
(b) the application has been selected for audit; and
(c) a person has obtained a certificate issued by an Australian
conformity assessment body to the effect that the body is
satisfied that an appropriate conformity assessment procedure
has been applied to devices of that kind; and
(d) the certificate has been given to the Secretary; and
(e) if the conformity assessment body determination that relates
to the body is limited as mentioned in
paragraph 41EWA(4)(b)—the Secretary is satisfied that the
certificate has been issued consistently with the
determination;
the Secretary may have regard to the certificate in auditing the
application.
(2) This section does not, by implication, limit the matters to which the
Secretary may have regard.
41FJ Procedure following audits
After auditing the application, the Secretary must:
(a) notify the applicant in writing of his or her decision within 20
working days after the decision is made; and
(b) if the decision is not to include the kind of device to which
the application relates in the Register—state in the notice the
reasons for the decision; and
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(c) if the decision is to include the kind of device in the Register
and all assessment fees for the application that are due and
payable have been paid:
(i) include the kind of device in the Register, in relation to
the person in relation to whom the application was
made; and
(ii) give the applicant a certificate of the inclusion of the
kind of device in the Register.
41FK Lapsing of applications
An application that has been selected for auditing lapses if:
(a) the applicant fails to comply with a notice under
section 41FH within 10 working days after the end of the
period specified in the notice; or
(b) the applicant does not comply with a requirement by the
Secretary under subsection 41FI(1A) to deliver to the office
to which the application was made a reasonable number of
samples of the kind of medical device to which the
application relates; or
(c) the applicant fails to comply with a notice under
section 41JA to give information relating to devices of that
kind to the Secretary within a further 10 working days from
the day specified in the notice; or
(d) information given to the Secretary by, or on behalf of, the
applicant in connection with the application, including
information given for the purpose of a requirement under
section 41JA, is false or misleading in a material particular;
or
(e) the applicant fails to pay an assessment fee for the
application in accordance with section 41LB or 41LC.
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Section 41FKA
Subdivision D—Miscellaneous
41FKA Medical devices (priority applicant) determinations
(1) The regulations may make provision for and in relation to
empowering the Secretary to make medical devices (priority
applicant) determinations.
(2) A medical devices (priority applicant) determination is a
determination that, for the purposes of this Act, a specified person
is a priority applicant in relation to any section 41FC application
that may be made by the person for the inclusion in the Register of
a medical device of a kind specified in the determination.
(3) The regulations may make provision for and in relation to the
following matters:
(a) applications for medical devices (priority applicant)
determinations;
(b) the approval by the Secretary of a form for such an
application;
(c) information that must accompany such an application;
(d) the application fee for such an application;
(e) empowering the Secretary to give the applicant a written
notice requiring the applicant to give to the Secretary
specified information or documents in connection with the
application within a specified period (which must be at least
10 working days after the notice is given to the applicant).
(4) The regulations may make provision for and in relation to the
following matters:
(a) empowering the Secretary to revoke a medical devices
(priority applicant) determination;
(b) the consequences of the revocation of a medical devices
(priority applicant) determination.
(5) Subsections (3) and (4) do not limit subsection (1).
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(6) The regulations may make provision for and in relation to the
priority to be given by the Secretary to consideration of a
section 41FC application where the applicant is a priority
applicant.
(7) The regulations may provide that, if:
(a) a person is a priority applicant in relation to a section 41FC
application made by the person; and
(b) a decision is made on the application;
a statement setting out the decision may be published on the
Department’s website.
(8) The express references in this section to the Secretary do not, by
implication, prevent the regulations from empowering the
Secretary to delegate any or all of the Secretary’s functions or
powers under regulations made for the purposes of this section.
(9) If a medical devices (priority applicant) determination is in force
under the regulations, the determination may be published on the
Department’s website.
(10) A medical devices (priority applicant) determination made under
the regulations is not a legislative instrument.
(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not
apply to the specification of a person in a medical devices (priority
applicant) determination.
Note: Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with
specification by class.
41FL Device number
If a kind of medical device is included in the Register, the
Secretary is to assign a unique device number to it.
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Section 41FM
41FM Duration of inclusion in the Register
(1) The inclusion of a kind of medical device in the Register
commences on the day specified for the purpose in the certificate
under section 41FF or 41FJ.
(2) The inclusion of a kind of medical device in the Register has effect
at all times:
(a) unless the kind of device is suspended from the Register
under Division 1 of Part 4-6; or
(b) until entry of the kind of device is cancelled from the
Register under Division 2 of Part 4-6.
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Section 41FN
Division 2—Conditions
Note: Breaching conditions of the inclusion of a kind of medical device may lead to suspension or cancellation of the entry of the kind of device from the Register (see Part 4-6), may be an offence (see subsections 41MN(1), (4) and (4A)), and may contravene a civil penalty provision (see subsection 41MNA(1)).
41FN Conditions applying automatically
Entry and inspection powers
(1) The inclusion of a kind of medical device in the Register is subject
to the conditions that the person in relation to whom the kind of
device is included in the Register will:
(a) allow an authorised person:
(i) to enter, at any reasonable time, any premises (including
premises outside Australia) at which that person or any
other person deals with medical devices of that kind;
and
(ii) while on those premises, to inspect those premises and
medical devices of any kind on those premises and to
examine, take measurements of, conduct tests on,
require tests to be conducted on or take samples of
medical devices of any kind on those premises or any
thing on those premises that relates to medical devices
of any kind; and
(iii) while on those premises, to make any still or moving
image or any recording of those premises or any thing
on those premises; and
(b) if requested to do so by an authorised person, produce to the
person such documents relating to devices of the kind
included in the Register as the person requires and allow the
person to copy the documents.
Delivery of samples
(2) The inclusion of a kind of medical device in the Register is subject
to a condition that the person in relation to whom the kind of
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device is included in the Register will deliver a reasonable number
of samples of the kind of device if the Secretary so requests:
(a) within the period specified in the request; and
(b) in accordance with any other requirements specified in the
request.
The period specified in the request must include at least 10
working days.
Availability etc. of information
(3) The inclusion of a kind of medical device in the Register is subject
to conditions that:
(a) at all times while the inclusion in the Register has effect, the
person in relation to whom the kind of device is included in
the Register:
(i) has available sufficient information to substantiate
compliance with the essential principles; or
(ii) has procedures in place, including a written agreement
with the manufacturer of the kind of devices setting out
the matters required by the regulations, to ensure that
such information can be obtained from the manufacturer
within the period specified in the regulations; and
(b) at all times while the inclusion in the Register has effect, the
person in relation to whom the kind of device is included in
the Register:
(i) has available sufficient information to substantiate that
the conformity assessment procedures have been
applied to the kind of medical device or that
requirements, comparable to those procedures, have
been applied to the kind of medical device to the
satisfaction of an overseas regulator; or
(ii) has available information relating to changes to the kind
of medical device, the product range, and quality
management system, of the manufacturer of the device;
or
(iii) has procedures in place, including a written agreement
with the manufacturer of the kind of devices setting out
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the matters required by the regulations, to ensure that
such information can be obtained from the manufacturer
within the period specified in the regulations; and
(c) at any time while the inclusion in the Register has effect, the
person in relation to whom the kind of device is included in
the Register will, if asked to do so by the Secretary, give the
information to the Secretary; and
(d) the person in relation to whom the kind of device is included
in the Register will give information of a kind mentioned in
subsection 41MP(2) or 41MPA(2) to the Secretary within the
period specified in the regulations; and
(e) the person in relation to whom the kind of device is included
in the Register will give the manufacturer of the kind of
medical device information relevant to:
(i) the manufacturer’s obligations under the conformity
assessment procedures or requirements comparable to
those procedures; and
(ii) whether medical devices of that kind comply with the
essential principles.
(4) The regulations may prescribe the amount, standard or kind of
information or evidence required for the purposes of
paragraphs (3)(c), (d) and (e).
Advertising material
(5) The inclusion of a kind of medical device in the Register is subject
to a condition that advertising material relating to medical devices
of that kind is consistent with the intended purpose as certified
under section 41FD.
Conditions prescribed by the regulations
(5A) The inclusion of a kind of medical device in the Register is subject
to such conditions (if any) as are prescribed by the regulations.
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Section 41FO
Conditions determined by the Minister
(5B) The inclusion of a kind of medical device in the Register is subject
to such conditions (if any) as are determined under
subsection (5C).
(5C) The Minister may, by legislative instrument, determine one or
more conditions for the purposes of subsection (5B).
Conditions do not limit other conditions
(6) A condition imposed under this section is in addition to any
conditions imposed under this Division.
41FO Conditions imposed when kinds of medical devices are
included in the Register
(1) If the Secretary includes a kind of medical device in the Register in
relation to a person, the Secretary may, in writing, impose
conditions on the inclusion of the kind of device in the Register.
(2) Conditions referred to in subsection (1) may relate to:
(a) manufacture of devices of that kind; or
(b) custody, intended purpose, supply, disposal or destruction of
devices of that kind; or
(c) keeping of records relating to devices of that kind, including
records relating to the tracking and location of devices of that
kind after their supply; or
(d) matters dealt with in, or matters additional to matters dealt
with in, the essential principles; or
(e) such other matters relating to devices of that kind as the
Secretary thinks appropriate.
41FP Conditions imposed after kinds of medical devices are
included in the Register
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register:
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(a) impose new conditions on including the kind of device in the
Register under this Chapter; or
(b) vary or remove existing conditions.
The power may be exercised at the person’s request or on the
Secretary’s own initiative.
(2) The imposition, variation or removal of a condition under this
section takes effect:
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the person; or
(aa) in the case of an imposition or variation requested by the
person, and to which paragraph (a) does not apply—on the
day specified in the notice, which must be at least 20 working
days after the notice is given to the person, unless the person
has agreed to an earlier day; or
(ab) in the case of a removal to which paragraph (a) does not
apply—on the day specified in the notice, which must be at
least 20 working days after the notice is given to the person,
unless the person has agreed to an earlier day; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
(3) For the purposes of paragraphs (2)(aa) and (ab), the earlier day
must not be earlier than the day the notice is given to the person.
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Part 4-6 Suspension and cancellation from the Register
Division 1 Suspension from the Register
Section 41G
Part 4-6—Suspension and cancellation from the
Register
Division 1—Suspension from the Register
Subdivision A—General power of suspension
41G What this Part is about
Inclusions in the Register may be suspended in certain
circumstances, such as when a conformity assessment document is
suspended. A kind of medical device that is suspended is taken not
to be included in the Register for most purposes.
Inclusions in the Register may also be cancelled in certain
circumstances.
41GA Suspension of kinds of medical devices from the Register
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register,
suspend the kind of device from the Register if:
(a) the Secretary is satisfied that:
(i) there is a potential risk of death, serious illness or
serious injury if the kind of device continues to be
included in the Register; and
(ii) it is likely that the person will, within the period of the
suspension, be able to take the action necessary to
ensure that the kind of device would not cause a
potential risk of death, serious illness or serious injury if
it were to continue to be included in the Register; or
(b) the Secretary is satisfied that it is likely that there are grounds
for cancelling the entry of the kind of device from the
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Section 41GB
Register under Division 2 (other than under
paragraph 41GL(a), (d) or (f) or section 41GM).
(2) The suspension may be limited to some medical devices of that
kind, as specified in the notice.
(3) The notice must specify the period of the suspension. The period
must not exceed 6 months.
Note: The period of the suspension may be extended under section 41GC.
(4) The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after the suspension,
a notice setting out particulars of the suspension.
41GB Notice of proposed suspension must be given in certain cases
(1) However, before suspending a kind of medical device from the
Register because it is likely that there are grounds for cancelling
the entry of the kind of device from the Register under
section 41GN, the Secretary must:
(a) inform the person by written notice that the Secretary
proposes the suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
suspension.
(2) The Secretary is not to make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions
the person makes under paragraph (1)(b).
41GC Duration of suspension
(1) The suspension takes effect:
(a) if the notice under subsection 41GA(1) states that the
suspension is necessary to prevent a potential risk of death,
serious illness or serious injury—on the day on which the
notice is given to the person; or
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Division 1 Suspension from the Register
Section 41GD
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
(2) The suspension has effect until:
(a) the Secretary revokes it under section 41GD; or
(b) the end of:
(i) the period specified in the notice under
subsection 41GA(3); or
(ii) if the period is extended under subsection (3) of this
section, the period as so extended.
Note: Unless a suspension of a kind of medical device has been revoked, the
entry of the kind of medical device is automatically cancelled from the
Register: see section 41GK.
(3) If a person in relation to whom a kind of medical device is
included in the Register shows that he or she has taken steps to
remove the grounds for cancelling the entry of the kind of device
from the Register under section 41GN, the Secretary may, by
written notice given to the person, extend the period specified in
the notice under subsection 41GA(1) by a further specified period
not exceeding 6 months.
(4) The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after the extension, a
notice setting out particulars of the extension.
41GD Revocation of suspension
(1) The Secretary must revoke the suspension if the Secretary is
satisfied that:
(a) the ground on which the kind of medical device concerned
was suspended from the Register no longer applies; and
(b) there are no other grounds for suspending the kind of device
from the Register.
(2) The Secretary’s power to revoke the suspension may be exercised:
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Suspension and cancellation from the Register Part 4-6
Suspension from the Register Division 1
Section 41GE
(a) if the person in relation to whom the kind of medical device
concerned is included in the Register applies in writing to the
Secretary; or
(b) on the Secretary’s own initiative.
(3) After revoking the suspension, the Secretary must:
(a) within 20 working days after the revocation, give written
notice of the revocation to the person in relation to whom the
kind of medical device concerned is included in the Register;
and
(b) as soon as practicable after the revocation, cause to be
published in the Gazette or on the Department’s website a
notice setting out particulars of the revocation.
(4) If the Secretary decides, after an application is made under
paragraph (2)(a), not to revoke the suspension, the Secretary must:
(a) notify the applicant in writing of his or her decision within 20
working days after the decision is made; and
(b) state in the notice the reasons for the decision.
41GE Treating applications for revocation as having been refused
(1) The applicant for the suspension to be revoked may give the
Secretary written notice that the applicant wishes to treat the
application as having been refused if:
(a) a period is prescribed under paragraph 63(2)(dd) for the
Secretary to make a decision on the application; and
(b) at the end of the period, the Secretary has not made a
decision.
(2) The notice may be given at any time before the Secretary makes a
decision on the application.
(3) If a notice has been given, this Act (except for subsection 60(5)) has
effect as if:
(a) the Secretary had decided not to revoke the suspension; and
(b) the Minister had made a decision under subsection 60(3)
confirming the decision of the Secretary; and
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Part 4-6 Suspension and cancellation from the Register
Division 1 Suspension from the Register
Section 41GF
(c) the Minister’s decision had been made on the day on which
notice was given to the Secretary.
Subdivision B—Suspension as a result of suspension of
conformity assessment document
41GF Suspension where conformity assessment certificate
suspended
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register,
suspend the kind of device from the Register if the conformity
assessment certificate applying to that kind of device is suspended
under Division 3 of Part 4-4.
(2) If the suspension under Division 3 of Part 4-4 is limited to some
medical devices of that kind, the suspension under this section is
taken to be limited to the same extent.
(3) The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after the suspension,
a notice setting out particulars of the suspension.
41GFA Suspension where other certificates or documents are
suspended
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register,
suspend the kind of device from the Register if:
(a) an Australian conformity assessment body certificate that
applies to the kind of device is suspended by the Australian
conformity assessment body; or
(b) an overseas regulator conformity assessment document that
applies to the kind of device is suspended by the overseas
regulator.
(2) However, before suspending the kind of device from the Register,
the Secretary must:
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Suspension and cancellation from the Register Part 4-6
Suspension from the Register Division 1
Section 41GG
(a) inform the person in writing that the Secretary proposes the
suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
suspension.
(3) The Secretary is not to make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
(4) The Secretary must cause to be published on the Department’s
website, as soon as practicable after the suspension, a notice setting
out particulars of the suspension.
41GG Duration of suspension
(1) A suspension under section 41GF or 41GFA takes effect on the
day on which the notice is given to the person.
(2) The suspension has effect until the Secretary revokes it under
section 41GH.
41GH Revocation of suspension
(1) The Secretary must revoke a suspension under section 41GF if:
(a) the suspension under Division 3 of Part 4-4 ceases to have
effect; and
(b) the Secretary is satisfied that there are no other grounds for
suspending the kind of device from the Register.
(1A) The Secretary may revoke a suspension under section 41GFA if:
(a) either:
(i) the suspension referred to in paragraph 41GFA(1)(a) or
(b) ends; or
(ii) the person in relation to whom the kind of medical
device is included in the Register provides the Secretary
with another conformity assessment document that
applies to the kind of device; and
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Chapter 4 Medical devices
Part 4-6 Suspension and cancellation from the Register
Division 1 Suspension from the Register
Section 41GI
(b) the Secretary is satisfied that there are no other grounds for
suspending the kind of device from the Register.
(2) After making a revocation under subsection (1) or (1A), the
Secretary must:
(a) within 20 working days after the revocation, give written
notice of the revocation to the person in relation to whom the
kind of medical device concerned is included in the Register;
and
(b) as soon as practicable after the revocation, cause to be
published in the Gazette or on the Department’s website a
notice setting out particulars of the revocation.
Subdivision C—Effect of suspension
41GI Effect of suspension
If all or some medical devices of a particular kind are suspended,
they are taken, for the purposes of this Act (other than Division 2
of Part 4-5, this Division and Part 4-8), not to be included in the
Register while the suspension has effect.
Note: Dealing in medical devices that are not included in the Register may
be an offence or may contravene a civil penalty provision: see
Division 3 of Part 4-11.
41GJ Powers of cancellation from Register unaffected
(1) This Subdivision does not affect the Secretary’s powers to cancel
the entry of kinds of medical devices from the Register under
Division 2.
(2) To the extent that a suspension under this Division relates to
medical devices to which such a cancellation relates, the
suspension ceases to have effect.
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Cancellation of entries from the Register Division 2
Section 41GK
Division 2—Cancellation of entries from the Register
41GK Automatic cancellation of entries of kinds of medical devices
from the Register
The Secretary must, by written notice given to the person in
relation to whom a kind of medical device is included in the
Register, cancel the entry of the kind of device from the Register
if:
(a) the kind of device has been suspended from the Register
under section 41GA, and the period applying to the
suspension under subsection 41GA(3) or 41GC(3) (as the
case requires) expires before the suspension is revoked under
section 41GD; or
(b) a conformity assessment certificate applying to that kind of
device is revoked under Division 4 of Part 4-4.
41GL Immediate cancellation of entries of kinds of medical devices
from the Register
The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register,
cancel the entry of the kind of device from the Register if:
(a) the Secretary is satisfied that there would be an imminent risk
of death, serious illness or serious injury if the kind of device
continues to be included in the Register; or
(b) devices of that kind are no longer therapeutic goods; or
(c) devices of that kind are no longer medical devices; or
(d) the person requests in writing the cancellation of the entry of
the kind of device from the Register; or
(e) the Secretary is satisfied that a statement made in or in
connection with:
(i) the application for including the kind of device in the
Register; or
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Part 4-6 Suspension and cancellation from the Register
Division 2 Cancellation of entries from the Register
Section 41GLA
(ii) the certification or purported certification under
section 41FD relating to the application;
was false or misleading in a material particular; or
(f) the annual charge payable under subsection 4(1B) of the
Therapeutic Goods (Charges) Act 1989 in respect of the
inclusion of the kind of device in the Register is not paid
within 20 working days after it becomes payable; or
(g) the person contravenes a direction, or a condition of a
direction, given to the person under subsection 42DV(1) in
relation to the advertising of the kind of device and the
Secretary is satisfied that the contravention is significant; or
(ga) if the person is a body corporate—a related body corporate of
the person contravenes a direction, or a condition of a
direction, given to the related body corporate under
subsection 42DV(1) in relation to the advertising of the kind
of device and the Secretary is satisfied that the contravention
is significant; or
(h) there is a breach, involving the kind of device, of an
applicable provision of the Therapeutic Goods Advertising
Code or any other requirement relating to advertising
applicable under Part 5-1 or under the regulations, and the
Secretary is satisfied that:
(i) the breach is significant; and
(ii) as a result of the breach, the presentation of devices of
that kind is misleading to a significant extent.
41GLA Revocation of cancellation of entries upon request
(1) If:
(a) the Secretary cancels the entry of a kind of medical device
because of the request of a person made under
paragraph 41GL(d); and
(b) before the end of the period of 90 days beginning on the day
the kind of device ceased to be included in the Register, the
person requests, in writing, the Secretary to revoke the
cancellation; and
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Cancellation of entries from the Register Division 2
Section 41GLB
(c) the request is accompanied by the prescribed application fee
(if any);
the Secretary may, by notice in writing given to the person, revoke
the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to
have occurred.
41GLB Revocation of cancellation of entries—payment of annual
charge
(1) If:
(a) the Secretary cancels the entry of a kind of medical device
because the annual charge payable by a person under
subsection 4(1B) of the Therapeutic Goods (Charges) Act
1989 in respect of the inclusion of the kind of device in the
Register was not paid within 20 working days after it
becomes payable; and
(b) before the end of the period of 90 days beginning on the day
the kind of device ceased to be included in the Register, the
person in relation to whom the kind of device was included
in the Register requests, in writing, the Secretary to revoke
the cancellation; and
(c) the annual charge payable under subsection 4(1B) of the
Therapeutic Goods (Charges) Act 1989 in respect of the
inclusion of the kind of device in the Register has been paid;
and
(d) the request is accompanied by the prescribed application fee
(if any);
the Secretary may, by notice in writing given to the person, revoke
the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to
have occurred.
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Chapter 4 Medical devices
Part 4-6 Suspension and cancellation from the Register
Division 2 Cancellation of entries from the Register
Section 41GM
41GM Cancellation of entries of kinds of medical devices from the
Register after section 41JA notice
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register,
cancel the entry of the kind of device from the Register if:
(a) the Secretary gives to the person a notice under section 41JA
requiring the person to give to the Secretary information or
documents relating to the kind of device; and
(b) the notice under section 41JA is given for the purposes of
ascertaining whether any of the certifications by the person
under section 41FD in relation to the kind of device are
incorrect; and
(c) the person fails to comply with the notice under section 41JA
within a further 10 working days from the day specified in
that notice.
(2) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register,
cancel the entry of the kind of device from the Register if:
(a) the Secretary gives to the person a notice under section 41JA
requiring the person to give to the Secretary information or
documents relating to whether medical devices of that kind
are being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia; and
(b) either:
(i) the information or documents given are to the effect that
medical devices of that kind are not being supplied in
Australia, imported into Australia or exported from
Australia; or
(ii) the person fails to comply with the notice under
section 41JA within a further 10 working days from the
day specified in that notice.
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Suspension and cancellation from the Register Part 4-6
Cancellation of entries from the Register Division 2
Section 41GN
41GN Cancellation of entries of kinds of medical devices from the
Register after notice of proposed cancellation
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register,
cancel the entry of the kind of device from the Register if:
(a) medical devices that were devices of that kind when the kind
of device was included in the Register have changed so those
medical devices are no longer devices of that kind; or
(b) the person in relation to whom the kind of medical device is
included in the Register refuses or fails to comply with a
condition to which that inclusion is subject; or
(c) the Secretary gives to the person a notice under section 41JA:
(i) that requires the person to give to the Secretary
information or documents relating to the kind of device;
and
(ii) in respect of which section 41GM does not apply;
and the person fails to comply with that notice within a
further 10 working days from the day specified in that notice;
or
(d) the person contravenes subsection 41MP(1) or 41MPA(1) in
relation to the kind of device; or
(e) the Secretary is satisfied that the safety or performance of the
kind of device is unacceptable; or
(f) the Secretary is satisfied that any certification, or part of a
certification, under section 41FD in relation to the
application for inclusion of the kind of device in the Register
is incorrect, or is no longer correct, in a material particular; or
(g) a conformity assessment document that applies to the kind of
device expires; or
(h) either of the following applies:
(i) an Australian conformity assessment body certificate
that applies to the kind of device is revoked by the
Australian conformity assessment body;
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Chapter 4 Medical devices
Part 4-6 Suspension and cancellation from the Register
Division 2 Cancellation of entries from the Register
Section 41GO
(ii) an overseas regulator conformity assessment document
that applies to the kind of device is revoked by the
overseas regulator; or
(i) the person contravenes a direction, or a condition of a
direction, given to the person under subsection 42DV(1) in
relation to the advertising of the kind of device; or
(j) if the person is a body corporate—a related body corporate of
the person contravenes a direction, or a condition of a
direction, given to the related body corporate under
subsection 42DV(1) in relation to the advertising of the kind
of device; or
(k) either of the following has not been complied with in relation
to the kind of device:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or the regulations.
(2) However, before cancelling the entry of the kind of device from the
Register, the Secretary must:
(a) inform the person in writing that the Secretary proposes the
cancellation and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
cancellation.
(3) The Secretary is not to make a decision relating to the proposed
cancellation until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
41GO Limiting cancellation of entries from Register to some
medical devices of a particular kind
(1) If the Secretary is satisfied that the ground for cancelling the entry
of a kind of medical device from the Register applies only to some
medical devices of that kind, the Secretary must limit the
cancellation to the medical devices to which that ground or any
other ground for cancellation applies.
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Suspension and cancellation from the Register Part 4-6
Cancellation of entries from the Register Division 2
Section 41GP
(2) If the cancellation of the entry of a kind of medical device from the
Register is limited to some medical devices of that kind, the
Secretary:
(a) must vary the entry in the Register accordingly; and
(b) must not delete the entry from the Register because of the
cancellation.
41GP Publication of cancellation of entry from Register
The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after cancelling an
entry from the Register of a kind of medical device, or of some
devices of a particular kind, a notice setting out particulars of the
cancellation.
41GQ Date of effect of cancellation of entries from Register
If the Secretary cancels an entry of a kind of medical device, or
some devices of a particular kind, from the Register, the
cancellation has effect:
(a) if the cancellation is under section 41GK or 41GL—on the
day on which the notice of cancellation is given to the person
in relation to whom the kind of device was included in the
Register; or
(b) in any other case—on such later day as is specified in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
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Chapter 4 Medical devices
Part 4-6A Exempting medical devices to deal with emergencies
Section 41GR
Part 4-6A—Exempting medical devices to deal with
emergencies
41GR What this Part is about
The Minister may exempt certain medical devices from various
provisions of this Chapter so that the devices may be stockpiled to
deal with possible future emergencies or made available urgently
to deal with actual emergencies.
Note 1: There are offences and civil penalty provisions related to the making
of exemptions under this Part: see Division 3A of Part 4-11.
Note 2: Some of the other provisions of this Act about medical devices
exempt under this Part are:
(a) section 41JCA (providing information to the Secretary); and
(b) section 41KA (public notification and recall of medical devices); and
(c) section 46A (search of premises).
41GS Minister may make exemptions
(1) The Minister may, by writing, exempt specified kinds of medical
devices from the operation of the following:
(a) Division 1 of Part 4-2 (essential principles);
(b) Division 1 of Part 4-3 (conformity assessment procedures);
(c) Part 4-4 (conformity assessment certificates);
(d) Part 4-5 (including medical devices in the Register).
(2) The Minister may make an exemption under subsection (1) only if
the Minister is satisfied that, in the national interest, the exemption
should be made so that:
(a) the devices may be stockpiled as quickly as possible in order
to create a preparedness to deal with a potential threat to
public health that may be caused by a possible future
emergency; or
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Exempting medical devices to deal with emergencies Part 4-6A
Section 41GT
(b) the devices can be made available urgently in Australia in
order to deal with an actual threat to public health caused by
an emergency that has occurred.
Period of exemption
(3) An exemption under subsection (1) comes into force:
(a) on the day the exemption is made; or
(b) on a later day specified in the exemption.
(4) An exemption under subsection (1) remains in force for the period
specified in the exemption, unless revoked earlier.
Note: Section 41GU deals with variation and revocation of the exemption.
Effect of inclusion of kind of medical device in the Register
(5) An exemption under subsection (1) ceases to have effect in relation
to a particular kind of medical device when that kind of medical
device becomes included in the Register under Part 4-5.
Exemption not a legislative instrument
(6) An exemption under subsection (1) is not a legislative instrument.
Disregard section 41BE
(7) For the purposes of this Act, disregard section 41BE in working
out the kinds of medical devices covered by an exemption under
subsection (1) of this section.
41GT Conditions of exemptions
An exemption under section 41GS is subject to conditions
specified in the exemption about any of the following:
(a) the quantity of medical devices that are exempt;
(b) the source of those medical devices;
(c) the persons or class of persons who may import,
manufacture, supply or export those medical devices;
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Part 4-6A Exempting medical devices to deal with emergencies
Section 41GU
(d) the supply of those medical devices (including the persons or
class of persons to whom medical devices may be supplied
for use and the circumstances under which a stockpile of
medical devices may be supplied for use);
(e) the storage and security of those medical devices;
(f) the keeping and disclosure of, and access to, records about
those medical devices;
(g) the disposal of those medical devices;
(h) the manner in which any of those medical devices are to be
dealt with if a condition of the exemption is breached;
(i) any other matters that the Minister thinks appropriate.
Whether or not medical devices are exempt under section 41GS is
not affected by whether or not there is a breach of a condition
under this section in relation to those medical devices.
Note 1: There are offences and civil penalty provisions related to the breach of
a condition of an exemption: see Division 3A of Part 4-11.
Note 2: Section 41GU deals with variation and revocation of the conditions.
41GU Variation or revocation of exemption
Variation of exemption
(1) The Minister may, by writing, vary an exemption made under
section 41GS by removing specified kinds of medical devices from
the exemption.
Revocation of exemption
(2) The Minister may, by writing, revoke an exemption made under
section 41GS.
Variation or revocation of conditions
(3) The Minister may, by writing:
(a) vary the conditions of an exemption made under
section 41GS (including by imposing new conditions); or
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Section 41GV
(b) revoke the conditions of an exemption made under
section 41GS.
When variation or revocation takes effect
(4) A variation or revocation under this section takes effect:
(a) if the Minister states in the variation or revocation that the
variation or revocation is necessary to prevent imminent risk
of death, serious illness or serious injury—on the day the
variation or revocation is made; or
(b) in any other case—on a later day specified in the variation or
revocation (which must not be earlier than 28 days after the
day the variation or revocation is made).
41GV Informing persons of exemption etc.
If the Minister makes an exemption under section 41GS, the
Minister must take reasonable steps to give a copy of the following
to each person covered by paragraph 41GT(c):
(a) the exemption;
(b) any variation or revocation of the exemption under
section 41GU.
41GW Notification and tabling
Notification
(1) The Secretary must cause a notice setting out particulars of the
following:
(a) an exemption made under section 41GS because of
paragraph 41GS(2)(b);
(b) a variation or revocation under section 41GU, to the extent
that the variation or revocation relates to an exemption made
under section 41GS because of paragraph 41GS(2)(b);
to be published in the Gazette within 5 working days after the day
on which the exemption, variation or revocation is made. However,
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Part 4-6A Exempting medical devices to deal with emergencies
Section 41GY
the exemption, variation or revocation is not invalid merely
because of a failure to comply with this subsection.
Tabling
(2) The Minister must cause a document setting out particulars of the
following:
(a) an exemption made under section 41GS because of
paragraph 41GS(2)(b);
(b) a variation or revocation under section 41GU, to the extent
that the variation or revocation relates to an exemption made
under section 41GS because of paragraph 41GS(2)(b);
to be tabled in each House of the Parliament within 5 sitting days
of that House after the day on which the exemption, variation or
revocation is made. However, the exemption, variation or
revocation is not invalid merely because of a failure to comply
with this subsection.
41GY Disposal of unused medical devices
(1) This section applies to a medical device if:
(a) an exemption under section 41GS in relation to that kind of
medical device ceases to have effect otherwise than because
that kind of medical device becomes included in the Register
under Part 4-5; and
(b) the medical device has not been used before the exemption so
ceases to have effect.
(2) The Secretary may arrange for the disposal of the medical device
in accordance with the regulations.
(3) Regulations made for the purposes of subsection (2) may set out
the methods by which the medical device is to be stored, supplied,
destroyed, exported or otherwise disposed of.
(4) A method set out in the regulations under subsection (3) must not
enable or permit any benefit to be conferred on a person (including
the Commonwealth) other than the owner of the medical device.
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Other exemptions from including medical devices in the Register Part 4-7
Section 41H
Part 4-7—Other exemptions from including
medical devices in the Register
41H What this Part is about
In addition to Part 4-6A, there are 4 other kinds of exemptions
from the prohibitions in Division 3 of Part 4-11 on dealing in
medical devices that are not included in the Register:
(a) medical devices exempted under the regulations;
(b) approval for medical devices to be used for special
treatment of individuals or for experimental
purposes;
(c) authorisation of health practitioners to supply
specified medical devices;
(d) medical devices exempted if substitutes are
unavailable or in short supply.
41HA Devices exempted from inclusion in the Register
(1) The regulations may exempt from the operation of Division 3 of
Part 4-11:
(a) all medical devices, except those medical devices of the
kinds prescribed for the purposes of this paragraph; or
(b) specified kinds of medical devices.
Note: Division 3 of Part 4-11 contains offences and civil penalty provisions
relating to dealing in medical devices that are not included in the
Register.
(2) An exemption may be subject to conditions that are prescribed in
the regulations.
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Part 4-7 Other exemptions from including medical devices in the Register
Section 41HB
Note: Breach of the conditions may be an offence: see subsection 41MN(9).
(3) An exemption under paragraph (1)(a) has effect only for classes of
persons prescribed in the regulations for the purposes of this
subsection.
(4) If the regulations revoke an exemption, the revocation takes effect
on the day specified. The day must not be earlier than 20 working
days after the day on which the regulations are made.
41HB Exemptions for special and experimental uses
(1) The Secretary may grant a written approval to a person for:
(a) the importation into Australia; or
(b) the exportation from Australia; or
(c) the supply in Australia;
of a specified medical device or kind of medical device (other than
medical devices included in the Register or exempt devices):
(d) for use in the treatment of another person; or
(e) for use solely for experimental purposes in humans.
(1A) An approval for use of the kind referred to in paragraph (1)(d) must
not be granted to a person unless the person is a health practitioner.
(2) The approval may be given subject to conditions specified in the
approval, including a condition relating to charging for medical
devices of the kinds in question.
Note: Breach of the conditions may be an offence: see subsection 41MN(9).
(3) In addition, the regulations may prescribe conditions that apply to a
person’s approval to use specified kinds of medical devices solely
for experimental purposes in humans. The conditions may relate to
one or more of the following:
(a) the preconditions on another person’s use of devices of those
kinds for those purposes;
(b) the principles to be followed in another person’s use of
devices of those kinds for those purposes;
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(c) the monitoring of another person’s use, and the results of that
use, of devices of those kinds for those purposes;
(d) the circumstances in which that other person must cease
using devices of those kinds for those purposes.
(4) An application to use specified medical devices in the treatment of
another person must be in a form (if any) approved, in writing, by
the Secretary and be accompanied by any information about the
devices that is required by the Secretary.
(5) An application to use specified kinds of medical devices solely for
experimental purposes in humans must:
(a) be made in writing; and
(b) be accompanied by any information about the kinds of
devices that is required by the Secretary; and
(c) be accompanied by the prescribed fee.
(6) The Secretary must:
(a) consider any application under this section; and
(b) assess any information submitted with the application; and
(c) notify the applicant, within 20 working days of making the
decision:
(i) of the decision; and
(ii) in the case of a decision not to grant the approval—of
the reasons for the decision.
(7) The use by a person for experimental purposes in humans of
specified kinds of medical devices that are the subject of an
approval granted to someone else under paragraph (1)(e) is subject
to the conditions (if any) specified in the regulations relating to one
or more of the following:
(a) the preconditions on the use of devices of those kinds for
those purposes;
(b) the principles to be followed in the use of devices of those
kinds for those purposes;
(c) the monitoring of the use, and the results of the use, of
devices of those kinds for those purposes;
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(d) the circumstances in which the person must cease the use of
devices of those kinds for those purposes.
Note: Breach of the conditions may be an offence: see subsection 41MN(9).
41HC Exemptions for health practitioners
(1) The Secretary may authorise, in writing, a specified medical
practitioner to supply specified kinds of medical devices for use in
the treatment of humans to a specified class of recipients.
(1A) An application for an authority under subsection (1) must be in a
form (if any) approved, in writing, by the Secretary.
(2) An authority under subsection (1) may be given subject to
conditions specified in the authority.
(3) The Secretary may impose conditions (or further conditions) on the
authority given to a person under subsection (1) by giving the
person written notice of the conditions.
(4) An authority under subsection (1) may only be given:
(a) to a medical practitioner included in a class of medical
practitioners prescribed by the regulations for the purposes of
this paragraph; and
(b) to a medical practitioner who has the approval of an ethics
committee to supply the specified kinds of medical devices
or the specified class of such devices; and
(c) in relation to a class or classes of recipients prescribed by the
regulations for the purposes of this paragraph.
However, the regulations may prescribe exceptional circumstances
in which paragraph (b) does not apply.
(5) The regulations may prescribe circumstances in which medical
devices may be supplied under an authority under subsection (1).
(6) The Minister may, by legislative instrument, make rules
authorising any health practitioner who is included in a specified
class of health practitioners to supply a specified kind of medical
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device, for use in the treatment of humans, to the class or classes of
recipients specified in those rules, so long as:
(a) that kind of medical device is supplied in the circumstances
specified in those rules; and
(b) the conditions (if any) specified in those rules are satisfied.
(6A) In making rules under subsection (6), the Minister must comply
with:
(a) such requirements (if any) as are prescribed by the
regulations; and
(b) such restrictions (if any) as are prescribed by the regulations;
and
(c) such limitations (if any) as are prescribed by the regulations.
(6B) If:
(a) a person is authorised, by subsection (6) rules, to supply a
specified kind of medical device; and
(b) the person supplies a medical device of that kind in
accordance with those rules;
the person must:
(c) notify the supply to the Secretary; and
(d) do so within 28 days after the supply.
(6C) A notification under subsection (6B) must:
(a) be in accordance with a form that is approved, in writing, by
the Secretary; and
(b) contain such information as is prescribed by the regulations.
(6D) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(6E) A person commits an offence if:
(a) the person is subject to a requirement under subsection (6B);
and
(b) the person omits to do an act; and
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(c) the omission breaches the requirement.
Penalty: 10 penalty units.
(6F) An offence against subsection (6E) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(6FA) Subsection (6E) does not apply in relation to a person and a
requirement to notify a supply of a medical device if a health
practitioner, on behalf of the person, does the following:
(a) notifies the supply to the Secretary within 28 days after the
supply;
(b) makes the notification in accordance with the requirements
referred to in subsection (6C).
Note: A defendant bears an evidential burden in relation to the matter in
subsection (6FA): see subsection 13.3(3) of the Criminal Code.
(6G) In recommending to the Governor-General that regulations should
be made for the purposes of paragraph (6C)(b), the Minister must
have regard to the principle that information should only be
prescribed for the purposes of that paragraph if the information is
reasonably required for the responsible scrutiny by the Secretary of
the operation of the scheme embodied in subsection (6).
(7) In this section:
medical practitioner means a person who is registered, in a State
or internal Territory, as a medical practitioner.
41HD Approvals if substitutes for medical devices are unavailable
or in short supply
(1) The Secretary may, by notice in writing, grant an approval to a
person for:
(a) the importation into Australia of a specified medical device;
or
(b) the importation into Australia of a specified medical device
and the supply in Australia of that device;
if the Secretary is satisfied that:
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(c) the kinds of medical devices included in the Register that
could act as a substitute for the medical device are
unavailable or are in short supply; and
(d) either:
(i) the medical device is registered or approved for general
marketing in at least one foreign country specified in a
determination under subsection (5); or
(ii) an application has been made in accordance with
section 41FC for inclusion in the Register of the kind of
medical device that includes the medical device and the
application has passed preliminary assessment; and
(e) the medical device is specified in a determination under
subsection (6); and
(f) the approval is necessary in the interests of public health.
Note: For specification by class, see the Acts Interpretation Act 1901 and
subsection 13(3) of the Legislation Act 2003.
(1A) The Secretary may, by notice in writing, grant an approval to a
person for:
(a) the importation into Australia of a specified medical device;
or
(b) the importation into Australia of a specified medical device
and the supply in Australia of that device;
if the Secretary is satisfied that:
(c) the kinds of medical devices included in the Register that
could act as a substitute for the medical device are
unavailable or are in short supply; and
(d) either:
(i) the medical device is not registered or approved for
general marketing in any of the foreign countries
specified in a determination under subsection (5); or
(ii) the medical device is registered or approved for general
marketing in at least one foreign country specified in a
determination under subsection (5), but is not readily
available for importation into, and supply in, Australia;
and
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(e) the medical device is registered or approved for general
marketing in a foreign country; and
(f) the manufacturing and quality control procedures used in the
manufacture of the medical device are acceptable; and
(g) the medical device is specified in a determination under
subsection (6); and
(h) the approval is necessary in the interests of public health.
Note: For specification by class, see the Acts Interpretation Act 1901 and
subsection 13(3) of the Legislation Act 2003.
