Prepared by the Office of Parliamentary Counsel, Canberra
Therapeutic Goods Act 1989
No. 21, 1990 as amended
Compilation start date: 11 December 2012
Includes amendments up to: Act No. 180, 2012
ComLaw Authoritative Act C2013C00132
About this compilation
The compiled Act
This is a compilation of the Therapeutic Goods Act 1989 as amended and in
force on 11 December 2012. It includes any amendment affecting the compiled
Act to that date.
This compilation was prepared on 28 March 2013.
The notes at the end of this compilation (the endnotes) include information
about amending Acts and instruments and the amendment history of each
amended provision.
Uncommenced provisions and amendments
If a provision of the compiled Act is affected by an uncommenced amendment,
the text of the uncommenced amendment is set out in the endnotes.
Application, saving and transitional provisions for amendments
If the operation of an amendment is affected by an application, saving or
transitional provision, the provision is set out in the endnotes.
Modifications
If a provision of the compiled Act is affected by a textual modification that is in
force, the text of the modifying provision is set out in the endnotes.
Provisions ceasing to have effect
If a provision of the compiled Act has expired or otherwise ceased to have
effect in accordance with a provision of the Act, details of the provision are set
out in the endnotes.
ComLaw Authoritative Act C2013C00132
Therapeutic Goods Act 1989 i
Contents
Chapter 1—Preliminary 1 1 Short title ...........................................................................................1
2 Commencement.................................................................................1
3 Interpretation .....................................................................................1
3AA Homoeopathic preparations and homoeopathic standards ...............18
3AB Anthroposophic preparations and anthroposophic standards...........19
3A Declaration—member of European Community .............................20
3B Declaration—country covered by non-EC/EFTA MRA..................20
3C Exempting monographs in pharmacopoeias ....................................21
4 Objects of Act..................................................................................21
5 Act to bind Crown ...........................................................................22
5A Application of the Criminal Code—extended geographical
jurisdiction.......................................................................................22
6 Operation of Act ..............................................................................22
6AAA Commonwealth consent to conferral of functions etc. on its
officers and authorities by corresponding State laws.......................23
6AAB When duty imposed .........................................................................23
6AAC Imposing duty under State law ........................................................25
6AAD Conferral of jurisdiction on federal courts.......................................25
6AAE Consequences of State law conferring duty, function or
power on Commonwealth officer or Commonwealth
authority ..........................................................................................26
6B Review of certain decisions under State laws..................................27
6C Fees payable to Commonwealth under State laws...........................27
7 Declaration that goods are/are not therapeutic goods ......................27
7A Authorised persons ..........................................................................28
7B Kits ..................................................................................................29
7C Secretary may arrange for use of computer programs to
make decisions ................................................................................29
7D Form for product information for medicine.....................................30
8 Power to obtain information with respect to therapeutic
goods ...............................................................................................30
9 Arrangements with States etc. .........................................................31
Chapter 2—Australian Register of Therapeutic Goods 32 9A Australian Register of Therapeutic Goods.......................................32
9B When registrations or listings of medical devices are taken to
be cancelled .....................................................................................33
9C Inspection of entries in Register ......................................................35
9D Variation of entries in Register........................................................35
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9E Publication of list of goods on Register ...........................................38
Chapter 3—Medicines and other therapeutic goods
that are not medical devices 39
Part 3-1—Standards 39 10 Determination of standards..............................................................39
10A Application of standards to medical devices....................................40
13 Special provisions relating to Ministerial standards and
default standards..............................................................................40
13A Special provisions relating to homoeopathic standards and
anthroposophic standards ................................................................42
14 Criminal offences for importing, supplying or exporting
goods that do not comply with standards.........................................42
14A Civil penalties for importing, supplying or exporting goods
that do not comply with standards ...................................................48
14B Application of Customs Act 1901 ....................................................49
15 Criminal offences relating to breaching a condition of a
consent.............................................................................................50
15AA Civil penalty relating to breaching a condition of a consent ............51
15AB Conditions relating to exceptional release of biologicals.................51
Part 3-2—Registration and listing of therapeutic goods 52
Division 1—Preliminary 52
15A Application of this Part to medical devices .....................................52
15B Application of this Part to a biological ............................................54
16 Therapeutic goods and gazetted groups...........................................55
18 Exempt goods ..................................................................................56
18A Exemption because of emergency ...................................................57
19 Exemptions for special and experimental uses ................................60