(2) The Secretary may, by notice in writing, grant an approval to a
person for:
(a) the importation into Australia of a specified medical device;
or
(b) the importation into Australia of a specified medical device
and the supply in Australia of that device;
if the Secretary is satisfied that:
(c) there are no kinds of medical devices that are included in the
Register that could act as a substitute for the medical device;
and
(d) an application has been made in accordance with
section 41FC for inclusion in the Register of the kind of
medical device that includes the medical device and the
application has passed preliminary assessment; and
(e) the medical device is specified in a determination under
subsection (6); and
(f) the approval is necessary in the interests of public health.
Note: For specification by class, see the Acts Interpretation Act 1901 and
subsection 13(3) of the Legislation Act 2003.
Application for approval
(3) An application for an approval must:
(a) be made to the Secretary; and
(b) be accompanied by such information relating to the medical
device as is required by the Secretary.
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Notification of Secretary’s decision
(4) If an application for an approval is made, the Secretary must, as
soon as practicable after deciding the application, notify the
applicant of:
(a) the decision; and
(b) if the decision is not to grant the approval—the reasons for
the decision.
Determinations
(5) The Secretary may, by legislative instrument, make a
determination specifying foreign countries for the purposes of
subparagraph (1)(d)(i).
(6) The Secretary may, by legislative instrument, make a
determination specifying medical devices that can be the subject of
an approval under this section.
Conditions
(7) The Secretary may grant an approval subject to any conditions that
are specified in the notice of approval.
Note: Breach of the conditions may be an offence: see subsection 41MN(9).
Period of approval
(8) The Secretary may grant an approval for such period as is specified
in the notice of approval.
When approval lapses
(9) The approval lapses if:
(a) the period specified in the notice of approval expires; or
(b) a decision has been made on an application that has been
made for inclusion in the Register of the kind of medical
device that includes the medical device.
(10) The approval lapses if:
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(a) the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f),
paragraph (1A)(c), (d), (e), (f), (g) or (h), or paragraph (2)(c),
(d), (e) or (f), as the case requires, no longer applies in
relation to the medical device, or that a condition of the
approval has been contravened; and
(b) the Secretary has given to the person to whom the approval
was granted a notice stating that the Secretary is so satisfied.
(11) The lapsing of the approval on the expiry of the period specified in
the notice of approval does not prevent another approval being
granted under this section in relation to the medical device before
that lapsing. The other approval may be expressed to take effect on
the expiry of that period.
Approval not a legislative instrument
(12) An approval under subsection (1), (1A) or (2) is not a legislative
instrument.
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Part 4-8—Obtaining information
41J What this Part is about
The Secretary may seek information or documents relating to:
• the application of conformity assessment procedures or
requirements comparable to those procedures;
• compliance with the essential principles;
• compliance with other requirements;
• distribution of, and other matters relating to, medical devices
covered by exemptions under Part 4-6A or Part 4-7.
Note: There are additional obligations relating to notifying defects in
medical devices: see sections 41MP, 41MPA, 41MQ and 41MR.
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Section 41JA
Division 1—Information relating to compliance with
requirements and other matters
41JA Secretary may require information or documents
(1) The Secretary may, by written notice given to a person:
(a) who is an applicant for a conformity assessment certificate
that would relate to a kind of medical device; or
(b) who holds a conformity assessment certificate, or an
Australian conformity assessment body certificate, that
relates to a kind of medical device; or
(ba) who held, at any time during the notice period under
subsection (2), a conformity assessment certificate, or an
Australian conformity assessment body certificate, that
related to a kind of medical device; or
(c) who is an applicant for the inclusion of a kind of medical
device in the Register; or
(d) in relation to whom a kind of medical device is included in
the Register; or
(da) in relation to whom a kind of medical device was, at any time
during the notice period under subsection (2), included in the
Register;
require the person to give to the Secretary information or
documents, relating to devices of that kind, that are relevant to one
or more of the following:
(e) whether the devices comply with the essential principles;
(f) whether the conformity assessment procedures have been
applied to the devices or whether requirements, comparable
to those procedures, have been applied to the devices;
(g) whether the devices comply with conditions (if any) imposed
on a conformity assessment certificate issued in respect of
the device or the inclusion of the device in the Register;
(h) whether either of the following has not been complied with in
relation to the devices:
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(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or under the regulations;
(i) if the kind of medical device is included in the Register in
relation to the person—whether medical devices of that kind
are being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia;
(ia) the safety and efficacy of the devices for the purposes for
which they are to be used;
(ib) the regulatory history of the devices in another country;
(j) any other matter prescribed by the regulations for the
purposes of this paragraph.
(1AA) If a notice is given under subsection (1) to a person covered by
paragraph (1)(ba), then paragraphs (1)(e) to (j) (to the extent to
which they are relevant) apply in relation to the period the person
held the certificate.
(1AB) If a notice is given under subsection (1) to a person covered by
paragraph (1)(da), then paragraphs (1)(e) to (j) (to the extent to
which they are relevant) apply in relation to the period the kind of
medical device was included in the Register.
(1A) The Secretary may, by written notice given to a person who is an
applicant for a conformity assessment certificate, require the
person to give to the Secretary such further information concerning
the application as is specified in the notice.
(1B) Requirements under subsections (1) and (1A) may be included in
the same notice.
(1C) The Secretary may, by written notice given to a person who holds a
conformity assessment certificate, require the person to give to the
Secretary specified information to be used by the Secretary in
deciding whether to suspend the certificate under section 41EM, or
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to revoke the certificate under section 41ET, in relation to the
circumstances referred to in paragraph 41ET(1)(e).
(1D) Requirements under subsections (1) and (1C) may be included in
the same notice.
(1E) The Secretary may, by written notice given to an Australian
corporation that has been an Australian conformity assessment
body require the corporation to give to the Secretary specified
information, or specified documents, relating to:
(a) the certification-related activities carried on by the
corporation while the corporation was an Australian
conformity assessment body; or
(b) the conditions referred to in subsection 41EWA(5) that
applied while the corporation was an Australian conformity
assessment body.
(2) For the purposes of paragraphs (1)(ba) and (da), the notice period
is the period:
(a) of the length specified in the regulations; and
(b) ending on the day before the Secretary gives the notice under
subsection (1).
(3) Nothing in this section affects the operation of Part VIIC of the
Crimes Act 1914 (which includes provisions that, in certain
circumstances, relieve persons from the requirement to disclose
spent convictions and require persons aware of such convictions to
disregard them).
41JB Complying with the Secretary’s requirements
(1) The person must give the information or documents to the
Secretary:
(a) within such reasonable time, being not less than 10 working
days from the day on which the notice is given, as is
specified in the notice; and
(b) in such form as is specified in the notice.
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(2) The form may require or permit information to be given in
accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Offence for failing to comply with a notice
(3) A person commits an offence if:
(a) the person is given a notice under section 41JA; and
(aa) the person is covered by paragraph 41JA(1)(b), (ba), (d) or
(da) or subsection 41JA(1E); and
(b) the person fails to comply with the notice.
Penalty: 500 penalty units.
Note: Failure to comply with the notice might also lead to suspension or
revocation of a conformity assessment certificate (see Divisions 3 and
4 of Part 4-4) or suspension or cancellation of the entry of a kind of
medical device in the Register (see Part 4-6).
(3A) Subsection (3) does not apply if the person has a reasonable
excuse.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (3A): see subsection 13.3(3) of the Criminal Code.
(3B) A person commits an offence if:
(a) the person is given a notice under section 41JA; and
(b) the person is covered by paragraph 41JA(1)(b), (ba), (d) or
(da) or subsection 41JA(1E); and
(d) the person fails to comply with the notice.
Penalty: 100 penalty units.
(3C) An offence against subsection (3B) is an offence of strict liability.
(3D) Subsection (3B) does not apply if the person has a reasonable
excuse.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (3D): see subsection 13.3(3) of the Criminal Code.
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Section 41JB
Offences for giving false or misleading information in purported
compliance with a notice
(4) A person commits an offence if:
(a) the person is given a notice under section 41JA in relation to
a kind of medical device; and
(b) the person gives information in purported compliance with
the notice; and
(c) the information is false or misleading in a material particular;
and
(d) either:
(i) the use of the kind of medical device has resulted in,
will result in, or is likely to result in, harm or injury to
any person; or
(ii) the use of the kind of medical device, if the kind of
medical device were used, would result in, or would be
likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (7) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(7) A person commits an offence if:
(a) the person is given a notice under section 41JA; and
(b) the person gives information in purported compliance with
the notice; and
(c) the information is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(8) A person commits an offence if:
(a) the person is given a notice under section 41JA; and
(b) the person gives information in purported compliance with
the notice; and
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(c) the information is false or misleading in a material particular.
Penalty: 100 penalty units.
(9) An offence against subsection (8) is an offence of strict liability.
41JBA Civil penalty for giving false or misleading information in
purported compliance with a notice
A person contravenes this section if:
(a) the person is given a notice under section 41JA; and
(b) the person gives information in purported compliance with
the notice; and
(c) the information is false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
41JC Self-incrimination
(1) A person is not excused from giving information or a document
under section 41JB on the ground that to do so would tend to
incriminate the person or expose the person to a penalty.
(2) However, in the case of an individual:
(a) the information given; or
(b) the giving of the document; or
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or document;
is not admissible in evidence in:
(d) criminal proceedings against the individual, except
proceedings under, or arising out of, subsection 41JB(4), (7)
or (8); or
(e) proceedings for a pecuniary penalty order against the
individual for a contravention of a civil penalty provision,
except civil proceedings under, or arising out of,
section 41JBA.
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Section 41JCA
Division 2—Information relating to medical devices
covered by exemptions
41JCA Secretary may require information etc. about medical
devices exempt under Part 4-6A
(1) This section applies to a person who is required to comply with a
condition of an exemption of a kind of medical device under
section 41GS.
(2) The Secretary may, by written notice given to the person, require
the person to give to the Secretary specified information or
documents relating to one or more of the following:
(a) the supply of devices of that kind;
(b) the handling of devices of that kind;
(c) the monitoring of the supply of devices of that kind;
(d) the results of the supply of devices of that kind;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to devices of that kind.
(3) The notice must specify a reasonable period within which the
person to whom the notice is given must comply. The period must
be at least 10 working days starting on the day on which the notice
is given.
(4) The notice may require information to be given in accordance with
specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
41JD Secretary may require information etc. about devices
exempted under section 41HA from inclusion in the
Register
(1) The Secretary may give the sponsor of kinds of medical devices
exempted under subsection 41HA(1) from Division 3 of Part 4-11,
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a written notice requiring the sponsor to give to the Secretary
specified information or documents relating to one or more of the
following:
(a) the supply of devices of those kinds;
(b) the handling of devices of those kinds;
(c) the monitoring of the supply of devices of those kinds;
(d) the results of the supply of devices of those kinds;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to devices of those
kinds.
(2) If a medical device is exempt under subsection 41HA(1) because a
medical practitioner has signed a statement in accordance with
regulations made for the purposes of this section, the Secretary
may give the medical practitioner a written notice requiring the
medical practitioner to give to the Secretary specified information
or documents relating to one or more of the following:
(a) the condition of the person to whom the medical device is to
be given or is given;
(b) the supply of the device;
(c) the handling of the device;
(d) the monitoring of the supply of the device;
(e) the results of the supply of the device;
(f) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to medical devices of
that kind.
(3) A notice under this section must specify a reasonable period within
which the person must comply. The period must be at least 10
working days starting on the day on which the notice is given.
(4) A notice under this section may require information to be given in
accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
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Section 41JE
41JE Secretary may require information relating to approvals
under section 41HB
Approval under subsection 41HB(1)
(1) The Secretary may give to a person granted an approval under
subsection 41HB(1) (special and experimental uses), in relation to
specified kinds of medical devices, a written notice requiring the
person to give to the Secretary specified information or documents
relating to one or more of the following:
(a) the supply of devices of those kinds;
(b) the handling of devices of those kinds;
(c) the monitoring of the supply of devices of those kinds;
(d) the results of the supply of devices of those kinds;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to devices of those
kinds.
Approval under subsection 41HB(1)—use by another person
(2) The Secretary may give to a person using specified kinds of
medical devices, that are the subject of an approval granted to
someone else under paragraph 41HB(1)(e) (use solely for
experimental purposes in humans), a written notice requiring the
person to give to the Secretary specified information or documents
relating to either of both of the following:
(a) the use of devices of those kinds;
(b) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to devices of those
kinds.
Compliance period
(3) A notice under this section must specify a reasonable period within
which the person to whom the notice is given must comply. The
period must be at least 10 working days starting on the day on
which the notice is given.
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Section 41JF
Information may need to be given in accordance with specified
software requirements
(4) A notice under this section may require information to be given in
accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
41JF Secretary may require information relating to health
practitioner authorisations
(1) The Secretary may give to a person who is granted an authority
under subsection 41HC(1) (exemptions for medical practitioners),
in relation to specified kinds of medical devices, a written notice
requiring the person to give to the Secretary specified information
or documents relating to one or more of the following:
(a) the supply of devices of those kinds;
(b) the handling of devices of those kinds;
(c) the monitoring of the supply of devices of those kinds;
(d) the results of the supply of devices of those kinds;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to devices of those
kinds.
(1A) If a person is authorised, by subsection 41HC(6) rules, to supply a
specified kind of medical device, the Secretary may give the
person a written notice requiring the person to give the Secretary
specified information or documents relating to one or more of the
following:
(a) the supply of devices of that kind;
(b) the handling of devices of that kind;
(c) the monitoring of the supply of devices of that kind;
(d) the results of the supply of devices of that kind;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to devices of that kind.
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Division 2 Information relating to medical devices covered by exemptions
Section 41JFA
(2) A notice under subsection (1) or (1A) must specify a reasonable
period within which the person to whom the notice is given must
comply. The period must be at least 10 working days starting on
the day on which the notice is given.
(3) A notice under subsection (1) or (1A) may require information to
be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
41JFA Secretary may require information relating to approvals
under section 41HD
(1) The Secretary may give to a person who is granted an approval
under subsection 41HD(1), (1A) or (2) in relation to a medical
device a written notice requiring the person to give to the Secretary
specified information or documents relating to one or more of the
following:
(a) the supply of the medical device;
(b) the handling of the medical device;
(c) the monitoring of the supply of the medical device;
(d) the results of the supply of the medical device;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to the kind of medical
device that includes the medical device.
(2) The notice must specify a reasonable period within which the
person must comply. The period must be at least 10 working days
starting on the day on which the notice is given.
(3) The notice may require information to be given in accordance with
specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
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Information relating to medical devices covered by exemptions Division 2
Section 41JG
41JG Criminal offences for failing to give information or documents
sought under this Division
(1) A person commits an offence if:
(a) the person is given a notice under section 41JCA, 41JD,
41JE, 41JF or 41JFA; and
(b) the person fails to comply with the notice.
Penalty: 400 penalty units.
(2) A person commits an offence if:
(a) the person is given a notice under section 41JCA, 41JD,
41JE, 41JF or 41JFA; and
(b) the person fails to comply with the notice.
Penalty: 100 penalty units.
(3) An offence against subsection (2) is an offence of strict liability.
41JH False or misleading information
(1) A person to whom a notice is given under section 41JCA, 41JD,
41JE, 41JF or 41JFA commits an offence if:
(a) the person gives information to the Secretary; and
(b) the person knows that the information:
(i) is false or misleading; or
(ii) omits any matter or thing without which the information
is misleading; and
(c) the information is given in compliance or purported
compliance with the notice.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) A person to whom a notice is given under section 41JCA, 41JD,
41JE, 41JF or 41JFA commits an offence if:
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Division 2 Information relating to medical devices covered by exemptions
Section 41JI
(a) the person gives information to the Secretary; and
(b) the information:
(i) is false or misleading; or
(ii) omits any matter or thing without which the information
is misleading; and
(c) the information is given in compliance or purported
compliance with the notice.
Penalty: 100 penalty units.
(3) An offence against subsection (2) is an offence of strict liability.
(4) Subsection (1) or (2) does not apply as a result of
subparagraph (1)(b)(i) or (2)(b)(i) if the information is not false or
misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (4): see subsection 13.3(3) of the Criminal Code.
(5) Subsection (1) or (2) does not apply as a result of
subparagraph (1)(b)(ii) or (2)(b)(ii) if the information did not omit
any matter or thing without which the information is misleading in
a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (5): see subsection 13.3(3) of the Criminal Code.
41JI False or misleading documents
(1) A person commits an offence if:
(a) the person produces a document to the Secretary; and
(b) the person knows that the document is false or misleading;
and
(c) the document is produced in compliance or purported
compliance with a notice given under section 41JCA, 41JD,
41JE, 41JF or 41JFA.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
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Section 41JJ
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(1A) A person commits an offence if:
(a) the person produces a document to the Secretary; and
(b) the document is false or misleading; and
(c) the document is produced in compliance or purported
compliance with a notice given under section 41JCA, 41JD,
41JE, 41JF or 41JFA.
Penalty: 100 penalty units.
(1B) An offence against subsection (1A) is an offence of strict liability.
(1C) Subsection (1) or (1A) does not apply if the document is not false
or misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (1C): see subsection 13.3(3) of the Criminal Code.
(2) Subsection (1) or (1A) does not apply to a person who produces a
document if the document is accompanied by a written statement
signed by the person or, in the case of a body corporate, by a
competent officer of the body corporate:
(a) stating that the document is, to the knowledge of the
first-mentioned person, false or misleading in a material
particular; and
(b) setting out, or referring to, the material particular in which
the document is, to the knowledge of the first-mentioned
person, false or misleading.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (2) (see subsection 13.3(3) of the Criminal Code).
41JJ Self-incrimination
(1) A person is not excused from giving information or a document
under a notice given under section 41JCA, 41JD, 41JE, 41JF or
41JFA on the ground that to do so would tend to incriminate the
person or expose the person to a penalty.
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Part 4-8 Obtaining information
Division 2 Information relating to medical devices covered by exemptions
Section 41JJ
(2) However, in the case of an individual:
(a) the information given; or
(b) the giving of the document; or
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or document;
is not admissible in evidence in:
(d) criminal proceedings against the individual, except
proceedings under, or arising out of, section 41JH or 41JI; or
(e) proceedings for a pecuniary penalty order against the
individual for a contravention of a civil penalty provision.
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Medical devices Chapter 4
Public notification, and recall, of medical devices Part 4-9
Section 41K
Part 4-9—Public notification, and recall, of medical
devices
41K What this Part is about
The Secretary can require action to recall medical devices, or to
inform the public about medical devices, that do not comply with
requirements or cannot lawfully be supplied.
41KA Public notification, and recall, of medical devices
(1) The Secretary may, in writing, impose requirements, relating to a
kind of medical device, on a person if:
(a) any of the circumstances referred to in the second column of
an item in the following table occur in relation to the kind of
device; and
(b) the person is referred to in the third column of that item of
the table.
Circumstances in which requirements may be imposed
Item Circumstance relating to a kind of medical Person subject to
device requirements
1. It is supplied while it is included in the
Register, but the Secretary is satisfied that
medical devices of that kind do not comply
with the essential principles
The person in relation to
whom it is included in the
Register
2. It is supplied while it is included in the
Register, but the Secretary is satisfied that the
conformity assessment procedures have not
been applied to medical devices of that kind
and that requirements, comparable to those
procedures, have not been applied to medical
devices of that kind
The person in relation to
whom it is included in the
Register
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Section 41KA
Circumstances in which requirements may be imposed
Item Circumstance relating to a kind of medical Person subject to
device requirements
3. It is supplied while:
(a) medical devices of that kind are exempt
devices; or
(b) there is an approval under section 41HB
relating to devices of that kind; or
(c) there is an authority under section 41HC
relating to devices of that kind; or
(d) there is an approval under
subsection 41HD(1), (1A) or (2) relating to
devices of that kind;
but the Secretary is satisfied that medical
devices of that kind do not comply with the
essential principles
The person supplying the
kind of medical device
4. It is supplied while:
(a) medical devices of that kind are exempt
devices; or
(b) there is an approval under section 41HB
relating to devices of that kind; or
(c) there is an authority under section 41HC
relating to devices of that kind; or
(d) there is an approval under
subsection 41HD(1), (1A) or (2) relating to
devices of that kind;
but the Secretary is satisfied that the
conformity assessment procedures have not
been applied to medical devices of that kind
and that requirements, comparable to those
procedures, have not been applied to medical
devices of that kind
The person supplying the
kind of medical device
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Section 41KA
Circumstances in which requirements may be imposed
Item Circumstance relating to a kind of medical Person subject to
device requirements
5. It is supplied while:
(a) it is not included in the Register; and
(aa) it is not covered by an exemption in force
under section 41GS; and
(b) it is not an exempt device; and
(c) there is not an approval under
section 41HB relating to devices of that
kind; and
(d) there is not an authority under
section 41HC relating to devices of that
kind; and
(e) there is not an approval under
subsection 41HD(1), (1A) or (2) relating to
devices of that kind.
The person supplying the
kind of medical device
5A. It is supplied while it is covered by an
exemption in force under section 41GS, and
the Secretary is satisfied that it is not fit to be
used for its intended purpose
The person supplying the
kind of medical device
5B. It is supplied while it is included in the
Register, but it appears to the Secretary that
the quality, safety or performance of medical
devices of that kind is unacceptable
The person in relation to
whom the kind of medical
device is included in the
Register
6. It has been suspended from the Register The person in relation to
whom it was included in the
Register
7. Its entry has been cancelled from the Register The person in relation to
whom it was included in the
Register
8. It is counterfeit goods (within the meaning of The person supplying the
section 42E) kind of medical device
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Section 41KB
(2) The requirements may be one or more of the following:
(a) to take specified steps, in the specified manner and within
such reasonable period as is specified, to recall medical
devices of that kind that have been distributed;
(b) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, to the effect that the circumstances referred to in
paragraph (1)(a) have occurred in relation to medical devices
of that kind;
(c) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, of specified information, or of information of a
specified kind, relating to either or both of the following:
(i) medical devices of that kind;
(ii) the circumstances referred to in paragraph (1)(a);
(d) to publish, in the specified manner and within such
reasonable period as is specified, specified information, or
information of a specified kind, relating to the manufacture
or distribution of medical devices of that kind;
(e) to notify the Secretary, in the specified manner and within
such reasonable period as is specified, of specified
information, or of information of a specified kind, relating to
the persons to whom medical devices of that kind have been
supplied.
(3) If the circumstances referred to in paragraph (1)(a) apply only to
some medical devices of that kind, the Secretary may limit the
imposition of the requirements to the medical devices of that kind
to which those circumstances apply.
(4) A requirement to recall medical devices under this section does not
apply to a medical device that cannot be recalled because it has
been administered to, or applied in the treatment of, a person.
41KB Publication of requirements
The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after imposing a
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Section 41KC
requirement under section 41KA, a notice setting out particulars of
the requirement.
41KC Criminal offences for failing to comply with requirements
relating to a kind of medical device
(1) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 41KA; and
(c) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 41KA.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 41KA.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
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Section 41KCA
41KCA Civil penalty for failing to comply with requirements
relating to a kind of medical device
A person contravenes this section if:
(a) the person does an act or omits to do an act; and
(b) the act or omission contravenes a requirement imposed on
the person under section 41KA.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
41KD Powers of suspension and cancellation unaffected
Imposition of a requirement under section 41KA does not affect
the Secretary’s powers to:
(a) suspend the entry of a kind of medical device, or some
medical devices of a particular kind, from the Register under
Part 4-6; or
(b) cancel the entry of a kind of medical device, or some medical
devices of a particular kind, in the Register under Part 4-6.
41KE Saving of other laws
This Part is not intended to exclude or limit the operation of any
other law of the Commonwealth or any law of a State or Territory.
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Assessment fees Part 4-10
Section 41L
Part 4-10—Assessment fees
41L What this Part is about
Conformity assessment fees must be paid for consideration of
applications for conformity assessment certificates. Application
audit assessment fees must be paid for auditing applications that
are required to be selected for auditing under
paragraph 41FH(1)(a).
41LA Assessment fees
(1) A conformity assessment fee specified in or determined in
accordance with the regulations is payable by a person in respect of
consideration of an application for a conformity assessment
certificate under Part 4-4.
(2) The regulations may prescribe different levels of conformity
assessment fees in relation to any one or more of the following:
(a) different kinds of manufacturers;
(b) different kinds of medical devices;
(c) different parts of the conformity assessment procedures that
are considered in relation to an application for a conformity
assessment certificate under Part 4-4.
(3) An application audit assessment fee specified in or determined in
accordance with the regulations is payable by a person in respect of
the auditing of an application for inclusion of a kind of medical
device in the Register under Part 4-5, if paragraph 41FH(1)(a)
required the Secretary to select the application for audit.
(4) The regulations may prescribe different levels of application audit
assessment fees in relation to any one or more of the following:
(a) different kinds of manufacturers;
(b) different kinds of medical devices;
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Section 41LB
(c) different levels of assessment of kinds of medical devices.
(5) The application audit assessment fee payable because of
subsection (3) is payable only in respect of considering the matters
set out in subsection 41FI(1).
41LB When assessment fee due for payment
Subject to sections 41LC and 41LE, an assessment fee payable by
an applicant is due and payable on the day, and in the manner,
specified in the regulations.
41LC Payment of assessment fee by instalments
(1) The regulations may provide for the payment of an assessment fee
to be made by such instalments and at such times as are ascertained
in accordance with the regulations, and the assessment fee is due
and payable accordingly.
(2) Regulations made for the purposes of subsection (1) may provide
that a person is not allowed to pay an assessment fee by instalments
if any part of an instalment of:
(a) that or any other assessment fee payable by the person; or
(b) any evaluation fee under section 24 payable by the person;
was unpaid immediately after the time when it became due for
payment.
(3) Subsection (2) does not limit the generality of subsection (1).
41LD Recovery of assessment fee
An assessment fee may be recovered by the Commonwealth as a
debt due to the Commonwealth.
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Section 41LE
41LE Reduction of conformity assessment fee where decision not
made within prescribed period
(1) Nothing in section 41LA, 41LB or 41LC requires the applicant to
pay more than 3/4 of the conformity assessment fee before the
making of the decision if:
(a) the application is for the issuing of a conformity assessment
certificate under Part 4-4; and
(b) consideration of the application will involve an examination
of the design of medical devices; and
(c) a period is prescribed under paragraph 63(2)(dc) for making a
decision on the application.
(2) If the decision is not made within that period, the conformity
assessment fee is 3/4 of the fee that, apart from this subsection,
would have been the conformity assessment fee.
(3) If:
(a) the decision is made within that period; and
(b) part of the conformity assessment fee under section 41LA is,
because of subsection (1) of this section, unpaid when the
decision is made;
that part becomes due and payable on the making of the decision.
(4) For the purposes of this section, a decision is taken to be made on
the application when the applicant is notified under
subsection 41EE(1) of the Secretary’s decision on the application.
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Part 4-11 Offences and civil penalty provisions relating to medical devices
Section 41M
Part 4-11—Offences and civil penalty provisions
relating to medical devices
41M What this Part is about
This Part contains offences and civil penalty provisions that are
aimed at ensuring that:
• the essential principles are complied with (see Division 1);
• the conformity assessment procedures have been applied to
kinds of medical devices or requirements, comparable to those
procedures, have been applied to kinds of medical devices
(see Division 2);
• administrative processes put in place by Parts 4-4 to 4-9 are
followed (see Divisions 3, 3A and 4).
Note: There are also some offences and civil penalty provisions in the earlier
Parts of this Chapter. They generally relate to matters ancillary to
administrative processes in those Parts (e.g. false or misleading
statements in applications).
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Offences and civil penalty provisions relating to medical devices Part 4-11
Non-compliance with essential principles Division 1
Section 41MA
Division 1—Non-compliance with essential principles
41MA Criminal offences for importing, supplying or exporting a
medical device that does not comply with essential
principles
Offences relating to importing a medical device
(1) A person commits an offence if:
(a) the person imports a medical device into Australia; and
(b) the medical device does not comply with the essential
principles relating to matters other than the labelling of the
device; and
(c) the Secretary has not consented to the importation; and
(ca) the device is not of a kind covered by an exemption in force
under section 41GS; and
(d) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the device
does not comply with the essential principles.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person imports a medical device into Australia; and
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Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 1 Non-compliance with essential principles
Section 41MA
(b) the medical device does not comply with the essential
principles relating to matters other than the labelling of the
device; and
(c) the Secretary has not consented to the importation; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person imports a medical device into Australia; and
(b) the medical device does not comply with the essential
principles relating to matters other than the labelling of the
device; and
(c) the Secretary has not consented to the importation; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Offences relating to supplying a medical device
(5) A person commits an offence if:
(a) the person supplies a medical device for use in Australia; and
(b) the medical device does not comply with the essential
principles; and
(c) the Secretary has not consented to the supply; and
(ca) the device is not of a kind covered by an exemption in force
under section 41GS; and
(d) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
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Medical devices Chapter 4
Offences and civil penalty provisions relating to medical devices Part 4-11
Non-compliance with essential principles Division 1
Section 41MA
(ii) the use of the device, if device were used, would result
in, or would be likely to result in, harm or injury to any
person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the device
does not comply with the essential principles.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (8) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(8) A person commits an offence if:
(a) the person supplies a medical device for use in Australia; and
(b) the medical device does not comply with the essential
principles; and
(c) the Secretary has not consented to the supply; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(8A) A person commits an offence if:
(a) the person supplies a medical device for use in Australia; and
(b) the medical device does not comply with the essential
principles; and
(c) the Secretary has not consented to the supply; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: 100 penalty units.
(8B) An offence against subsection (8A) is an offence of strict liability.
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Chapter 4 Medical devices
Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 1 Non-compliance with essential principles
Section 41MA
Offences relating to exporting a medical device
(9) A person commits an offence if:
(a) the person exports a medical device from Australia; and
(b) the medical device does not comply with the essential
principles relating to matters other than the labelling of the
device for supply in Australia; and
(c) the Secretary has not consented to the exportation; and
(ca) the device is not of a kind covered by an exemption in force
under section 41GS; and
(d) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the device
does not comply with the essential principles.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (12) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(12) A person commits an offence if:
(a) the person exports a medical device from Australia; and
(b) the medical device does not comply with the essential
principles relating to matters other than the labelling of the
device for supply in Australia; and
(c) the Secretary has not consented to the exportation; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
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Medical devices Chapter 4
Offences and civil penalty provisions relating to medical devices Part 4-11
Non-compliance with essential principles Division 1
Section 41MAA
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(13) A person commits an offence if:
(a) the person exports a medical device from Australia; and
(b) the medical device does not comply with the essential
principles relating to matters other than the labelling of the
device for supply in Australia; and
(c) the Secretary has not consented to the exportation; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: 100 penalty units.
(14) An offence against subsection (13) is an offence of strict liability.
41MAA Civil penalties for importing, supplying or exporting a
medical device that does not comply with essential
principles
Civil penalty relating to importing a medical device
(1) A person contravenes this subsection if:
(a) the person imports a medical device into Australia; and
(b) the medical device does not comply with the essential
principles relating to matters other than the labelling of the
device; and
(c) the Secretary has not consented to the importation; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Civil penalty relating to supplying a medical device
(2) A person contravenes this subsection if:
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Chapter 4 Medical devices
Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 1 Non-compliance with essential principles
Section 41MB
(a) the person supplies a medical device for use in Australia; and
(b) the medical device does not comply with the essential
principles; and
(c) the Secretary has not consented to the supply; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Civil penalty relating to exporting a medical device
(3) A person contravenes this subsection if:
(a) the person exports a medical device from Australia; and
(b) the medical device does not comply with the essential
principles relating to matters other than the labelling of the
device for supply in Australia; and
(c) the Secretary has not consented to the exportation; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
41MB Exceptions
(1) Sections 41MA and 41MAA do not apply if:
(a) the medical device complies with one or more medical device
standards that apply to it; and
(b) the medical device fails to comply with the essential
principles only in respect of a part or parts of the essential
principles to which that medical device standard, or one or
more of those medical device standards, relate.
Note: Medical device standards are determined under Division 2 of Part 4-2.
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Medical devices Chapter 4
Offences and civil penalty provisions relating to medical devices Part 4-11
Non-compliance with essential principles Division 1
Section 41MC
(2) For the purposes of this section, a medical device standard relates
to a part or parts of the essential principles only if the standard
specifies that part or parts.
Note 1: In the prosecution for an offence, the defendant bears an evidential
burden in relation to the matters in this section (see subsection 13.3(3)
of the Criminal Code).
Note 2: In proceedings for the contravention of a civil penalty provision, the
defendant must prove the matters in this section.
41MC Criminal offences relating to breaching a condition of a
consent
(1) The consent of the Secretary under section 41MA or 41MAA may
be given:
(a) unconditionally or subject to conditions; or
(b) in respect of particular medical devices or kinds of medical
devices.
(2) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent; and
(c) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: 2,000 penalty units.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (5) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(5) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent.
Penalty: 500 penalty units.
(6) A person commits an offence if:
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Chapter 4 Medical devices
Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 1 Non-compliance with essential principles
Section 41MCA
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent.
Penalty: 100 penalty units.
(7) An offence against subsection (6) is an offence of strict liability.
41MCA Civil penalty relating to breaching a condition of a consent
A person contravenes this section if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent
imposed under section 41MC.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
41MD Treating medical devices as prohibited imports or exports
If:
(a) the importation or exportation of a medical device is an
offence under subsection 41MA(1), (4), (4A), (9), (12) or
(13) or a contravention of subsection 41MAA(1) or (3); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the device included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
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Medical devices Chapter 4
Offences and civil penalty provisions relating to medical devices Part 4-11
Failure to apply conformity assessment procedures Division 2
Section 41ME
Division 2—Failure to apply conformity assessment
procedures
41ME Criminal offences for failing to apply conformity assessment
procedures—manufacturers
Offences relating to supplying a medical device
(1) A person commits an offence if:
(a) the person manufactures a medical device; and
(b) the person supplies the device in Australia; and
(c) the conformity assessment procedures have not been applied
to the device; and
(ca) the device is not of a kind covered by an exemption in force
under section 41GS; and
(d) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the
conformity assessment procedures have not been applied to
the device.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person manufactures a medical device; and
(b) the person supplies the device in Australia; and
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Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 2 Failure to apply conformity assessment procedures
Section 41ME
(c) the conformity assessment procedures have not been applied
to the device; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person manufactures a medical device; and
(b) the person supplies the device in Australia; and
(c) the conformity assessment procedures have not been applied
to the device; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Offences relating to exporting a medical device
(5) A person commits an offence if:
(a) the person manufactures a medical device; and
(b) the person exports the device from Australia; and
(c) the conformity assessment procedures have not been applied
to the device; and
(ca) the device is not of a kind covered by an exemption in force
under section 41GS; and
(d) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the
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Offences and civil penalty provisions relating to medical devices Part 4-11
Failure to apply conformity assessment procedures Division 2
Section 41ME
conformity assessment procedures have not been applied to
the device.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (8) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(8) A person commits an offence if:
(a) the person manufactures a medical device; and
(b) the person exports the device from Australia; and
(c) the conformity assessment procedures have not been applied
to the device; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(9) A person commits an offence if:
(a) the person manufactures a medical device; and
(b) the person exports the device from Australia; and
(c) the conformity assessment procedures have not been applied
to the device; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: 100 penalty units.
(10) An offence against subsection (9) is an offence of strict liability.
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Chapter 4 Medical devices
Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 2 Failure to apply conformity assessment procedures
Section 41MEA
41MEA Civil penalties for failing to apply conformity assessment
procedures—manufacturers
Civil penalty relating to supplying a medical device
(1) A person contravenes this subsection if:
(a) the person supplies a medical device in Australia; and
(b) the person has manufactured the device; and
(c) the conformity assessment procedures have not been applied
to the device; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Civil penalty relating to exporting a medical device
(2) A person contravenes this subsection if:
(a) the person exports a medical device from Australia; and
(b) the person has manufactured the device; and
(c) the conformity assessment procedures have not been applied
to the device; and
(d) the device is not of a kind covered by an exemption in force
under section 41GS.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
41MF Criminal offences for failing to apply conformity assessment
procedures—sponsors
Offences relating to supplying a medical device
(1) A person commits an offence if:
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Medical devices Chapter 4
Offences and civil penalty provisions relating to medical devices Part 4-11
Failure to apply conformity assessment procedures Division 2
Section 41MF
(a) the person supplies a medical device in Australia; and
(b) the conformity assessment procedures have not been applied
to the device; and
(ba) the device is not of a kind covered by an exemption in force
under section 41GS; and
(c) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(d) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the
conformity assessment procedures have not been applied to
the device.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (2) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) A person commits an offence if:
(a) the person supplies a medical device in Australia; and
(b) the conformity assessment procedures have not been applied
to the device; and
(c) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Offences relating to exporting a medical device
(3) A person commits an offence if:
(a) the person exports a medical device from Australia; and
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Chapter 4 Medical devices
Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 2 Failure to apply conformity assessment procedures
Section 41MF
(b) the conformity assessment procedures have not been applied
to the device; and
(ba) the device is not of a kind covered by an exemption in force
under section 41GS; and
(c) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(d) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the
conformity assessment procedures have not been applied to
the device.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person exports a medical device from Australia; and
(b) the conformity assessment procedures have not been applied
to the device; and
(c) the device is not of a kind covered by an exemption in force
under section 41GS.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Exception
(5) This section does not apply if the defendant was not the sponsor of
the device at the time of the supply or exportation, as the case may
be.
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Medical devices Chapter 4
Offences and civil penalty provisions relating to medical devices Part 4-11
Failure to apply conformity assessment procedures Division 2
Section 41MG
Note: A defendant bears an evidential burden in relation to the matters in
subsection (5): see subsection 13.3(3) of the Criminal Code.
41MG Exceptions
(1) Sections 41ME, 41MEA and 41MF do not apply to the extent that:
(a) the quality management systems applied to the medical
device comply with one or more conformity assessment
standards that apply to them; and
(b) the conformity assessment procedures have not been applied
to the device only in respect of a part or parts of the
conformity assessment procedures to which one or more of
those conformity assessment standards relate.
Note: Conformity assessment standards are determined under Division 2 of
Part 4-3.
(2) For the purposes of this section, a conformity assessment standard
relates to a part or parts of the conformity assessment procedures
only if the standard specifies that part or parts.
(3) Sections 41ME, 41MEA and 41MF do not apply if an overseas
regulator conformity assessment document is in force in relation to
the medical device.
Note 1: In the prosecution for an offence, the defendant bears an evidential
burden in relation to the matters in this section (see subsection 13.3(3)
of the Criminal Code).
Note 2: In proceedings for the contravention of a civil penalty provision, the
defendant must prove the matters in this section.
41MH Criminal offence for making false statements in declarations
A person commits an offence if:
(a) the person makes a statement in or in connection with a
declaration, relating to the application of conformity
assessment procedures, or the application of requirements
comparable to those procedures, to a medical device that the
person has manufactured; and
(b) the statement is false or misleading in a material particular.
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Chapter 4 Medical devices
Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 2 Failure to apply conformity assessment procedures
Section 41MHA
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
41MHA Civil penalty for making false statements in declarations
A person contravenes this section if:
(a) the person manufactures a medical device; and
(b) the person makes a statement in or in connection with a
declaration relating to the application of conformity
assessment procedures, or the application of requirements
comparable to those procedures, to the device; and
(c) the statement is false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
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Offences and civil penalty provisions relating to medical devices Part 4-11
Medical devices not included in the Register and related matters Division 3
Section 41MI
Division 3—Medical devices not included in the Register
and related matters
41MI Criminal offences for importing, exporting, supplying or
manufacturing a medical device not included in the
Register
(1) A person commits an offence if:
(a) the person:
(i) imports a medical device into Australia; or
(ii) exports a medical device from Australia; or
(iii) supplies a medical device in Australia; or
(iv) manufactures a medical device in Australia; and
(b) none of the following subparagraphs applies in relation to the
device:
(i) the device is of a kind included in the Register in
relation to the person;
(ia) the device is of a kind covered by an exemption in force
under section 41GS;
(ii) the device is an exempt device;
(iii) the device is the subject of an approval under
section 41HB or an authority under section 41HC;
(iv) the device is the subject of an approval under
subsection 41HD(1), (1A) or (2) that is held by the
person; and
(c) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in, or would be likely to result in, harm or injury
to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 3 Medical devices not included in the Register and related matters
Section 41MI
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person:
(i) imports a medical device into Australia; or
(ii) exports a medical device from Australia; or
(iii) supplies a medical device in Australia; or
(iv) manufactures a medical device in Australia; and
(b) none of the following subparagraphs applies in relation to the
device:
(i) the device is of a kind included in the Register in
relation to the person;
(ia) the device is of a kind covered by an exemption in force
under section 41GS;
(ii) the device is an exempt device;
(iii) the device is the subject of an approval under
section 41HB or an authority under section 41HC;
(iv) the device is the subject of an approval under
subsection 41HD(1), (1A) or (2) that is held by the
person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person:
(i) imports a medical device into Australia; or
(ii) exports a medical device from Australia; or
(iii) supplies a medical device in Australia; or
(iv) manufactures a medical device in Australia; and
(b) none of the following subparagraphs applies in relation to the
device:
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Offences and civil penalty provisions relating to medical devices Part 4-11
Medical devices not included in the Register and related matters Division 3
Section 41MI
(i) the device is of a kind included in the Register in
relation to the person;
(ii) the device is of a kind covered by an exemption in force
under section 41GS;
(iii) the device is an exempt device;
(iv) the device is the subject of an approval under
section 41HB or an authority under section 41HC;
(v) the device is the subject of an approval under
subsection 41HD(1), (1A) or (2) that is held by the
person.
Penalty: 100 penalty units.
(5A) An offence against subsection (5) is an offence of strict liability.
Defence if person was not the sponsor of the goods
(6) It is a defence to a prosecution under subsection (1), (4) or (5) if
the defendant proves that the defendant was not the sponsor of the
device at the time of the importation, exportation, supply, or
manufacture, as the case may be.
Note: A defendant bears a legal burden in relation to the matters in
subsection (6): see section 13.4 of the Criminal Code.
Exception
(7) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or performance of the medical device;
or
(ii) a matter relating to the labelling or packaging of the
medical device; or
(iii) the improper use of the medical device; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or performance of the medical device;
or
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Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 3 Medical devices not included in the Register and related matters
Section 41MIA
(ii) a matter relating to the labelling or packaging of the
medical device; or
(iii) the improper use of the medical device.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (7): see subsection 13.3(3) of the Criminal Code.
41MIA Notice required to adduce evidence in support of exception
under subsection 41MI(7)
(1) If:
(a) a defendant is committed for trial for an offence against
subsection 41MI(1); or
(b) an offence against subsection 41MI(1) is to be heard and
determined by a court of summary jurisdiction;
the committing magistrate or the court must:
(c) inform the defendant of the requirements of this section; and
(d) cause a copy of this section to be given to the defendant.
(2) A defendant must not, without leave of the court, adduce evidence
in support of the exception under subsection 41MI(7) unless:
(a) if paragraph (1)(a) applies—more than 21 days before the
trial begins; or
(b) if paragraph (1)(b) applies—more than 21 days before the
hearing of the offence begins;
he or she gives notice of particulars of the exception.
(3) A defendant must not, without leave of the court, call any other
person to give evidence in support of the exception unless:
(a) the notice under subsection (2) includes the name and
address of the person or, if the name and address is not
known to the defendant at the time he or she gives the notice,
any information in his or her possession that might be of
material assistance in finding the person; and
(b) if the name or the address is not included in the notice—the
court is satisfied that the defendant before giving the notice
took, and after giving the notice continued to take, all
reasonable steps to ascertain the name or address; and
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(c) if the name or address is not included in the notice, but the
defendant subsequently ascertains the name or address or
receives information that might be of material assistance in
finding the person—the defendant immediately gives notice
of the name, address or other information, as the case may
be; and
(d) if the defendant is told by or on behalf of the prosecutor that
the person has not been found by the name, or at the address,
given by the defendant:
(i) the defendant immediately gives notice of any
information in the defendant’s possession that might be
of material assistance in finding the person; or
(ii) if the defendant later receives any such information—
the defendant immediately gives notice of the
information.
(4) A notice purporting to be given under this section on behalf of the
defendant by his or her legal practitioner is, unless the contrary is
proved, taken as having been given with the authority of the
defendant.
(5) Any evidence tendered to disprove that the exception applies may,
subject to direction by the court, be given before or after evidence
is given in support of the exception.
(6) A notice of particulars of the exception must be given, in writing,
to the Director of Public Prosecutions. A notice is taken as having
been given if it is:
(a) delivered to or left at the Office of the Director of Public
Prosecutions; or
(b) sent by certified mail addressed to the Director of Public
Prosecutions at the Office of the Director of Public
Prosecutions.
(7) In this section:
Director of Public Prosecutions means a person holding office as,
or acting as, the Director of Public Prosecutions under the Director
of Public Prosecutions Act 1983.
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Division 3 Medical devices not included in the Register and related matters
Section 41MIB
41MIB Civil penalty for importing, exporting, supplying or
manufacturing a medical device not included in the
Register
(1) A person contravenes this section if:
(a) the person does any of the following:
(i) imports a medical device into Australia;
(ii) exports a medical device from Australia;
(iii) supplies a medical device in Australia;
(iv) manufactures a medical device in Australia; and
(b) none of the following subparagraphs apply in relation to the
device:
(i) the device is of a kind included in the Register in
relation to the person;
(ia) the device is of a kind covered by an exemption in force
under section 41GS;
(ii) the device is an exempt device;
(iii) the device is the subject of an approval under
section 41HB or an authority under section 41HC;
(iv) the device is the subject of an approval under
subsection 41HD(1), (1A) or (2) that is held by the
person.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exception
(2) Subsection (1) does not apply if the defendant proves that the
defendant was not the sponsor of the device at the time of the
importation, exportation, supply, or manufacture, as the case may
be.
41MJ Treating medical devices as prohibited imports or exports
If:
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Section 41MK
(a) the importation or exportation of a medical device is an
offence under subsection 41MI(1), (4) or (5) or a
contravention of section 41MIB; and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the device included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
41MK Wholesale supply of medical devices not included in the
Register
A person commits an offence if:
(a) the person supplies a medical device in Australia; and
(b) none of the following subparagraphs applies in relation to the
device:
(i) the device is of a kind included in the Register;
(ia) the device is of a kind covered by an exemption in force
under section 41GS;
(ii) the device is an exempt device;
(iii) the device is the subject of an approval under
section 41HB or an authority under section 41HC;
(iv) the device is the subject of an approval under
subsection 41HD(1), (1A) or (2) that is held by the
person; and
(c) the person to whom the device is supplied is not the ultimate
consumer of the device.
Penalty: 120 penalty units.
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Division 3 Medical devices not included in the Register and related matters
Section 41ML
41ML False advertising about medical devices
(1) A person commits an offence if:
(a) the person, by any means, advertises a medical device as
being for a purpose; and
(b) the device is of a kind included in the Register; and
(c) the purpose is not a purpose accepted in relation to that
inclusion; and
(d) either:
(i) the use of the medical device for the advertised purpose
has resulted in, will result in, or is likely to result in,
harm or injury to any person; or
(ii) the use of the medical device for the advertised purpose,
if the medical device were so used, would result in, or
would be likely to result in, harm or injury to any
person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(2) A person commits an offence if:
(a) the person, by any means, advertises a medical device as
being for a purpose; and
(b) the device is of a kind included in the Register; and
(c) the purpose is not a purpose accepted in relation to that
inclusion.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(3) A person commits an offence if:
(a) the person, by any means, advertises a medical device as
being for a purpose; and
(b) the device is of a kind included in the Register; and
(c) the purpose is not a purpose accepted in relation to that
inclusion.
Penalty: 100 penalty units.
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Section 41MLA
(4) An offence against subsection (3) is an offence of strict liability.
41MLA Civil penalty for making misrepresentations about medical
devices
(1) A person contravenes this section if:
(a) the person makes a representation of a kind referred to in
subsection (2); and
(b) the representation is false or misleading.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
(2) Subsection (1) applies to the following representations:
(a) representations that medical devices are of a kind included in
the Register;
(b) representations that medical devices are exempt devices;
(c) representations that medical devices are the subject of an
approval under section 41HB or an authority under
section 41HC;
(d) representations that medical devices are the subject of an
approval under subsection 41HD(1), (1A) or (2).
41MLB Civil penalty for false advertising about medical devices
A person contravenes this section if:
(a) the person, by any means, advertises a medical device as
being for a purpose; and
(b) the device is of a kind included in the Register; and
(c) the purpose is not a purpose accepted in relation to that
inclusion.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Section 41MM
41MM Claims about arranging supplies of medical devices
A person commits an offence if:
(a) the person claims, by any means, that the person or another
person can arrange the supply of a medical device; and
(b) none of the following subparagraphs applies in relation to the
device:
(i) the device is of a kind included in the Register;
(ii) the device is of a kind covered by an exemption in force
under section 41GS;
(iii) the device is an exempt device;
(iv) the device is the subject of an approval under
section 41HB or an authority under section 41HC that
covers the supply of the device by the person or other
person;
(v) the device is the subject of an approval under
subsection 41HD(1), (1A) or (2) that covers the supply
of the device by the person or other person.
Penalty: 60 penalty units.
41MN Criminal offences relating to breaches of conditions
Offences relating to breaching a condition of the inclusion of a
kind of medical device in the Register
(1) A person commits an offence if:
(a) a kind of medical device is included in the Register in
relation to the person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the kind of device in the Register; and
(d) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Section 41MN
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) a kind of medical device is included in the Register in
relation to the person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the kind of device in the Register.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) a kind of medical device is included in the Register in
relation to the person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the kind of device in the Register.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Offences relating to breaching a condition of a conformity
assessment certificate
(5) A person commits an offence if:
(a) a conformity assessment certificate is issued in respect of the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the conformity
assessment certificate; and
(d) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to a person.
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Section 41MN
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (8) instead:
see section 53A.
(8) A person commits an offence if:
(a) a conformity assessment certificate is issued in respect of the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the conformity
assessment certificate.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(8A) A person commits an offence if:
(a) a conformity assessment certificate is issued in respect of the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the conformity
assessment certificate.
Penalty: 100 penalty units.
(8B) An offence against subsection (8A) is an offence of strict liability.
Offence relating to breaching a condition of an exemption or
approval, or a condition applicable under regulations
(9) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches:
(i) a condition of an exemption applicable under
regulations made for the purposes of section 41HA; or
(ii) a condition of an approval under section 41HB; or
(iii) a condition applicable under regulations made for the
purposes of subsection 41HB(7); or
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Section 41MNA
(iv) a condition of an approval under subsection 41HD(1),
(1A) or (2).
Penalty: 60 penalty units.
Offences relating to breaching a condition of a conformity
assessment body determination
(10) An Australian corporation commits an offence if:
(a) the corporation does an act or omits to do an act; and
(b) the act or omission breaches a condition referred to in
subsection 41EWA(5); and
(c) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: 20,000 penalty units.
(11) An Australian corporation commits an offence if:
(a) the corporation does an act or omits to do an act; and
(b) the act or omission breaches a condition referred to in
subsection 41EWA(5).
Penalty: 5,000 penalty units.
(12) An Australian corporation commits an offence if:
(a) the corporation does an act or omits to do an act; and
(b) the act or omission breaches a condition referred to in
subsection 41EWA(5).
Penalty: 500 penalty units.
(13) An offence against subsection (12) is an offence of strict liability.
41MNA Civil penalties for breaching conditions
(1) A person contravenes this subsection if:
(a) a kind of medical device is included in the Register in
relation to the person; and
(b) the person does an act or omits to do an act; and
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Section 41MNA
(c) the act or omission breaches a condition of the inclusion of
the kind of device in the Register.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
(2) A person contravenes this subsection if:
(a) a conformity assessment certificate is issued in respect of the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the conformity
assessment certificate.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
(3) An Australian corporation contravenes this subsection if:
(a) the corporation does an act or omits to do an act; and
(b) the act or omission breaches a condition referred to in
subsection 41EWA(5).
Maximum civil penalty: 50,000 penalty units.
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Section 41MNB
Division 3A—Offences and civil penalties related to
exemptions under Part 4-6A
41MNB Criminal offences for breaching a condition of an
exemption
(1) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a
medical device; and
(b) the device is of a kind covered by an exemption in force
under section 41GS; and
(c) the act or omission results in the breach of a condition of the
exemption; and
(d) the act or omission is likely to cause a serious risk to public
health.
Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) Strict liability applies to paragraph (1)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(3) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a
medical device; and
(b) the device is of a kind covered by an exemption in force
under section 41GS; and
(c) the act or omission results in the breach of a condition of the
exemption.
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
(4) Strict liability applies to paragraph (3)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
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Section 41MNC
(5) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a
medical device; and
(b) the device is of a kind covered by an exemption in force
under section 41GS; and
(c) the act or omission results in the breach of a condition of the
exemption.
Penalty: 60 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
41MNC Civil penalty for breaching a condition of an exemption
A person contravenes this section if:
(a) the person does an act or omits to do an act in relation to a
medical device; and
(b) the device is of a kind covered by an exemption in force
under section 41GS; and
(c) the act or omission results in the breach of a condition of the
exemption.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
41MND Civil penalty for making misrepresentations about medical
devices
A person contravenes this section if:
(a) the person makes a representation that medical devices are of
a kind covered by an exemption in force under section 41GS;
and
(b) the representation is false or misleading.
Maximum civil penalty:
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Section 41MND
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Division 4 Other offences and civil penalty provisions
Section 41MO
Division 4—Other offences and civil penalty provisions
41MO Criminal offences for misusing medical devices exempted for
special or experimental uses
(1) A person commits an offence if:
(a) the person has been granted an authority under
subsection 41HC(1) relating to a specified kind of medical
device; and
(b) the person supplies a medical device of that kind:
(i) otherwise than in accordance with the authority; or
(ii) otherwise than in accordance with any conditions to
which the authority is subject; or
(iii) otherwise than in accordance with any regulations made
for the purpose of subsection 41HC(5); and
(c) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(d) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because:
(i) the supply is not in accordance with the authority; or
(ii) the supply is not in accordance with the conditions to
which the authority is subject; or
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 41HC(5).
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
(4) A person commits an offence if:
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Section 41MO
(a) the person has been granted an authority under
subsection 41HC(1) relating to a specified kind of medical
device; and
(b) the person supplies a medical device of that kind:
(i) otherwise than in accordance with the authority; or
(ii) otherwise than in accordance with any conditions to
which the authority is subject; or
(iii) otherwise than in accordance with any regulations made
for the purpose of subsection 41HC(5).
Penalty: 500 penalty units.
(4AA) A person commits an offence if:
(a) the person has been granted an authority under
subsection 41HC(1) relating to a specified kind of medical
device; and
(b) the person supplies a medical device of that kind:
(i) otherwise than in accordance with the authority; or
(ii) otherwise than in accordance with any conditions to
which the authority is subject; or
(iii) otherwise than in accordance with any regulations made
for the purpose of subsection 41HC(5).
Penalty: 100 penalty units.
(4AB) An offence against subsection (4AA) is an offence of strict
liability.
(4A) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 41HC(6) rules; and
(c) the person supplies a medical device of a kind specified in
those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
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Section 41MO
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules; and
(e) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(f) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because:
(i) the supply is not in accordance with those rules; or
(ii) the supply is not in the circumstances specified in those
rules; or
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(4C) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 41HC(6) rules; and
(c) the person supplies a medical device of a kind specified in
those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: 500 penalty units.
(4D) A person commits an offence if:
(a) the person is a health practitioner; and
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Section 41MO
(b) the person is included in a class of health practitioners
specified in subsection 41HC(6) rules; and
(c) the person supplies a medical device of a kind specified in
those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: 100 penalty units.
(4E) An offence against subsection (4D) is an offence of strict liability.
(5) A person commits an offence if:
(a) the person has been granted an approval under section 41HB
relating to a specified medical device or specified kind of
medical device; and
(b) the person uses a medical device of that kind:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans;
otherwise than in accordance with the approval; and
(c) either:
(i) the use of the device has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in, or would be likely to result in, harm or injury
to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (8) instead:
see section 53A.
(8) A person commits an offence if:
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Division 4 Other offences and civil penalty provisions
Section 41MP
(a) the person has been granted an approval under section 41HB
relating to a specified medical device or specified kind of
medical device; and
(b) the person uses a medical device of that kind:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans;
otherwise than in accordance with the approval.
Penalty: 500 penalty units.
(9) A person commits an offence if:
(a) the person has been granted an approval under section 41HB
relating to a specified medical device or specified kind of
medical device; and
(b) the person uses a medical device of that kind:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans;
otherwise than in accordance with the approval.
Penalty: 100 penalty units.
(10) An offence against subsection (9) is an offence of strict liability.
41MP Criminal offence for failing to notify adverse events etc.
(1) A person commits an offence if:
(a) the person is a person in relation to whom a kind of medical
device is included in the Register; and
(b) the person knows that particular information is information
of a kind mentioned in subsection (2); and
(c) the person fails to give that information to the Secretary
within the period specified in the regulations (whether or not
the person has already given to the Secretary other
information relating to the same matter).
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
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Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) The information with which subsection (1) is concerned is
information of the following kinds:
(a) information relating to:
(i) any malfunction or deterioration in the characteristics or
performance of the kind of device; or
(ii) any inadequacy in the design, production, labelling,
instructions for use or advertising materials of the kind
of device; or
(iii) any use in accordance with, or contrary to, the use
intended by the manufacturer of the kind of device;
that might lead, or might have led, to the death of a patient or
a user of the device, or to a serious deterioration in his or her
state of health;
(b) information relating to any technical or medical reason for a
malfunction or deterioration of a kind referred to in
subparagraph (a)(i) that has led the manufacturer to take steps
to recall devices of that kind that have been distributed;
(c) information that indicates that a device of that kind does not
comply with the essential principles;
(d) information that indicates that a certificate or other document
(other than a certificate or other document issued by the
Secretary under this Act) used for the purpose of an
application under subsection 41FC(1) to signify:
(i) compliance with the essential principles; or
(ii) the application of relevant conformity assessment
procedures to a device of that kind or the application of
requirements, comparable to those procedures, to a
device of that kind;
has been restricted, suspended, revoked or is no longer in
effect.
41MPA Civil penalty for failing to notify adverse events etc.
(1) A person contravenes this section if:
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(a) a kind of medical device is included in the Register in
relation to the person; and
(b) the information is of a kind mentioned in subsection (2); and
(c) the person does not give information of a kind mentioned in
subsection (2) to the Secretary within the period specified in
the regulations (whether or not the person has already given
to the Secretary other information relating to the same
matter).
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
(2) The information with which subsection (1) is concerned is
information of the following kinds:
(a) information relating to:
(i) any malfunction or deterioration in the characteristics or
performance of the kind of device; or
(ii) any inadequacy in the design, production, labelling,
instructions for use or advertising materials of the kind
of device; or
(iii) any use in accordance with, or contrary to, the use
intended by the manufacturer of the kind of device;
that might lead, or might have led, to the death of a patient or
user of the device, or to a serious deterioration in his or her
state of health;
(b) information relating to any technical or medical reason for a
malfunction or deterioration of a kind referred to in
subparagraph (a)(i) that has led the manufacturer to take steps
to recall devices of that kind that have been distributed;
(c) information that indicates that a device of that kind does not
comply with the essential principles;
(d) information that indicates that a certificate or other document
(other than a certificate or other document issued by the
Secretary under this Act) used for the purpose of an
application under subsection 41FC(1) to signify:
(i) compliance with the essential principles; or
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(ii) the application of relevant conformity assessment
procedures to a device of that kind or the application of
requirements, comparable to those procedures, to a
device of that kind;
has been restricted, suspended, revoked or is no longer in
effect.
41MPB Relief from liability for contraventions for failing to notify
adverse events etc.
(1) If:
(a) proceedings for the contravention of section 41MPA (a civil
penalty provision) are brought against a person; and
(b) in the proceedings it appears to the Court that the person has,
or may have, contravened that section but that:
(i) the person has a reasonable excuse; and
(ii) having regard to all the circumstances of the case, the
person ought fairly to be excused for the contravention;
the Court may relieve the person either wholly or partly from a
liability to which the person would otherwise be subject, or that
might otherwise be imposed on the person, because of the
contravention.
(2) If a person thinks that proceedings for the contravention of
section 41MPA will or may be begun against them, they may apply
to the Court for relief.
(3) On an application under subsection (2), the Court may grant relief
under subsection (1) as if proceedings had been begun in the Court.
(4) For the purposes of subsection (2) as applying for the purposes of a
case tried by a judge with a jury:
(a) a reference in that subsection to the Court is a reference to
the judge; and
(b) the relief that may be granted includes withdrawing the case
in whole or in part from the jury and directing judgment to be
entered for the person on such terms as to costs as the judge
thinks appropriate.
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Division 4 Other offences and civil penalty provisions
Section 41MQ
41MQ Notification of adverse events etc. where application
withdrawn or lapses
(1) If an application for inclusion of a kind of medical device in the
Register is withdrawn or lapses, the Secretary may give the
applicant written notice requiring the applicant:
(a) to inform the Secretary in writing whether the applicant is
aware of any information of a kind mentioned in
subsection 41MP(2) or 41MPA(2) relating to the kind of
device; and
(b) if the applicant is aware of such information, to give the
information to the Secretary in writing.
(2) Notice under subsection (1) may only be given within 10 working
days after an application is withdrawn or lapses.
(3) A person commits an offence if the person fails to comply with the
requirements of a notice under subsection (1) within 20 working
days after the notice is given to the person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person gives information in purported compliance with a
notice under this section; and
(b) the information is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
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Section 41MR
41MR Civil penalties for failing to notify adverse effects etc. where
application withdrawn or lapses
Civil penalty for failing to comply with requirements of a notice
(1) A person contravenes this subsection if the person does not comply
with the requirements of a notice under subsection 41MQ(1) within
20 working days after the day on which the notice is given to the
person.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
Civil penalty for giving false or misleading information in
purported compliance with requirements of a notice
(2) A person contravenes this subsection if:
(a) the person gives information in purported compliance with a
notice under subsection 41MQ(1); and
(b) the information is false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
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Part 5-1 Advertising and generic information
Division 1 Preliminary
Section 42AA
Chapter 5—Advertising, counterfeit
therapeutic goods and product
tampering
Part 5-1—Advertising and generic information
Division 1—Preliminary
42AA This Part not to apply to advertisements directed at health
professionals etc.
(1) This Part does not apply to advertisements directed exclusively to:
(a) medical practitioners, psychologists, dentists, pharmacists,
optometrists, chiropractors, physiotherapists, nurses,
midwives, dental hygienists, dental prosthetists, dental
therapists or osteopaths; or
(b) persons who are:
(i) engaged in the business of wholesaling therapeutic
goods; or
(ii) purchasing officers in hospitals; or
(c) herbalists, homoeopathic practitioners, naturopaths,
nutritionists, practitioners of traditional Chinese medicine or
podiatrists registered under a law of a State or Territory; or
(d) a class of persons specified under subsection (1A).
(1A) The Minister may, by legislative instrument, specify a class of
persons for the purposes of paragraph (1)(d).
(2) This Part does not apply to advertisements directed exclusively to
persons who are members of an Australian branch (however
described) of one of the bodies prescribed for the purposes of this
subsection.
(3) For the purposes of subsection (2), a person is taken to be a
member of an Australian branch of one of those bodies if, and only
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Section 42AB
if, the person has the qualifications and training that are necessary
or appropriate for membership of the relevant body.
(4) This Part does not apply to advice or information given directly to
a patient by a person referred to in paragraph (1)(a) or (c) or
subsection (2) in the course of treatment of that patient.
42AB This Part not to apply to advertisements for goods not for
human use
This Part does not apply to advertisements in respect of goods that
are not for use in humans.
42AC This Part not to apply to advertisements for exported goods
(1) Subject to subsection (2), this Part does not apply to
advertisements solely for therapeutic goods that have been
exported or are intended exclusively for export.
(2) Sections 42DKB, 42DLA and 42DLC and Divisions 5 and 6 apply
in relation to advertisements of that kind.
42B Definitions
In this Part, unless the contrary intention appears:
approval number means the distinguishing number allocated to an
approved advertisement by the Secretary under regulation 5J of the
Therapeutic Goods Regulations.
approved advertisement means an advertisement:
(a) approved under regulation 5G, or taken to be approved by the
Secretary under subregulation 5H(2), or approved by the
Minister on review under regulation 5M, of the Therapeutic
Goods Regulations; and
(b) the approval of which has not been withdrawn.
broadcaster, in relation to an advertisement for therapeutic goods,
means a person (other than a person who is required to enter those
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Section 42B
goods on the Register) who undertakes, as a business activity in its
own right:
(a) the broadcasting of the advertisement in broadcast media; or
(b) the placement of the advertisement for such broadcasting.
broadcast media, in relation to an advertisement or generic
information, means any means (other than a means declared in the
regulations to be an exempted means) by which the information is
disseminated electronically in a visible or audible form or a
combination of such forms.
generic information, in relation to therapeutic goods, includes any
statement, pictorial representation or design, however made, about
the composition, properties or other characteristics of therapeutic
goods, but does not include:
(a) an advertisement about the goods; or
(b) generic information included in an advertisement about the
goods; or
(c) bona fide news.
mainstream media means any magazine or newspaper for
consumers containing a range of news, public interest items,
advertorials, advertisements or competitions.
prohibited representation means a representation referred to in
subsection 42DJ(1).
publisher, in relation to an advertisement for therapeutic goods,
means a person (other than a person who is required to enter those
goods on the Register) who undertakes, as a business activity in its
own right:
(a) the publishing of the advertisement in specified media other
than broadcast media; or
(b) the placement of the advertisement for such publication.
publishing, in relation to an advertisement, includes inserting
material within the pages of an item of mainstream media.
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Section 42BAA
required representation means a representation referred to in
subsection 42DJ(2).
restricted representation means a representation referred to in
section 42DD.
specified media, in relation to an advertisement or generic
information, means:
(a) mainstream media; or
(b) broadcast media; or
(c) cinematograph films; or
(d) displays about goods, including posters:
(i) in shopping malls (except inside an individual shop);
and
(ii) in or on public transport; and
(iii) on billboards.
visual broadcast media means broadcast media that is intended to
be viewed by its audience.
42BAA Therapeutic Goods Advertising Code
(1) The Minister may, by legislative instrument, make a code relating
to advertisements about therapeutic goods.
(2) Despite subsection 14(2) of the Legislation Act 2003, an instrument
under subsection (1) of this section may make provision in relation
to a matter by applying, adopting or incorporating, with or without
modification, any matter contained in an instrument or other
writing as in force or existing from time to time.
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Section 42BA
Division 2—Therapeutic goods advertisements for which
an approval is required
42BA Application of Division
This Division applies only to advertisements to which Part 2 of the
Therapeutic Goods Regulations applies.
42C Offences relating to publication of advertisements
(1) A person commits an offence if:
(a) the person:
(i) publishes or broadcasts; or
(ii) causes to be published or broadcast;
in specified media, an advertisement that is required by the
Therapeutic Goods Regulations to be an approved
advertisement; and
(b) the advertisement is not an approved advertisement.
Penalty: 60 penalty units.
Note: Advertising that requires approval under Part 2 of the Therapeutic
Goods Regulations 1990 must also comply with the Therapeutic
Goods Advertising Code.
(2) A person commits an offence if:
(a) the person:
(i) publishes or broadcasts; or
(ii) causes to be published or broadcast;
an advertisement in specified media; and
(b) the advertisement is not an approved advertisement in that it
differs, in any respect, from the advertisement that was
approved.
Penalty: 60 penalty units.
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Note: Advertising that requires approval under Part 2 of the Therapeutic
Goods Regulations 1990 must also comply with the Therapeutic
Goods Advertising Code.
(3) It is a defence to a prosecution under subsection (2) if:
(a) the person prosecuted is a publisher or broadcaster who
received the advertisement to which the prosecution relates
for publication or broadcasting in specified media in the
ordinary course of business; or
(b) the particular advertisement to which the prosecution relates
differs only in respect of a matter mentioned in
paragraph 5C(2)(b), (e) or (f) of the Therapeutic Goods
Regulations.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (3) (see subsection 13.3 of the Criminal Code).
(4) A person commits an offence if:
(a) the person:
(i) publishes or broadcasts; or
(ii) causes to be published or broadcast;
a particular advertisement in specified media referred to in
paragraph (a), (c) or (d) of the definition of specified media;
and
(b) the advertisement:
(i) does not display its approval number; or
(ii) displays a number purporting to be its approval number
but that is not its approval number; or
(iii) displays an approval number that has expired.
Penalty: 30 penalty units.
Note: Advertising that requires approval under Part 2 of the Therapeutic
Goods Regulations 1990 must also comply with the Therapeutic
Goods Advertising Code.
(5) It is a defence to a prosecution under subsection (4) if the person
prosecuted:
(a) is a publisher who received the advertisement to which the
prosecution relates for publication in specified media referred
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to in paragraph (a), (c) or (d) of the definition of specified
media; or
(b) is a broadcaster who received the advertisement to which the
prosecution relates for broadcasting in visual broadcast
media;
in the ordinary course of business.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (5) (see subsection 13.3 of the Criminal Code).
(6) A person commits an offence if:
(a) the person:
(i) publishes or broadcasts; or
(ii) causes to be published or broadcast;
in specified media, an approved advertisement; and
(b) the person’s action is in contravention of a condition to
which the approval of the advertisement is subject.
Penalty: 60 penalty units.
Note: Advertising that requires approval under Part 2 of the Therapeutic
Goods Regulations 1990 must also comply with the Therapeutic
Goods Advertising Code.
(7) It is a defence to a prosecution under subsection (6) if the person
prosecuted is a publisher or broadcaster who received the
advertisement to which the prosecution relates for publication or
broadcasting in specified media in the ordinary course of business.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (7) (see subsection 13.3 of the Criminal Code).
(8) An offence against this section is an offence of strict liability.
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Section 42DA
Division 3—General provisions about advertising
therapeutic goods
42DA Simplified outline
The following is a simplified outline of this Division:
This Division has 2 kinds of application.
First, Part 2 of the Therapeutic Goods Regulations 1990 deals with
the Secretary approving certain advertisements and it refers to
provisions of this Division.
Second, the offences in Division 3A of this Part refer to provisions
of this Division.
42DB Definitions
In this Division:
applicant means an applicant for approval of the use of a restricted
representation in an advertisement about therapeutic goods.
approval holder, in relation to a restricted representation, means
the person to whom notice of approval of the use of the restricted
representation was given.
42DD Restricted representations
For the purposes of this Part, a representation in an advertisement
about therapeutic goods that refers to a form of a disease,
condition, ailment or defect identified in a part of the Therapeutic
Goods Advertising Code as a serious form of a disease, condition,
ailment or defect is a restricted representation.
Note: See sections 42DL and 42DLB for offences and a civil penalty for
advertising therapeutic goods, where the advertisement contains a
restricted representation.
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Section 42DE
42DE Applications for approval of use of restricted representation
(1) An application for approval of the use of a restricted representation
must be made to the Secretary in accordance with a form approved,
in writing, by the Secretary.
(2) An approval of a form may require or permit an application to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
42DF Approval of use of restricted representation
(1) If an application for approval of the use of a restricted
representation is made, the Secretary must approve the use of the
restricted representation if the Secretary is satisfied that:
(a) the representation is accurate and balanced; and
(b) the representation is not misleading or likely to be
misleading.
(2) Otherwise, the Secretary must refuse to approve the use of the
restricted representation.
(3) An approval may be subject to conditions imposed by the
Secretary.
(4) In deciding whether to approve or refuse to approve the use of a
restricted representation, the Secretary must take into
consideration:
(a) any recommendation of the Therapeutic Goods Advertising
Code Council; and
(b) any advice of a committee that is established under the
regulations and is prescribed by the regulations for the
purposes of this paragraph; and
(c) the public interest criteria mentioned in the part of the
Therapeutic Goods Advertising Code dealing with restricted
representations.
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Section 42DG
42DG Notice of approval or refusal
(1) The Secretary must give written notice to the applicant of the
approval of, or of the refusal to approve, the use of a restricted
representation.
(2) If written notice is not given to the applicant within the period of
60 days after the day on which the application was made (or within
such longer period as the Secretary specifies by written notice to
the applicant before the end of that period), the Secretary is taken
to have approved the use of the restricted representation at the end
of the period.
(3) If an approval is subject to conditions, the conditions must be set
out in the notice.
(4) A notice of refusal to approve the use of a restricted representation
must:
(a) give the Secretary’s reasons for the refusal; and
(b) inform the applicant of the applicant’s right to have the
Secretary’s decision reviewed by the Minister under
section 60.
42DH Variation of conditions of approval
(1) The Secretary, by written notice to an approval holder, may vary
any condition of approval of the use of a restricted representation.
(2) The notice must:
(a) give the Secretary’s reasons for the variation; and
(b) inform the approval holder of the approval holder’s right to
have the Secretary’s decision reviewed by the Minister under
section 60.
42DI Withdrawal of approval
(1) The Secretary, by written notice, may withdraw the approval of the
use of a restricted representation if:
(a) the Secretary is satisfied that:
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Section 42DJ
(i) information given by the applicant in the application
was false or incorrect and the Secretary, or the Minister
on review of a decision of the Secretary under
section 42DF or 42DH, relied on the information in
deciding to approve the use of the representation; or
(ii) the restricted representation has become a prohibited
representation; or
(iii) there has been a breach of a condition of approval; or
(b) both:
(i) additional information about the safety of the
therapeutic goods becomes available; and
(ii) the Secretary is satisfied that, if that information had
been available at the time of the approval, the Secretary
would not have approved the use of the restricted
representation; or
(c) the use of the restricted representation is permitted under
subsection 42DK(1).
(2) The notice must:
(a) give the Secretary’s reasons for the withdrawal; and
(b) inform the approval holder of the approval holder’s right to
have the Secretary’s decision reviewed by the Minister under
section 60.
42DJ Prohibited and required representations
(1) For the purposes of this Part, representations of a kind specified in
regulations made for the purposes of this subsection are prohibited
representations about therapeutic goods of a kind specified in those
regulations.
(2) For the purposes of this Part, representations of a kind specified in
regulations made for the purposes of this subsection are required
representations about the therapeutic goods of a kind specified in
those regulations.
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Section 42DK
42DK Permitted use of restricted or prohibited representations
Restricted representations
(1) The Secretary may, by writing, permit the use of specified
restricted representations in specified advertisements about
specified therapeutic goods.
Prohibited representations
(2) The Secretary may, by writing, permit the use of specified
prohibited representations:
(a) on the label of specified therapeutic goods; or
(b) on the package in which specified therapeutic goods are
contained; or
(c) on any material included with the package in which specified
therapeutic goods are contained;
if the Secretary is satisfied that the representations are necessary
for the appropriate use of the goods.
(3) The Secretary may, by writing, permit the use of specified
prohibited representations in specified advertisements about
specified therapeutic goods if the Secretary is satisfied that the
representations are necessary in the interests of public health.
Conditions
(4) A permission under this section may be subject to conditions
specified in the permission.
Permission not a legislative instrument
(5) A permission under this section is not a legislative instrument.
Publication
(6) As soon as practicable after giving a permission under this section,
the Secretary must cause the permission to be published on the
Department’s website.
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Division 3A Therapeutic goods advertisements for which an approval is not required
Section 42DKA
Division 3A—Therapeutic goods advertisements for which
an approval is not required
42DKA Application of Division
This Division applies to advertisements about therapeutic goods
other than advertisements for which an approval is required under
Part 2 of the Therapeutic Goods Regulations 1990.
42DKB Certain representations not to be advertised
(1) If a representation in an advertisement about therapeutic goods is
false or misleading, the Secretary may, by notice given to a person
apparently responsible for:
(a) advertising the therapeutic goods; or
(b) causing the advertising of the therapeutic goods;
prevent that person from advertising the therapeutic goods, or
causing the advertising of the therapeutic goods, in circumstances
where the advertisement contains that representation (whether in
express terms or by necessary implication).
Note: See sections 42DLA and 42DLC for criminal offences and a civil
penalty for contravening the notice.
(2) A notice under subsection (1) is not a legislative instrument.
Publication
(3) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause the notice to be published on the
Department’s website.
42DL Advertising offences—general
(1) A person commits an offence if:
(a) the person:
(i) advertises, by any means, therapeutic goods; or
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(ii) causes the advertising, by any means, of therapeutic
goods; and
(b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to
the advertisement; and
(c) either:
(i) the use of the goods in reliance on the advertisement has
resulted in, will result in, or is likely to result in, harm
or injury to any person; or
(ii) the use of the goods in reliance on the advertisement, if
the goods were so used, would result in, or would be
likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(2) A person commits an offence if:
(a) the person:
(i) advertises, by any means, therapeutic goods; or
(ii) causes the advertising, by any means, of therapeutic
goods; and
(b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to
the advertisement.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(3) A person commits an offence if:
(a) the person:
(i) advertises, by any means, therapeutic goods; or
(ii) causes the advertising, by any means, of therapeutic
goods; and
(b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to
the advertisement.
Penalty: 100 penalty units.
(4) An offence against subsection (3) is an offence of strict liability.
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Section 42DL
Contravening provisions
(5) This subsection applies to the advertisement if it contains a
prohibited representation (whether in express terms or by necessary
implication) about the goods and either of the following applies:
(a) no permission under section 42DK is in force in relation to
the prohibited representation;
(b) a permission under section 42DK is in force in relation to the
prohibited representation but the use of the prohibited
representation is not in accordance with the permission or a
condition of the permission.
(6) This subsection applies to the advertisement if it does not contain a
required representation about the goods.
(7) This subsection applies to the advertisement if it contains a
restricted representation (whether in express terms or by necessary
implication) and either of the following applies:
(a) neither an approval under section 42DF nor a permission
under section 42DK is in force in relation to the restricted
representation;
(b) an approval under section 42DF or a permission under
section 42DK is in force in relation to the restricted
representation but the use of the restricted representation is
not in accordance with the approval or permission or a
condition of the approval or permission.
(8) This subsection applies to the advertisement if it contains a
reference to this Act, other than in a statement of the registration
number, listing number or device number of the goods.
(9) This subsection applies to the advertisement if it contains a
statement, pictorial representation or design suggesting or implying
the goods have been recommended or approved by or on behalf of
a government or government authority (including a foreign
government or foreign government authority), other than:
(a) a statement of the availability of the goods as a
pharmaceutical benefit; or
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(b) a statement, pictorial representation or design authorised or
required by a government or government authority (not
including a foreign government or foreign government
authority); or
(c) a statement, pictorial representation or design prescribed by
the regulations for the purposes of this paragraph.
(10) This subsection applies to the advertisement if it refers to
substances, or goods containing substances, included in
Schedule 3, 4 or 8 to the current Poisons Standard but not in
Appendix H of the current Poisons Standard, other than a reference
authorised or required by a government or government authority
(not including a foreign government or foreign government
authority).
(11) This subsection applies to the advertisement if it refers to a
biological, other than a reference authorised or required by a
government or government authority (not including a foreign
government or foreign government authority).
(12) This subsection applies to the advertisement if it refers to
therapeutic goods that are not entered in the Register and that are
prescribed by the regulations for the purposes of this subsection,
other than a reference authorised or required by a government or
government authority (not including a foreign government or
foreign government authority).
Continuing offences
(13) A person who contravenes subsection (1), (2) or (3) commits a
separate offence in respect of each day (including a day of a
conviction for the offence or any later day) during which the
contravention continues.
(14) The maximum penalty for each day that an offence against
subsection (1), (2) or (3) continues is 10% of the maximum
pecuniary penalty that can be imposed in respect of that offence.
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Section 42DLA
42DLA Advertising offences—contravening section 42DKB notice
(1) A person commits an offence if:
(a) the Secretary has given a notice to the person under
section 42DKB in relation to therapeutic goods; and
(b) the person does an act or omits to do an act; and
(c) the act or omission contravenes the notice; and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because of the
contravention.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(2) A person commits an offence if:
(a) the Secretary has given a notice to the person under
section 42DKB; and
(b) the person does an act or omits to do an act; and
(c) the act or omission contravenes the notice.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(3) A person commits an offence if:
(a) the Secretary has given a notice to the person under
section 42DKB; and
(b) the person does an act or omits to do an act; and
(c) the act or omission contravenes the notice.
Penalty: 100 penalty units.
(4) An offence against subsection (3) is an offence of strict liability.
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Section 42DLB
42DLB Civil penalty relating to advertisements—general
(1) A person contravenes this subsection if:
(a) the person:
(i) advertises, by any means, therapeutic goods; or
(ii) causes the advertising, by any means, of therapeutic
goods; and
(b) subsection (2), (3), (4), (5), (6), (7), (8) or (9) applies to the
advertisement.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Contravening provisions
(2) This subsection applies to the advertisement if it contains a
prohibited representation (whether in express terms or by necessary
implication) about the goods and either of the following applies:
(a) no permission under section 42DK is in force in relation to
the prohibited representation;
(b) a permission under section 42DK is in force in relation to the
prohibited representation but the use of the prohibited
representation is not in accordance with the permission or a
condition of the permission.
(3) This subsection applies to the advertisement if it does not contain a
required representation about the goods.
(4) This subsection applies to the advertisement if it contains a
restricted representation (whether in express terms or by necessary
implication) and either of the following applies:
(a) neither an approval under section 42DF nor a permission
under section 42DK is in force in relation to the restricted
representation;
(b) an approval under section 42DF or a permission under
section 42DK is in force in relation to the restricted
representation but the use of the restricted representation is
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Section 42DLB
not in accordance with the approval or permission or a
condition of the approval or permission.
(5) This subsection applies to the advertisement if it contains a
reference to this Act, other than in a statement of the registration
number, listing number or device number of the goods.
(6) This subsection applies to the advertisement if it contains a
statement, pictorial representation or design suggesting or implying
the goods have been recommended or approved by or on behalf of
a government or government authority (including a foreign
government or foreign government authority), other than:
(a) a statement of the availability of the goods as a
pharmaceutical benefit; or
(b) a statement, pictorial representation or design authorised or
required by a government or government authority (not
including a foreign government or foreign government
authority); or
(c) a statement, pictorial representation or design prescribed by
the regulations for the purposes of this paragraph.
(7) This subsection applies to the advertisement if it refers to
substances, or goods containing substances, included in
Schedule 3, 4 or 8 to the current Poisons Standard but not in
Appendix H of the current Poisons Standard, other than a reference
authorised or required by a government or government authority
(not including a foreign government or foreign government
authority).
(8) This subsection applies to the advertisement if it refers to a
biological, other than a reference authorised or required by a
government or government authority (not including a foreign
government or foreign government authority).
(9) This subsection applies to the advertisement if it refers to
therapeutic goods that are not entered in the Register and that are
prescribed by the regulations for the purposes of this subsection,
other than a reference authorised or required by a government or
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government authority (not including a foreign government or
foreign government authority).