19A Exemptions where unavailability etc. of therapeutic goods.............62
19B Criminal offences relating to registration or listing etc. of
imported, exported, manufactured and supplied therapeutic
goods ...............................................................................................64
19C Notice required to adduce evidence in support of exception
under subsection 19B(6)..................................................................68
19D Civil penalties relating to registration or listing etc. of
imported, exported, manufactured and supplied therapeutic
goods ...............................................................................................69
20 Criminal offences relating to notifying the Secretary and to
importing goods exempt under section 18A ....................................71
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20A Civil penalty relating to the importation, exportation,
manufacture or supply of sponsored goods without proper
notification ......................................................................................73
21 Offence relating to wholesale supply...............................................74
21A General criminal offences relating to this Part.................................74
21B General civil penalties relating to this Part ......................................79
22 General offences relating to this Part...............................................80
22AA Civil penalty for breaching a condition of an exemption.................83
22A Criminal offences for false statements in applications for
registration.......................................................................................83
22B Civil penalty for false statements in applications for
registration.......................................................................................84
Division 2—Registration and listing 85
23 Applications generally.....................................................................85
24 Applications for registration ............................................................85
24A When evaluation fee due for payment .............................................86
24B Payment of evaluation fee by instalments .......................................86
24C Recovery of evaluation fee ..............................................................87
24D Refund of evaluation fee where evaluation not completed
within prescribed period ..................................................................87
24E Deemed refusal of application .........................................................87
25 Evaluation and registration of therapeutic goods.............................88
25AA Approved product information for medicine ...................................92
25A When the Secretary must not use protected information .................93
25B Registration of therapeutic device to which EC/EFTA
attestation of conformity applies .....................................................94
26 Listing of therapeutic goods ............................................................95
26AA Listing of therapeutic device to which EC/EFTA attestation
of conformity applies.......................................................................98
26A Listing of certain medicines.............................................................99
26B Certificates required in relation to patents .....................................102
26BA Approved form for notices ............................................................104
26BB Permissible ingredients..................................................................104
26BC Variation of determination under section 26BB—Minister’s
initiative.........................................................................................105
26BD Variation of determination under section 26BB—application
by person .......................................................................................105
26C Certificates required in relation to patent infringement
proceedings....................................................................................106
26D Requirements for interlocutory injunction.....................................108
27 Registration or listing number .......................................................110
28 Conditions of registration or listing ...............................................110
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28A Certification of manufacturing steps outside Australia
following application for listing ....................................................114
29 Duration of registration or listing ..................................................114
29A Criminal offence for failing to notify adverse effects etc. of
goods .............................................................................................114
29AA Civil penalty for failing to notify adverse effects etc. of
goods .............................................................................................115
29B Notification of adverse effects etc. where application
withdrawn or lapses.......................................................................116
29C Civil penalties for failing to notify adverse effects etc. where
application withdrawn or lapses ....................................................116
29D Suspension of registration or listing ..............................................117
29E When suspension takes effect etc. .................................................118
29F Revocation of suspension ..............................................................119
29G Effect of suspension ......................................................................120
30 Cancellation of registration or listing ............................................120
30A Revocation of cancellation of registration or listing upon
request ...........................................................................................123
30C Consultation with Gene Technology Regulator.............................123
30D Secretary may seek advice about classes of GM products or
genetically modified organisms .....................................................124
30E Secretary to take advice into account ............................................125
Division 2A—Public notification and recovery of therapeutic
goods 126
30EA Public notification and recovery of therapeutic goods...................126
30EB Publication of requirements...........................................................128
30EC Criminal offences for non-compliance with requirements.............128
30ECA Civil penalty for non-compliance with requirements.....................129
30ED Powers of suspension and cancellation unaffected ........................129