Exception
(10) Subsection (1) does not apply if:
(a) the person is a broadcaster, a datacaster, the SBS or a person
of a kind prescribed by the regulations for the purposes of
this paragraph; and
(b) as a result of steps taken by the person, it was reasonable for
the person to assume that subsections (2) to (9) did not apply
to the advertisement.
(11) In this section:
broadcaster has the meaning given by clause 3 of Schedule 2 to the
Broadcasting Services Act 1992.
datacaster means a person who holds a datacasting licence (within
the meaning of the Broadcasting Services Act 1992).
SBS has the same meaning as in the Special Broadcasting Service
Act 1991.
42DLC Civil penalty relating to advertisements—contravening
section 42DKB notice
A person contravenes this section if:
(a) the Secretary has given a notice to the person under
section 42DKB; and
(b) the person does an act or omits to do an act; and
(c) the act or omission contravenes the notice.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Division 3A Therapeutic goods advertisements for which an approval is not required
Section 42DM
42DM Offences—non-compliance with the Therapeutic Goods
Advertising Code
(1) A person commits an offence if:
(a) the person:
(i) advertises, by any means, therapeutic goods; or
(ii) causes the advertising, by any means, of therapeutic
goods; and
(b) the advertisement does not comply with the Therapeutic
Goods Advertising Code; and
(c) either:
(i) the use of the goods in reliance on the advertisement has
resulted in, will result in, or is likely to result in, harm
or injury to any person; or
(ii) the use of the goods in reliance on the advertisement, if
the goods were so used, would result in, or would be
likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(2) A person commits an offence if:
(a) the person:
(i) advertises, by any means, therapeutic goods; or
(ii) causes the advertising, by any means, of therapeutic
goods; and
(b) the advertisement does not comply with the Therapeutic
Goods Advertising Code.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(3) A person commits an offence if:
(a) the person:
(i) advertises, by any means, therapeutic goods; or
(ii) causes the advertising, by any means, of therapeutic
goods; and
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(b) the advertisement does not comply with the Therapeutic
Goods Advertising Code.
Penalty: 100 penalty units.
(4) An offence against subsection (3) is an offence of strict liability.
Continuing offences
(5) A person who contravenes subsection (1), (2) or (3) commits a
separate offence in respect of each day (including a day of a
conviction for the offence or any later day) during which the
contravention continues.
(6) The maximum penalty for each day that an offence against
subsection (1), (2) or (3) continues is 10% of the maximum
pecuniary penalty that can be imposed in respect of that offence.
42DMA Civil penalty—non-compliance with the Therapeutic Goods
Advertising Code
(1) A person contravenes this section if:
(a) the person:
(i) advertises, by any means, therapeutic goods; or
(ii) causes the advertising, by any means, of therapeutic
goods; and
(b) the advertisement does not comply with the Therapeutic
Goods Advertising Code.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exception
(2) Subsection (1) does not apply if:
(a) the person is a broadcaster, a datacaster, the SBS or a person
of a kind prescribed by the regulations for the purposes of
this paragraph; and
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(b) as a result of steps taken by the person, it was reasonable for
the person to assume that the advertisement complied with
the Therapeutic Goods Advertising Code.
(3) In this section:
broadcaster has the meaning given by clause 3 of Schedule 2 to the
Broadcasting Services Act 1992.
datacaster means a person who holds a datacasting licence (within
the meaning of the Broadcasting Services Act 1992).
SBS has the same meaning as in the Special Broadcasting Service
Act 1991.
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Generic information about ingredients or components of therapeutic goods Division 4
Section 42DN
Division 4—Generic information about ingredients or
components of therapeutic goods
42DN Application of Division
This Division applies to generic information about goods that:
(a) may be used as an ingredient or component in the
manufacture of therapeutic goods; and
(b) although not presented for supply as therapeutic goods, come
within the meaning of therapeutic goods because they are
represented to be:
(i) for therapeutic use; or
(ii) for use as an ingredient or component in the
manufacture of other therapeutic goods.
42DO Compliance with the Code
Generic information to which this Division applies must comply
with the provisions of the Therapeutic Goods Advertising Code
that are prescribed by the regulations for the purposes of this
section as if those provisions applied to generic information in the
same way as they apply to advertisements.
42DP Offences—dissemination of generic information
(1) A person commits an offence if:
(a) the person disseminates, by any means, generic information
about therapeutic goods to the public or a section of the
public; and
(b) the dissemination of that generic information does not
comply with the provisions of the Therapeutic Goods
Advertising Code that are prescribed by regulations for the
purposes of section 42DO.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
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Division 4 Generic information about ingredients or components of therapeutic goods
Section 42DQ
(2) A person commits an offence if:
(a) the person disseminates, by any means, generic information
about therapeutic goods to the public or a section of the
public; and
(b) the dissemination of that generic information does not
comply with the provisions of the Therapeutic Goods
Advertising Code that are prescribed by regulations for the
purposes of section 42DO.
Penalty: 100 penalty units.
(3) An offence against subsection (2) is an offence of strict liability.
42DQ Civil penalty for dissemination of generic information
A person contravenes this section if:
(a) the person disseminates, by any means, generic information
about therapeutic goods to the public or a section of the
public; and
(b) the dissemination of that generic information does not
comply with the provisions of the Therapeutic Goods
Advertising Code that are prescribed by regulations for the
purposes of section 42DO.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Section 42DR
Division 5—Secretary may require information or
documents
42DR Secretary may require information or documents
Advertisements
(1) The Secretary may, by written notice given to a person apparently
responsible for advertising therapeutic goods, or for causing the
advertising of therapeutic goods, require the person to give to the
Secretary specified information, or to produce to the Secretary
specified documents, relating to the advertisement.
Generic information
(2) The Secretary may, by written notice given to a person apparently
responsible for disseminating, or for causing the disseminating of,
generic information about therapeutic goods to the public or a
section of the public, require the person to give to the Secretary
specified information, or to produce to the Secretary specified
documents, relating to the dissemination.
Manner of compliance
(3) The person must give the information, or produce the documents,
to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice or within such longer
period as the Secretary allows; and
(b) in the form specified in the notice.
Note: Section 42DS contains criminal offences for failing to comply with
the notice and for giving false or misleading information or documents
and section 42DT contains a civil penalty for giving false or
misleading information or documents.
(4) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
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Division 5 Secretary may require information or documents
Section 42DS
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Notice not a legislative instrument
(5) A notice under subsection (1) or (2) is not a legislative instrument.
42DS Criminal offences for failing to comply with a notice etc.
(1) A person commits an offence if:
(a) the person is given a notice under section 42DR; and
(b) the person fails to comply with the notice.
Penalty: 500 penalty units.
(2) A person commits an offence if:
(a) the person is given a notice under section 42DR; and
(b) the person fails to comply with the notice.
Penalty: 100 penalty units.
(3) An offence against subsection (2) is an offence of strict liability.
(4) A person commits an offence if:
(a) the person is given a notice under section 42DR; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person is given a notice under section 42DR; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
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Section 42DT
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
42DT Civil penalty for giving false or misleading information or
document in compliance with a notice
A person contravenes this section if:
(a) the person is given a notice under section 42DR; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
42DU Self-incrimination
(1) A person is not excused from giving information or producing a
document under section 42DR on the ground that the information
or the production of the document might tend to incriminate the
person or expose the person to a penalty.
(2) However, in the case of an individual:
(a) the information given or the document produced; and
(b) giving the information or producing the document; and
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or producing
the document;
are not admissible in evidence against the individual:
(d) in criminal proceedings, except proceedings for an offence
against subsection 42DS(4) or (5); or
(e) in civil proceedings, except proceedings under section 42Y
for a contravention of section 42DT.
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Division 6 Directions about advertisements or generic information
Section 42DV
Division 6—Directions about advertisements or generic
information
42DV Directions about advertisements or generic information
Advertisements
(1) If, in relation to the advertising of therapeutic goods, the Secretary
is satisfied that there has been a contravention of this Act or the
regulations, the Secretary may, in writing, direct a person
apparently responsible for advertising the therapeutic goods, or for
causing the advertising of the therapeutic goods, to do one or more
of the following:
(a) cease the advertisement;
(b) make a retraction;
(c) make a correction;
(d) recover any advertisement that is still in circulation;
(e) destroy the advertisement;
(f) cease making a particular claim or representation made by
the advertisement.
Generic information
(2) If, in relation to the dissemination of generic information about
therapeutic goods to the public or a section of the public, the
Secretary is satisfied that there has been a contravention of this Act
or the regulations, the Secretary may, in writing, direct a person
apparently responsible for the dissemination, or for causing the
dissemination, to do one or more of the following:
(a) withdraw the generic information;
(b) make a retraction;
(c) make a correction;
(d) recover any generic information that is still in circulation;
(e) destroy the generic information;
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Section 42DW
(f) cease making a particular claim or representation made by
the generic information.
Conditions
(3) A direction under subsection (1) or (2) may be subject to
conditions specified in the direction.
(4) Without limiting subsection (3), the conditions may relate to one or
more of the following:
(a) the period for doing a thing the subject of the direction;
(b) in relation to the making of a retraction or correction, either
or both of the following:
(i) the form and manner of the retraction or correction;
(ii) the period for which the retraction or correction must be
made publicly available;
(c) the reporting to the Secretary of compliance with the
direction.
Direction not a legislative instrument
(5) A direction under subsection (1) or (2) is not a legislative
instrument.
Publication
(6) As soon as practicable after giving a direction under subsection (1)
or (2), the Secretary must cause the direction to be published on the
Department’s website.
42DW Offences—contravening direction under section 42DV
(1) A person commits an offence if:
(a) the Secretary has given a direction to the person under
subsection 42DV(1) or (2) in relation to therapeutic goods;
and
(b) the person does an act or omits to do an act; and
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Section 42DX
(c) the act or omission contravenes the direction or a condition
of the direction; and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because of the
contravention.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(2) A person commits an offence if:
(a) the Secretary has given a direction to the person under
subsection 42DV(1) or (2); and
(b) the person does an act or omits to do an act; and
(c) the act or omission contravenes the direction or a condition
of the direction.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(3) A person commits an offence if:
(a) the Secretary has given a direction to the person under
subsection 42DV(1) or (2); and
(b) the person does an act or omits to do an act; and
(c) the act or omission contravenes the direction or a condition
of the direction.
Penalty: 100 penalty units.
(4) An offence against subsection (3) is an offence of strict liability.
42DX Civil penalty for contravening direction under section 42DV
A person contravenes this section if:
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(a) the Secretary has given a direction to the person under
subsection 42DV(1) or (2); and
(b) the person does an act or omits to do an act; and
(c) the act or omission contravenes the direction or a condition
of the direction.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Division 7 Public warning notices
Section 42DY
Division 7—Public warning notices
42DY Secretary may issue a public warning notice
(1) The Secretary may issue to the public a written notice containing a
warning about therapeutic goods if:
(a) the Secretary reasonably suspects that there has been a
contravention of this Act or the regulations in relation to:
(i) the advertising of the therapeutic goods; or
(ii) the dissemination of generic information about the
therapeutic goods to the public or a section of the
public; and
(b) the Secretary is satisfied that it is in the public interest to
issue the notice.
(2) If:
(a) the Secretary gives a person a notice (the substantiation
notice) under subsection 42DR(1) or (2); and
(b) the person fails to comply with the substantiation notice; and
(c) the Secretary is satisfied that it is in the public interest to
issue a notice under this subsection;
the Secretary may issue to the public a written notice containing a
warning that the person has failed to comply with the
substantiation notice, and specifying the matter to which the
substantiation notice related.
(3) Subsection (2) does not limit subsection (1).
(4) A notice under this section is not a legislative instrument.
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Section 42E
Part 5-2—Counterfeit therapeutic goods
42E Offence of dealing with counterfeit therapeutic goods
(1) A person commits an offence if:
(a) the person intentionally:
(i) manufactures goods in Australia; or
(ii) supplies goods in Australia; or
(iii) imports goods into Australia; or
(iv) exports goods from Australia; and
(b) the goods are therapeutic goods; and
(c) the goods are counterfeit and the person knows that fact or is
reckless as to whether that fact exists.
Penalty: 7 years imprisonment or 2,000 penalty units, or both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) Goods are counterfeit if any of the following contain a false
representation of a matter listed in subsection (3):
(a) the label or presentation of the goods;
(b) any document or record relating to the goods or their
manufacture;
(c) any advertisement for the goods.
(3) The matters are as follows:
(a) the identity or name of the goods;
(b) the formulation, composition or design specification of the
goods or of any ingredient or component of them;
(c) the presence or absence of any ingredient or component of
the goods;
(d) the strength or size of the goods (other than the size of any
pack in which the goods are contained);
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(e) the strength or size of any ingredient or component of the
goods;
(f) the sponsor, source, manufacturer or place of manufacture of
the goods.
(5) To avoid doubt, a term that is defined in subsection 3(1) in relation
to therapeutic goods and used in this section in relation to goods
has in this section the meaning given by subsection 3(1).
42EA Civil penalty relating to dealing with counterfeit therapeutic
goods
A person contravenes this section if:
(a) the person does any of the following:
(i) manufactures goods in Australia;
(ii) supplies goods in Australia;
(iii) imports goods into Australia;
(iv) exports goods from Australia; and
(b) the goods are therapeutic goods; and
(c) the goods are counterfeit.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
42EB Relief from liability for certain contraventions relating to
dealing with counterfeit therapeutic goods
(1) If:
(a) proceedings for the contravention of section 42EA (a civil
penalty provision) are brought against a person; and
(b) in the proceedings it appears to the Court that the person has,
or may have, contravened that section but that:
(i) the person has a reasonable excuse; and
(ii) having regard to all the circumstances of the case, the
person ought fairly to be excused for the contravention;
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the Court may relieve the person either wholly or partly from a
liability to which the person would otherwise be subject, or that
might otherwise be imposed on the person, because of the
contravention.
(2) If a person thinks that proceedings for the contravention of
section 42EA will or may be begun against them, they may apply
to the Court for relief.
(3) On an application under subsection (2), the Court may grant relief
under subsection (1) as if proceedings had been begun in the Court.
(4) For the purposes of subsection (2) as applying for the purposes of a
case tried by a judge with a jury:
(a) a reference in that subsection to the Court is a reference to
the judge; and
(b) the relief that may be granted includes withdrawing the case
in whole or in part from the jury and directing judgment to be
entered for the person on such terms as to costs as the judge
thinks appropriate.
Exception
(5) This section does not apply to civil proceedings against a person
for manufacturing therapeutic goods in Australia that are
counterfeit (see subparagraph 42EA(a)(i)).
42F Customs treatment of counterfeit therapeutic goods
Imported counterfeit therapeutic goods
(1) If the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to apply to
an import of counterfeit therapeutic goods, that Act has effect as if
the goods included in the import were goods described as forfeited
to the Crown under section 229 of that Act because they were
prohibited imports within the meaning of that Act.
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Section 42F
Exported counterfeit therapeutic goods
(2) If the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to apply to
an export of counterfeit therapeutic goods, that Act has effect as if
the goods included in the export were goods described as forfeited
to the Crown under section 229 of that Act because they were
prohibited exports within the meaning of that Act.
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Section 42T
Part 5-3—Product tampering
42T Notifying of actual or potential tampering
(1) A person commits an offence if:
(a) the person supplies, manufactures or is a sponsor of, or
proposes to supply, manufacture or become a sponsor of,
therapeutic goods; and
(b) either:
(i) the person knows that some or all of those therapeutic
goods, or any other therapeutic goods, are or have been
subject to actual or potential tampering; or
(ii) some or all of those therapeutic goods, or any other
therapeutic goods, are or have been subject to actual or
potential tampering, and the person is reckless as to that
fact; and
(c) the person fails, within 24 hours after becoming aware of, or
becoming aware of a substantial risk of, the actual or
potential tampering, to notify the Secretary.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) A person commits an offence if:
(a) the person supplies, manufactures or is a sponsor of, or
proposes to supply, manufacture or become a sponsor of,
therapeutic goods; and
(b) the person receives information or a demand; and
(c) either:
(i) the person knows that the information or demand relates
(either expressly or by implication) to actual or potential
tampering with some or all of those therapeutic goods,
or any other therapeutic goods; or
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Section 42U
(ii) the information or demand relates (either expressly or
by implication) to actual or potential tampering with
some or all of those therapeutic goods, or any other
therapeutic goods, and the person is negligent as to that
fact; and
(d) the person fails to notify the Secretary of the information or
demand within 24 hours after receiving it.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(3) For the purposes of subparagraph (2)(c)(ii), the person is only
taken to be negligent as to the fact that the information or demand
is of the kind referred to in that subparagraph if:
(a) the person’s acts or omissions involve such a great falling
short of the standard of care that a reasonable person would
exercise in the circumstances; and
(b) there is such a high risk that the information or demand is of
that kind;
that the acts or omissions merit criminal punishment.
(4) For the purposes of this section, it does not matter whether, at the
time of receipt of the information or demand:
(a) the person has possession or control of the therapeutic goods
to which the information or demand relates; or
(b) the therapeutic goods are in existence.
42U Meaning of actual or potential tampering etc.
Actual or potential tampering, in relation to therapeutic goods,
means:
(a) tampering with the therapeutic goods; or
(b) causing the therapeutic goods to be tampered with; or
(c) proposing to tamper with the therapeutic goods; or
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Section 42V
(d) proposing to cause the therapeutic goods to be tampered
with.
42V Recall of therapeutic goods because of actual or potential
tampering
(1) The Secretary may, in writing, impose requirements under this
section on a person if:
(a) the person supplies or has supplied therapeutic goods of a
particular kind, or a particular batch of therapeutic goods of
that kind; and
(b) the Secretary is satisfied that therapeutic goods of that kind,
or included in that batch, are, have been or could possibly be,
subject to actual or potential tampering.
(2) The requirements may be one or more of the following:
(a) to take specified steps, in the specified manner and within
such reasonable period as is specified, to recall therapeutic
goods of that kind, or included in that batch, that the person
has supplied;
(b) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, that therapeutic goods of that kind, or included in
that batch, are, or have been, subject to actual or potential
tampering;
(c) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, that therapeutic goods of that kind, or included in
that batch, could possibly be subject to actual or potential
tampering.
(3) Requirements referred to in paragraph (2)(a) do not apply to
therapeutic goods that cannot be recalled because they have been
administered to, or applied in the treatment of, a person.
(4) The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after imposing such
requirements, a notice setting out particulars of the requirements.
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Section 42V
(5) The Secretary may impose requirements under this section whether
or not the Secretary has been notified under section 42T.
(6) A person commits an offence if:
(a) the person fails to comply with a requirement under
subsection (1) in relation to a supply of therapeutic goods;
and
(b) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(c) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the person
failed to comply with the requirement.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (6C) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(6C) A person commits an offence if the person fails to comply with a
requirement under subsection (1) in relation to a supply of
therapeutic goods.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(6D) A person commits an offence if the person fails to comply with a
requirement under subsection (1) in relation to a supply of
therapeutic goods.
Penalty: 100 penalty units.
(6E) An offence against subsection (6D) is an offence of strict liability.
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Section 42VA
(7) This section does not prevent the Secretary from taking action
under section 29D or 30, Division 6 or 7 of Part 3-2A or Division 1
or 2 of Part 4-6.
42VA Civil penalty relating to the recall of therapeutic goods
because of actual or potential tampering
A person contravenes this section if the person fails to comply with
a requirement under subsection 42V(1) in relation to a supply of
therapeutic goods.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
42VB Relief from liability for contraventions relating to the recall of
therapeutic goods because of actual or potential
tampering
(1) If:
(a) proceedings for the contravention of section 42VA (a civil
penalty provision) are brought against a person; and
(b) in the proceedings it appears to the Court that the person has,
or may have, contravened that section but that:
(i) the person has acted honestly; and
(ii) having regard to all the circumstances of the case, the
person ought fairly to be excused for the contravention;
the Court may relieve the person either wholly or partly from a
liability to which the person would otherwise be subject, or that
might otherwise be imposed on the person, because of the
contravention.
(2) If a person thinks that proceedings for the contravention of
section 42VA will or may be begun against them, they may apply
to the Court for relief.
(3) On an application under subsection (2), the Court may grant relief
under subsection (1) as if proceedings had been begun in the Court.
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Section 42W
(4) For the purposes of subsection (2) as applying for the purposes of a
case tried by a judge with a jury:
(a) a reference in that subsection to the Court is a reference to
the judge; and
(b) the relief that may be granted includes withdrawing the case
in whole or in part from the jury and directing judgment to be
entered for the person on such terms as to costs as the judge
thinks appropriate.
42W Supply etc. of therapeutic goods that are subject to recall
requirements
(1) A person commits an offence if:
(a) the person supplies therapeutic goods in Australia; and
(b) either:
(i) the person knows that the therapeutic goods are of a
kind, or are included in a batch, in respect of which
requirements have been imposed under section 42V, on
that person or another person, to recall therapeutic
goods; or
(ii) the therapeutic goods are of such a kind, or are included
in such a batch, and the person is reckless as to that fact;
and
(c) the Secretary has not consented in writing to the supply.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) A person commits an offence if:
(a) the person exports therapeutic goods from Australia; and
(b) either:
(i) the person knows that the therapeutic goods are of a
kind, or are included in a batch, in respect of which
requirements have been imposed under section 42V, on
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Section 42X
that person or another person, to recall therapeutic
goods; or
(ii) the therapeutic goods are of such a kind, or are included
in such a batch, and the person is reckless as to that fact;
and
(c) the Secretary has not consented in writing to the exportation.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(3) The Secretary must not give consent relating to an exportation
unless satisfied that there are exceptional circumstances that justify
giving the consent.
42X Saving of other laws
This Part is not intended to exclude or limit the operation of any
other law of the Commonwealth or any law of a State or Territory.
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Chapter 5A Enforcement
Part 5A-1 Civil penalties
Division 1 Obtaining an order for a civil penalty
Section 42Y
Chapter 5A—Enforcement
Part 5A-1—Civil penalties
Division 1—Obtaining an order for a civil penalty
42Y Federal Court may order person to pay pecuniary penalty for
contravening civil penalty provision
Application for order
(1) Within 6 years of a person (the wrongdoer) contravening a civil
penalty provision, the Secretary may apply on behalf of the
Commonwealth to the Federal Court for an order that the
wrongdoer pay the Commonwealth a pecuniary penalty.
Court may order wrongdoer to pay pecuniary penalty
(2) If the Court is satisfied that the wrongdoer has contravened a civil
penalty provision, the Court may order the wrongdoer to pay to the
Commonwealth for each contravention the pecuniary penalty that
the Court determines is appropriate (but not more than the
maximum amount specified for the provision).
Determining amount of pecuniary penalty
(3) In determining the pecuniary penalty, the Court must have regard
to all relevant matters, including:
(a) the nature and extent of the contravention; and
(b) the nature and extent of any loss or damage suffered as a
result of the contravention; and
(c) the circumstances in which the contravention took place; and
(d) whether the person has previously been found by the Court in
proceedings under this Act to have engaged in any similar
conduct.
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Civil penalties Part 5A-1
Obtaining an order for a civil penalty Division 1
Section 42YA
Civil evidence and procedure rules apply
(4) The Court must apply the rules of evidence and procedure for civil
matters when hearing and determining an application for an order
under this section.
Note: The standard of proof in civil proceedings is the balance of
probabilities: see section 140 of the Evidence Act 1995.
Conduct contravening more than one civil penalty provision
(5) If conduct constitutes a contravention of 2 or more civil penalty
provisions, proceedings may be instituted under this Act against a
person in relation to the contravention of any one or more of those
provisions. However, the person is not liable to more than one
pecuniary penalty under this section in respect of the same
conduct.
42YA What is a civil penalty provision?
A subsection of this Act (or a section of this Act that is not divided
into subsections) is a civil penalty provision if the words “civil
penalty” and one or more amounts in penalty units are set out at the
foot of the subsection (or section).
42YC Persons involved in contravening civil penalty provision
(1) A person must not:
(a) aid, abet, counsel or procure a contravention of a civil
penalty provision; or
(b) induce (by threats, promises or otherwise) a contravention of
a civil penalty provision; or
(c) conspire to contravene a civil penalty provision.
(2) This Act applies to a person who contravenes subsection (1) in
relation to a civil penalty provision as if the person had
contravened the civil penalty provision.
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Part 5A-1 Civil penalties
Division 1 Obtaining an order for a civil penalty
Section 42YCA
42YCA Continuing contraventions of civil penalty provisions
(1) If an act or thing is required under a civil penalty provision to be
done:
(a) within a particular period; or
(b) before a particular time;
then the obligation to do that act or thing continues until the act or
thing is done (even if the period has expired or the time has
passed).
(2) A person who contravenes a civil penalty provision that requires an
act or thing to be done:
(a) within a particular period; or
(b) before a particular time;
commits a separate contravention of that provision in respect of
each day during which the contravention occurs (including the day
the order under subsection 42Y(2) is made or any later day).
42YD Recovery of a pecuniary penalty
If the Federal Court orders a person to pay a pecuniary penalty:
(a) the penalty is payable to the Commonwealth; and
(b) the Commonwealth may enforce the order as if it were a
judgment of the Court.
42YE Gathering information for application for pecuniary penalty
(1) This section applies if it appears to the Secretary that a person (the
wrongdoer) may have contravened a civil penalty provision.
(2) If the Secretary, on reasonable grounds, suspects that a person
other than the wrongdoer can give information relevant to an
application for a civil penalty order in relation to the contravention,
whether or not such an application has been made, the Secretary
may, by writing given to the person, require the person to give all
reasonable assistance in connection with such an application.
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Obtaining an order for a civil penalty Division 1
Section 42YE
(3) Subsection (2) does not apply in relation to a duly qualified legal
practitioner who is acting, or has acted, for the wrongdoer.
(4) If a person fails to give assistance as required under subsection (2),
the Federal Court may, on the application of the Secretary, order
the person to comply with the requirement as specified in the order.
(5) If a person fails to give assistance as required under subsection (2),
the person commits an offence against this subsection.
Penalty: 30 penalty units.
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Part 5A-1 Civil penalties
Division 2 Civil penalty proceedings and criminal proceedings
Section 42YF
Division 2—Civil penalty proceedings and criminal
proceedings
42YF Civil proceedings after criminal proceedings
The Federal Court must not make a pecuniary penalty order against
a person for a contravention of a civil penalty provision if the
person has been convicted of an offence constituted by conduct
that is substantially the same as the conduct constituting the
contravention.
42YG Criminal proceedings during civil proceedings
(1) Proceedings for a pecuniary penalty order against a person for a
contravention of a civil penalty provision are stayed if:
(a) criminal proceedings are started or have already been started
against the person for an offence; and
(b) the offence is constituted by conduct that is substantially the
same as the conduct alleged to constitute the contravention.
(2) The proceedings for the order may be resumed if the person is not
convicted of the offence. Otherwise, the proceedings for the order
are dismissed.
42YH Criminal proceedings after civil proceedings
Criminal proceedings may not be started against a person for
conduct that is substantially the same as conduct constituting a
contravention of a civil penalty provision if a pecuniary penalty
order has been made against the person in respect of that conduct.
42YI Evidence given in proceedings for civil penalty not admissible
in criminal proceedings
Evidence of information given or evidence of production of
documents by an individual is not admissible in criminal
proceedings against the individual if:
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Section 42YI
(a) the individual previously gave the evidence or produced the
documents in proceedings for a pecuniary penalty order
against the individual for a contravention of a civil penalty
provision (whether or not the order was made); and
(b) the conduct alleged to constitute the offence is substantially
the same as the conduct that was claimed to constitute the
contravention.
However, this does not apply to a criminal proceeding in respect of
the falsity of the evidence given by the individual in the
proceedings for the pecuniary penalty order.
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Chapter 5A Enforcement
Part 5A-2 Infringement notices
Section 42YJ
Part 5A-2—Infringement notices
42YJ Simplified outline of this Part
The Secretary can give a person an infringement notice for a
contravention of a provision of this Act or the regulations that is an
offence of strict liability or for a contravention of a civil penalty
provision.
The person can choose to pay an amount as an alternative to having
court proceedings brought against the person for the contravention.
If the person does not choose to pay the amount, proceedings can
be brought against the person in relation to the contravention.
42YK When an infringement notice may be given
(1) If the Secretary reasonably believes that a person has contravened:
(a) a provision of this Act or the regulations that is an offence of
strict liability; or
(b) a civil penalty provision;
the Secretary may give to the person an infringement notice for the
alleged contravention.
(2) The infringement notice must be given within 12 months after the
day on which the contravention is alleged to have taken place.
(3) A single infringement notice must relate only to a single
contravention of a single provision unless subsection (4) applies.
(4) The Secretary may give a person a single infringement notice
relating to multiple contraventions of a single provision if:
(a) the provision requires the person to do a thing within a
particular period or before a particular time; and
(b) the person fails or refuses to do that thing within that period
or before that time; and
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(c) the failure or refusal occurs on more than 1 day; and
(d) each contravention is constituted by the failure or refusal on
one of those days.
Note: For continuing offences, see subsection 4K(2) of the Crimes Act 1914.
For continuing contraventions of civil penalty provisions, see
section 42YCA of this Act.
42YKA Matters to be included in an infringement notice
(1) An infringement notice must:
(a) be identified by a unique number; and
(b) state the day on which it is given; and
(c) state the name of the person to whom the notice is given; and
(d) state the name and contact details of the person who gave the
notice; and
(e) give brief details of the alleged contravention, or each alleged
contravention, to which the notice relates, including:
(i) the provision that was allegedly contravened; and
(ii) the maximum penalty that a court could impose for each
contravention, if the provision were contravened; and
(iii) the time (if known) and day of, and the place of, each
alleged contravention; and
(f) state the amount that is payable under the notice; and
(g) give an explanation of how payment of the amount is to be
made; and
(h) state that, if the person to whom the notice is given pays the
amount within 28 days after the day the notice is given, then
(unless the notice is withdrawn):
(i) if the provision is an offence of strict liability—the
person will not be liable to be prosecuted in a court for
the alleged contravention; or
(ii) if the provision is a civil penalty provision—
proceedings seeking an order under subsection 42Y(2)
will not be brought in relation to the alleged
contravention; and
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(i) state that payment of the amount is not an admission of guilt
or liability; and
(j) state that the person may apply to the Secretary to have the
period in which to pay the amount extended; and
(k) state that the person may choose not to pay the amount and,
if the person does so:
(i) if the provision is an offence of strict liability—the
person may be prosecuted in a court for the alleged
contravention; or
(ii) if the provision is a civil penalty provision—
proceedings seeking an order under subsection 42Y(2)
may be brought in relation to the alleged contravention;
and
(l) set out how the notice can be withdrawn; and
(m) state that if the notice is withdrawn:
(i) if the provision is an offence of strict liability—the
person may be prosecuted in a court for the alleged
contravention; or
(ii) if the provision is a civil penalty provision—
proceedings seeking an order under subsection 42Y(2)
may be brought in relation to the alleged contravention;
and
(n) state that the person may make written representations to the
Secretary seeking the withdrawal of the notice.
(2) If the notice relates to only one alleged contravention of the
provision by the person, the amount to be stated in the notice for
the purposes of paragraph (1)(f) is the lesser of:
(a) one-fifth of the maximum penalty that a court could impose
on the person for that contravention; and
(b) 12 penalty units where the person is an individual, or 60
penalty units where the person is a body corporate.
(3) If the notice relates to more than one alleged contravention of the
provision by the person, the amount to be stated in the notice for
the purposes of paragraph (1)(f) is the lesser of:
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(a) one-fifth of the amount worked out by adding together the
maximum penalty that a court could impose on the person for
each alleged contravention; and
(b) either:
(i) if the person is an individual—the number of penalty
units worked out by multiplying the number of alleged
contraventions by 12; or
(ii) if the person is a body corporate—the number of
penalty units worked out by multiplying the number of
alleged contraventions by 60.
Note: Under section 42YK, a single infringement notice may only deal with
multiple contraventions if they are contraventions of a single
provision continuing over a period.
42YKB Extension of time to pay amount
(1) A person to whom an infringement notice has been given may
apply to the Secretary for an extension of the period referred to in
paragraph 42YKA(1)(h).
(2) If the application is made before the end of that period, the
Secretary may, in writing, extend that period. The Secretary may
do so before or after the end of that period.
(3) If the Secretary extends that period, a reference in this Part, or in a
notice or other instrument under this Part, to the period referred to
in paragraph 42YKA(1)(h) is taken to be a reference to that period
so extended.
(4) If the Secretary does not extend that period, a reference in this Part,
or in a notice or other instrument under this Part, to the period
referred to in paragraph 42YKA(1)(h) is taken to be a reference to
the period that ends on the later of the following days:
(a) the day that is the last day of the period referred to in
paragraph 42YKA(1)(h);
(b) the day that is 7 days after the day the person was given
notice of the Secretary’s decision not to extend.
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Part 5A-2 Infringement notices
Section 42YKC
(5) The Secretary may extend the period more than once under
subsection (2).
42YKC Withdrawal of an infringement notice
Representations seeking withdrawal of notice
(1) A person to whom an infringement notice has been given may
make written representations to the Secretary seeking the
withdrawal of the notice.
Withdrawal of notice
(2) The Secretary may withdraw an infringement notice given to a
person (whether or not the person has made written representations
seeking the withdrawal).
(3) When deciding whether or not to withdraw an infringement notice
(the relevant infringement notice), the Secretary:
(a) must take into account any written representations seeking
the withdrawal that were given by the person to the
Secretary; and
(b) may take into account the following:
(i) whether a court has previously imposed a penalty on the
person for a contravention of a provision of this Act or
the regulations that is an offence of strict liability or for
a contravention of a civil penalty provision;
(ii) the circumstances of the alleged contravention;
(iii) whether the person has paid an amount, stated in an
earlier infringement notice, for a contravention of a
provision of this Act or the regulations that is an offence
of strict liability or for a contravention of a civil penalty
provision if the contravention is constituted by conduct
that is the same, or substantially the same, as the
conduct alleged to constitute the contravention in the
relevant infringement notice;
(iv) any other matter the Secretary considers relevant.
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Section 42YKD
Notice of withdrawal
(4) Notice of the withdrawal of the infringement notice must be given
to the person. The withdrawal notice must state:
(a) the person’s name and address; and
(b) the day the infringement notice was given; and
(c) the identifying number of the infringement notice; and
(d) that the infringement notice is withdrawn; and
(e) that:
(i) if the provision is an offence of strict liability—the
person may be prosecuted in a court for the alleged
contravention; or
(ii) if the provision is a civil penalty provision—
proceedings seeking an order under subsection 42Y(2)
may be brought in relation to the alleged contravention.
Refund of amount if infringement notice withdrawn
(5) If:
(a) the Secretary withdraws the infringement notice; and
(b) the person has already paid the amount stated in the notice;
the Commonwealth must refund to the person an amount equal to
the amount paid.
42YKD Effect of payment of amount
(1) If the person to whom an infringement notice for an alleged
contravention of a provision is given pays the amount stated in the
notice before the end of the period referred to in
paragraph 42YKA(1)(h):
(a) any liability of the person for the alleged contravention is
discharged; and
(b) if the provision is an offence of strict liability—the person
may not be prosecuted in a court for the alleged
contravention; and
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(c) if the provision is a civil penalty provision—proceedings
seeking an order under subsection 42Y(2) may not be
brought in relation to the alleged contravention; and
(d) the person is not regarded as having admitted guilt or liability
for the alleged contravention; and
(e) if the provision is an offence of strict liability—the person is
not regarded as having been convicted of the alleged offence.
(2) Subsection (1) does not apply if the notice has been withdrawn.
42YKE Effect of this Part
This Part does not:
(a) require an infringement notice to be given to a person for an
alleged contravention of a provision of this Act or the
regulations that is an offence of strict liability or an alleged
contravention of a civil penalty provision; or
(b) affect the liability of a person for an alleged contravention of
a provision of this Act or the regulations that is an offence of
strict liability or an alleged contravention of a civil penalty
provision if:
(i) the person does not comply with an infringement notice
given to the person for the contravention; or
(ii) an infringement notice is not given to the person for the
contravention; or
(iii) an infringement notice is given to the person for the
contravention and is subsequently withdrawn; or
(c) prevent the giving of 2 or more infringement notices to a
person for an alleged contravention of a provision of this Act
or the regulations that is an offence of strict liability or an
alleged contravention of a civil penalty provision; or
(d) limit a court’s discretion to determine the amount of a
penalty to be imposed on a person who is found to have
contravened a provision of this Act or the regulations that is
an offence of strict liability or to have contravened a civil
penalty provision.
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Enforceable undertakings Part 5A-3
Section 42YL
Part 5A-3—Enforceable undertakings
42YL Enforcement of undertakings
(1) The Secretary may accept a written undertaking given by a person
in connection with a matter in relation to which the Secretary has a
power or function under this Act or the regulations.
(2) The person may withdraw or vary the undertaking at any time, but
only with the consent of the Secretary.
(3) The Secretary must publish details of the undertaking, as in force
from time to time, on the internet.
(4) If the Secretary considers that the person who gave the undertaking
has breached any of its terms, the Secretary may apply to the
Federal Court for an order under subsection (5).
(5) If the Court is satisfied that the person has breached a term of the
undertaking, the Court may make all or any of the following
orders:
(a) an order directing the person to comply with that term of the
undertaking;
(b) an order directing the person to pay to the Commonwealth an
amount up to the amount of any financial benefit that the
person has obtained directly or indirectly and that is
reasonably attributable to the breach;
(c) any order that the Court considers appropriate directing the
person to compensate any other person who has suffered loss
or damage as a result of the breach;
(d) any other order that the Court considers appropriate.
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Chapter 5A Enforcement
Part 5A-4 Injunctions
Section 42YM
Part 5A-4—Injunctions
42YM Simplified outline of this Part
The Secretary can seek injunctions from the Federal Court or
Federal Circuit Court to restrain a person from contravening this
Act or the regulations, or to compel compliance with this Act or
the regulations.
Interim injunctions are also available.
42YN Grant of injunctions
Restraining injunctions
(1) If a person has engaged, is engaging or is proposing to engage, in
conduct in contravention of this Act or the regulations, the Federal
Court or Federal Circuit Court may, on application by the
Secretary, grant an injunction:
(a) restraining the person from engaging in the conduct; and
(b) if, in the court’s opinion, it is desirable to do so—requiring
the person to do a thing.
Performance injunctions
(2) If:
(a) a person has refused or failed, or is refusing or failing, or is
proposing to refuse or fail, to do a thing; and
(b) the refusal or failure was, is or would be a contravention of
this Act or the regulations;
the Federal Court or Federal Circuit Court may, on application by
the Secretary, grant an injunction requiring the person to do that
thing.
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Section 42YO
42YO Interim injunctions
Grant of interim injunctions
(1) Before deciding an application for an injunction under
section 42YN, the Federal Court or Federal Circuit Court may
grant an interim injunction:
(a) restraining a person from engaging in conduct; or
(b) requiring a person to do a thing.
No undertakings as to damages
(2) The Federal Court or Federal Circuit Court must not require the
Secretary to give an undertaking as to damages as a condition of
granting an interim injunction.
42YP Discharging or varying injunctions
The Federal Court or Federal Circuit Court may discharge or vary
an injunction granted by that court under this Part.
42YQ Certain limits on granting injunctions not to apply
Restraining injunctions
(1) The power of the Federal Court or Federal Circuit Court under this
Part to grant an injunction restraining a person from engaging in
conduct may be exercised:
(a) whether or not it appears to the court that the person intends
to engage again, or to continue to engage, in conduct of that
kind; and
(b) whether or not the person has previously engaged in conduct
of that kind; and
(c) whether or not there is an imminent danger of substantial
damage to any other person if the person engages in conduct
of that kind.
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Section 42YR
Performance injunctions
(2) The power of the Federal Court or Federal Circuit Court under this
Part to grant an injunction requiring a person to do a thing may be
exercised:
(a) whether or not it appears to the court that the person intends
to refuse or fail again, or to continue to refuse or fail, to do
that thing; and
(b) whether or not the person has previously refused or failed to
do that thing; and
(c) whether or not there is an imminent danger of substantial
damage to any other person if the person refuses or fails to do
that thing.
42YR Other powers of court unaffected
The powers conferred on the Federal Court or Federal Circuit
Court under this Part are in addition to, and not instead of, any
other powers of the court, whether conferred by this Act or
otherwise.
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Administration Chapter 6
Payment of charges Part 6-1
Section 43
Chapter 6—Administration
Part 6-1—Payment of charges
43 By whom charges payable
(1) An annual registration charge, annual listing charge or annual
charge for inclusion in the Register is payable by the person in
relation to whom the therapeutic goods concerned are registered,
listed or included in the Register.
(2) An annual licensing charge is payable by the holder of the licence
to which the charge relates.
(3) An annual conformity assessment body determination charge is
payable by the Australian corporation that is the subject of the
conformity assessment body determination to which the charge
relates.
44 Time for payment of charges
Annual registration charge, annual listing charge or annual
charge for inclusion in the Register
(1) An annual registration charge, annual listing charge or annual
charge for inclusion in the Register for a financial year becomes
payable:
(a) if the registration, listing or inclusion in the Register of the
therapeutic goods concerned commenced in that financial
year—on the day worked out under the regulations; and
(b) in any other case:
(i) on 1 October in that year; or
(ii) if the regulations specify another day for the purposes of
this subparagraph—on that other day in that year.