Division 3—General 130
30F Criminal offences for goods exempt under section 18A not
conforming to standards etc...........................................................130
30FA Civil penalty for goods exempt under section 18A not
conforming to standards etc...........................................................132
30G Disposal of unused goods exempt under section 18A ...................132
30H Record for goods exempt under section 18A.................................133
31 Secretary may require information ................................................134
31AAA Civil penalty for providing false or misleading information
in relation to medicines listed under section 26A..........................138
31A Secretary may require information etc. about goods exempt
under section 18.............................................................................139
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31AA Secretary may require information etc. about goods exempt
under section 18A..........................................................................140
31B Secretary may require information relating to approvals and
authorities under section 19...........................................................141
31C Criminal offence for failing to give information or
documents sought under section 31A, 31AA or 31B.....................142
31D False or misleading information ....................................................142
31E False or misleading documents......................................................143
31F Self-incrimination..........................................................................144
Part 3-2A—Biologicals 145
Division 1—Preliminary 145
32 What this Part is about...................................................................145
32A Meaning of biological ...................................................................145
32AA Biological classes ..........................................................................146
32AB When biologicals are separate and distinct from other
biologicals .....................................................................................146
Division 2—Main criminal offences and civil penalties 147
32B What this Division is about ...........................................................147
32BA Criminal offences for importing a biological.................................147
32BB Criminal offences for exporting a biological .................................149
32BC Criminal offences for manufacturing a biological .........................152
32BD Criminal offences for supplying a biological.................................154
32BE Notice required to adduce evidence in support of exception
to offences .....................................................................................156
32BF Civil penalties for importing, exporting, manufacturing or
supplying a biological....................................................................158
32BG Criminal offence and civil penalty relating to a failure to
notify the Secretary about manufacturing......................................161
32BH Criminal offence relating to wholesale supply ..............................163
32BI Criminal offence for using a biological not included in the
Register..........................................................................................163
32BJ General criminal offences relating to this Part...............................166
32BK Civil penalty for making misrepresentations about
biologicals .....................................................................................167
Division 3—Exemptions 168
Subdivision A—Preliminary 168
32C What this Division is about ...........................................................168
Subdivision B—Exempting biologicals under the regulations 168
32CA Exempt biologicals ........................................................................168
Subdivision C—Exempting biologicals to deal with emergencies 169
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32CB Minister may make exemptions.....................................................169
32CC Conditions of exemptions..............................................................170
32CD Variation or revocation of exemption............................................171
32CE Informing persons of exemption etc. .............................................171
32CF Notification and tabling .................................................................172
32CG Disposal of unused biologicals ......................................................172
32CH Criminal offences for breaching a condition of an exemption .......173
32CI Civil penalty for breaching a condition of an exemption...............174
32CJ Criminal offences and civil penalty for biologicals not
conforming to standards etc...........................................................174
Subdivision D—Exempting biologicals for special and
experimental uses 177
32CK Approvals for importing, exporting or supplying a biological
for special and experimental uses ..................................................177
32CL Conditions of use of biological for experimental purposes in
humans ..........................................................................................178
32CM Exemptions for medical practitioners ............................................179
32CN Criminal offences relating to the giving of an authority to a
medical practitioner .......................................................................180
Subdivision E—Exempting biologicals where substitutes are
unavailable etc. 182
32CO Approvals where substitutes for biologicals are unavailable
etc. .................................................................................................182
Division 4—Including biologicals in the Register 185
Subdivision A—Preliminary 185
32D What this Division is about ...........................................................185
Subdivision B—Class 1 biologicals 185
32DA Application for inclusion in the Register .......................................185
32DB Inclusion of Class 1 biological in the Register ..............................186
32DC Refusal to include Class 1 biological in the Register.....................187
Subdivision C—Biologicals other than Class 1 biologicals 187
32DD Application for inclusion in the Register .......................................187
32DE Evaluation of biologicals ...............................................................188
32DF Inclusion of biological in the Register ...........................................188
32DG Refusal to include biological in the Register .................................189
32DH Lapsing of application ...................................................................190
32DI Evaluation fee................................................................................190
32DJ When evaluation fee due for payment ...........................................191
32DK Payment of evaluation fee by instalments .....................................191
32DL Recovery of evaluation fee ............................................................191
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32DM Reduction of evaluation fee where evaluation not completed
within prescribed period ................................................................191
Subdivision D—Transitional provisions for existing biologicals 192
32DN Transitional provisions for existing biologicals.............................192
Subdivision E—Criminal offences and civil penalties 195
32DO Criminal offences for false statements in applications for
including biologicals in the Register .............................................195
32DP Civil penalty for false statements in applications for
including biologicals in the Register .............................................196
32DQ Criminal offence and civil penalty for failing to notify
adverse effects etc. of biological while it is included in the
Register..........................................................................................196
32DR Criminal offences and civil penalties for failing to notify
adverse effects etc. of biological where application
withdrawn or lapses.......................................................................197
Subdivision F—Advice from Gene Technology Regulator 199
32DS Consultation with Gene Technology Regulator.............................199
32DT Secretary may seek advice about classes of GM products or
genetically modified organisms .....................................................200
32DU Secretary to take advice into account ............................................200
Division 5—Conditions 202
32E What this Division is about ...........................................................202
32EA Conditions applying automatically ................................................202
32EB Certification of manufacturing steps outside Australia..................204
32EC Imposition of conditions by legislative instrument........................205
32ED Imposition of conditions at time biological included in the
Register..........................................................................................205
32EE Imposition or variation or removal of conditions after
biological included in the Register ................................................205
32EF Criminal offences for breach of condition .....................................206
32EG Civil penalty for breach of condition.............................................207
Division 6—Suspension from the Register 208
32F What this Division is about ...........................................................208
32FA Suspension of biological from the Register ...................................208
32FB When suspension takes effect etc. .................................................209
32FC Revocation of suspension ..............................................................210
32FD Effect of suspension ......................................................................211
Division 7—Cancellation from the Register 212
32G What this Division is about ...........................................................212
32GA Immediate cancellation of biological from the Register in
various circumstances....................................................................212
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32GB Immediate cancellation of biological from the Register after
failure to comply with information gathering notice .....................213
32GC Cancellation of biological from the Register after notice of
proposed cancellation ....................................................................214
32GD Revocation of cancellation of biological upon request ..................215
32GE Publication of cancellation of entry from Register ........................215
32GF Date of effect of cancellation of entries from Register ..................216
Division 8—Public notification and recovery of biologicals 217
32H What this Division is about ...........................................................217
32HA Public notification and recovery of biologicals .............................217
32HB Publication of requirements...........................................................220
32HC Criminal offences for non-compliance with requirements.............220
32HD Civil penalty for non-compliance with requirements.....................221
32HE Powers of suspension and cancellation unaffected ........................221
Division 9—Obtaining information or documents 222
Subdivision A—Preliminary 222
32J What this Division is about ...........................................................222
Subdivision B—Obtaining information or documents for
biologicals included or proposed to be included in
the Register 222
32JA Secretary may require information or documents ..........................222
32JB Criminal offences for failing to comply with a notice etc..............224
32JC Civil penalty for giving false or misleading information or
document in compliance with a notice ..........................................225
32JD Self-incrimination..........................................................................225
Subdivision C—Obtaining information or documents for
biologicals covered by exemptions 226
32JE Secretary may require information etc. about biologicals
exempt under the regulations.........................................................226
32JF Secretary may require information etc. about biologicals
exempt to deal with emergencies...................................................227
32JG Secretary may require information etc. about biologicals
exempt for special and experimental uses .....................................228
32JH Secretary may require information etc. about biologicals
exempt where substitutes are unavailable etc. ...............................230
32JI Criminal offences for failing to comply with a notice etc..............230
32JJ Civil penalty for giving false or misleading information or
document in compliance with a notice ..........................................231
32JK Self-incrimination..........................................................................231
Subdivision D—Inspecting, copying and retaining documents 232
32JL Secretary may inspect and copy documents ..................................232