This subsection is subject to subsection (3).
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Section 44A
Annual licensing charge
(2) An annual licensing charge for a financial year becomes payable:
(a) if the licence commenced in that financial year—on the day
of that commencement; and
(b) in any other case:
(i) on 1 October in that year; or
(ii) if the regulations specify another day for the purposes of
this subparagraph—on that other day in that year.
This subsection is subject to subsection (3).
Annual conformity assessment body determination charge
(2A) An annual conformity assessment body determination charge for a
financial year becomes payable:
(a) if the conformity assessment body determination was made
in that financial year—on the 28th day after the
determination came into force; and
(b) in any other case:
(i) on 1 October in that year; or
(ii) if the regulations specify another day for the purposes of
this subparagraph—on that other day in that year.
This subsection is subject to subsection (3).
Charge may become payable on a later day
(3) The Secretary may, by notice in writing given to a person, specify
a later day on which a charge referred to in subsection (1), (2) or
(2A) becomes payable by the person for a financial year. The
notice has effect accordingly.
Interpretation
(4) This section is subject to section 44A.
44A Exemptions from liability to pay charges
(1) The regulations may make provision for and in relation to:
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(a) exempting a person from liability to pay annual registration
charge, annual listing charge or annual charge for inclusion
in the Register for a financial year (the current year) if the
person’s turnover of the therapeutic goods concerned for the
financial year specified in the regulations is of low value; and
(b) the making of an application for an exemption and requiring
payment of that charge for the current year if the application
is refused; and
(c) cancelling an exemption and requiring payment of that
charge for the current year.
Fees
(2) The regulations may require applications for exemptions to be
accompanied by a specified fee. A fee must not be such as to
amount to taxation.
Statements prepared by approved persons
(3) The regulations may require a person who is applying for an
exemption, or who has been granted an exemption, to provide a
statement:
(a) that is prepared by an approved person; and
(b) that specifies whether the person’s turnover of the therapeutic
goods concerned for the financial year concerned is of low
value.
Additional information
(4) The regulations may provide for the obtaining of additional
information or documents from applicants for exemptions or
persons granted exemptions.
Merits review
(5) The regulations may provide for review by the Administrative
Appeals Tribunal of decisions of the Secretary to refuse
applications for exemptions or to cancel exemptions.
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Section 44B
No limit on subsection (1)
(6) Subsections (2) to (5) do not limit subsection (1).
Low value turnover
(7) For the purposes of this section, the regulations may specify when
a person’s turnover of therapeutic goods for a financial year is of
low value. The regulations may specify different rules for different
therapeutic goods.
Interpretation
(8) This section does not limit paragraph 63(3)(b) (about the refund,
reduction or waiving of fees or charges).
Definitions
(9) In this section:
approved person means a person included in a class of persons
specified in regulations made for the purposes of this definition.
turnover has the meaning prescribed by the regulations.
44B Recovery of unpaid charges
An amount of an annual registration charge, an annual listing
charge, an annual charge for inclusion in the Register, an annual
licensing charge or an annual conformity assessment body
determination charge that remains unpaid at the end of the period
of 28 days after the day on which the charge becomes payable may
be recovered by the Commonwealth as a debt due to the
Commonwealth.
Note: Section 44 sets out the day on which a charge becomes payable.
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Section 45
45 Therapeutic Goods Administration Account
(1) There is continued in existence the Therapeutic Goods
Administration Account.
Note: The Account was established by subsection 5(3) of the Financial
Management Legislation Amendment Act 1999.
(2) The Account is a special account for the purposes of the Public
Governance, Performance and Accountability Act 2013.
(3) There must be credited to the Account amounts equal to:
(a) amounts received by the Commonwealth by way of annual
registration charge, annual listing charge, annual charge for
inclusion in the Register, annual licensing charge and annual
conformity assessment body determination charge; and
(b) interest received by the Commonwealth from the investment
of an amount standing to the credit of the Account; and
(c) money received by the Commonwealth in relation to property
paid for after a debit from the Account; and
(d) money received by the Commonwealth for services provided
or to be provided, by or on behalf of the Commonwealth,
using amounts standing to the credit of the Account
(including amounts received by way of fees payable under
the regulations); and
(e) donations for the furtherance of a purpose of the Account that
are received by the Commonwealth; and
(f) receipts relating to the recovery of debts (other than debts in
respect of statutory fines and penalties) by the
Commonwealth that are associated with expenditure of an
amount standing to the credit of the Account.
Note: An Appropriation Act provides for amounts to be credited to a special
account if any of the purposes of the special account is a purpose that
is covered by an item in the Appropriation Act.
(4) The purposes of the Account are to make payments:
(a) to further the objects of this Act (as set out in section 4); and
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(b) to enable the Commonwealth to participate in the
international harmonisation of regulatory controls on
therapeutic goods and other related activities.
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Entry, searches and warrants Part 6-2
Section 45A
Part 6-2—Entry, searches and warrants
45A Definitions
In this Part, unless the contrary intention appears:
evidential material means:
(a) in respect of an offence against this Act:
(i) any thing with respect to which the offence has been
committed or is suspected, on reasonable grounds, to
have been committed; or
(ii) any thing as to which there are reasonable grounds for
suspecting that it will afford evidence as to the
commission of the offence; or
(iii) any thing as to which there are reasonable grounds for
suspecting that it is intended to be used for the purpose
of committing the offence; and
(b) in respect of a contravention of a civil penalty provision:
(i) any thing with respect to which the civil penalty
provision has been contravened or is suspected, on
reasonable grounds, of having been contravened; or
(ii) any thing as to which there are reasonable grounds for
suspecting that it will afford evidence as to the
contravention of the civil penalty provision; or
(iii) any thing as to which there are reasonable grounds for
suspecting that it is intended to be used for the purpose
of contravening the civil penalty provision.
occupier, in relation to premises, includes a person present at the
premises who is in apparent control of the premises.
seize includes secure against interference.
thing includes a substance, and a thing in electronic or magnetic
form.
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Chapter 6 Administration
Part 6-2 Entry, searches and warrants
Section 46
46 Searches to monitor compliance with Act or regulations
(1) Subject to subsections (2) and (3), an authorised person may, for
the purpose of finding out whether this Act or the regulations have
been complied with:
(a) enter any premises; and
(b) exercise the powers set out in subsection 48(1) and
section 48BA.
(2) The authorised person must not enter the premises unless:
(a) the occupier of the premises has consented to the entry; or
(b) the entry is made under a warrant issued under section 49.
(3) An authorised person is not entitled to exercise any powers under
subsection (1) in relation to premises if:
(a) the occupier of the premises has required the authorised
person to produce his or her identity card for inspection by
the occupier; and
(b) the authorised person fails to comply with the requirement.
46A Searches of certain premises to monitor compliance with Act
(1) An authorised person may, subject to subsections (2) and (3), and
to the extent that it is reasonably necessary for the purpose of
finding out whether this Act or the regulations have been complied
with, enter premises to which this section applies and do any of the
following:
(a) search the premises and any thing on the premises;
(aa) examine or observe any activity conducted on the premises;
(b) inspect, examine, take measurements of, conduct tests on or
take samples of any therapeutic goods on the premises or any
thing on the premises that relates to any therapeutic goods;
(c) make any still or moving image or any recording of the
premises or any thing on the premises;
(d) inspect any book, record or document on the premises;
(e) take extracts from or make copies of any such book, record
or document.
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Section 46A
(2) An authorised person must not, under subsection (1), enter
premises that are a residence unless:
(a) the occupier of the premises has consented to the entry; or
(b) the premises are used for commercial purposes in relation to
therapeutic goods, in addition to residential purposes.
(3) An authorised person is not entitled to exercise any powers under
subsection (1) in relation to premises if:
(a) the occupier of the premises has required the authorised
person to produce his or her identity card for inspection by
the occupier; and
(b) the authorised person fails to comply with the requirement.
(4) This section applies to:
(a) premises of a person:
(ia) who is required to comply with a condition of an
exemption of therapeutic goods under section 18A; or
(i) who has been granted an approval or authority under
subsection 19(1) or (5); or
(ii) who has been granted an approval under section 19A; or
(iiaaa) who is required to comply with a condition of an
exemption of biologicals under section 32CB; or
(iiaab) who has been granted an approval under
subsection 32CK(1) or an authority under
subsection 32CM(1); or
(iiaac) who has been granted an approval under
subsection 32CO(1), (1A) or (2); or
(iiaa) who is required to comply with a condition of an
exemption of a kind of medical device under
section 41GS; or
(iia) who has been granted an approval or authority under
subsection 41HB(1) or 41HC(1); or
(iib) who has been granted an approval under
subsection 41HD(1), (1A) or (2); or
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(iii) in relation to whom therapeutic goods are registered,
listed or included in the Register;
being premises connected with:
(iv) the importation, export, manufacture or supply of
therapeutic goods; or
(v) the keeping of documents relating to the importation,
export, manufacture or supply of therapeutic goods; or
(vi) the keeping of records in compliance with a condition
under paragraph 28(5)(c) or (ca) or 32EC(2)(c); and
(b) premises to which the person in relation to whom therapeutic
goods are registered, listed or included in the Register, or the
sponsor of the goods, must allow access as a condition of the
registration or listing of the therapeutic goods; and
(c) premises in relation to which a licence has been granted
under Part 3-3 for, or a conformity assessment certificate
issued under Part 4-4, in relation to the manufacture of
therapeutic goods, or premises at which records are kept in
relation to such manufacture; and
(d) premises of a person who has been issued with, or who has
applied for, an Australian conformity assessment body
certificate.
46B Searches and seizures on public health grounds
(1) Subject to subsection (2), if an authorised person has reasonable
grounds for suspecting that:
(a) there may be on any premises a particular thing in respect of
which this Act or the regulations have not been complied
with; and
(b) it is necessary in the interests of public health to exercise
powers under this section in order to avoid an imminent risk
of death, serious illness or serious injury;
the authorised person may, to the extent that it is reasonably
necessary for the purpose of avoiding an imminent risk of death,
serious illness or serious injury, enter the premises and do any of
the following:
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(c) search the premises for the thing;
(d) if the authorised person finds the thing on the premises—
seize it.
(2) An authorised person is not entitled to exercise any powers under
subsection (1) in relation to premises if:
(a) the occupier of the premises has required the authorised
person to produce his or her identity card for inspection by
the occupier; and
(b) the authorised person fails to comply with the requirement.
47 Searches and seizures related to offences and civil penalty
provisions
(1) Subject to subsections (2) and (3), if an authorised person has
reasonable grounds for suspecting that there may be evidential
material in respect of an offence against this Act, in respect of a
contravention of a civil penalty provision or in respect of both on
any premises, the authorised person may:
(a) enter the premises; and
(b) exercise the powers set out in subsection (4),
subsection 48(1) and section 48C; and
(c) if the authorised person finds the thing on the premises—
seize it.
(2) The authorised person must not enter the premises unless:
(a) the occupier of the premises has consented to the entry; or
(b) the entry is made under a warrant issued under section 50.
(3) An authorised person is not entitled to exercise any powers under
subsection (1) in relation to premises if:
(a) the occupier of the premises has required the authorised
person to produce his or her identity card for inspection by
the occupier; and
(b) the authorised person fails to comply with the requirement.
(4) If:
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(a) in the course of searching, in accordance with a warrant, for a
particular thing, an authorised person finds another thing that
the authorised person believes on reasonable grounds to be
evidential material in respect of an offence against this Act,
in respect of a contravention of a civil penalty provision or in
respect of both; and
(b) the authorised person believes, on reasonable grounds, that it
is necessary to seize that other thing in order to prevent its
concealment, loss or destruction, or its use:
(i) in committing, continuing or repeating an offence
against this Act; or
(ii) in committing, continuing or repeating a contravention
of a civil penalty provision;
the warrant is taken to authorise the authorised person to seize that
other thing.
48 General powers of authorised persons in relation to premises
(1) The powers an authorised person may exercise under paragraphs
46(1)(b) and 47(1)(b) are as follows:
(a) to search the premises and any thing on the premises;
(aa) to examine or observe any activity conducted on the
premises;
(b) to inspect, examine, take measurements of, conduct tests on
or take samples of any therapeutic goods on the premises or
any thing on the premises that relates to any therapeutic
goods;
(c) to make any still or moving image or any recording of the
premises or any thing on the premises;
(d) if the authorised person was only authorised to enter the
premises because the occupier of the premises consented to
the entry—to require the occupier to:
(i) answer any questions put by the authorised person; and
(ii) produce any book, record or document requested by the
authorised person;
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(e) if the authorised person was authorised to enter the premises
by a warrant under section 49 or 50—to require any person in
or on the premises to:
(i) answer any questions put by the authorised person; and
(ii) produce any book, record or document requested by the
authorised person;
(f) to inspect any book, record or document on the premises;
(g) to take extracts from or make copies of any such book, record
or document;
(h) to take onto the premises such equipment and materials as the
authorised person requires for the purpose of exercising
powers in relation to the premises.
(3) A person must not refuse or fail to comply with a requirement
under paragraph (1)(e).
Penalty: 30 penalty units.
(3A) Subsection (3) does not apply if the person has a reasonable
excuse.
Note: The defendant bears an evidential burden in relation to the matter in
subsection (3A). See subsection 13.3(3) of the Criminal Code.
(4) It is a reasonable excuse for a person to refuse or fail to answer a
question or produce a document if answering the question, or
producing the document, would tend to incriminate the person.
48A Details of warrant to be given to occupier etc.
(1) If a warrant in relation to premises is being executed and the
occupier of the premises or another person who apparently
represents the occupier is present at the premises, the authorised
person must make available to that person a copy of the warrant.
(2) The authorised person must identify himself or herself to that
person.
(3) The copy of the warrant referred to in subsection (1) need not
include the signature of the magistrate who issued the warrant.
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48AA Completing execution of warrant under section 50 after
temporary cessation
(1) This section applies if an authorised person who is executing a
warrant under section 50 in relation to premises temporarily ceases
its execution and leaves the premises.
(2) The authorised person may complete the execution of the warrant
if:
(a) the warrant is still in force; and
(b) the authorised person is absent from the premises:
(i) for not more than 1 hour; or
(ii) if there is an emergency situation, for not more than 12
hours or such longer period as allowed by a magistrate
under subsection (5); or
(iii) for a longer period if the occupier of the premises
consents in writing.
Application for extension in emergency situation
(3) An authorised person may apply to a magistrate for an extension of
the 12-hour period mentioned in subparagraph (2)(b)(ii) if:
(a) there is an emergency situation; and
(b) the authorised person believes on reasonable grounds that the
authorised person will not be able to return to the premises
within that period.
(4) If it is practicable to do so, before making the application, the
authorised person must give notice to the occupier of the premises
of his or her intention to apply for an extension.
Extension in emergency situation
(5) A magistrate may extend the period during which the authorised
person may be away from the premises if:
(a) an application is made under subsection (3); and
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(b) the magistrate is satisfied, by information on oath or
affirmation, that there are exceptional circumstances that
justify the extension; and
(c) the extension would not result in the period ending after the
warrant ceases to be in force.
48B Announcement before entry
(1) An authorised person must, before entering the premises under a
warrant:
(a) announce that he or she is authorised to enter the premises;
and
(b) give any person at the premises an opportunity to allow entry
to the premises.
(2) An authorised person is not required to comply with subsection (1)
if he or she believes on reasonable grounds that immediate entry to
the premises is required to ensure:
(a) the safety of a person; or
(b) that the effective execution of the warrant is not frustrated.
48BA Use of electronic equipment at premises for monitoring
compliance with Act or regulations
(1) An authorised person may operate electronic equipment at the
premises to see whether information relevant to determining
whether this Act or the regulations have been complied with is
accessible by doing so.
(2) If the authorised person, after operating the equipment, finds that
information relevant to determining whether this Act or the
regulations have been complied with is accessible by doing so, he
or she may:
(a) operate electronic equipment on the premises to put the
information in documentary form and remove the documents
so produced from the premises; or
(b) operate electronic equipment on the premises to transfer the
information to a disk, tape or other storage device that:
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(i) is brought to the premises for the exercise of the power;
or
(ii) is on the premises and the use of which for that purpose
has been agreed in writing by the occupier of the
premises;
and remove the disk, tape or other storage device from the
premises.
(3) An authorised person may operate electronic equipment as
mentioned in subsection (1) or (2) only if the authorised person
believes on reasonable grounds that the operation of the equipment
can be carried out without damage to the equipment.
Note: For compensation for damage to electronic equipment, see
section 48D.
(4) If the authorised person believes on reasonable grounds that:
(a) information relevant to determining whether this Act or the
regulations have been complied with may be accessible by
operating electronic equipment at the premises; and
(b) expert assistance is required to operate the equipment; and
(c) if he or she does not take action under this subsection, the
information may be destroyed, altered or otherwise interfered
with;
he or she may do whatever is necessary to secure the equipment,
whether by locking it up, placing a guard or otherwise.
(5) The authorised person must give notice to the occupier of the
premises of his or her intention to secure equipment and of the fact
that the equipment may be secured for up to 24 hours.
(6) The equipment may be secured:
(a) for a period not exceeding 24 hours; or
(b) until the equipment has been operated by the expert;
whichever happens first.
(7) The authorised person may apply to a magistrate for an extension
of the 24-hour period if the authorised person believes on
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reasonable grounds that the equipment needs to be secured for
longer than that period.
(8) The authorised person must give notice to the occupier of the
premises of his or her intention to apply for an extension, and the
occupier is entitled to be heard in relation to the application.
(9) The 24-hour period may be extended more than once.
48C Use of electronic equipment at premises relating to offences and
civil penalty provisions
(1) An authorised person may operate electronic equipment at the
premises to see whether evidential material in respect of an offence
against this Act, in respect of a contravention of a civil penalty
provision or in respect of both is accessible by doing so.
(2) If the authorised person, after operating the equipment, finds that
evidential material in respect of an offence against this Act, in
respect of a contravention of a civil penalty provision or in respect
of both is accessible by doing so, he or she may:
(a) seize the equipment and any disk, tape or other associated
device; or
(b) operate electronic equipment on the premises to put the
evidential material in documentary form and remove the
documents so produced from the premises; or
(c) operate electronic equipment on the premises to transfer the
evidential material to a disk, tape or other storage device that:
(i) is brought to the premises for the exercise of the power;
or
(ii) is on the premises and the use of which for that purpose
has been agreed in writing by the occupier of the
premises;
and remove the disk, tape or other storage device from the
premises.
(2A) An authorised person may operate electronic equipment as
mentioned in subsection (1) or (2) only if the authorised person
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believes on reasonable grounds that the operation of the equipment
can be carried out without damage to the equipment.
Note: For compensation for damage to electronic equipment, see
section 48D.
(3) An authorised person may seize equipment under paragraph (2)(a)
only if:
(a) it is not practicable to put the material in documentary form
as mentioned in paragraph (2)(b) or to transfer the material as
mentioned in paragraph (2)(c); or
(b) possession by the occupier of the equipment could constitute
an offence.
(4) If the authorised person believes on reasonable grounds that:
(a) evidential material in respect of an offence against this Act,
in respect of a contravention of a civil penalty provision or in
respect of both may be accessible by operating electronic
equipment at the premises; and
(b) expert assistance is required to operate the equipment; and
(c) if he or she does not take action under this subsection, the
material may be destroyed, altered or otherwise interfered
with;
he or she may do whatever is necessary to secure the equipment,
whether by locking it up, placing a guard or otherwise.
(5) The authorised person must give notice to the occupier of the
premises of his or her intention to secure equipment and of the fact
that the equipment may be secured for up to 24 hours.
(6) The equipment may be secured:
(a) for a period not exceeding 24 hours; or
(b) until the equipment has been operated by the expert;
whichever happens first.
(7) The authorised person may apply to a magistrate for an extension
of the 24-hour period if the authorised person believes on
reasonable grounds that the equipment needs to be secured for
longer than that period.
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(8) The authorised person must give notice to the occupier of the
premises of his or her intention to apply for an extension, and the
occupier is entitled to be heard in relation to the application.
(9) The 24-hour period may be extended more than once.
48D Compensation for damage to electronic equipment
(1) If:
(a) damage is caused to equipment as a result of it being
operated as mentioned in section 48BA or 48C; and
(b) the damage was caused as a result of:
(i) insufficient care being exercised in selecting the person
who was to operate the equipment; or
(ii) insufficient care being exercised by the person operating
the equipment;
compensation for the damage is payable to the owner of the
equipment.
(2) Compensation is payable out of money appropriated by the
Parliament for the purpose.
(3) In determining the amount of compensation payable, regard is to
be had to whether the occupier of the premises and his or her
employees and agents, if they were available at the time, had
provided any warning or guidance as to the operation of the
equipment that was appropriate in the circumstances.
48E Copies of seized things to be provided
(1) Subject to subsection (2), if an authorised person seizes, under a
warrant relating to premises:
(a) a document, film, computer file or other thing that can be
readily copied; or
(b) a storage device the information in which can be readily
copied;
the authorised person must, if requested to do so by the occupier of
the premises or another person who apparently represents the
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occupier and who is present when the warrant is executed, give a
copy of the thing or the information to that person as soon as
practicable after the seizure.
(2) Subsection (1) does not apply if possession of the document, film,
computer file, thing or information by the occupier could constitute
an offence against a law of the Commonwealth or contravention of
a civil penalty provision.
48F Occupier entitled to be present during search
(1) If a warrant in relation to premises is being executed and the
occupier of the premises or another person who apparently
represents the occupier is present at the premises, the person is
entitled to observe the search being conducted.
(2) The right to observe the search being conducted ceases if the
person impedes the search.
(3) This section does not prevent 2 or more areas of the premises being
searched at the same time.
48FA Responsibility to provide facilities and assistance
(1) The occupier of premises to which a warrant relates, or another
person who apparently represents the occupier, must provide an
authorised person executing the warrant with all reasonable
facilities and assistance for the effective exercise of the authorised
person’s powers.
(2) A person commits an offence if:
(a) the person is subject to subsection (1); and
(b) the person fails to comply with that subsection.
Penalty for contravention of this subsection:30 penalty units.
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48G Receipts for things seized under warrant
(1) If a thing is seized under this Part, the authorised person must
provide a receipt for the thing.
(2) If 2 or more things are seized or moved, they may be covered in
the one receipt.
48H Retention of seized things
(1) Subject to any contrary order of a court, if an authorised person
seizes a thing under this Part, an authorised person must return it if:
(a) the reason for its seizure no longer exists or it is decided that
it is not to be used in evidence; or
(b) the period of 90 days after its seizure ends;
whichever first occurs, unless the thing is forfeited or forfeitable to
the Commonwealth.
(2) At the end of the 90 days specified in subsection (1), an authorised
person must take reasonable steps to return the thing to the person
from whom it was seized, unless:
(a) proceedings in respect of which the thing may afford
evidence were instituted before the end of the 90 days and
have not been completed (including an appeal to a court in
relation to those proceedings); or
(b) an authorised person may retain the thing because of an order
under section 48J; or
(c) an authorised person is otherwise authorised (by a law, or an
order of a court, of the Commonwealth or of a State or
Territory) to retain, destroy or dispose of the thing.
(3) The thing may be returned under subsection (2) either
unconditionally or on such terms and conditions as the Secretary
sees fit.
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48J Magistrate may permit a thing to be retained
(1) An authorised person may apply to a magistrate for an order that he
or she may retain the thing for a further period if:
(a) before the end of 90 days after the seizure; or
(b) before the end of a period previously specified in an order of
a magistrate under this section;
proceedings in respect of which the thing may afford evidence
have not commenced.
(2) If the magistrate is satisfied that it is necessary for an authorised
person to continue to retain the thing:
(a) for the purposes of an investigation as to whether an offence
against this Act has been committed; or
(b) to enable evidence of an offence against this Act to be
secured for the purposes of a prosecution; or
(c) for the purposes of an investigation as to whether a civil
penalty provision has been contravened; or
(d) to enable evidence of a contravention of a civil penalty
provision to be secured for the purposes of civil proceedings;
the magistrate may order that an authorised person may retain the
thing for a period (not being a period exceeding 3 years) specified
in the order.
(3) Before making the application, the authorised person must:
(a) take reasonable steps to discover who has an interest in the
retention of the thing; and
(b) if it is practicable to do so, notify each person whom the
authorised person believes to have such an interest of the
proposed application.
49 Monitoring warrants
(1) An authorised person may apply to a magistrate for a warrant
under this section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant if
the magistrate is satisfied, by information on oath, that it is
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reasonably necessary that one or more authorised persons should
have access to the premises for the purposes of finding out whether
this Act or the regulations have been complied with.
(3) The magistrate must not issue the warrant unless the authorised
person or some other person has given to the magistrate, either
orally or by affidavit, such further information (if any) as the
magistrate requires concerning the grounds on which the issue of
the warrant is being sought.
(4) The warrant must:
(a) authorise one or more authorised persons (whether or not
named in the warrant), with such assistance and by such
force as is necessary and reasonable:
(i) to enter the premises; and
(ii) to exercise the powers set out in subsection 48(1) and
section 48BA in relation to the premises; and
(b) state whether the entry is authorised to be made at any time
of the day or night or during specified hours of the day or
night; and
(c) specify the day (not more than 6 months after the issue of the
warrant) on which the warrant ceases to have effect; and
(d) state the purpose for which the warrant is issued.
50 Offence and civil penalty provision related warrants
(1) An authorised person may apply to a magistrate for a warrant
under this section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant if
the magistrate is satisfied, by information on oath, that there are
reasonable grounds for suspecting that there is, or there may be
within the next 72 hours, in or on the premises evidential material
in respect of an offence against this Act, in respect of a
contravention of a civil penalty provision or in respect of both.
(3) The magistrate must not issue the warrant unless the authorised
person or some other person has given to the magistrate, either
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orally or by affidavit, such further information (if any) as the
magistrate requires concerning the grounds on which the issue of
the warrant is being sought.
(4) The warrant must:
(a) name one or more authorised persons; and
(b) authorise the persons so named, with such assistance and by
such force as is necessary and reasonable:
(i) to enter the premises; and
(ii) to exercise the powers set out in subsections 47(4) and
48(1) and section 48C; and
(iii) to seize the evidential material; and
(c) state whether the entry is authorised to be made at any time
of the day or night or during specified hours of the day or
night; and
(d) specify the day (not more than one week after the issue of the
warrant) on which the warrant ceases to have effect; and
(e) state the purpose for which the warrant is issued.
51 Offence and civil penalty provision related warrants by telephone
(1) If, in an urgent case, an authorised person considers it necessary to
do so, the person may apply to a magistrate by telephone for a
warrant under section 50 in relation to premises.
(2) Before applying for the warrant, the person must prepare an
information of the kind mentioned in subsection 50(2) in relation to
the premises that sets out the grounds on which the warrant is
sought.
(3) If it is necessary to do so, the person may apply for the warrant
before the information is sworn.
(4) If the magistrate is satisfied:
(a) after having considered the terms of the information; and
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(b) after having received such further information (if any) as the
magistrate requires concerning the grounds on which the
issue of the warrant is being sought;
that there are reasonable grounds for issuing the warrant, the
magistrate may complete and sign the same warrant that the
magistrate would issue under section 50 if the application had been
made under that section.
(5) If the magistrate completes and signs the warrant:
(a) the magistrate must:
(i) tell the authorised person what the terms of the warrant
are; and
(ii) tell the authorised person the day on which and the time
at which the warrant was signed; and
(iii) tell the authorised person the day (not more than one
week after the magistrate completes and signs the
warrant) on which the warrant ceases to have effect; and
(iv) record on the warrant the reasons for granting the
warrant; and
(b) the authorised person must:
(i) complete a form of warrant in the same terms as the
warrant completed and signed by the magistrate; and
(ii) write on the form the name of the magistrate and the
day on which and the time at which the warrant was
signed.
(6) The authorised person must also, not later than the day after the
day of expiry or execution of the warrant, whichever is the earlier,
send to the magistrate:
(a) the form of warrant completed by the person; and
(b) the information referred to in subsection (2), which must
have been duly sworn.
(7) When the magistrate receives those documents, the magistrate
must:
(a) attach them to the warrant that the magistrate completed and
signed; and
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(b) deal with them in the way in which the magistrate would
have dealt with the information if the application had been
made under section 50.
(8) A form of warrant duly completed under subsection (5) is authority
for any entry, search, seizure or other exercise of a power that the
warrant signed by the magistrate authorises.
(9) If:
(a) it is material, in any proceedings, for a court to be satisfied
that an exercise of a power was authorised by this section;
and
(b) the warrant signed by the magistrate authorising the exercise
of the power is not produced in evidence;
the court must assume, unless the contrary is proved, that the
exercise of the power was not authorised by such a warrant.
(10) A reference in this Part to a warrant under section 50 includes a
reference to a warrant signed by a magistrate under this section.
51A Inspections for purposes of Mutual Recognition Convention
(1) A person may request the Secretary to arrange for an authorised
person to inspect premises, and specified processes being carried
out on those premises, for the purposes of paragraph 2 of Article 3
of the Mutual Recognition Convention.
(2) An authorised person may make an inspection in accordance with
arrangements under subsection (1).
51B Offences relating to warrants
(1) A person must not make, in an application for a warrant, a
statement that the person knows to be false or misleading in a
material particular.
Penalty: Imprisonment for 2 years.
(2) A person must not:
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(a) state in a document that purports to be a form of warrant
under section 51 the name of a magistrate unless that
magistrate issued the warrant; or
(b) state on a form of warrant under that section a matter that, to
the person’s knowledge, departs in a material particular from
the form authorised by the magistrate; or
(c) purport to execute, or present to another person, a document
that purports to be a form of warrant under that section that
the first-mentioned person knows:
(i) has not been approved by a magistrate under that
section; or
(ii) to depart in a material particular from the terms
authorised by a magistrate under that section; or
(d) give to a magistrate a form of warrant under that section that
is not the form of warrant that the person purported to
execute.
Penalty: Imprisonment for 2 years.
52 Identity cards
(1) The Secretary is to ensure that each authorised person is issued
with an identity card that incorporates a recent photograph of the
person.
(3) Where a person ceases to be an authorised person, the person must,
as soon as practicable after so ceasing, return the person’s identity
card to the Secretary.
Penalty: 1 penalty unit.
(4) An offence under subsection (3) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
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Section 52AA
Part 6-3—Scheduling of substances
52AA Overview
This Part provides the basis for a uniform system in Australia of
access controls for goods containing scheduled substances.
The scheduling of substances allows restrictions to be placed on
their supply to the public, in the interests of public health and
safety. This is aimed at minimising the risks of poisoning from,
and the misuse and abuse of, scheduled substances.
52A Definitions
(1) In this Part, unless the contrary intention appears:
current Poisons Standard means:
(a) if no document has been prepared under
paragraph 52D(2)(b)—the first Poisons Standard; or
(b) otherwise—the document last prepared under that
paragraph (including as amended).
first Poisons Standard means the latest edition at the
commencement of this Part of the document known as the
Standard for the Uniform Scheduling of Drugs and Poisons
published by the Australian Health Ministers’ Advisory Council.
scheduling, in relation to a substance, means determining the
schedule or schedules to the current Poisons Standard in which the
name or a description of the substance is to be included.
substance means:
(a) an ingredient, compound, material or preparation which, or
the use of which, may cause death, illness or injury to
persons or animals; or
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(b) an ingredient, compound, material or preparation specified
under subsection (2);
and includes any ingredient, compound, material or preparation
referred to in a schedule to the current Poisons Standard (as in
force immediately before 1 July 2010).
(2) The Secretary may, by legislative instrument, specify an
ingredient, compound, material or preparation for the purposes of
paragraph (b) of the definition of substance in subsection (1).
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
52B Advisory Committee on Medicines Scheduling
(1) The Advisory Committee on Medicines Scheduling is established
by this section.
(2) Subject to subsection (3), the Committee is to be constituted, and
to hold meetings, in accordance with the regulations.
(3) The Commonwealth, each State, the Australian Capital Territory
and the Northern Territory are each entitled to nominate a member
of the Committee in accordance with the regulations.
(4) The functions of the Committee are as follows:
(a) subject to subsection (5), to make recommendations to the
Secretary in relation to the classification and scheduling of
substances that are, or are included in, therapeutic goods;
(b) to make recommendations to the Secretary in relation to
other changes to the current Poisons Standard (other than the
schedules);
(c) to reconsider a recommendation made under paragraph (a) or
(b) at the request of the Secretary;
(d) subject to subsection (5), to provide advice to the Secretary
in relation to the restrictions (including restrictions as to
accessibility and availability) to be imposed in respect of
particular substances that are, or are included in, therapeutic
goods;
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(e) to provide advice to the Secretary in relation to any matter
referred to it by the Secretary;
(f) any other functions that are prescribed by the regulations.
(5) Paragraphs (4)(a) and (d) do not apply in relation to substances to
the extent that the substances are included in goods other than
therapeutic goods.
52C Advisory Committee on Chemicals Scheduling
(1) The Advisory Committee on Chemicals Scheduling is established
by this section.
(2) Subject to subsection (3), the Committee is to be constituted, and
to hold meetings, in accordance with the regulations.
(3) The Commonwealth, each State, the Australian Capital Territory
and the Northern Territory are each entitled to nominate a member
of the Committee in accordance with the regulations.
(4) The functions of the Committee are as follows:
(a) subject to subsection (5), to make recommendations to the
Secretary in relation to the classification and scheduling of
substances;
(b) to make recommendations to the Secretary in relation to
other changes to the current Poisons Standard (other than the
schedules);
(c) to reconsider a recommendation made under paragraph (a) or
(b) at the request of the Secretary;
(d) subject to subsection (5), to provide advice to the Secretary
in relation to the restrictions (including restrictions as to
accessibility and availability) to be imposed in respect of
particular substances;
(e) to provide advice to the Secretary in relation to any matter
referred to it by the Secretary;
(f) any other functions that are prescribed by the regulations.
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(5) Paragraphs (4)(a) and (d) do not apply in relation to substances to
the extent that the substances are, or are included in, therapeutic
goods.
52CA Joint meetings
The Advisory Committee on Medicines Scheduling and the
Advisory Committee on Chemicals Scheduling may hold joint
meetings in accordance with the regulations.
52D Poisons Standard
(1) On the commencement of this Part, the first Poisons Standard is
taken to have been prepared and made available by the then
National Drugs and Poisons Schedule Committee.
(2) Subject to this Act and the regulations, the Secretary may:
(a) amend the current Poisons Standard; or
(b) prepare a document (including schedules containing the
names or descriptions of substances or classes of substances),
in substitution for the current Poisons Standard.
(3) The Secretary may exercise a power under subsection (2) on the
Secretary’s own initiative or following an application under
section 52EAA.
(4A) An instrument made under paragraph (2)(a) or (b) after the
commencement of this subsection is a legislative instrument, but
section 42 (disallowance) of the Legislation Act 2003 does not
apply to the instrument.
(4B) Despite subsection 14(2) of the Legislation Act 2003, an instrument
made under paragraph (2)(a) or (b) of this section may make
provision in relation to a matter by applying, adopting or
incorporating any matter contained in an instrument or other
writing as in force or existing from time to time.
(5) In this section:
amend, in relation to the current Poisons Standard, means:
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(a) alter any provision (including a reference to a substance) in
the current Poisons Standard; or
(b) omit any provision (including a reference to a substance)
from the current Poisons Standard; or
(c) insert any provision (including a reference to a substance) in
the current Poisons Standard.
52E Secretary to take certain matters into account in exercising
powers
(1) In exercising a power under subsection 52D(2), the Secretary must
take the following matters into account (where relevant):
(a) the risks and benefits of the use of a substance;
(b) the purposes for which a substance is to be used and the
extent of use of a substance;
(c) the toxicity of a substance;
(d) the dosage, formulation, labelling, packaging and
presentation of a substance;
(e) the potential for abuse of a substance;
(f) any other matters that the Secretary considers necessary to
protect public health.
(2) In exercising a power under subsection 52D(2), the Secretary must
comply with any guidelines of:
(a) the Australian Health Ministers’ Advisory Council; and
(b) the subcommittee of the Council known as the National
Coordinating Committee on Therapeutic Goods (or any
replacement subcommittee);
notified to the Secretary for the purposes of this section.
(3) In exercising a power under subsection 52D(2), the Secretary must
have regard to any recommendations or advice of the Advisory
Committee on Medicines Scheduling or the Advisory Committee
on Chemicals Scheduling.
(4) In exercising a power under subsection 52D(2), the Secretary may
seek advice from either or both of the following:
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(a) any committee that the Secretary considers appropriate
(whether or not the committee is established under this Act or
the regulations);
(b) any person.
(5) Subsections (2) to (4) do not limit the information the Secretary
may consider in exercising a power under subsection 52D(2).
52EAA Application for amendment of the Poisons Standard
(1) A person may apply to the Secretary for an amendment of the
current Poisons Standard.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved by the
Secretary; and
(b) set out the amendment sought; and
(c) be delivered to an office of the Department specified in the
form; and
(d) be accompanied by the prescribed application fee.
Further information
(3) The Secretary may, by notice in writing given to the person,
require the person to give to the Secretary, within such reasonable
time as is specified in the notice, such further information
concerning the application as is specified in the notice.
Applications or information may be given electronically
(4) An approval of a form mentioned in paragraph (2)(a), or a notice
mentioned in subsection (3), may require or permit an application
or information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
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52EB Compensation for acquisition of property
(1) If the operation of section 52EA would result in an acquisition of
property from a person otherwise than on just terms, the
Commonwealth is liable to pay a reasonable amount of
compensation to the person.
(2) If the Commonwealth and the person do not agree on the amount
of the compensation, the person may institute proceedings in the
Federal Court for the recovery from the Commonwealth of such
reasonable amount of compensation as the court determines.
(3) In this section:
acquisition of property has the same meaning as in
paragraph 51(xxxi) of the Constitution.
just terms has the same meaning as in paragraph 51(xxxi) of the
Constitution.
52EC Review of scheduling regime
(1) The Minister must cause an independent review of the operation of
this Part to be conducted, with particular reference to the
amendments to this Part made by the Therapeutic Goods
Amendment (2009 Measures No. 2) Act 2009 (the amendments).
(2) The review must:
(a) start not later than 1 July 2013; and
(b) be completed within 6 months.
(3) The review must report on:
(a) the system of access controls for goods containing scheduled
substances established by this Part;
(b) the outcomes of the administration of scheduled substances
by the Secretary and by the committees established by this
Part;
(c) the effect of the amendments on the therapeutic goods
industry and on individual parties within the industry;
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(d) whether there are adequate avenues for review of decisions
made by the Secretary and by the committees established by
this Part;
and may make recommendations for further changes to the
scheduling regime.
(4) The review must be conducted by a panel which must comprise not
less than three, and not more than five, persons with relevant
expertise.
(5) As part of the review, the panel must invite and consider public
submissions.
(6) The panel must give the Minister a written report of the review.
(7) The Minister must cause a copy of the report to be laid before each
House of the Parliament within 15 sitting days of that House after
the day on which the Minister receives the report.
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Section 53
Chapter 7—Miscellaneous
53 Retention of material on withdrawal of application
Where a person withdraws an application for:
(a) registration; or
(b) listing; or
(ba) inclusion of a biological in the Register; or
(c) a conformity assessment certificate; or
(d) inclusion of a kind of medical device in the Register; or
(e) a licence;
the Department may retain the application and any material
submitted in connection with the application.
53A Alternative verdicts for various offences
If a jury acquits a person of an offence against a provision listed in
column 2 of an item in the following table, but is satisfied beyond
reasonable doubt of facts that prove that the person is guilty of the
offence listed in column 3 of that item, the jury may convict the
person of the offence listed in column 3 of that item:
Alternative verdicts for various offences
Column 1 Column 2 Column 3
Item If a prosecution is for the jury may instead
an offence against... convict the person of an
offence against...
1A subsection 9G(1) subsection 9G(4)
1 subsection 14(1) subsection 14(4)
2 subsection 14(6) subsection 14(9)
3 subsection 14(10) subsection 14(13)
4 subsection 15(2) subsection 15(5)
5 subsection 19B(1) subsection 19B(4)
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Alternative verdicts for various offences
Column 1 Column 2 Column 3
Item If a prosecution is for the jury may instead
an offence against... convict the person of an
offence against...
6 subsection 21A(1) subsection 21A(4)
7 subsection 21A(5) subsection 21A(8)
8 subsection 21A(9) subsection 21A(9A)
8A subsection 21A(11A) subsection 21A(11C)
9 subsection 21A(12) subsection 21A(12A)
9A subsection 22(2) subsection 22(3)
10 subsection 22A(1) subsection 22A(4)
11 subsection 30EC(1) subsection 30EC(4)
12 subsection 30F(4B) subsection 30F(5)
13 subsection 31(5A) subsection 31(6)
13A subsection 32BA(1) subsection 32BA(4)
13B subsection 32BB(1) subsection 32BB(4)
13C subsection 32BC(1) subsection 32BC(4)
13D subsection 32BD(1) subsection 32BD(4)
13E subsection 32BI(1) subsection 32BI(4)
13EA subsection 32BJ(2A) subsection 32BJ(2B)
13EB subsection 32CJ(6) subsection 32CJ(7)
13F subsection 32CN(1) subsection 32CN(4)
13FA subsection 32CN(5) subsection 32CN(7)
13G subsection 32DO(1) subsection 32DO(4)
13H subsection 32EF(1) subsection 32EF(4)
13J subsection 32HC(1) subsection 32HC(4)
13K subsection 32JB(2) subsection 32JB(5)
14 subsection 35(1) subsection 35(4)
15 subsection 35(5) subsection 35(9)
16 subsection 35B(1) subsection 35B(4)
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Alternative verdicts for various offences
Column 1 Column 2 Column 3
Item If a prosecution is for the jury may instead
an offence against... convict the person of an
offence against...