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32JM Secretary may retain documents ....................................................232
Part 3-3—Manufacturing of therapeutic goods 233 33A Application of this Part to medical devices ...................................233
33B Application of this Part to biologicals ...........................................233
34 Exempt goods and exempt persons................................................233
35 Criminal offences relating to manufacturing therapeutic
goods .............................................................................................233
35A Civil penalties relating to manufacturing therapeutic goods..........237
35B Criminal offences relating to breaching a condition of a
licence............................................................................................237
35C Civil penalty relating to breaching a condition of a licence...........238
36 Manufacturing principles...............................................................239
37 Application for licence ..................................................................239
38 Grant of licence .............................................................................241
38A Guidelines for multi-site licences ..................................................243
38B Splitting multi-site licences ...........................................................244
39 Term of licence..............................................................................246
40 Conditions of licences ...................................................................246
40A Variation of manufacturing site authorisations—Secretary’s
own initiative.................................................................................249
40B Variation of licences—application by licence holder ....................249
41 Revocation and suspension of licences..........................................251
41AA Spent convictions scheme..............................................................254
41AAA Transfer of licences .......................................................................254
41A Publication of list of manufacturers etc. ........................................254
Chapter 4—Medical devices 256
Part 4-1—Introduction 256
Division 1—Overview of this Chapter 256
41B General ..........................................................................................256
41BA Requirements for medical devices (Parts 4-2 and 4-3) ..................256
41BB Administrative processes (Parts 4-4 to 4-10).................................256
41BC Enforcement (Part 4-11) ................................................................257
Division 2—Interpretation 258
41BD What is a medical device ...............................................................258
41BE Kinds of medical devices...............................................................259
41BEA Excluded purposes.........................................................................260
41BF System or procedure packs ............................................................260
41BG Manufacturers of medical devices .................................................260
41BH Meaning of compliance with essential principles ..........................261
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41BI Meaning of non-application of conformity assessment
procedures .....................................................................................262
Division 3—Application provisions 263
41BJ Application of this Chapter to medical devices covered by
Part 3-2 ..........................................................................................263
41BJA Application of this Chapter to a biological ....................................263
41BK Application of the Criminal Code .................................................265
Part 4-2—Essential principles and medical device standards 266 41C What this Part is about...................................................................266
Division 1—Essential principles 267
41CA Essential principles........................................................................267
Division 2—Medical device standards 268
41CB Medical device standards...............................................................268
41CC Content of medical device standards .............................................268
41CD Inconsistencies between medical device standards........................269
Part 4-3—Conformity assessment procedures 270 41D What this Part is about...................................................................270
Division 1—Conformity assessment procedures 271
41DA Conformity assessment procedures ...............................................271
41DB Medical device classifications .......................................................272
Division 2—Conformity assessment standards 273
41DC Conformity assessment standards..................................................273
41DD Content of conformity assessment standards .................................273
41DE Inconsistencies between conformity assessment standards ...........274
Part 4-4—Conformity assessment certificates 275 41E What this Part is about...................................................................275
Division 1—Issuing conformity assessment certificates 276
41EA When conformity assessment certificates are required ..................276
41EB Applications...................................................................................276
41EC Considering applications ...............................................................277
41ED Time for making decisions on applications ...................................278
41EE Procedure following making a decision whether to issue
certificate .......................................................................................279
41EF Duration of certificate....................................................................279
41EG Lapsing of applications..................................................................279
41EH Treating applications as having been refused ................................280
41EI Criminal offences for making a false statement.............................281
41EIA Civil penalty for making a false statement ....................................282
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Division 2—Conditions 283
41EJ Automatic conditions on conformity assessment certificates ........283
41EK Conditions imposed when conformity assessment certificates
are issued .......................................................................................285
41EL Conditions imposed after issuing a conformity assessment
certificate .......................................................................................285