17 subsection 41EI(1) subsection 41EI(4)
18 subsection 41FE(1) subsection 41FE(4)
19 subsection 41JB(4) subsection 41JB(7)
20 subsection 41KC(1) subsection 41KC(4)
21 subsection 41MA(1) subsection 41MA(4)
22 subsection 41MA(5) subsection 41MA(8)
23 subsection 41MA(9) subsection 41MA(12)
24 subsection 41MC(2) subsection 41MC(5)
25 subsection 41ME(1) subsection 41ME(4)
26 subsection 41ME(5) subsection 41ME(8)
27 subsection 41MF(1) subsection 41MF(2)
28 subsection 41MF(3) subsection 41MF(4)
29 subsection 41MI(1) subsection 41MI(4)
29A subsection 41ML(1) subsection 41ML(2)
30 subsection 41MN(1) subsection 41MN(4)
31 subsection 41MN(5) subsection 41MN(8)
31A subsection 41MN(10) subsection 41MN(11)
32 subsection 41MO(1) subsection 41MO(4)
32A subsection 41MO(4A) subsection 41MO(4C)
33 subsection 41MO(5) subsection 41MO(8)
33A subsection 42DL(1) subsection 42DL(2)
33B subsection 42DLA(1) subsection 42DLA(2)
33C subsection 42DM(1) subsection 42DM(2)
33D subsection 42DW(1) subsection 42DW(2)
34 subsection 42V(6) subsection 42V(6C)
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54 Offences and forfeiture
(3) If a court:
(a) convicts a person of an offence against this Act; or
(aa) makes an order under section 19B of the Crimes Act 1914 in
respect of a person charged with an offence against this Act;
or
(b) orders a person to pay a pecuniary penalty for the
contravention of a civil penalty provision;
in relation to any therapeutic goods, the court may order that the
goods be forfeited to the Commonwealth and, if an order is made,
the goods become the property of the Commonwealth.
(4) Where goods are so forfeited, the Secretary may cause notice of the
forfeiture to be published in the Gazette or on the Department’s
website.
(5) Goods forfeited under an order referred to in subsection (3) are to
be disposed of in such manner as the Secretary directs.
54AA Offences for contravening conditions or requirements
imposed under the regulations
(1) If:
(a) a person holds a licence or a permission to import or export
therapeutic goods; and
(b) the person engages in conduct; and
(c) the conduct breaches a condition or a requirement to which
the licence or permission is subject under the regulations;
the person commits an offence punishable on conviction by a fine
of no more than the number of penalty units specified in whichever
of subsection (2) or (3) applies.
(1A) In subsection (1):
engage in conduct means:
(a) do an act; or
(b) omit to perform an act.
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(2) If:
(a) the condition or requirement relates to the possession,
custody, transport, use or disposal of the goods; or
(b) the regulation providing for the condition or requirement
states that the purpose of the condition or requirement is to
protect the safety of the public;
the number of penalty units for the contravention is 240 penalty
units.
(3) If subsection (2) does not apply, the number of penalty units for the
contravention is 50 penalty units.
54AB Criminal offence for damaging etc. documents
(1) A person commits an offence if:
(a) the person damages, destroys, alters, conceals or falsifies a
document; and
(b) the document is created, retained or issued for the purposes
of this Act, or for purposes that include the purposes of this
Act.
Penalty: 7 years imprisonment or 2,000 penalty units, or both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) Strict liability applies to paragraph (1)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
54AC Civil penalty for damaging etc. documents
A person contravenes this section if:
(a) the person damages, destroys, alters, conceals or falsifies a
document; and
(b) the document is created, retained or issued for the purposes
of this Act, or for purposes that include the purposes of this
Act; and
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(c) the damage, destruction, alteration, concealment or
falsification is likely to interfere with the proper
administration of this Act or the regulations.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
54A Time for bringing prosecutions
A prosecution for an offence against this Act may be commenced
at any time within 3 years after the commission of the offence.
54B Personal liability of an executive officer of a body corporate—
general
(1) An executive officer of a body corporate commits an offence if:
(a) the body corporate commits an offence against this Act
covered by section 54BA; and
(b) the officer knew that the offence would be committed; and
(c) the officer was in a position to influence the conduct of the
body in relation to the commission of the offence; and
(d) the officer failed to take all reasonable steps to prevent the
commission of the offence.
Note: An offence against this Act includes an offence against the
regulations: see subsection 3(7).
(2) The maximum penalty for an offence against subsection (1) is:
(a) the maximum penalty that a court could impose in respect of
an individual for the offence committed by the body
corporate; or
(b) if the offence committed by the body corporate is an offence
against subsection 41MN(10)—imprisonment for 5 years or
4,000 penalty units, or both.
(3) An executive officer of a body corporate contravenes this
subsection if:
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(a) the body corporate contravenes a civil penalty provision; and
(b) the officer knew that the contravention would occur; and
(c) the officer was in a position to influence the conduct of the
body in relation to the contravention; and
(d) the officer failed to take all reasonable steps to prevent the
contravention.
(4) The maximum civil penalty for a contravention of subsection (3)
is:
(a) the maximum civil penalty that a court could impose in
respect of an individual for the civil penalty provision
contravened by the body corporate; or
(b) if the civil penalty provision contravened by the body
corporate is subsection 41MNA(3)—5,000 penalty units.
(5) In this section:
executive officer of a body corporate means a person, by whatever
name called and whether or not a director of the body, who is
concerned in, or takes part in, the management of the body.
54BA Personal liability of an executive officer of a body corporate—
offences covered
For the purposes of paragraph 54B(1)(a), this section covers
offences against:
(a) the provisions of this Act listed in the following table; and
(b) a provision of a regulation prescribed for the purpose of this
paragraph; and
(c) section 6 of the Crimes Act 1914, or section 11.1, 11.4 or
11.5 of the Criminal Code, in relation to an offence
mentioned in paragraph (a) or (b) of this subsection; and
(d) section 136.1, 137.1 or 137.2 of the Criminal Code in
relation to this Act or a regulation.
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Section 54BA
Corporate offences for which executive officers may be personally liable
Item Provisions of this Act
Subsection 9G(1)
Subsection 14(1), (6) or (10)
Subsection 15(2)
Subsection 19B(1)
4A Subsection 21A(1) or (5)
Subsection 22(2) or (7AB)
Subsection 22A(1)
Subsection 29A(1)
Subsection 29B(3) or (4)
Subsection 30EC(1)
Subsection 30F(4B)
Subsection 31(5A)
Subsection 31D(1)
Subsection 31E(1)
Subsection 32BA(1)
Subsection 32BB(1)
Subsection 32BC(1)
Subsection 32BD(1)
17A Subsection 32BJ(2A)
Subsection 32CH(1)
Subsection 32CJ(6)
Subsection 32DO(1)
Subsection 32DQ(1)
Subsection 32DR(3) or (4)
Subsection 32EF(1)
Subsection 32HC(1)
Subsection 32JB(2)
Subsection 32JI(2)
Subsection 35(1) or (5)
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Section 54BA
Corporate offences for which executive officers may be personally liable
Item Provisions of this Act
27AA Subsection 35B(1)
27A Subsection 41AD(1)
27B Subsection 41AE(1)
Subsection 41EI(1)
Subsection 41FE(1)
Subsection 41JB(4)
Subsection 41JH(1)
Subsection 41JI(1)
Subsection 41KC(1)
Subsection 41MA(1), (5) or (9)
Subsection 41MC(2)
Subsection 41ME(1) or (5)
Subsection 41MF(1) or (3)
Section 41MH
Subsection 41MI(1)
39A Subsection 41ML(1)
Subsection 41MN(1), (5) or (10)
Subsection 41MNB(1)
Subsection 41MP(1)
Subsection 41MQ(3) or (4)
43A Subsection 42DL(1)
43B Subsection 42DLA(1)
43C Subsection 42DM(1)
43D Subsection 42DW(1)
Subsection 42E(1)
Subsection 42T(1) or (2)
Subsection 42V(6)
Subsection 42W(1) or (2)
Subsection 54AB(1)
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54C Establishing whether an executive officer took reasonable steps
to prevent the commission of an offence or the
contravention of a civil penalty provision
(1) For the purposes of section 54B, in determining whether an
executive officer of a body corporate failed to take all reasonable
steps to prevent the commission of the offence or the contravention
of a civil penalty provision, a court is to have regard to:
(a) what action (if any) the officer took towards ensuring that the
body’s employees, agents and contractors have a reasonable
knowledge and understanding of the requirements to comply
with this Act and the regulations, in so far as those
requirements affect the employees, agents or contractors
concerned; and
(b) what action (if any) the officer took when he or she became
aware that the body was committing an offence against, or
otherwise contravening, this Act or the regulations.
(2) This section does not, by implication, limit the generality of
section 54B.
(3) In this section, executive officer has the same meaning as in
section 54B.
55 Conduct by directors, employees and agents
(1) Where, in proceedings for an offence against this Act, or for a
contravention of a civil penalty provision, it is necessary to
establish the state of mind of a body corporate in relation to
particular conduct, it is sufficient to show:
(a) that the conduct was engaged in by a director, employee or
agent of the body corporate within the scope of his or her
actual or apparent authority; and
(b) that the director, employee or agent had the state of mind.
(2) Any conduct engaged in on behalf of a body corporate by a
director, employee or agent of the body corporate within the scope
of his or her actual or apparent authority is to be taken, for the
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purposes of a prosecution for an offence against this Act, or for a
contravention of a civil penalty provision, to have been engaged in
also by the body corporate unless the body corporate establishes
that the body corporate took reasonable precautions and exercised
due diligence to avoid the conduct.
(3) Where, in proceedings for an offence against this Act, or for a
contravention of a civil penalty provision, it is necessary to
establish the state of mind of a person other than a body corporate
in relation to particular conduct, it is sufficient to show that:
(a) the conduct was engaged in by an employee or agent of the
person within the scope of his or her actual or apparent
authority; and
(b) the employee or agent had the state of mind.
(4) Any conduct engaged in on behalf of a person other than a body
corporate (in this subsection called the employer) by an employee
or agent of the employer within the scope of his or her actual or
apparent authority is to be taken, for the purposes of a prosecution
for an offence against this Act, or for a contravention of a civil
penalty provision, to have been engaged in also by the employer
unless the employer establishes that he or she took reasonable
precautions and exercised due diligence to avoid the conduct.
(5) Where:
(a) a person other than a body corporate is convicted of an
offence; and
(b) the person would not have been convicted of the offence if
subsections (3) and (4) had not been enacted;
the person is not liable to be punished by imprisonment for that
offence.
(6) A reference in subsection (1) or (3) to the state of mind of a person
includes a reference to:
(a) the knowledge, intention, opinion, belief or purpose of the
person; and
(b) the person’s reasons for the intention, opinion, belief or
purpose.
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(7) A reference in this section to a director of a body corporate
includes a reference to a constituent member of a body corporate
incorporated for a public purpose by a law of the Commonwealth,
of a State or of a Territory.
(8) A reference in this section to engaging in conduct includes a
reference to failing or refusing to engage in conduct.
56 Judicial notice
All courts (except in proceedings under Chapter 4) are to take
judicial notice of the British Pharmacopoeia, the European
Pharmacopoeia, the United States Pharmacopeia-National
Formulary, a homoeopathic pharmacopoeia and an anthroposophic
pharmacopoeia.
56A Certificates to provide evidence of certain matters
(1) The Secretary or a person authorised in writing by him or her to
give certificates under this section may certify in writing that, at a
specified time, or at all times during a specified period:
(a) there was no exemption in effect under section 18 or 18A in
relation to particular therapeutic goods; or
(aaaa) a person was not exempt under subsection 32CA(1) in
relation to a particular biological or there was no exemption
under subsection 32CA(2) in relation to a particular
biological; or
(aaab) there was no exemption in effect under section 32CB in
relation to a particular biological; or
(aaa) there was no exemption in force under section 41GS in
relation to a particular kind of medical device; or
(aa) particular medical devices were not exempt devices;
(b) there was no approval under subsection 19(1) or authority
under subsection 19(5) granted to a particular person in
relation to particular therapeutic goods; or
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(baa) there was no approval under subsection 32CK(1) or authority
under subsection 32CM(1) granted to a particular person in
relation to a particular biological; or
(ba) there was no approval or authority in effect under
section 41HB or subsection 41HC(1) granted to a particular
person in relation to particular medical devices;
(bb) there was no approval under subsection 41HD(1), (1A) or (2)
granted to a particular person in relation to particular medical
devices; or
(c) there was no approval under section 19A granted to a
particular person in relation to particular therapeutic goods;
or
(ca) there was no approval under subsection 32CO(1), (1A) or (2)
granted to a particular person in relation to a particular
biological; or
(d) particular therapeutic goods were or were not included in the
Register as registered goods; or
(da) particular therapeutic goods were or were not included in the
Register as provisionally registered goods; or
(e) particular therapeutic goods were or were not included in the
Register as listed goods; or
(eaa) a particular biological was or was not included in the
Register; or
(ea) particular medical devices were or were not medical devices
of a kind included in the Register; or
(eb) particular medical devices were suspended from the Register;
or
(f) particular therapeutic goods were included in the Register
subject to conditions including those specified in the
certificate; or
(g) the registration, listing or inclusion in the Register of the
particular therapeutic goods had been suspended or
cancelled; or
(h) there was no declaration under section 7 which applied to
particular therapeutic goods; or
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(ha) there was no determination under section 7AA which applied
to particular goods; or
(i) a person was or was not the holder of a licence in force under
Part 3-3; or
(j) the licence is subject to conditions including those specified
in the certificate; or
(k) there was no exemption in effect under subsection 34(1) that
applied to particular therapeutic goods or a particular class of
therapeutic goods; or
(l) there was no exemption in effect under subsection 34(2) that
applied to a particular person in relation to one or more of the
following:
(i) the manufacture of particular therapeutic goods;
(ii) a particular step in the manufacture of particular
therapeutic goods;
(iii) the manufacture of a particular class of therapeutic
goods;
(iv) a particular step in the manufacture of a particular class
of therapeutic goods; or
(la) there was no conformity assessment body determination in
force in respect of a particular Australian corporation; or
(lb) a conformity assessment body determination was in force in
respect of a particular Australian corporation and the
determination:
(i) was of general application; or
(ii) was limited to the extent specified in the certificate; or
(m) a conformity assessment certificate has been issued relating
to a particular kind of medical device; or
(n) a conformity assessment certificate was subject to conditions
including those specified in the certificate under this section;
or
(o) a conformity assessment certificate was suspended.
(2) A certificate under subsection (1) may relate to more than one of
the matters referred to in paragraphs (1)(a) to (o).
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(3) In proceedings for an offence against this Act or a contravention of
a civil penalty provision, a certificate under subsection (1) is prima
facie evidence of the matters specified in the certificate.
(4) In proceedings for:
(a) an offence against section 14 or 41MA; or
(b) the contravention of section 14A or 41MAA (civil penalty
provisions);
a certificate by the Secretary to the effect that:
(c) the Secretary did not consent to the importation, supply or
exportation that is the subject of the proceedings; or
(d) the Secretary consented to that importation, supply or
exportation subject to conditions specified in the certificate;
is prima facie evidence of the matters specified in the certificate.
(5) In proceedings for an offence against this Act or a contravention of
a civil penalty provision, a document purporting to be a certificate
given under this section is, unless the contrary is proved, taken to
be such a certificate and to have been duly given.
57 Delegation
(1) Subject to subsections (2), (6) and (8) to (11), the Minister or the
Secretary may, by signed instrument, delegate to:
(a) an officer of the Department; or
(b) an officer of an authority of the Commonwealth that has
functions in relation to therapeutic goods; or
(ba) an APS employee in an Agency (within the meaning of the
Public Service Act 1999) that has functions in relation to
therapeutic goods; or
(c) a person occupying or acting in an office, or holding an
appointment, declared by the regulations to be an office or
appointment the occupant or holder of which may be a
delegate under this section; or
(d) a person seconded to the Department from:
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(i) an authority of a State or a Territory that has functions
relating to therapeutic goods, health or law enforcement;
or
(ii) a national regulatory authority of a foreign country that
has national responsibility relating to therapeutic goods,
health or law enforcement; or
(iii) an international organisation that has a function relating
to therapeutic goods, health or law enforcement;
all or any of his or her powers and functions under this Act.
(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d)
or 41HB(1)(d) may be delegated under subsection (1) only to a
person referred to in paragraph (1)(a) or (c) who is registered, or
eligible for registration, in a State or internal Territory, as a
medical or dental practitioner or as a pharmacist.
(3) Subject to the regulations, the Secretary may, in such
circumstances as are prescribed, by signed instrument, delegate all
or any of his or her powers under paragraph 19(1)(a), 32CK(1)(d)
or 41HB(1)(d) to a person who is registered, in a State or internal
Territory, as a medical or dental practitioner.
(4) A delegate under subsection (3) is, in the exercise of a delegated
power, subject to the directions of:
(a) the Secretary; or
(b) an officer of the Department authorised in writing by the
Secretary; or
(c) a person referred to in paragraph (1)(c).
(5) Without limiting the generality of matters that may be dealt with
by regulations made for the purposes of subsection (3), the
regulations may make provision in relation to the following:
(a) the persons who may be delegates;
(b) the circumstances in which delegates may grant approvals for
the purposes of paragraph 19(1)(a), 32CK(1)(d) or
41HB(1)(d);
(c) the conditions to which any approvals granted by delegates
are to be subject;
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(d) requiring information to be given by delegates to the
Secretary.
(6) The powers of the Secretary under subsection 19(5), 32CM(1) or
41HC(1) may be delegated only to a person referred to in
paragraph (1)(a) or (c) who is registered, or eligible for
registration, in a State or internal Territory as a medical or dental
practitioner.
(7) The regulations may prescribe the circumstances in which, and the
requirements subject to which, delegates may grant authorities
under subsection 19(5), 32CM(1) or 41HC(1).
(8) The powers of the Secretary under section 19A or 32CO may be
delegated only to a person who holds, occupies or performs the
duties of a position in the Department prescribed by the
regulations.
(9) The powers of the Secretary under section 41HD may be delegated
only to a person who holds, occupies or performs the duties of a
position in the Department prescribed by the regulations.
(10) The power of the Minister under subsection 18A(1) may be
delegated only to the Secretary.
(10A) The power of the Minister under subsection 32CB(1) may be
delegated only to the Secretary.
(11) The power of the Minister under subsection 41GS(1) may be
delegated only to the Secretary.
58 Export certifications
(1) The Secretary may issue export certification for goods for
therapeutic use in humans, including certifications for the purposes
of the World Health Organisation Certification Scheme on the
Quality of Pharmaceutical Products Moving in International
Commerce.
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(2) A State or Territory must not issue export certifications for goods
for therapeutic use in humans.
(3) Such fee as is prescribed is payable in respect of:
(a) an application for a certification under this section; and
(b) where an inspection of a manufacturing site is necessary for
the purposes of the issue of a certification under this
section—the inspection of that site.
59 Fees
(1) No fees are payable under this Act in respect of an event occurring
before 1 July 1990.
(2) Fees prescribed under this Act must not be such as to amount to
taxation.
60 Review of decisions
(1) In this section and section 60A:
decision has the same meaning as in the Administrative Appeals
Tribunal Act 1975.
initial decision means a decision of the Secretary or of a delegate
of the Secretary:
(a) under the definition of therapeutic devices in subsection 3(1)
or under subsection 7(1) or 41BD(3); or
(aa) under subsection 7C(3); or
(ab) under section 9C, 9D or 9F; or
(b) refusing to grant, or imposing conditions on a grant of, a
consent under section 14 or 14A; or
(c) under Part 3-2 (registration and listing of therapeutic goods);
or
(ca) under Part 3-2A (Biologicals); or
(d) under Part 3-3 (manufacturing of therapeutic goods); or
(e) under Part 4-4 (conformity assessment certificates); or
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(f) under Part 4-5 (including medical devices in the Register),
other than:
(i) a decision under section 41FH (selecting applications
for auditing); or
(ii) a decision about which aspects of the matters referred to
in paragraphs 41FI(1)(a) and (b) to consider in auditing
an application under Subdivision C of Division 1 of
Part 4-5; or
(g) under Part 4-6 (suspension and cancellation from the
Register); or
(h) under Part 4-7 (exempting medical devices from inclusion in
the Register); or
(i) under Part 4-8 (obtaining information); or
(j) under Part 4-9 (public notification and recovery of medical
devices); or
(k) refusing to grant, or imposing conditions on a grant of, a
consent for the purposes of section 41MA or 41MAA
(non-compliance with essential principles); or
(l) under section 42DF, 42DH or 42DI or subsection 42DV(1) or
(2).
reviewable decision means a decision of the Minister under
subsection (3).
(1A) For the avoidance of doubt, the following are not initial decisions
for the purposes of this section or section 60A:
(aa) a preliminary assessment under section 23B, 32DDA or
41FDB;
(a) a proposal to suspend a conformity assessment certificate
under section 41EM;
(b) a proposal to revoke a conformity assessment certificate
under section 41ET;
(c) a proposal to suspend a kind of medical device from the
Register under section 41GA;
(d) a proposal to cancel the entry of a kind of medical device on
the Register under section 41GN.
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(2) Subject to this section, a person whose interests are affected by an
initial decision may, by notice in writing given to the Minister:
(a) if this Act requires the person to be given notice in writing of
the decision, or of particulars of the decision—within 90 days
after the notice is given to the person; or
(b) otherwise—within 90 days after the earlier of:
(i) notice of the decision, or of particulars of the decision,
being published in the Gazette or on the Department’s
website; and
(ii) the decision first coming to the person’s notice;
request the Minister to reconsider the decision.
(2A) A request under subsection (2) may be accompanied by
information in support of the request.
(2AA) If the Secretary or a delegate of the Secretary makes a decision
under subsection 9D(1A) or (1B) to vary an entry in the Register in
relation to a medicine, a person is not entitled to request the
Minister to reconsider the decision unless the person is the person
in relation to whom the medicine is registered.
(2AB) If the Secretary or a delegate of the Secretary:
(a) makes a decision under section 22D in relation to an
application under section 22C; or
(b) makes a decision under section 22E in relation to an
application under subsection 22E(3); or
(c) makes a decision under section 23B in relation to an
application for provisional registration of a medicine; or
(d) makes a decision under subsection 25(3) in relation to an
application for provisional registration of a medicine;
a person is not entitled to request the Minister to reconsider the
decision unless the person made the application.
(2AC) If the Secretary or a delegate of the Secretary makes a decision
under section 22F to revoke a provisional determination under
section 22D, a person is not entitled to request the Minister to
reconsider the decision unless the person made the application for
that provisional determination.
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(2B) If the Secretary or a delegate of the Secretary decides, under
paragraph 26BE(4)(b), to refuse to make a recommendation, a
person is not entitled to request the Minister to reconsider the
decision unless the person made an application under
subsection 26BE(1) for the recommendation.
(2C) If the Secretary or a delegate of the Secretary decides, under
subsection 26BJ(8), to refuse to make a recommendation, a person
is not entitled to request the Minister to reconsider the decision
unless the person made an application under subsection 26BJ(1)
for the recommendation.
(2D) If the Secretary or a delegate of the Secretary:
(a) makes a decision under subsection 29(6) in relation to an
application under subsection 29(4); or
(b) makes a decision under subsection 29(9) to end, or extend,
the provisional registration period for a medicine;
a person is not entitled to request the Minister to reconsider the
decision unless the person is the person in relation to whom the
medicine is provisionally registered.
(3) Subject to paragraph 60A(2)(b), the Minister must, as soon as
practicable after receiving a request under subsection (2),
reconsider the initial decision and, as a result of that
reconsideration, may:
(a) confirm the initial decision; or
(b) revoke the initial decision, or revoke that decision and make
a decision in substitution for the initial decision.
(3A) Subject to subsection 60A(2), in reconsidering the initial decision:
(a) the Minister must take into account any information referred
to in subsection (2A); and
(b) the Minister must not take into account any other information
provided by, or on behalf of, the person after the making of
the request, other than:
(i) information provided in response to a request from the
Minister; or
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(ii) information that indicates that the quality, safety or
efficacy of therapeutic goods is unacceptable.
(3B) Paragraph (3A)(a) does not limit the information the Minister may
take into account in reconsidering the initial decision.
(3C) If, under paragraph (3)(b), the Minister revokes an initial decision
and makes a decision in substitution for the initial decision then the
substituted decision:
(a) is taken to be a decision of the Secretary (except for the
purpose of any review of the substituted decision); and
(b) has effect, or is taken to have had effect, on and from the date
determined by the Minister.
(4) Where a person who has made a request under subsection (2) does
not receive notice of the decision of the Minister on
reconsideration, or (if applicable) notice that the matter has been
remitted under paragraph 60A(2)(b), within 60 days of the making
of the request, the Minister is taken to have confirmed under
subsection (3) the initial decision.
(5) After reconsideration of an initial decision, the Minister must give
the applicant a notice in writing stating the result of the
reconsideration and that the applicant may, except where
subsection 28(4) of the Administrative Appeals Tribunal Act 1975
applies, apply for a statement setting out the reasons for the
decision on reconsideration and may, subject to that Act, make an
application to the Administrative Appeals Tribunal for review of
that decision.
(5A) If:
(a) the initial decision is one the particulars of which are
required to be published in the Gazette or on the
Department’s website; and
(b) the Minister revokes the initial decision;
the Secretary must, as soon as practicable after the revocation,
cause to be published in the Gazette, or on the Department’s
website, a notice setting out particulars of the revocation.
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(5B) If:
(a) the initial decision is one the particulars of which are
required to be published in the Gazette or on the
Department’s website; and
(b) the Minister revokes the initial decision and makes a decision
(the substituted decision) in substitution for the initial
decision;
the Secretary must, as soon as practicable after the substituted
decision is made, cause to be published in the Gazette, or on the
Department’s website, a notice setting out particulars of the
substituted decision.
(6) Where written notice of the making of an initial decision is given
to a person whose interests are affected by the decision, the notice
is to include a statement to the effect that a person whose interests
are affected by the decision may:
(a) seek a reconsideration of the decision under this section; and
(b) subject to the Administrative Appeals Tribunal Act 1975, if
the person is dissatisfied with the decision upon
reconsideration, make an application to the Administrative
Appeals Tribunal for review of that decision.
(7) Any failure to comply with the requirements of subsection (5) or (6)
in relation to a decision does not affect the validity of the decision.
(8) An application may be made to the Administrative Appeals
Tribunal for review of a reviewable decision.
60A New information on review—discretion to remit
(1) This section applies only if the Secretary or an authorised delegate
makes a decision under section 25, 32DF, 32DG or 41EC in
relation to therapeutic goods.
(2) If a person (the appellant) whose interests are affected by the
decision requests the Minister to reconsider the decision, and
lodges initial new information in support of that request, the
Minister must either:
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(a) take that information into account when he or she reconsiders
the decision; or
(b) remit the matter to an authorised delegate for a fresh
decision.
(3) If the appellant applies to the Administrative Appeals Tribunal for
review of the decision on reconsideration, and lodges initial new
information or later new information (or both) in support of that
application, the Tribunal may, if the Tribunal thinks fit, remit the
matter to an authorised delegate for a fresh decision.
(4) If:
(a) the appellant applies to the Administrative Appeals Tribunal
for review of the decision on reconsideration and lodges
initial new information in support of that application; and
(b) the appellant does not lodge later new information in support
of that application;
the Tribunal must not remit the matter under subsection (3) if all of
the initial new information is information that the Minister took
into account under paragraph (2)(a) in making the decision on
reconsideration.
(5) If:
(a) the appellant lodges initial new information or later new
information (or both) in support of an application to the
Administrative Appeals Tribunal for review of the decision
on reconsideration; and
(b) the Tribunal does not remit the matter under subsection (3);
the Tribunal, in reviewing the decision on reconsideration:
(c) may consider initial new information (if any) that the
Minister took into account under paragraph (2)(a) in making
the decision on reconsideration; and
(d) must not consider any other initial new information, except
initial new information that indicates that the quality, safety
or efficacy of the therapeutic goods is unacceptable; and
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(e) must not consider any later new information, except later
new information that indicates that the quality, safety or
efficacy of the therapeutic goods is unacceptable.
(6) If:
(aa) the matter relates to a decision under section 25; and
(a) the Minister or the Tribunal remits the matter; and
(b) the appellant has paid, as a further evaluation fee, the
evaluation fee that the appellant would have to pay under
section 24 on making a new application for registration of the
therapeutic goods;
the authorised delegate must make a decision under section 25,
taking into account the initial new information or later new
information (or both), as the case may be, as if a fresh application
for registration had been made.
(6AA) If:
(a) the matter relates to a decision under section 32DF or 32DG;
and
(b) the Minister or the Tribunal remits the matter; and
(c) the appellant has paid, as a further evaluation fee, the
evaluation fee that the appellant would have to pay under
section 32DI on making a new application for inclusion of
the biological in the Register;
the authorised delegate must make a decision whether or not to
include the biological in the Register, taking into account the initial
new information or later new information (or both), as the case
may be, as if a fresh application for inclusion of the biological in
the Register had been made.
(6A) If:
(a) the matter relates to a decision under section 41EC; and
(b) the Minister or the Tribunal remits the matter; and
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(c) the appellant has paid, as a further conformity assessment
fee, the conformity assessment fee that the appellant would
have to pay under section 41LA on making a new application
for a conformity assessment certificate;
the authorised delegate must make a decision under section 41EC,
taking into account the initial new information or later new
information (or both), as the case may be, as if a fresh application
for a conformity assessment certificate had been made.
(7) To remove any doubt, the authorised delegate’s fresh decision is to
be treated, for the purposes of subsequent applications of section 60
and this section, as a decision under Part 3-2, 3-2A or 4-4.
(8) In this section:
authorised delegate means a delegate of the Secretary:
(a) exercising a power to decide whether to register therapeutic
goods; or
(aa) exercising a power to decide whether to include a biological
in the Register; or
(b) exercising a power to decide whether to issue a conformity
assessment certificate.
initial new information means information that:
(a) was in existence at the time the decision referred to in
subsection (1) was made; and
(b) was not made available to the Secretary or authorised
delegate for the purpose of making that decision; and
(c) is relevant to that decision;
and includes any opinions that are wholly or substantially based on
such information (whether the opinions were formed before or
after that decision was made).
later new information means information that:
(a) was in existence at the time the decision on reconsideration
was made; and
(b) was not made available to the Minister or delegate of the
Minister for the purpose of making that decision; and
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(c) is relevant to that decision;
and includes any opinions that are wholly or substantially based on
such information (whether the opinions were formed before or
after that decision was made).
61 Release of information
(1) In this section:
therapeutic goods information means information in relation to
therapeutic goods that is held by the Department and relates to the
performance of the Department’s functions (including functions
relating to the EC Mutual Recognition Agreement or the EFTA
Mutual Recognition Agreement).
(2) The Secretary may:
(a) release to the World Health Organisation therapeutic goods
information relating to:
(i) notifications concerning therapeutic goods the
consumption or supply of which in Australia has been
prohibited or severely restricted, or relating to the
reasons for that action; or
(ii) the licensing status of Australian manufacturers of
therapeutic goods and their compliance with the
manufacturing principles; or
(iii) the content of reports to the Department concerning
adverse effects of therapeutic goods; or
(iv) the issue of, imposition of conditions on, or revocation
of, conformity assessment certificates;
for use in the development of policies relating to the
regulation of therapeutic goods or for the provision of
information to regulatory authorities of member countries of
the World Health Organisation; or
(b) release, in confidence, therapeutic goods information to the
World Health Organisation, being information concerning
proceedings of committees established under the regulations.
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(3) The Secretary may release to an authority of the Commonwealth, a
State or a Territory that has functions relating to therapeutic goods,
therapeutic goods information relating to:
(a) reported problems and complaints concerning therapeutic
goods, the Department’s investigation of those problems and
complaints and any action that the Department has taken or
proposes to take in relation to those problems and
complaints; or
(b) reports of inspections conducted under this Act or the
regulations; or
(c) decisions to revoke or suspend, or not to issue, licences for
the manufacturing of therapeutic goods; or
(d) conditions of licences; or
(e) reports of the testing of samples of therapeutic goods; or
(f) the issue of, imposition of conditions on, or revocation of,
conformity assessment certificates;
for use in the performance of those functions.
(3A) The Secretary may release information obtained in response to a
notice under section 31A, 31AA, 31B, 31BA, 32JE, 32JF, 32JG,
32JH, 41AB, 41JCA, 41JD, 41JE or 41JF to:
(a) an authority of the Commonwealth, a State or a Territory that
has functions relating to therapeutic goods; and
(b) the body in a State or Territory responsible for the
registration of medical practitioners in that State or Territory;
and
(c) the body in a State or Territory responsible for the
registration of pharmacists in that State or Territory.
(4) The Secretary may release to a national regulatory authority of
another country, being an authority that has national responsibility
relating to therapeutic goods, therapeutic goods information
relating to:
(a) recommendations of advisory committees on therapeutic
goods supplied in or proposed for supply in Australia, and
any conditions that are or will be applicable to that supply; or
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(b) decisions on the registration or listing, or the suspension or
cancellation of the registration or listing, of therapeutic
goods; or
(baa) decisions on the inclusion of biologicals in the Register, or
the suspension or cancellation of the inclusion of biologicals
in the Register; or
(ba) decisions on the inclusion of kinds of medical devices in the
Register, or the suspension or cancellation of the inclusion of
kinds of medical devices in the Register; or
(c) the withdrawal from supply in Australia of therapeutic goods
and the reasons for that action; or
(d) the licensing status of Australian manufacturers of
therapeutic goods and their compliance with the
manufacturing principles; or
(e) proceedings of committees established under the regulations;
or
(f) the issue of, imposition of conditions on, or revocation of,
conformity assessment certificates;
for use in the performance of those functions or for furthering
international co-operation in the regulation of therapeutic goods.
(4A) The Secretary may release to:
(a) an authority of the Commonwealth, a State or a Territory that
has functions relating to therapeutic goods, health or law
enforcement; or
(b) a national regulatory authority of another country that has
national responsibility relating to therapeutic goods, health or
law enforcement; or
(ba) an international organisation that has a function relating to
therapeutic goods, health or law enforcement;
therapeutic goods information relating to one or more of the
following:
(c) notifications received under section 42T;
(d) action taken by the Secretary under Part 5-3;
(da) action taken by the Secretary under section 30EA (about
notification and recall of therapeutic goods);
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(db) action taken by the Secretary under section 32HA (about
notification and recall of biologicals);
(dc) action taken by the Secretary under section 41KA (about
notification and recall of medical devices);
(e) contraventions, or possible contraventions, of Part 5-2 or
Part 5-3;
(f) any cases, or possible cases, of actual or potential tampering
with therapeutic goods;
(fa) any cases, or possible cases, of counterfeit therapeutic goods;
(g) information relating to an offence committed against this
Act, or alleged to have been committed against this Act,
involving therapeutic goods;
(h) information relating to the contravention of a civil penalty
provision, or the alleged contravention of a civil penalty
provision, involving therapeutic goods;
(i) a breach of a requirement of this Act or the regulations.
(4B) The release of therapeutic goods information mentioned in
paragraphs (4A)(g), (h) and (i) is not taken, for the purposes of
paragraph 6.2(b) of Australian Privacy Principle 6, to be authorised
by this Act.
(5) The Secretary may release to a national regulatory authority of
another country, or an international organisation, being another
country or an organisation with which the Commonwealth has
cooperative arrangements relating to the assessment or regulation
of therapeutic goods, the following information the release of
which is consistent with those arrangements:
(a) therapeutic goods information;
(b) information relating to Australian conformity assessment
bodies and either to conformity assessment body
determinations or to certification-related activities of
Australian conformity assessment bodies.
(5AA) The Secretary may release to a person, body or authority that is
specified, or is of a kind specified, under subsection (5AB)
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therapeutic goods information of a kind specified under that
subsection for a purpose specified under that subsection.
(5AB) For the purpose of subsection (5AA), the Minister may, by
legislative instrument, specify one or more of the following:
(a) a person, body or authority;
(b) kinds of persons, bodies or authorities;
(c) kinds of therapeutic goods information;
(d) purposes.
(5A) The Secretary may release to the public therapeutic goods
information relating to any decision or action taken under this Act
or the regulations.
(5B) The release of therapeutic goods information under
subsection (5A) is not taken, for the purposes of paragraph 6.2(b)
of Australian Privacy Principle 6, to be authorised by this Act.
(5C) The Secretary may release to the public therapeutic goods
information of a kind specified under subsection (5D).
(5D) The Minister may, by legislative instrument, specify kinds of
therapeutic goods information for the purpose of subsection (5C).
(6) The Secretary may release to a person, on application by that
person, therapeutic goods information of a kind identified in the
regulations relating to:
(a) therapeutic goods included in the Register; or
(b) therapeutic goods in relation to which an application for
registration, listing or inclusion in the Register has been
made.
(6A) Regulations made for the purposes of subsection (6) may:
(a) relate to therapeutic goods generally or to a class of such
goods; and
(b) authorise the release of therapeutic goods information to
persons generally or to a class of persons.
(7) The Secretary may release therapeutic goods information:
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(a) the release of which is necessary to ensure the safe use of
particular therapeutic goods; or
(b) relating to the reasons for the withdrawal of therapeutic
goods from supply in Australia.
(8) Subject to section 25A, therapeutic goods information provided to
the Department in relation to a matter may:
(a) be used by the Department in the consideration of another
matter within its functions relating to therapeutic goods; and
(b) be provided to a committee appointed to advise the Minister
or the Secretary on matters relating to therapeutic goods,
including a committee of the National Health and Medical
Research Council.
(8A) Regulations prescribing fees in respect of applications for
information under the regulations:
(a) may include provision for the payment of deposits on
account of such fees; and
(b) may provide for fees that take into account the time spent by
officers of the Department in:
(i) searching for or retrieving information; or
(ii) making, or doing anything related to the making of, a
decision on an application; and
(c) may provide for fees that take into account the direct costs
incurred by the Commonwealth in making available an
officer to supervise the inspection by an applicant of any
document containing information to which an application
relates.
(8C) If, under the regulations, a person is liable to pay a fee in respect of
an application for information, the Secretary must notify the
person, in writing, accordingly, and must give to the person,
together with that notification, a statement setting out the basis on
which the amount of that fee is calculated.
(10) Nothing in this or any other Act requires the Secretary to disclose
to any person, court or tribunal information referred to in
subsection 25(2E) (including as that subsection applies because of
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subsection 32DE(2) or 32EB(3)) or 26(2D) if the disclosure would
constitute a breach of the Mutual Recognition Convention.
(11) This section (except subsection (10)) has effect subject to the
Freedom of Information Act 1982.
(12) The subsections of this section permitting the release of
information have effect independently of each other.
61A Immunity from civil actions
(1) No civil action, suit or proceeding lies against:
(a) the Commonwealth; or
(b) a protected person;
in respect of loss, damage or injury of any kind suffered by another
person as a result of anything done, or omitted to be done, by a
protected person in relation to the performance or purported
performance, or in relation to the exercise or purported exercise, of
a protected person’s functions, duties or powers under this Act or
the regulations.
(2) Subsection (1) does not apply to an act or omission in bad faith.
(3) A reference in subsection (1) to anything omitted to be done
includes a reference to a failure to make a decision.
(4) In this section:
protected person means any of the following:
(a) the Minister;
(b) the Secretary;
(c) a person to whom powers or functions are delegated under
subsection 57(1);
(d) a member of a committee established under this Act or the
regulations;
(e) an authorised person in relation to a provision of this Act
(other than this section);
(f) an authorised officer (within the meaning of the regulations);
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(g) an authorised person (within the meaning of the regulations);
(h) a person assisting a person (a primary person) referred to in
paragraph (a), (b), (c), (d), (e), (f) or (g) in relation to the
performance or purported performance, or in relation to the
exercise or purported exercise, of a primary person’s
functions, duties or powers under this Act or the regulations.
63 Regulations
(1) The Governor-General may make regulations, not inconsistent with
this Act, prescribing matters:
(a) required or permitted to be prescribed by this Act; or
(b) necessary or convenient to be prescribed for carrying out or
giving effect to this Act.
(2) The regulations may:
(a) make provision in relation to:
(i) the establishment of committees to advise the Minister
or the Secretary on matters relating to therapeutic
goods; and
(ii) the functions and powers of those committees; and
(iii) the payment of remuneration and allowances to
members of those committees; and
(b) prescribe requirements for the storage and transport of
therapeutic goods; and
(c) prescribe requirements for the advertising of therapeutic
goods; and
(d) provide for the procedures to be followed by the Department
in the sampling and testing of therapeutic goods; and
(da) provide for the periods within which evaluations under
section 25 in relation to specified therapeutic goods or
specified classes of such goods are to be completed; and
(daaaa) provide for the periods within which evaluations under
section 26AE in relation to specified medicines or specified
classes of medicines are to be completed; and
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(daaa) provide for the periods within which evaluations under
section 26BE in relation to recommendations to vary a
section 26BB determination are to be completed; and
(daa) provide for the periods within which evaluations under
section 32DE in relation to specified biologicals or specified
classes of biologicals are to be completed; and
(db) provide for the periods within which decisions under
section 41EP to revoke suspensions of conformity
assessment certificates are to be made, in cases where
applications for revocation have been made under
paragraph 41EP(2)(a); and
(dc) provide for the periods within which decisions on
applications for the issuing of conformity assessment
certificates under Part 4-4 are to be made if considering the
applications involves examining the design of medical
devices; and
(dd) provide for the periods within which decisions under
section 41GD to revoke suspensions of entries on the
Register are to be made, in cases where applications for
revocation have been made under paragraph 41GD(2)(a); and
(de) provide for the periods within which the performance of
specified functions conferred on the Secretary by this Act is
to be completed; and
(df) provide for the periods within which specified decisions
under this Act are to be made by the Secretary; and
(e) prescribe requirements for informational material that is
included with therapeutic goods; and
(f) make provision for the transfer of registration, listing or
inclusion in the Register of therapeutic goods and of licences;
and
(g) make provision for the testing of therapeutic goods, the
inspection of manufacturing operations or the evaluation of
data concerning therapeutic goods by the Department at the
request of persons; and
(h) prescribe fees in respect of matters under this Act or the
regulations; and
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(j) prescribe penalties not exceeding 10 penalty units for
offences against the regulations.
(3) The regulations may:
(a) prescribe different fees under this Act in relation to:
(i) different classes of goods; or
(ii) in the case of fees under Part 3-3—different steps in the
manufacture of goods; or
(b) provide for the refund, reduction or waiving of fees or
charges in cases identified in the regulations; or
(c) specify the type of information relating to therapeutic goods
manufactured by licence holders that the Secretary may,
under subsection 37(2), require to be supplied by the holders
of licences at the time of payment of annual licensing charges
in respect of the licences.
(3A) The regulations may provide for:
(a) the granting of a licence or permission to import or export
therapeutic goods; and
(b) licences or permissions to import or export therapeutic goods
to be subject to conditions or requirements; and
(c) the assignment of a licence or permission to import or export
therapeutic goods; and
(d) the surrender of a licence or permission to import or export
therapeutic goods; and
(e) the revocation of a licence or permission to import or export
therapeutic goods.
(4) The regulations may make provision for a matter by applying,
adopting or incorporating, with or without modification, any matter
contained in an instrument:
(a) as that instrument is in force at the time when the regulations
take effect; or
(b) as that instrument is in force from time to time.
(5) For the purposes of section 2, regulations may be made before the
commencement of this Act as if this Act were in force, but do not
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come into effect on a day earlier than the day on which this Act
commences.
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Chapter 8—Repeal and transitional
provisions
66 Transitional arrangements for goods required to be registered or
listed
(1) This section applies to therapeutic goods in relation to a person if,
immediately before the commencement of this Act, the person was
supplying goods of that kind in Australia for use in humans.
(2) Where:
(a) this section applies to therapeutic goods in relation to a
person; and
(b) the Secretary is not aware of the person having been
convicted of an offence against a law of the Commonwealth,
of a State or of an internal Territory in respect of goods of
that kind during the period of 2 years ending on the
commencement of this Act; and
(c) if the goods are imported goods—the Secretary is not aware
of the person having, during that period, imported goods of
that kind into Australia otherwise than in accordance with
regulations in force under the Customs Act 1901;
subsections 20(1) and (2) do not apply to goods of that kind in
relation to the person during the period of 3 months after that
commencement.
(3) Where:
(a) this section applies to therapeutic goods in relation to a
person; and
(b) the person makes an application for registration or listing of
goods of that kind in accordance with section 23 and within 3
months after the commencement of this Act;
then:
(c) subsection 20(1) does not apply to goods of that kind in
relation to the person during the period of 6 months after that
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commencement or before the end of such longer period as the
Secretary specifies by notice published in the Gazette before
the end of that first-mentioned period; and
(d) subsection 20(2) does not apply to goods of that kind in
relation to the person during the period of 12 months after
that commencement or before the end of such longer period
as the Secretary specifies by notice published in the Gazette
before the end of that first-mentioned period.
(3A) If, on an application under subsection (3), goods have been
registered without having been evaluated, the Secretary may, if he
or she thinks it appropriate, give the person in relation to whom the
goods are registered written notice that the goods are to be
evaluated to determine whether they should continue to be
registered.
(4) A person who makes an application in accordance with subsection (3)
is not required to pay:
(a) any application fee for the registration or listing of the goods
to which the application relates; or
(b) in the case of an application for the registration of goods—
any fee for the evaluation of the goods for registration;
but where the goods are later evaluated to determine whether the
goods should continue to be registered, such fee as is prescribed is
payable in respect of that evaluation.
(4A) In relation to an evaluation conducted for the purposes of this
section:
(a) section 25 has effect as if:
(i) the person in respect of whom the goods are registered
were an applicant for the registration of the goods; and
(ii) the reference in paragraph (1)(b) to an evaluation fee
under section 24 were a reference to a fee payable under
subsection (4) of this section; and
(b) sections 24A, 24B and 24C have effect as if any reference in
those sections to section 24 were a reference to subsection (4)
of this section; and
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(c) sections 24D and 24E do not apply.
(4B) If, on an application under subsection (3), goods have been listed
without consideration of the matters mentioned in paragraphs
26(1)(c) to (m), the Secretary may, if he or she thinks it
appropriate, give the person in relation to whom the goods are
listed written notice that the Secretary intends to determine
whether the goods should continue to be listed.
(4C) If notice is given under subsection (4B), section 26 applies as if the
person in relation to whom the goods are listed were an applicant
for the listing of the goods.
(5) Section 21 does not apply, during the period of 15 months after the
commencement of this Act or during such longer period as the
Secretary specifies by notice published in the Gazette before the
end of that first-mentioned period, to any goods.
(6) Where a person suffers any kind of loss, damage or injury caused
by, or arising out of, the use by the person of therapeutic goods to
which this section applies, no liability in respect of that loss,
damage or injury attaches to the Commonwealth, the Secretary or
any delegate of the Secretary.
67 Transitional provision for therapeutic goods for export only
Section 20 does not apply, during the period of 6 months after the
commencement of this Act, to therapeutic goods manufactured in
Australia solely for export from Australia.
68 Transitional arrangements for Part 3-3
(1) This section applies to a step in the manufacture of therapeutic
goods in relation to a person in relation to premises in Australia if,
before the commencement of this Act, the person was carrying out
that step in relation to goods of that kind at those premises.
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(2) Where:
(a) this section applies to a step in the manufacture of therapeutic
goods in relation to a person in relation to premises; and
(b) the Secretary is not aware of the person having been
convicted of an offence against a law of the Commonwealth,
of a State or of an internal Territory in respect of goods of
that kind during the period of 2 years ending on the
commencement of this Act;
subsection 35(1) does not apply the carrying out of that step by the
person in relation to goods of that kind at those premises during the
period of 4 months after that commencement.
(3) Where:
(a) this section applies to a step in the manufacture of therapeutic
goods in relation to a person in relation to premises; and
(b) the person makes an application for a licence to carry out that
step in relation to goods of that kind at those premises in
accordance with section 37 and within 4 months after the
commencement of this Act;
subsection 35(1) does not apply to the carrying out of that step by
the person in relation to goods of that kind at those premises until
the application is determined.
69 Continuation of standards and requirements
Any standards that were in force immediately before the
commencement of this Act under Part 2 of the Therapeutic Goods
Act 1966, and any requirements that were in force at that time
under section 15 of the Therapeutic Goods Act 1966, continue in
force as if they were standards made under Part 3-1 of this Act.
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Endnotes
Endnote 1—About the endnotes
Endnotes
Endnote 1—About the endnotes
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that
has amended (or will amend) the compiled law. The information includes
commencement details for amending laws and details of any application, saving
or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at
the provision (generally section or equivalent) level. It also includes information
about any provision of the compiled law that has been repealed in accordance
with a provision of the law.
Editorial changes
The Legislation Act 2003 authorises First Parliamentary Counsel to make
editorial and presentational changes to a compiled law in preparing a
compilation of the law for registration. The changes must not change the effect
of the law. Editorial changes take effect from the compilation registration date.
If the compilation includes editorial changes, the endnotes include a brief
outline of the changes in general terms. Full details of any changes can be
obtained from the Office of Parliamentary Counsel.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe
the amendment to be made. If, despite the misdescription, the amendment can
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be given effect as intended, the amendment is incorporated into the compiled
law and the abbreviation “(md)” added to the details of the amendment included
in the amendment history.
If a misdescribed amendment cannot be given effect as intended, the
abbreviation “(md not incorp)” is added to the details of the amendment
included in the amendment history.
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Endnote 2—Abbreviation key
Endnote 2—Abbreviation key
ad = added or inserted o = order(s)
am = amended Ord = Ordinance
amdt = amendment orig = original
c = clause(s) par = paragraph(s)/subparagraph(s)
/sub-subparagraph(s)C[x] = Compilation No. x
Ch = Chapter(s) pres = present
def = definition(s) prev = previous
Dict = Dictionary (prev…) = previously
disallowed = disallowed by Parliament Pt = Part(s)
Div = Division(s) r = regulation(s)/rule(s)
ed = editorial change reloc = relocated
exp = expires/expired or ceases/ceased to have renum = renumbered
effect rep = repealed
F = Federal Register of Legislation rs = repealed and substituted
gaz = gazette s = section(s)/subsection(s)
LA = Legislation Act 2003 Sch = Schedule(s)
LIA = Legislative Instruments Act 2003 Sdiv = Subdivision(s)
(md) = misdescribed amendment can be given SLI = Select Legislative Instrument
effect SR = Statutory Rules
(md not incorp) = misdescribed amendment Sub-Ch = Sub-Chapter(s)
cannot be given effect SubPt = Subpart(s)
mod = modified/modification underlining = whole or part not
commenced or to be commencedNo. = Number(s)
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Endnote 3—Legislation history
Endnote 3—Legislation history
Act Number Assent Commencement Application,
and year saving and
transitional
provisions
Therapeutic Goods Act 21, 1990 17 Jan 1990 15 Feb 1991 (s 2)
1989
Community Services and 141, 1990 28 Dec Part 8 (s 78–81): 15 Feb —
Health Legislation 1990 1991 (s 2(6))
Amendment Act (No. 2)
1990
Community Services and 84, 1991 26 June s 14: 1 Aug 1991 (s. 2(2) s 33–36
Health Legislation 1991 and gaz 1991, No. S207)
Amendment Act 1991 Remainder: 26 June
1991
Therapeutic Goods 204, 1991 24 Dec 24 Dec 1991 (s 2) s 4(2), 10(2) and
Amendment Act 1991 1991 13(2)
Health, Housing and 88, 1992 30 June s 82–88: 30 Jun 1992 s 83(2)
Community Services 1992 (s (1))
Legislation Amendment
Act 1992
Health and Community 76, 1993 25 Nov s 29(h) and 30–32: 14 s 33(2), 36(2),
Services Legislation 1993 Feb 1994 (gaz 1994, No 41(2), 49(2), 50(2)
Amendment Act (No. 2) GN5) and 51(2)
1993 s 29(i), 37(b), 38(b), 47
and 50(1)(d): 2 May
1994 (gaz 1994, No
S149)
Remainder: 25 Nov 1993
Customs, Excise and 85, 1995 1 July 1995 s 12 (items 5, 6): 1 July s 18
Bounty Legislation 1995 (s 2(1))
Amendment Act 1995 s 18: 1 Jul 1995 (s 2(1))
Therapeutic Goods 6, 1996 11 June 11 June 1996 (s 2) s 84
Amendment Act 1996 1996
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Endnote 3—Legislation history
Act Number Assent Commencement Application,
and year saving and
transitional
provisions
Therapeutic Goods
Amendment Act 1997
as amended by
Therapeutic Goods
Legislation
Amendment Act 1999
116, 1997
3, 1999
7 July 1997
29 Mar
1999
Schedule 1 (Part 2
(items 2–14)): 1 Jan
1999 (gaz 1998, No
S609)
Remainder: 7 July 1997
(No 3, 1999 below)
—
—
Audit (Transitional and
Miscellaneous)
Amendment Act 1997
152, 1997 24 Oct
1997
Sch 2 (item 1249): 1 Jan
1998 (gaz 1997, No
GN49) (s 2(2))
—
Therapeutic Goods
Legislation Amendment
Act 1998
34, 1998 17 Apr
1998
17 Apr 1998 (s 2) —
Therapeutic Goods
Legislation Amendment
Act 1999
3, 1999 29 Mar
1999
Sch 2: 1 Jan 1999 (gaz
1998, No S609) (s 2(3))
Remainder: 1 Apr 1999
(gaz 1999, No S143)
—
Public Employment
(Consequential and
Transitional)
Amendment Act 1999
146, 1999 11 Nov
1999
Sch 1 (items 936–938):
5 Dec 1999 (gaz 1999,
No S584) (s 2(1))
—
Therapeutic Goods 12, 2000 31 Mar 31 Mar 2000 (s 2) —
Amendment Act 2000 2000
Therapeutic Goods 56, 2000 30 May 30 May 2000 (s 2) Sch 1 (item 5)
Amendment Act (No. 2) 2000
2000
Therapeutic Goods 120, 2000 12 Sept Sch1: 10 Oct 2000 Sch 1 (items 4, 6,
Amendment Act (No. 3) 2000 Remainder: 12 Sept 8, 10, 17)
2000 2000
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 3—Legislation history
Act Number Assent Commencement Application,
and year saving and
transitional
provisions
Gene Technology 170, 2000 21 Dec 22 June 2001 (s 2) —
(Consequential 2000
Amendments) Act 2000
Therapeutic Goods 14, 2001 22 Mar 22 Sept 2001 Sch 1 (item 36)
Amendment Act 2001 2001
Australia New Zealand 81, 2001 10 July s 2(6): 10 Jul 2001 s 2(6)
Food Authority 2001 (s 2(1)(a))
Amendment Act 2001 Sch 3 (item 8): 1 July
2002 (s 2(2), (5) and gaz
2002, No GN30)
Health and Aged Care 111, 2001 17 Sept 17 Sept 2001 (s 2) s. 4
Legislation Amendment 2001
(Application of Criminal
Code) Act 2001
Therapeutic Goods 23, 2002 4 Apr 2002 4 Apr 2002 (s 2) —
Amendment Act (No. 1)
2002
Therapeutic Goods 24, 2002 4 Apr 2002 Sch 1: 4 Oct 2002 (s 2(1) Sch 1 (items 38,
Amendment (Medical item 2) 46, 55)
Devices) Act 2002 Sch 2: (s 2(1) item 5) s 2(1) (item 3)
(Sch 2 (item 8) rep No (rep by No 140,
140, 2007 (s 2)) 2007, Sch 1
Remainder: 4 Apr 2002 (item 7))
as amended by
Therapeutic Goods 56, 2002 3 July 2002 Sch 3 (item 22): (No 56, —
and Other Legislation 2002 below)
Amendment Act 2002
Therapeutic Goods 39, 2006 3 May 2006 Sch 1 (item 158): (h) —
Amendment Act
(No. 1) 2006
Therapeutic Goods 140, 2007 14 Sept Sch 1 (items 7, 8): 3 Oct —
Amendment Act 2007 2007 2007
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
670
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 3—Legislation history
Act Number Assent Commencement Application,
and year saving and
transitional
provisions
Therapeutic Goods and
Other Legislation
Amendment Act 2002
56, 2002 3 July 2002 Sch 1 (items 1–5), Sch 3
(items 1–3, 6–21) and
Sch 4 (item 2): 3 July
2002 (s 2(1) items 1, 3,
8)
Sch 1 (items 6, 7), Sch 3
(item 4) and Sch 4
(item 1): 4 Oct 2002
(s 2(1) items 2, 4, 7)
Sch 3 (item 5): never
commenced (s 2(1)
item 5)
Sch 3 (items 20,
21)
Therapeutic Goods
Amendment Act (No. 1)
2003
39, 2003 27 May
2003
Sch 1 (items 1–19) and
Sch 2: 27 Nov 2003 (s
2(1) items 2, 6)
Sch 1 (items 41, 55, 60):
27 May 2003 (s 2(1)
item 3)
Sch 1 (items 41,
55, 60)
Sch 1 (item 79): 17 Sept
2001 (s 2(1) item 4)
US Free Trade
Agreement
Implementation Act
2004
120, 2004 16 Aug
2004
Sch 7: 1 Jan 2005 Sch 7 (item 7)
Financial Framework
Legislation Amendment
Act 2005
8, 2005 22 Feb
2005
s 4 and Sch 1 (items 493,
496): 22 Feb 2005
s 4 and Sch 1
(item 496)
Therapeutic Goods
Amendment Act (No. 2)
2006
2, 2006 1 Mar 2006 Sch 1: 3 Apr 2006
(s 2(1) item 2)
Remainder: 1 Mar 2006
Sch 1 (item 15)
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
671
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 3—Legislation history
Act Number Assent Commencement Application,
and year saving and
transitional
provisions
Therapeutic Goods 5, 2006 3 Mar 2006 3 Mar 2006 (s 2) s. 3
Amendment (Repeal of
Ministerial responsibility
for approval of RU486)
Act 2006
Therapeutic Goods 39, 2006 3 May 2006 Sch 1 (items 1–117, s 2(1) (item 5)
Amendment Act (No. 1) 119–157): 31 May 2006 (rep by 140, 2007,
2006 Sch 1 (item 118): 27 Sch. 1 (item 4))
Nov 2003
Remainder: 3 May 2006
as amended by
Therapeutic Goods 140, 2007 14 Sept Sch 1 (items 4–6): 3 Oct —
Amendment Act 2007 2007 2007
National Health and 50, 2006 9 June 2006 Sch 1: 1 July 2006 —
Medical Research Remainder: 9 June 2006
Council Amendment Act
2006
Therapeutic Goods 96, 2006 5 Sept 2006 5 Sept 2006 (s 2) —
Amendment Act (No. 3)
2006
Therapeutic Goods 140, 2007 14 Sept 3 Oct 2007 (s 2) —
Amendment Act 2007 2007
Therapeutic Goods 9, 2008 20 Mar 20 Mar 2008 (s 2) —
Amendment (Poisons 2008
Standard) Act 2008
Statute Law Revision 73, 2008 3 July 2008 Sch 1 (item 47): 17 Sep —
Act 2008 2001 (s 2(1) item 31)
Therapeutic Goods 96, 2008 3 Oct 2008 Sch 1 (items 1–3): 1 Jan Sch. 1 (item 3)
Legislation Amendment 2009 (s 2(1) item 2)
(Annual Charges) Act
2008
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 3—Legislation history
Act Number
and year
Assent Commencement Application,
saving and
transitional
provisions
Therapeutic Goods
Amendment (Medical
Devices and Other
Measures) Act 2009
38, 2009 17 June
2009
Sch 1, 2 and 5–7:
18 June 2009 (s 2(1)
items 2, 5)
Sch 3: 1 Dec 2009
(s 2(1) item 3)
Sch 4: 1 July 2009
(s 2(1) item 4)
Remainder: 17 June
Sch 2 (item 4),
Sch 3 (item 23),
Sch 4 (item 20),
Sch 5 (item 3) and
Sch 6 (item 12)
2009 (s 2(1) item 1)
Therapeutic Goods 76, 2009 27 Aug
Amendment (2009 2009
Measures No. 1) Act
2009
Therapeutic Goods
Amendment (2009
Measures No. 2) Act
2009
96, 2009 29 Sept
2009
Sch 1, 3, 6 and Sch 7
(items 1–28): 28 Aug
2009 (s 2(1) items 2, 4,
7, 8)
Sch 2: 25 Feb 2010
(s 2(1) item 3)
Sch 4: 1 July 2011
(s 2(1) item 5)
Sch 5: 8 Feb 2010 (s 2(1)
item 6))
Sch 7 (items 29–58): 25
Jan 2010 (s 2(1) item 9)
Remainder: 27 Aug 2009
(s 2(1) item 1)
Sch 1: 1 July 2010
(s 2(1) item 2)
Sch 2 and Sch 3
(items 1–7): 30 Sept
2009 (s 2(1) items 3, 4)
Sch 3 (items 8–10): 29
Mar 2010
Remainder: 29 Sept
2009
Sch 1 (item 7),
Sch 2 (items 25,
26), Sch 3
(item 16), Sch 5
(item 5), Sch 6
(item 14) and Sch
7 (items 26–28,
56–59)
Sch. 1 (item 13),
Sch. 2 (item 4)
and Sch. 3
(items 7, 10)
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
673
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Endnotes
Endnote 3—Legislation history
Act Number Assent Commencement Application,
and year saving and
transitional
provisions
Statute Law Revision
Act 2010
8, 2010 1 Mar 2010 Sch 5 (items 124, 137):
1 Mar 2010(s 2(1)
items 31, 38)
—
Therapeutic Goods
Amendment (2009
Measures No. 3) Act
2010
54, 2010 31 May
2010
Sch 1: 31 May 2011
(s 2(1) item 2)
Sch 2–6: 1 June 2010
(s 2(1) item 3)
Remainder: 31 May
2010 (s 2(1) item 1)
Sch 1 (items 58–
60), Sch. 2
(items 15, 16),
Sch 3 (item 3),
Sch 4 (item 6),
Sch 5 (item 2) and
Sch 6 (item 20)
Therapeutic Goods
Amendment (2010
Measures No. 1) Act
2010
141, 2010 15 Dec
2010
Sch 1 and Sch 2
(items 7A–21): 16 Dec
2010 (s 2(1) items 2, 4)
Sch 1A and Sch 2
Sch 1A (item 10)
and Sch 2
(items 7, 21)
(items 1A–7): 12 Jan
2011 (s 2(1) items 2A, 3)
Sch 2 (items 22, 23):
31 May 2011 (s 2(1)
item 5)
Remainder: 15 Dec 2010
(s 2(1) item 1)
Statute Law Revision 5, 2011 22 Mar Schedule 7 (item 140): —
Act 2011 2011 19 Apr 2011 (s 2(1)
item 18)
Acts Interpretation
Amendment Act 2011
46, 2011 27 June
2011
Sch 2 (items 1150–1156)
and Sch 3 (items 10, 11):
27 Dec 2011
Sch. 3 (items 10,
11)
Therapeutic Goods
Amendment (2011
Measures No. 1) Act
2011
77, 2011 25 July
2011
26 July 2011 (s 2) Sch. 1 (items 6–8)
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
674
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 3—Legislation history
Act Number Assent Commencement Application,
and year saving and
transitional
provisions
Statute Law Revision 136, 2012 22 Sept Sch 6 (items 85–88): —
Act 2012 2012 22 Sept 2012
Personal Liability for 180, 2012 10 Dec Sch 5 and Sch 7: 11 Dec Sch 7
Corporate Fault Reform 2012 2012 (s 2)
Act 2012
Privacy Amendment
(Enhancing Privacy
Protection) Act 2012
197, 2012 12 Dec
2012
Sch 5 (item 98) and Sch
6 (items 15–19): 12 Mar
2014 (s 2(1) items 3, 19)
Sch 6 (item 1): 12 Dec
2012 (s 2(1) item 16)
Sch 6 (items 1,
15–19)
Therapeutic Goods
Amendment (2013
Measures No. 1) Act
2014
4, 2014 28 Feb
2014
28 Feb 2014 Sch 1 (items 23–
25), Sch 2
(item 16), Sch 3
(item 8), Sch 4
(item 4), Sch 5
(items 11, 12),
Sch 6 (item 14),
Sch 7 (item 5),
Sch 8 (item 2),
Sch 9 (item 2),
Sch 10 (item 2),
Sch 11 (item 3),
Sch 12 (item 2),
Sch 13 (items 6,
7), Sch 14
(item 3), Sch 15
(item 4) and Sch
16 (item 6)
Statute Law Revision 31, 2014 27 May Sch 8 (items 44, 45): —
Act (No. 1) 2014 2014 24 June 2014
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 3—Legislation history
Act Number Assent Commencement Application,
and year saving and
transitional
provisions
Public Governance, 62, 2014 30 June Sch 12 (items 230, 231) Sch 14
Performance and 2014 and Sch 14: 1 July 2014
Accountability (s 2(1) items 6, 14)
(Consequential and
Transitional Provisions)
Act 2014
as amended by
Public Governance 36, 2015 13 Apr Sch 2 (item 7) and Sch 7: Sch 7
and Resources 2015 14 Apr 2015 (s 2)
Legislation
Amendment Act
(No. 1) 2015
as amended by
Acts and 126, 2015 10 Sept Sch 1 (item 486): 5 Mar —
Instruments 2015 2016 (s 2(1) item 2)
(Framework
Reform)
(Consequential
Provisions) Act
2015
Acts and Instruments 126, 2015 10 Sept Sch 1 (item 495): 5 Mar —
(Framework Reform) 2015 2016 (s 2(1) item 2)
(Consequential
Provisions) Act 2015
Statute Law Revision 5, 2015 25 Feb Sch 3 (items 195–199): —
Act (No. 1) 2015 2015 25 Mar 2015 (s 2(1)
item 10)
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 3—Legislation history
Act Number Assent Commencement Application,
and year saving and
transitional
provisions
Customs and Other 41, 2015 20 May Sch 6 (items 190–197) Sch 6 (item 197)
Legislation Amendment 2015 and Sch 9: 1 July 2015 and Sch 9
(Australian Border (s 2(1) items 2, 7)
Force) Act 2015
as amended by
Australian Border 115, 2017 30 Oct Sch 1 (item 26): 1 July —
Force Amendment 2017 2015 (s 2(1) item 2)
(Protected
Information) Act 2017
Acts and Instruments
(Framework Reform)
(Consequential
Provisions) Act 2015
126, 2015 10 Sept
2015
Sch 1 (items 643–651): 5
Mar 2016 (s 2(1) item 2)
—
Statute Law Revision
Act (No. 1) 2016
4, 2016 11 Feb
2016
Sch 4 (items 1, 316–
320): 10 Mar 2016 (s
2(1) item 6)
—
Narcotic Drugs 12, 2016 29 Feb Sch 5 (item 1): 29 Oct —
Amendment Act 2016 2016 2016 (s 2(1) item 4)
Narcotic Drugs 76, 2016 23 Nov Sch 2 (items 47, 48): —
Legislation Amendment 2016 23 Nov 2016 (s 2(1)
Act 2016 item 3)
Therapeutic Goods 47, 2017 19 June Sch 1 and Sch 9: 1 July Sch 5 (item 4),
Amendment (2016 2017 2017 (s 2(1) items 2, 4) Sch 9 (item 3),
Measures No. 1) Act Sch 2, Sch 3 (items 2– Sch 10 (item 63),
2017 37), Sch 4–8, Sch 10– Sch 11 (item 2)
12): 20 June 2017 (s 2(1) and Sch 12
items 3, 5) (item 58)
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
677
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 3—Legislation history
Act Number
and year
Assent Commencement Application,
saving and
transitional
provisions
Therapeutic Goods
Amendment (2017
Measures No. 1) Act
2018
7, 2018 5 Mar 2018 Sch 1–5, 6 (items 1–51)
and 7–9: 6 Mar 2018
(s 2(1) items 2–5, 7–9)
Sch 6 (items 59–65):
1 July 2020 (s 2(1)
item 6)
Sch 2 (items 21–
23), Sch 4 (30, 50,
70), Sch 5
(item 66), Sch 6
(items 48–51),
Sch 6 (item 65),
Sch 7 (items 330–
342), Sch 8
(item 6) and Sch 9
(items 39–41)
Therapeutic Goods
Amendment (2018
Measures No. 1) Act
2018
104, 2018 21 Sept
2018
Sch 1: 1 Jan 2019 (s 2(1)
item 2)
Sch 2 (items 1–13): 22
Sept 2018 (s 2(1) item 3)
Sch 2 (items 14, 15): 19
Oct 2018 (s 2(1) item 4)
Sch 1 (item 4) and
Sch 2 (items 13,
15)
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 4—Amendment history
Endnote 4—Amendment history
Provision affected How affected
Chapter 1
Part 1, heading ...............................rep. No. 24, 2002
Chapter 1 heading ..........................ad No. 24, 2002
s 3 ..................................................am No. 141, 1990; No. 84, 1991; No. 88, 1992; No. 76, 1993; No. 6, 1996;
No. 116, 1997; No. 34, 1998; No. 3, 1999; Nos. 12, 56, 120 and 170, 2000;
No 14, 2001; No 81, 2001; No 111, 2001; No 24, 2002 (as am by No 56,
2002); No 56, 2002; No 39, 2003; No 5, 2006; No 39, 2006; No 50, 2006;
No 9, 2008; No 38, 2009; No 76, 2009; No 96, 2009; No 54, 2010; No 141,
2010; No 5, 2011; No 4, 2014; No 31, 2014; No 41, 2015; No 47, 2017; No
7, 2018; No 104, 2018
s 3AA.............................................ad No. 76, 2009
am No 126, 2015
s 3AB ad. No. 76, 2009
am No 126, 2015
s. 3A...............................................ad No. 116, 1997
am. No. 12, 2000; No 4, 2014
s. 3B...............................................ad No. 56, 2002
am No 4, 2014
s. 3C...............................................ad No. 38, 2009
am No 126, 2015
s. 4 .................................................rs No. 204, 1991; No. 76, 1993; No. 3, 1999
am. No. 24, 2002
s. 5 .................................................am No. 39, 2006
s. 5A...............................................ad No. 111, 2001
rs. No. 39, 2006
am No 7, 2018
s. 6 .................................................am No. 76, 1993
s. 6AA............................................ad No. 6, 1996
am. No. 111, 2001
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 4—Amendment history
Provision affected How affected
rep. No. 5, 2006
s. 6AB............................................ad No. 6, 1996
rep. No. 5, 2006
s. 6A...............................................ad No. 76, 1993
am. No. 146, 1999; No. 24, 2002
rep. No. 56, 2002
s 6AAA..........................................ad No. 56, 2002
s 6AAB ..........................................ad No. 56, 2002
s 6AAC ..........................................ad No. 56, 2002
s 6AAD..........................................ad No. 56, 2002
s. 6AAE .........................................ad No. 56, 2002
am. No. 56, 2002; No. 54, 2010; No 7, 2018
s 6B................................................ad No. 76, 1993
s 6C ad. No. 76, 1993
s. 7 .................................................am No. 76, 1993; No. 24, 2002; No. 141, 2010; No 4, 2014
s 7AA.............................................ad No 4, 2014
am No 126, 2015
s. 7A...............................................ad No. 76, 1993
s. 7B...............................................ad No. 76, 1993
am. No. 24, 2002; No. 54, 2010; No 4, 2014
s. 7C...............................................ad No. 76, 2009
s. 7D...............................................ad No. 141, 2010
s. 8 .................................................am No. 84, 1991; No. 6, 1996; No. 111, 2001; No. 38, 2009; No 4, 2014
s. 9 .................................................am No. 54, 2010
Chapter 2
Chapter 2 ................................ ad. No. 24, 2002
s. 9A...............................................ad No. 24, 2002
am. No. 56, 2002; No. 54, 2010; No 4, 2014; No 7, 2018
s. 9B...............................................ad No. 24, 2002
am. No. 140, 2007
s. 9C...............................................ad No. 24, 2002
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 4—Amendment history
Provision affected How affected
am. No. 38, 2009
s. 9D...............................................ad No. 24, 2002
am No 54, 2010; No 141, 2010; No 77, 2011; No 47, 2017; No 7, 2018; No
104, 2018
s. 9E...............................................ad No. 24, 2002
s 9F ................................................ad No 4, 2014
s 9G................................................ad No 4, 2014
am No 7, 2018
s 9H................................................ad No 4, 2014
Chapter 3
Part 2 heading ................................rep. No. 24, 2002
Chapter 3 heading ..........................ad No. 24, 2002
Chapter 3 ................................ am No. 24, 2002; No 140, 2007
Part 3-1
Part 3-1 heading.............................ad No. 24, 2002
s. 10 ...............................................am No. 24, 2002; Nos. 38 and 76, 2009; No 46, 2011; No 126, 2015; No
47, 2017; No 104, 2018
s 10A..............................................ad No. 24, 2002
s 11 ................................................rep. No. 76, 2009
s 12 rep. No. 76, 2009
s. 13 ...............................................rs No. 38, 2009
am No 4, 2014
s. 13A.............................................ad No. 76, 2009
s. 14 ...............................................am No. 85, 1995; No. 6, 1996; No. 39, 2003
rs. No. 39, 2006
am. No 38, 2009; No 54, 2010; No 180, 2012; No 4, 2014; No 7, 2018
s. 14A.............................................ad No. 39, 2006
am. No. 54, 2010; No 4, 2014
s. 14B.............................................ad No. 39, 2006
am No 41, 2015; No 7, 2018
s. 15 ...............................................am No. 6, 1996; No. 111, 2001
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 4—Amendment history
Provision affected How affected
rs. No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 7, 2018
s. 15AA..........................................ad No. 39, 2006
s. 15AB..........................................ad No. 54, 2010
Part 3-2
Part 3 heading ................................rep. No. 24, 2002
Part 3-2 heading.............................ad No. 24, 2002
Division 1
s. 15A.............................................ad No. 24, 2002
s. 15B.............................................ad No. 54, 2010
s. 16 ...............................................am No. 141, 1990; No. 84, 1991; No. 76, 1993; No. 14, 2001; No. 24,
2002
s. 17 ...............................................am No. 84, 1991; No. 3, 1999; No. 56, 2002
rep. No. 24, 2002
s. 18 ...............................................rs No. 204, 1991
am. No. 120, 2000
s. 18A.............................................ad No. 23, 2002
am. No. 39, 2006; No. 38, 2009; No. 54, 2010
s. 19 ...............................................am No. 204, 1991; No. 6, 1996; No. 120, 2000; No. 54, 2010; No 12,
2016; No 76, 2016; No 47, 2017; No 7, 2018; No 104, 2018
s. 19A.............................................ad No. 6, 1996
am. No. 76, 2009; No 4, 2014; No 47, 2017; No 7, 2018
s. 19B.............................................ad No. 39, 2006
am. No. 38, 2009; No. 180, 2012; No 41, 2015; No 7, 2018
s 19C..............................................ad No. 39, 2006
s 19D..............................................ad No. 39, 2006
am No 41, 2015
s. 20 ...............................................am No. 204, 1991; No. 85, 1995; No. 6, 1996; No. 56, 2000; No. 111,
2001; No. 23, 2002; No. 39, 2003; No. 39, 2006; No. 38, 2009; No 4,
2016; No 7, 2018
s. 20A.............................................ad No. 39, 2006
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 21 ...............................................am No. 204, 1991; No. 6, 1996; No. 111, 2001; No. 23, 2002; No. 38,
2009
s. 21A.............................................ad No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 47, 2017; No 7, 2018
s. 21B.............................................ad No. 39, 2006
am No 7, 2018
s. 22 ...............................................am No. 204, 1991; No. 6, 1996; No. 120, 2000; Nos. 14 and 111, 2001;
No. 23, 2002; No. 39, 2003; No. 39, 2006; No. 180, 2012; Nos. 38 and 96,
2009; No 4, 2016; No 7, 2018
s. 22AA..........................................ad No. 39, 2006
s. 22A.............................................ad No. 204, 1991
am. No. 6, 1996; No. 111, 2001; No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 7, 2018
s. 22B.............................................ad No. 39, 2006
Division 1A
Division 1A................................ad No 7, 2018
s 22C..............................................ad No 7, 2018
s 22D..............................................ad No 7, 2018
s 22E..............................................ad No 7, 2018
s 22F ..............................................ad No 7, 2018
Division 2
s. 23 ...............................................am No. 84, 1991; No. 76, 1993; No. 141, 2010
rs No 7, 2018
s. 23AA..........................................ad No. 6, 1996
rep. No. 5, 2006
ad No 7, 2018
s 23A..............................................ad No 7, 2018
s 23B..............................................ad No 7, 2018
s 23C..............................................ad No 7, 2018
s. 24 ...............................................am Nos. 84 and 204, 1991; No. 77, 2011; No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 24A.............................................ad No. 84, 1991
am. No. 204, 1991; No. 77, 2011
s. 24B.............................................ad No. 84, 1991
am. No. 24, 2002
s. 24C.............................................ad No. 84, 1991
s. 24D.............................................ad No. 204, 1991
am. No. 56, 2002; No. 76, 2009; No. 77, 2011; No 4, 2014
s. 24E.............................................ad No. 88, 1992
s. 25 ...............................................am Nos. 84 and 204, 1991; No. 76, 1993; No 6, 1996; No. 116, 1997; No
34, 1998; No. 12, 2000; Nos. 24 and 56, 2002; No. 39, 2003; No. 120,
2004; No. 2, 2006; Nos. 54 and 141, 2010; No 4, 2014; No 7, 2018
s 25AAA................................ ad No 47, 2017
am No 104, 2018
s. 25AA..........................................ad No. 141, 2010
am No 4, 2014; No 7, 2018
s 25AB...........................................ad No 4, 2014
am No 7, 2018
s 25AC...........................................ad No 4, 2014
am No 7, 2018
s. 25A.............................................ad No. 34, 1998
am. No. 54, 2010
s. 25B.............................................ad No. 116, 1997 (as am. by No. 3, 1999)
am. No. 56, 2002; No 7, 2018
s. 26 ...............................................am No. 76, 1993; No. 6, 1996; No. 116, 1997; No. 12, 2000; No. 14, 2001;
Nos. 24 and 56, 2002; No. 39, 2003; No. 120, 2004; No. 2, 2006; No. 76,
2009; Nos. 54 and 141, 2010; No 4, 2014; No 7, 2018
s. 26AA..........................................ad No. 116, 1997
am. No. 56, 2002; No 7, 2018
s. 26A.............................................ad No. 6, 1996
am. No. 116, 1997; No. 12, 2000; No. 14, 2001; Nos. 24 and 56, 2002;
No. 39, 2003; No. 120, 2004; No. 2, 2006; No. 76, 2009; Nos. 54 and 141,
2010; No 4, 2014; No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 26AB...........................................ad No 7, 2018
s 26AC...........................................ad No 7, 2018
s 26AD...........................................ad No 7, 2018
s 26AE ...........................................ad No 7, 2018
s. 26B.............................................ad No. 120, 2004
am. No. 2, 2006; No. 38, 2009; No 4, 2016
s. 26BA..........................................ad No. 2, 2006
am No 4, 2014; No 7, 2018
s. 26BB ..........................................ad No. 76, 2009
rs. No. 141, 2010
am No 126, 2015; No 7, 2018
s. 26BC ..........................................ad No 76, 2009
am No 141, 2010
s. 26BD..........................................ad No. 76, 2009
am. No. 141, 2010
rep No 47, 2017
s. 26BE ..........................................ad No. 76, 2009
rep. No. 141, 2010
ad No 47, 2017
am No 7, 2018
s 26BF............................................ad No 7, 2018
s 26BG...........................................ad No 7, 2018
s 26BH...........................................ad No 7, 2018
s 26BJ ............................................ad No 7, 2018
s. 26C.............................................ad No. 120, 2004
am. No. 38, 2009
s. 26D.............................................ad No. 120, 2004
s. 27 ...............................................rs No. 84, 1991
s. 28 ...............................................am No. 84, 1991; No. 76, 1993; No. 3, 1999; No. 14, 2001; No. 39, 2003;
No. 76, 2009; No. 54, 2010; No 4, 2014; No 47, 2017
Therapeutic Goods Act
ed C67
1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
am No 7, 2018
s. 28A.............................................ad No. 76, 2009
am No 7, 2018
s 29 ................................................am No. 76, 2009; No 7, 2018
s. 29A.............................................ad No. 88, 1992
am. No. 6, 1996; No. 39, 2003; No. 39, 2006; No 38, 2009; No 180, 2012
s. 29AA..........................................ad No. 39, 2006
s. 29B.............................................ad No. 88, 1992
am. No. 6, 1996; No. 111, 2001; No. 39, 2003; No. 39, 2006; No. 38, 2009;
No 180, 2012
s. 29C.............................................ad No. 39, 2006
s. 29D.............................................ad No. 76, 2009
am No 4, 2014; No 7, 2018
s. 29E.............................................ad No. 76, 2009
am No 4, 2014
s. 29F .............................................ad No. 76, 2009
am No 4, 2014
s. 29G.............................................ad No. 76, 2009
s. 30 ...............................................am No. 88, 1992; No. 6, 1996; No. 34, 1998; No. 56, 2000; Nos. 14 and
111, 2001; No. 39, 2003; No. 39, 2006; No. 76, 2009; No. 141, 2010; No 4,
2014; No 47, 2017; No 7, 2018
s. 30A.............................................ad No. 6, 1996
am. No. 111, 2001; No. 23, 2002
rep. No. 39, 2003
ad. No. 76, 2009
s 30AA...........................................ad No 47, 2017
s. 30B.............................................ad No. 116, 1997
rep. No. 39, 2003
ad No 4, 2014
s. 30C.............................................ad No. 170, 2000
am. No. 96, 2009; No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 30D.............................................ad No. 170, 2000
am. No. 96, 2009
s. 30E.............................................ad No. 170, 2000
Division 2A
Division 2A heading ......................rs No 47, 2017
Division 2A................................ad. No. 39, 2003
s. 30EA ..........................................ad No. 39, 2003
am. No. 39, 2006; No. 76, 2009; No. 54, 2010; No 4, 2014; No 47, 2017;
No 7, 2018
s. 30EB ..........................................ad No. 39, 2003
am No 4, 2014
s. 30EC ..........................................ad No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 7, 2018
s. 30ECA................................ ad. No. 39, 2006
s. 30ED ..........................................ad No. 39, 2003
am. No. 76, 2009
s 30EE............................................ad No 47, 2017
Division 2B
Division 2B................................ad No 104, 2018
s 30EF............................................ad No 104, 2018
s 30EG ...........................................ad No 104, 2018
s 30EH ...........................................ad No 104, 2018
s 30EI.............................................ad No 104, 2018
s 30EJ ............................................ad No 104, 2018
Division 3
s. 30F .............................................ad No. 23, 2002
am. No. 39, 2006; No. 38, 2009; No 180, 2012; No 126, 2015; No 47,
2017; No 7, 2018
s. 30FA ..........................................ad No. 39, 2006
s. 30G.............................................ad No. 23, 2002
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 30H.............................................ad No. 23, 2002
am. No. 38, 2009
s 31 ................................................am No 84, 1991; No 76, 1993; No 6, 1996; No 34, 1998; No 14, 2001; No
111, 2001; No 39, 2003; No 39, 2006; No 38, 2009; No 54, 2010; No 141,
2010; No 77, 2011; No 180, 2012; No 4, 2014; No 47, 2017; No 7, 2018;
No 104, 2018
s. 31AAA................................ ad. No. 39, 2006
am No 4, 2014
s. 31A.............................................ad No. 120, 2000
am. No. 39, 2006
s. 31AA..........................................ad No. 23, 2002
am. No. 39, 2006
s. 31B.............................................ad No. 120, 2000
am. No. 39, 2006; No 47, 2017
s 31BA...........................................ad No 47, 2017
s. 31C.............................................ad No. 120, 2000
am. No. 23, 2002
rs. No. 39, 2006
am. No. 38, 2009; No 47, 2017; No 7, 2018
s. 31D.............................................ad No. 120, 2000
am. No. 23, 2002; No. 39, 2006; No. 38, 2009; No 180, 2012; No 4, 2016;
No 47, 2017; No 7, 2018
s. 31E.............................................ad No. 120, 2000
am. No. 39, 2006; No. 38, 2009; No 180, 2012; No 4, 2016; No 47, 2017;
No 7, 2018
s. 31F .............................................ad No. 120, 2000
am. No. 39, 2006; No 47, 2017; No 7, 2018
Part 3-2A
Part 3-2A ................................ ad. No. 54, 2010
Division 1
s. 32 ...............................................am Nos. 84 and 204, 1991; No. 76, 1993; No. 6, 1996
rep. No. 24, 2002
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Endnotes
Endnote 4—Amendment history
Provision affected How affected
ad. No. 54, 2010
am No 47, 2017
s. 32A.............................................ad No. 54, 2010
am No 126, 2015
s 32AA...........................................ad No. 54, 2010
am No 7, 2018
s 32AB...........................................ad No. 54, 2010
Division 2
s. 32B.............................................ad No. 54, 2010
s. 32BA..........................................ad No. 54, 2010
am No. 180, 2012; No 47, 2017; No 7, 2018
s. 32BB ..........................................ad No. 54, 2010
am No. 180, 2012; No 7, 2018
s 32BBA ................................ ad No 7, 2018
s. 32BC ..........................................ad No. 54, 2010
am No. 180, 2012; No 7, 2018
s. 32BD..........................................ad No. 54, 2010
am No. 180, 2012; No 47, 2017; No 7, 2018
s. 32BE ..........................................ad No. 54, 2010
s. 32BF...........................................ad No. 54, 2010
am No 47, 2017; No 7, 2018
s. 32BG..........................................ad No. 54, 2010
am No 7, 2018
s. 32BH..........................................ad No. 54, 2010
am No 47, 2017; No 7, 2018
s. 32BI ...........................................ad No. 54, 2010
am No 47, 2017; No 7, 2018
s. 32BJ ...........................................ad No. 54, 2010
am No 47, 2017; No 7, 2018
s. 32BK..........................................ad No. 54, 2010
am No 47, 2017; No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 32BL ...........................................ad No 7, 2018
Division 3
Subdivision A
s. 32C.............................................ad No. 54, 2010
Subdivision B
s. 32CA..........................................ad No. 54, 2010
am No 126, 2015
Subdivision C
s. 32CB ..........................................ad No 54, 2010
am No 46, 2011
s 32CC ...........................................ad No 54, 2010
s 32CD...........................................ad No 54, 2010
am No 46, 2011
s. 32CE ..........................................ad No. 54, 2010
s. 32CF...........................................ad No. 54, 2010
s. 32CG..........................................ad No. 54, 2010
s. 32CH..........................................ad No 54, 2010
am No 180, 2012
s. 32CI ...........................................ad No. 54, 2010
s. 32CJ ...........................................ad No. 54, 2010
am No. 180, 2012; No 47, 2017; No 7, 2018
Subdivision D
Subdivision D heading...................rs No 47, 2017
s 32CK...........................................ad No. 54, 2010
am No 7, 2018
s 32CL ...........................................ad No. 54, 2010
s 32CM ..........................................ad No. 54, 2010
am No 47, 2017; No 7, 2018; No 104, 2018
s 32CN...........................................ad No. 54, 2010
am No 47, 2017; No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
Subdivision E
s. 32CO..........................................ad No. 54, 2010
am No 47, 2017; No 7, 2018
Division 4
Subdivision A
s. 32D.............................................ad No. 54, 2010
Subdivision B
s. 32DA..........................................ad No. 54, 2010
am No 4, 2014
s. 32DB..........................................ad No. 54, 2010
s. 32DC..........................................ad No. 54, 2010
Subdivision C
s. 32DD..........................................ad No. 54, 2010
am No 7, 2018
s 32DDA................................ ad No 7, 2018
s. 32DE ..........................................ad No. 54, 2010
am No 4, 2014; No 7, 2018
ed C69
s 32DEA ................................ ad No 47, 2017
am No 104, 2018
s. 32DF ..........................................ad No. 54, 2010
am No 7, 2018
s. 32DG..........................................ad No. 54, 2010
am No 7, 2018
s. 32DH..........................................ad No. 54, 2010
am No 7, 2018
s. 32DI ...........................................ad No. 54, 2010
am No 7, 2018
s. 32DJ ...........................................ad No. 54, 2010
s. 32DK..........................................ad No. 54, 2010
s. 32DL ..........................................ad No. 54, 2010
Therapeutic Goods Act 1989
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Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 32DM .........................................ad No. 54, 2010
Subdivision D
s. 32DN..........................................ad No. 54, 2010
Subdivision E
s. 32DO..........................................ad No. 54, 2010
am No. 180, 2012; No 7, 2018
s. 32DP ..........................................ad No. 54, 2010
s. 32DQ..........................................ad No. 54, 2010
am No 180, 2012
s. 32DR..........................................ad No. 54, 2010
am No 180, 2012
Subdivision F
s 32DS ...........................................ad No. 54, 2010
s 32DT ...........................................ad No. 54, 2010
s 32DU...........................................ad No. 54, 2010
Division 5
s. 32E.............................................ad No. 54, 2010
s. 32EA ..........................................ad No. 54, 2010
am No 7, 2018
s. 32EB ..........................................ad No. 54, 2010
s. 32EC ..........................................ad No. 54, 2010
am No 7, 2018
s. 32ED ..........................................ad No. 54, 2010
s. 32EE...........................................ad No. 54, 2010
am No 4, 2014
s. 32EF...........................................ad No. 54, 2010
am No. 180, 2012; No 7, 2018
s. 32EG ..........................................ad No. 54, 2010
Division 6
s. 32F .............................................ad No. 54, 2010
s. 32FA ..........................................ad No. 54, 2010
Therapeutic Goods Act 1989
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
am No 4, 2014; No 7, 2018
s. 32FB...........................................ad No. 54, 2010
am No 4, 2014
s. 32FC...........................................ad No. 54, 2010
am No 4, 2014
s. 32FD ..........................................ad No. 54, 2010
Division 7
s. 32G.............................................ad No. 54, 2010
s. 32GA..........................................ad No. 54, 2010
am No 4, 2014; No 7, 2018
s. 32GB..........................................ad No. 54, 2010
am No 4, 2014
s. 32GC..........................................ad No. 54, 2010
am No 4, 2014; No 7, 2018
s. 32GD..........................................ad No. 54, 2010
s 32GDA................................ ad No 47, 2017
s. 32GE ..........................................ad No. 54, 2010
am No 4, 2014
s. 32GF ..........................................ad No. 54, 2010
Division 8
Division 8 heading.........................rs No 47, 2017
s. 32H.............................................ad No. 54, 2010
am No 47, 2017
s. 32HA..........................................ad No. 54, 2010
am No 4, 2014; No 47, 2017; No 7, 2018
s. 32HB..........................................ad No. 54, 2010
am No 4, 2014
s. 32HC..........................................ad No. 54, 2010
am No. 180, 2012; No 7, 2018
s. 32HD..........................................ad No. 54, 2010
s. 32HE ..........................................ad No. 54, 2010
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 32HF ...........................................ad No 47, 2017
Division 9
Subdivision A
s. 32J..............................................ad No. 54, 2010
Subdivision B
s. 32JA...........................................ad No. 54, 2010
am No 4, 2014
s. 32JB ...........................................ad No. 54, 2010
am No 180, 2012; No 4, 2014; No 7, 2018
s. 32JC ...........................................ad No. 54, 2010
s. 32JD...........................................ad No. 54, 2010
am No 7, 2018
Subdivision C
s. 32JE ...........................................ad No. 54, 2010
s. 32JF............................................ad No. 54, 2010
s. 32JG...........................................ad No. 54, 2010
am No 47, 2017
s. 32JH...........................................ad No. 54, 2010
am No 47, 2017
s. 32JI.............................................ad No. 54, 2010
am No 180, 2012; No 7, 2018
s. 32JJ ............................................ad No. 54, 2010
s. 32JK...........................................ad No. 54, 2010
am No 7, 2018
Subdivision D
s 32JL ............................................ad No. 54, 2010
s 32JM ...........................................ad No. 54, 2010
s. 33 ...............................................rep No. 24, 2002
Part 3-3
Part 4 heading ................................rep. No. 24, 2002
Part 3-3 heading.............................ad No. 24, 2002
Therapeutic Goods Act 1989
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 33A.............................................ad No. 24, 2002
s. 33B.............................................ad No. 54, 2010
s. 35 ...............................................am No. 6, 1996; No. 111, 2001; No. 23, 2002; No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009; No. 54, 2010; No. 180, 2012; No 7, 2018
s. 35A.............................................ad No. 39, 2006
am. No. 54, 2010
s. 35B.............................................ad No. 39, 2006
am. No. 38, 2009; No 7, 2018
s. 35C.............................................ad No. 39, 2006
s. 36 ...............................................am No. 76, 2009; No 47, 2017
s. 37 ...............................................am No. 76, 1993; No. 56, 2002; No. 96, 2006; No. 76, 2009
am No 4, 2014
s. 38 ...............................................am No. 76, 1993; No. 34, 1998; No. 39, 2003; No. 39, 2006; Nos. 38 and
76, 2009; No 46, 2011; No 4, 2014
s 38A..............................................ad No. 76, 2009
s 38B..............................................ad No. 76, 2009
s. 39 ...............................................am No. 23, 2002; No. 54, 2010
s. 40 ...............................................am No. 76, 1993; No. 56, 2002; No. 39, 2003; Nos. 38 and 76, 2009;
No. 54, 2010; No. 4, 2014
s 40A..............................................ad No 76, 2009
s 40B..............................................ad No 76, 2009
am No 46, 2011; No 7, 2018
s. 41 ...............................................am No. 34, 1998; No. 23, 2002; No. 39, 2003; No. 39, 2006; Nos. 38 and
76, 2009; No. 54, 2010; No 4, 2014
s 41AAAA ................................ad No 4, 2014
s. 41AA..........................................ad No. 38, 2009
s 41AB...........................................ad No 47, 2017
s 41AC...........................................ad No 47, 2017
s 41AD...........................................ad No 47, 2017
s 41AE ...........................................ad No 47, 2017
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 41AF ...........................................ad No 47, 2017
s 41AG...........................................ad No 47, 2017
s. 41AAA................................ ad. No. 76, 2009
s 41A (prev s 42)............................am No 76, 1993
renum No 24, 2002
am No 76, 2009
Chapter 4
Chapter 4 ................................ ad. No. 24, 2002
am No 140, 2007
Part 4-1
Division 1
s. 41B.............................................ad No. 24, 2002
am. No. 39, 2006
s. 41BA..........................................ad No. 24, 2002
am No 7, 2018
s. 41BB ..........................................ad No. 24, 2002
am. No. 38, 2009; No 47, 2017; No 7, 2018
s. 41BC ..........................................ad No. 24, 2002
am. No. 39, 2006
Division 2
s. 41BD..........................................ad No. 24, 2002
am. No. 76, 2009; No 4, 2014
s. 41BE ..........................................ad No. 24, 2002
am. No. 76, 2009
s. 41BEA................................ ad. No. 96, 2009
s. 41BF...........................................ad No. 24, 2002
s. 41BG..........................................ad No. 24, 2002
am. No. 76, 2009
s 41BH...........................................ad No 24, 2002
s 41BI ............................................ad No 24, 2002
s 41BIA..........................................ad No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 41BIB..........................................ad No 7, 2018
Division 3
s. 41BJ ...........................................ad No. 24, 2002
s. 41BJA ................................ ad. No. 54, 2010
s. 41BK..........................................ad No. 24, 2002
Part 4-2
s. 41C.............................................ad No 24, 2002
am No 39, 2006
Division 1
s. 41CA..........................................ad No. 24, 2002
Division 2
s. 41CB ..........................................ad No. 24, 2002
am. No. 76, 2009; No 126, 2015
s. 41CC ..........................................ad No. 24, 2002
am. No. 38, 2009; No. 46, 2011; No 4, 2014
s. 41CD..........................................ad No. 24, 2002
Part 4-3
s. 41D.............................................ad No 24, 2002
am No 39, 2006
Division 1
s 41DA...........................................ad No. 24, 2002
s 41DB...........................................ad No. 24, 2002
Division 2
s. 41DC..........................................ad No. 24, 2002
am. No. 76, 2009; No 126, 2015
s. 41DD..........................................ad No. 24, 2002
am. No. 46, 2011; No 4, 2014
s. 41DE ..........................................ad No. 24, 2002
Part 4-4
s. 41E.............................................ad No. 24, 2002
am No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
Division 1
s 41EA ...........................................ad No 24, 2002
s 41EB ...........................................ad No 24, 2002
am No. 39, 2006
s. 41EC ..........................................ad No. 24, 2002
am. No. 39, 2003; No. 39, 2006; No. 38, 2009; No 7, 2018
s 41ECA.........................................ad No 47, 2017
am No 104, 2018
s. 41ED ..........................................ad No. 24, 2002
am. No. 54, 2010
s 41EE............................................ad No. 24, 2002
am No 7, 2018
s 41EF............................................ad No. 24, 2002
am No 7, 2018
s. 41EG ..........................................ad No. 24, 2002
am. No. 38, 2009; No. 141, 2010; No 7, 2018
s. 41EH ..........................................ad No. 24, 2002
s. 41EI............................................ad No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 7, 2018
s. 41EIA.........................................ad No. 39, 2006
Division 2
Division 2 heading.........................am No. 39, 2006
Division 2 ................................ am No 7, 2018
s. 41EJ ...........................................ad No. 24, 2002
am. Nos. 38 and 76, 2009
s. 41EK ..........................................ad No. 24, 2002
s. 41EL...........................................ad No. 24, 2002
am No 4, 2014
Division 3
Division 3 ................................ am No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 41EM ad. No. 24, 2002
s 41EN ...........................................ad No. 24, 2002
s 41EO ...........................................ad No. 24, 2002
s 41EP............................................ad No. 24, 2002
s 41EQ ...........................................ad No. 24, 2002
Division 4
Division 4 ................................ am No 7, 2018
s. 41ER ..........................................ad No. 24, 2002
s. 41ES...........................................ad No. 24, 2002
am No 4, 2014
s. 41ET...........................................ad No. 24, 2002
am. No. 39, 2003; No. 39, 2006; No. 38, 2009; No 7, 2018
s. 41EU ..........................................ad No. 24, 2002
s. 41EV ..........................................ad No. 24, 2002
am No 4, 2014
s. 41EW .........................................ad No. 24, 2002
Part 4–4A
Part 4–4A................................ ad No 47, 2017
s 41EWA ................................ ad No 47, 2017
am No 7, 2018
s 41EWB................................ ad No 7, 2018
s 41EWC................................ ad No 7, 2018
s 41EWD ................................ ad No 7, 2018
Part 4-5
s. 41F .............................................ad No. 24, 2002
am No 7, 2018
Division 1
s. 41FA ..........................................ad No. 24, 2002
am No 39, 2006; No 7, 2018
s. 41FB...........................................ad No. 24, 2002
rep No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
Subdivision A
s. 41FC...........................................ad No. 24, 2002
am No 39, 2006
rs No 7, 2018
s. 41FD ..........................................ad No. 24, 2002
am. No. 39, 2003; No. 96, 2009; No 4, 2014; No 7, 2018
s 41FDA.........................................ad No 7, 2018
s 41FDB.........................................ad No 7, 2018
s. 41FE...........................................ad No. 24, 2002
am. No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 7, 2018
s. 41FEA................................ ad. No. 39, 2006
Subdivision B
s. 41FF ...........................................ad No. 24, 2002
am. No. 96, 2009; No 7, 2018
s. 41FG ..........................................ad No. 24, 2002
rs No 7, 2018
Subdivision C
s. 41FH ..........................................ad No. 24, 2002
am No 4, 2014; No 7, 2018
s. 41FI............................................ad No. 24, 2002
am No 7, 2018
s 41FIA ..........................................ad No 47, 2017
rs No 7, 2018
s. 41FJ............................................ad No. 24, 2002
s. 41FK ..........................................ad No. 24, 2002
am. No. 141, 2010; No 4, 2014; No 7, 2018
Subdivision D
s 41FKA.........................................ad No 47, 2017
am No 104, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
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Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 41FL............................................ad No 24, 2002
s 41FM...........................................ad No 24, 2002
am No 7, 2018
Division 2
Division 2 heading.........................rs No. 39, 2006
Division 2 ................................ am No 7, 2018
s. 41FN ..........................................ad No. 24, 2002
am. No. 39, 2006; No. 76, 2009; No 47, 2017; No 7, 2018; No 104, 2018
s. 41FO ..........................................ad No. 24, 2002
s. 41FP ...........................................ad No. 24, 2002
am No 4, 2014
Part 4-6
Division 1
Subdivision A
s. 41G.............................................ad No. 24, 2002
am No 7, 2018
s. 41GA..........................................ad No. 24, 2002
am No 4, 2014; No 7, 2018
s. 41GB..........................................ad No. 24, 2002
s. 41GC..........................................ad No. 24, 2002
am No 4, 2014
s. 41GD..........................................ad No. 24, 2002
am No 4, 2014
s. 41GE ..........................................ad No. 24, 2002
Subdivision B
Subdivision B heading ...................rs No 7, 2018
s. 41GF ..........................................ad No. 24, 2002
am No 4, 2014; No 7, 2018
s 41GFA.........................................ad No 7, 2018
s. 41GG..........................................ad No. 24, 2002
am No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
701
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 41GH..........................................ad No. 24, 2002
am No 4, 2014; No 7, 2018
Subdivision C
s. 41GI ...........................................ad No. 24, 2002
am No 39, 2006
s. 41GJ ...........................................ad No. 24, 2002
Division 2
s. 41GK..........................................ad No. 24, 2002
s. 41GL ..........................................ad No. 24, 2002
am. No. 39, 2003; No 4, 2014; No 7, 2018
s 41GLA ................................ ad No 4, 2014
s 41GLB.........................................ad No 47, 2017
s. 41GM .........................................ad No. 24, 2002
am No 4, 2014
s. 41GN..........................................ad No. 24, 2002
am. No. 39, 2006; No 7, 2018
s. 41GO..........................................ad No. 24, 2002
s. 41GP ..........................................ad No. 24, 2002
am No 4, 2014
s. 41GQ..........................................ad No. 24, 2002
Part 4-6A
Part 4-6A ................................ ad. No. 38, 2009
s 41GR...........................................ad No 38, 2009
am No 47, 2017
s 41GS ...........................................ad No 38, 2009
s 41GT ...........................................ad No 38, 2009
s 41GU...........................................ad No 38, 2009
s 41GV...........................................ad No 38, 2009
s 41GW..........................................ad No 38, 2009
s 41GX...........................................ad No. 38, 2009
rep. No. 54, 2010
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
702
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 41GY..........................................ad No. 38, 2009
Part 4-7
Part 4-7 heading.............................rs No. 38, 2009
s. 41H.............................................ad No. 24, 2002
am. No. 38, 2009; No. 141, 2010; No 47, 2017
s. 41HA..........................................ad No. 24, 2002
am. No. 39, 2006
s. 41HB..........................................ad No. 24, 2002
am. No. 39, 2006; No 7, 2018
s. 41HC..........................................ad No. 24, 2002
am. No. 54, 2010; No 47, 2017; No 7, 2018; No 104, 2018
s. 41HD..........................................ad No. 141, 2010
am No 126, 2015; No 47, 2017; No 7, 2018
Part 4-8
s. 41J..............................................ad No. 24, 2002
am No. 39, 2006; No 7, 2018
Division 1
s. 41JA...........................................ad No. 24, 2002
am. No. 39, 2003; Nos. 38 and 76, 2009; No 4, 2014; No 7, 2018
s. 41JB ...........................................ad No. 24, 2002
am. No. 39, 2006; No. 38, 2009; No 180, 2012; No 4, 2014; No 7, 2018
s. 41JBA ................................ ad. No. 39, 2006
s. 41JC ...........................................ad No. 24, 2002
am. No. 39, 2006; No 7, 2018
Division 2
s. 41JCA ................................ ad. No. 38, 2009
s 41JD............................................ad No. 24, 2002
am. No. 39, 2006
s 41JE ............................................ad No. 24, 2002
am. No. 39, 2006
s 41JF.............................................ad No. 24, 2002
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
703
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
am. No. 39, 2006; No 47, 2017
s. 41JFA.........................................ad No. 141, 2010
am No 47, 2017
s. 41JG...........................................ad No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009; No. 141, 2010; No 7, 2018
s. 41JH...........................................ad No. 24, 2002
am. No. 39, 2006; No. 38, 2009; No. 141, 2010; No 180, 2012; No 4, 2016;
No 7, 2018
s. 41JI.............................................ad No. 24, 2002
am. No. 39, 2006; No. 38, 2009; No. 141, 2010; No 180, 2012; No 4, 2016;
No 7, 2018
s. 41JJ ............................................ad No. 24, 2002
am. No. 39, 2006; No. 38, 2009; No. 141, 2010
Part 4-9
Part 4-9 heading.............................rs No 47, 2017
s. 41K.............................................ad No. 24, 2002
am No 47, 2017
s. 41KA..........................................ad No. 24, 2002
am. No. 38, 2009; Nos. 54, and 141, 2010; No 47, 2017; No 7, 2018
s. 41KB..........................................ad No. 24, 2002
am No 4, 2014
s. 41KC..........................................ad No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 7, 2018
s. 41KCA ................................ ad. No. 39, 2006
s. 41KD..........................................ad No. 24, 2002
s 41KE ...........................................ad No 47, 2017
Part 4-10
s. 41L.............................................ad No. 24, 2002
s 41LA ...........................................ad No 24, 2002
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
704
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 41LB ...........................................ad No 24, 2002
s 41LC ...........................................ad No 24, 2002
s 41LD ...........................................ad No 24, 2002
s 41LE............................................ad No 24, 2002
Part 4-11
Part 4-11 heading...........................rs No. 39, 2006
s. 41M............................................ad No. 24, 2002
am. No. 39, 2006; No. 38, 2009; No 7, 2018
Division 1
s. 41MA .........................................ad No. 24, 2002
am. No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 7, 2018
s. 41MAA ................................ ad. No. 39, 2006
am. No. 38, 2009; No 7, 2018
s. 41MB .........................................ad No. 24, 2002
am. No. 39, 2006
s. 41MC .........................................ad No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 7, 2018
s. 41MCA ................................ ad. No. 39, 2006
s. 41MD .........................................ad No. 24, 2002
am. No. 39, 2006; No 41, 2015; No 7, 2018
Division 2
s. 41ME..........................................ad No. 24, 2002
am. No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 7, 2018
s. 41MEA................................ ad. No. 39, 2006
am. No. 38, 2009
s. 41MF..........................................ad No. 24, 2002
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
705
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
am. No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009; No 180, 2012; No 7, 2018
s. 41MG .........................................ad No. 24, 2002
am. No. 39, 2006; No 7, 2018
s. 41MH .........................................ad No. 24, 2002
am No. 39, 2003; No 39, 2006; No. 38, 2009; No 180, 2012; No 4, 2016;
No 7, 2018
s 41MHA ................................ ad No 39, 2006
am No 7, 2018
Division 3
s. 41MI...........................................ad No. 24, 2002
am. No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009; No. 141, 2010; No 180, 2012; No 47, 2017; No 7, 2018
s. 41MIA................................ ad. No. 39, 2006
s. 41MIB ................................ ad. No. 39, 2006
am. No. 38, 2009; No. 141, 2010; No 47, 2017
s. 41MJ ..........................................ad No. 24, 2002
am. No. 39, 2006; No 41, 2015; No 7, 2018
s. 41MK .........................................ad No. 24, 2002
am. No. 38, 2009; No. 141, 2010; No 4, 2016; No 47, 2017
s. 41ML..........................................ad No. 24, 2002
am. No. 39, 2006; No. 38, 2009
rs. No. 96, 2009; No 7, 2018
s. 41MLA................................ ad. No. 39, 2006
am. No. 141, 2010; No 47, 2017
s 41MLB................................ ad No 7, 2018
s. 41MM ................................ ad. No. 24, 2002
am. No. 38, 2009; No 4, 2016
rs No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
706
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 41MN .........................................ad No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009; No. 141, 2010; No 180, 2012; No 47, 2017; No 7, 2018
s. 41MNA ................................ ad. No. 39, 2006
am No 7, 2018
Division 3A
Division 3A................................ad. No. 38, 2009
s. 41MNB ................................ ad. No. 38, 2009
am No 180, 2012
s. 41MNC ................................ ad. No. 38, 2009
s. 41MND ................................ ad. No. 38, 2009
Division 4
Division 4 heading.........................rs No. 39, 2006
s. 41MO .........................................ad No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009; No 47, 2017; No 7, 2018
s. 41MP..........................................ad No. 24, 2002
am. No. 39, 2006; No. 38, 2009; No 180, 2012; No 4, 2016; No 47, 2017;
No 7, 2018
s 41MPA................................ ad. No. 39, 2006
am No 47, 2017; No 7, 2018
s 41MPB ................................ ad. No. 39, 2006
s. 41MQ .........................................ad No. 24, 2002
am. No. 39, 2006; No. 38, 2009; No 180, 2012; No 4, 2016
s. 41MR .........................................ad No. 39, 2006
Chapter 5
Part 4A heading .............................rep. No. 24, 2002
Chapter 5 heading ..........................ad No. 24, 2002
Part 4A...........................................ad No. 3, 1999
Part 5-1
Part 5-1 heading.............................ad No. 24, 2002
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
707
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
rs. No. 39, 2003
Division 1
Division 1 of ................................ad. No. 39, 2003
s. 42AA..........................................ad No. 39, 2003
am. No. 76, 2009
s. 42AB..........................................ad No. 39, 2003
s. 42AC..........................................ad No. 39, 2003
am. No. 38, 2009; No 7, 2018
s. 42A.............................................ad No. 3, 1999
rep. No. 39, 2003
s. 42B.............................................ad No. 3, 1999
am. No. 39, 2003; No. 38, 2009; No 7, 2018
s. 42BAA ................................ ad. No. 76, 2009
am No 104, 2018
Division 2
Division 2 ................................ rep No 7, 2018
Division 2 heading.........................ad No. 39, 2003
rep No 7, 2018
s. 42BA..........................................ad No. 39, 2003
rep No 7, 2018
s. 42C.............................................ad No. 3, 1999
rs. No. 39, 2003
am. No. 39, 2006; No 4, 2016
rep No 7, 2018
s. 42D.............................................ad No. 3, 1999
rep. No. 39, 2003
Division 3
Division 3 ................................ ad. No. 39, 2003
s. 42DA..........................................ad No. 39, 2003
rs. No. 38, 2009; No 7, 2018
s. 42DB..........................................ad No. 39, 2003
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
708
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 42DC..........................................ad No. 39, 2003
rep. No. 38, 2009
s. 42DD..........................................ad No. 39, 2003
am. Nos. 38 and 76, 2009; No 7, 2018
s 42DE ...........................................ad No 39, 2003
rs No 104, 2018
s. 42DF ..........................................ad No. 39, 2003
am. No 76, 2009; No 7, 2018
s 42DG...........................................ad No 39, 2003
s 42DH...........................................ad No 39, 2003
s 42DI ............................................ad No 39, 2003
am No 7, 2018
s 42DK...........................................ad No 39, 2003
am No 8, 2010
rs No 7, 2018
Division 3A
Division 3A heading ......................ad No. 38, 2009
rs No 7, 2018
s 42DKA................................ ad. No. 38, 2009
rep No 7, 2018
s 42DKB ................................ ad. No. 38, 2009
am No 7, 2018
s. 42DL ..........................................ad No. 39, 2003
am. No. 38, 2009; No. 54, 2010; No 4, 2014
rs No 7, 2018
s 42DLA ................................ ad No 7, 2018
s 42DLB.........................................ad No 7, 2018
s 42DLC.........................................ad No 7, 2018
s. 42DM .........................................ad No. 39, 2003
am No 4, 2016
rs No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
709
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 42DMA ................................ ad No 7, 2018
Division 4
Division 4 ................................ ad. No. 39, 2003
s 42DN...........................................ad No. 39, 2003
s 42DO...........................................ad No. 39, 2003
am No 7, 2018
s 42DP ...........................................ad No. 39, 2003
am No 4, 2016
rs No 7, 2018
s 42DQ...........................................ad No 7, 2018
Division 5
Division 5 ................................ ad No 7, 2018
s 42DR...........................................ad No 7, 2018
s 42DS ...........................................ad No 7, 2018
s 42DT ...........................................ad No 7, 2018
s 42DU...........................................ad No 7, 2018
Division 6
Division 6 ................................ ad No 7, 2018
s 42DV...........................................ad No 7, 2018
s 42DW..........................................ad No 7, 2018
s 42DX...........................................ad No 7, 2018
Division 7
Division 7 ................................ ad No 7, 2018
s 42DY...........................................ad No 7, 2018
Part 5-2
Part 4B heading..............................rep. No. 24, 2002
Part 5-2 heading.............................ad No. 24, 2002
Part 4B...........................................ad No. 56, 2000
s. 42E.............................................ad No. 56, 2000
am. No. 39, 2003; No. 39, 2006; No. 38, 2009; No 180, 2012; No 4, 2016
s 42EA ...........................................ad No. 39, 2006
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
710
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 42EB ...........................................ad No. 39, 2006
s. 42F .............................................ad No. 56, 2000
am No 41, 2015
Part 5-3
Part 4C heading..............................rep. No. 24, 2002
Part 5-3 heading.............................ad No. 24, 2002
Part 4C...........................................ad No. 120, 2000
s. 42T.............................................ad No. 120, 2000
am. No. 39, 2006; No. 38, 2009; No 180, 2012; No 4, 2016; No 47, 2017
s. 42U.............................................ad No. 120, 2000
s. 42V.............................................ad No. 120, 2000
am. No. 24, 2002; No. 39, 2006; No. 38, 2009; No. 54, 2010; No 180,
2012; No 4, 2014; No 47, 2017; No 7, 2018
s 42VA...........................................ad No. 39, 2006
am No 47, 2017
s 42VB...........................................ad No. 39, 2006
am No 47, 2017
s. 42W............................................ad No. 120, 2000
am. No. 39, 2006; No. 38, 2009; No 180, 2012; No 4, 2016; No 47, 2017
s. 42X.............................................ad No. 120, 2000
Chapter 5A
Chapter 5A................................ad. No. 39, 2006
Part 5A-1
Division 1
s. 42Y.............................................ad No. 39, 2006
s. 42YA..........................................ad No. 39, 2006
s. 42YB..........................................ad No. 39, 2006
rep No 31, 2014
s. 42YC..........................................ad No. 39, 2006
s 42YCA ................................ ad No 7, 2018
s. 42YD..........................................ad No. 39, 2006
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
711
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 42YE ..........................................ad No. 39, 2006
am. No. 38, 2009
Division 2
s 42YF ...........................................ad No. 39, 2006
s 42YG...........................................ad No. 39, 2006
s 42YH...........................................ad No. 39, 2006
s 42YI ............................................ad No. 39, 2006
Part 5A-2
Part 5A–2................................ rs No 7, 2018
s 42YJ ............................................ad No. 39, 2006
rs No 7, 2018
s 42YK...........................................ad No. 39, 2006
rs No 7, 2018
s 42YKA................................ ad No 7, 2018
s 42YKB ................................ ad No 7, 2018
s 42YKC ................................ ad No 7, 2018
s 42YKD................................ ad No 7, 2018
s 42YKE ................................ ad No 7, 2018
Part 5A-3
s. 42YL ..........................................ad No. 39, 2006
am. No. 8, 2010
Part 5A-4
Part 5A–4................................ ad No 7, 2018
s 42YM ..........................................ad No 7, 2018
s 42YN...........................................ad No 7, 2018
s 42YO...........................................ad No 7, 2018
s 42YP ...........................................ad No 7, 2018
s 42YQ...........................................ad No 7, 2018
s 42YR...........................................ad No 7, 2018
Chapter 6
Part 5 heading ................................rep. No. 24, 2002
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
712
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
Chapter 6 heading ..........................ad No. 24, 2002
Part 6-1
Part 6-1 heading.............................ad No. 24, 2002
s. 43 ...............................................am No. 24, 2002; No 7, 2018
s. 44 ...............................................am No. 84, 1991; No. 24, 2002
rs. No. 96, 2008
am No 7, 2018
s. 44A.............................................ad No. 96, 2008
s. 44B.............................................ad No. 54, 2010
am No 7, 2018
s. 45 ...............................................rs No. 152, 1997
am. No. 24, 2002
rs. No. 8, 2005
am No 62, 2014; No 7, 2018
Part 6-2
Part 6 heading ................................rep. No. 6, 1996
Part 5A heading .............................ad No. 6, 1996
rep. No. 24, 2002
Part 6-2 heading.............................ad No. 24, 2002
s. 45A.............................................ad No. 6, 1996
am. No. 39, 2006
s. 46 ...............................................rs No. 6, 1996
am No 7, 2018
s. 46A.............................................ad No. 6, 1996
am. Nos. 23 and 24, 2002; Nos. 38 and 76, 2009; Nos. 54 and 141, 2010;
No 47, 2017; No 7, 2018
s. 46B.............................................ad No 6, 1996
s. 47 ...............................................am No. 76, 1993
rs. No. 6, 1996
am. No. 39, 2006; No 7, 2018
s. 48 ...............................................am No. 6, 1996; No. 111, 2001; Nos. 38 and 76, 2009; No 7, 2018
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
713
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s 48A..............................................ad No. 6, 1996
s 48AA...........................................ad No 7, 2018
s 48B..............................................ad No. 6, 1996
s 48BA...........................................ad No 7, 2018
s. 48C.............................................ad No. 6, 1996
am. No. 39, 2006; No 7, 2018
s. 48D.............................................ad No. 6, 1996
am No 7, 2018
s. 48E.............................................ad No. 6, 1996
am. No. 39, 2006; No 7, 2018
s 48F ..............................................ad No 6, 1996
s 48FA ...........................................ad No 7, 2018
s 48G..............................................ad No 6, 1996
s 48H..............................................ad No 6, 1996
s. 48J..............................................ad No. 6, 1996
am. No. 39, 2006
s. 49 ...............................................am No. 6, 1996; No 7, 2018
s. 50 ...............................................am No 6, 1996; No. 39, 2006; No 7, 2018
s. 51 ...............................................am No 6, 1996; No 39, 2006
s. 51A.............................................ad No. 76, 1993
am No 7, 2018
s. 51B.............................................ad No. 6, 1996
am. No. 38, 2009
s. 52 ...............................................am No. 6, 1996; No. 111, 2001; No. 38, 2009
Part 6-3
Part 5B heading..............................rep. No. 24, 2002
Part 6-3 heading.............................ad No. 24, 2002
rs. No. 96, 2009
Part 5B...........................................ad No. 3, 1999
s. 52AA..........................................ad No. 96, 2009
s. 52A.............................................ad No. 3, 1999
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
714
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
am. No. 96, 2009; No 126, 2015
s 52B..............................................ad No. 3, 1999
rs. No. 96, 2009
s 52C..............................................ad No. 3, 1999
rs. No. 96, 2009
s. 52CA..........................................ad No. 96, 2009
s. 52D.............................................ad No. 3, 1999
am. No. 9, 2008; No. 96, 2009; No 126, 2015
s. 52E.............................................ad No. 3, 1999
rs. No. 96, 2009
s. 52EAA ................................ ad. No. 96, 2009
s 52EA ...........................................ad No. 9, 2008
rep No 126, 2015
s 52EB ...........................................ad No. 9, 2008
s. 52EC ..........................................ad No. 96, 2009
Part 5C heading..............................rep. No. 24, 2002
Part 6-4 heading.............................ad No. 24, 2002
rep. No. 76, 2009
Part 5C...........................................ad No. 3, 1999
Part 6-4 ..........................................rep. No. 76, 2009
s 52F ..............................................ad No. 3, 1999
rep. No. 76, 2009
s 52G..............................................ad No. 3, 1999
rep. No. 76, 2009
Chapter 7
Part 6 heading ................................ad No. 6, 1996
rep. No. 24, 2002
Chapter 7 heading ..........................ad No. 24, 2002
s. 53 ...............................................rs No. 24, 2002
am. No. 54, 2010
s. 53A.............................................ad No. 39, 2006
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
715
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
am. No. 54, 2010; No 4, 2014; No 47, 2017; No 7, 2018
s. 54 ...............................................am No. 204, 1991; No. 76, 1993; No. 6, 1996; No. 24, 2002; No. 39, 2006;
No 4, 2014; No 7, 2018
s. 54AA..........................................ad No. 3, 1999
am. No. 111, 2001; No. 39, 2003; No. 73, 2008; No 4, 2016
s. 54AB..........................................ad No. 39, 2003
am. No. 39, 2006; No. 38, 2009; No 180, 2012; No 4, 2016
s. 54A.............................................ad No 6, 1996
s. 54B.............................................ad No. 39, 2006
am. No. 180, 2012; No 7, 2018
s. 54BA..........................................ad No. 180, 2012
am No 47, 2017; No 7, 2018
s. 54C.............................................ad No. 39, 2006
s 55 ................................................am No 6, 1996; No 39, 2006; No 5, 2015
s. 56 ...............................................am No. 24, 2002; Nos. 38 and 76, 2009
s. 56A.............................................ad No. 6, 1996
am. No. 24, 2002; No. 39, 2006; Nos. 38 and 76, 2009; Nos. 54 and 141,
2010; No 4, 2014; No 47, 2017; No 7, 2018
s. 57 ...............................................am Nos. 84 and 204, 1991; No. 88, 1992; No. 6, 1996; No. 146, 1999;
Nos. 23 and 24, 2002; No. 5, 2006; Nos. 38 and 96, 2009; Nos. 54 and 141,
2010; No 47, 2017
s. 58 ...............................................am No. 76, 1993; No. 76, 2009
s. 59 ...............................................am No. 54, 2010
s. 60 ...............................................am No. 6, 1996; No. 24, 2002; No. 39, 2003; No. 39, 2006; No. 76, 2009;
Nos. 54 and 141, 2010; No 4, 2014; No 47, 2017; No 7, 2018
s. 60A.............................................ad No. 6, 1996
am. No. 24, 2002; No. 54, 2010
s. 61 ...............................................am No. 84, 1991; No. 88, 1992; No. 76, 1993; No. 116, 1997; No. 34,
1998; Nos. 12 and 120, 2000; No. 24, 2002; No. 39, 2006; Nos. 38 and 76,
2009; No. 54, 2010; No 197, 2012; No 47, 2017; No 7, 2018
s. 61A.............................................ad No. 54, 2010
s. 62 ...............................................rep. No. 136, 2012
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
716
Authorised Version C2019C00066 registered 22/01/2019
Endnotes
Endnote 4—Amendment history
Provision affected How affected
s. 63 ...............................................am No. 204, 1991; No. 76, 1993; No. 6, 1996; No. 34, 1998; No. 24, 2002;
No. 54, 2010; No 47, 2017; No 7, 2018
Chapter 8
Part 7 heading ................................rep. No. 24, 2002
Chapter 8 heading ..........................ad No. 24, 2002
s. 64 ...............................................rep. No. 136, 2012
s. 65 ...............................................rep. No. 136, 2012
s. 66 ...............................................am No. 76, 1993
s. 69 ...............................................am No. 24, 2002; No. 136, 2012
Schedule ................................ am. No. 141, 1990
rep. No. 136, 2012
Therapeutic Goods Act 1989
Compilation No. 72 Compilation date: 1/1/19 Registered: 22/1/19
717