Division 3—Suspension of conformity assessment certificates 286
41EM Suspension of conformity assessment certificates .........................286
41EN Notice of proposed suspension ......................................................286
41EO Duration of suspension ..................................................................286
41EP Revocation of suspension ..............................................................287
41EQ Powers of revocation of conformity assessment certificates
unaffected ......................................................................................288
Division 4—Revocation of conformity assessment certificates 289
41ER Automatic revocation of conformity assessment certificates.........289
41ES Immediate revocation of conformity assessment certificates.........289
41ET Revocation of conformity assessment certificates after notice
of proposed revocation ..................................................................289
41EU Limiting revocation of conformity assessment certificates to
some medical devices of a particular kind .....................................291
41EV Publication of revocation etc. of conformity assessment
certificates .....................................................................................292
41EW Date of effect of revocation etc. of conformity assessment
certificates .....................................................................................292
Part 4-5—Including medical devices in the Register 293 41F What this Part is about...................................................................293
Division 1—Including medical devices in the Register 294
41FA What this Division is about ...........................................................294
41FB How this Division works ...............................................................295
Subdivision A—Applications 295
41FC Applications...................................................................................295
41FD Matters to be certified....................................................................296
41FE Criminal offences for making a false statement.............................297
41FEA Civil penalty for making a false statement ....................................299
Subdivision B—Including kinds of medical devices in the Register 299
41FF Obligation to include kinds of medical devices in the
Register..........................................................................................299
41FG Notification of unsuccessful applications ......................................300
Subdivision C—Auditing of applications 300
41FH Selecting applications for auditing ................................................300
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41FI Auditing of applications ................................................................300
41FJ Procedure following audits ............................................................301
41FK Lapsing of applications..................................................................301
Subdivision D—Miscellaneous 302
41FL Device number ..............................................................................302
41FM Duration of inclusion in the Register .............................................302
Division 2—Conditions 303
41FN Conditions applying automatically ................................................303
41FO Conditions imposed when kinds of medical devices are
included in the Register .................................................................305
41FP Conditions imposed after kinds of medical devices are
included in the Register .................................................................306
Part 4-6—Suspension and cancellation from the Register 307
Division 1—Suspension from the Register 307
Subdivision A—General power of suspension 307
41G What this Part is about...................................................................307
41GA Suspension of kinds of medical devices from the Register............307
41GB Notice of proposed suspension must be given in certain cases ......308
41GC Duration of suspension ..................................................................308
41GD Revocation of suspension ..............................................................309
41GE Treating applications for revocation as having been refused .........310
Subdivision B—Suspension as a result of suspension under
Part 4-4 310
41GF Suspension of kinds of medical devices from the Register............310
41GG Duration of suspension ..................................................................311
41GH Revocation of suspension ..............................................................311
Subdivision C—Effect of suspension 311
41GI Effect of suspension ......................................................................311
41GJ Powers of cancellation from Register unaffected ..........................312
Division 2—Cancellation of entries from the Register 313
41GK Automatic cancellation of entries of kinds of medical devices
from the Register ...........................................................................313
41GL Immediate cancellation of entries of kinds of medical
devices from the Register ..............................................................313
41GM Cancellation of entries of kinds of medical devices from the
Register after section 41JA notice .................................................314
41GN Cancellation of entries of kinds of medical devices from the
Register after notice of proposed cancellation...............................315
41GO Limiting cancellation of entries from Register to some
medical devices of a particular kind ..............................................316
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41GP Publication of cancellation of entry from Register ........................316
41GQ Date of effect of cancellation of entries from Register ..................317
Part 4-6A—Exempting medical devices to deal with
emergencies 318 41GR What this Part is about...................................................................318
41GS Minister may make exemptions.....................................................318
41GT Conditions of exemptions..............................................................319
41GU Variation or revocation of exemption............................................320
41GV Informing persons of exemption etc. .............................................321
41GW Notification and tabling .................................................................321
41GY Disposal of unused medical devices ..............................................322
Part 4-7—Other exemptions from including medical devices in
the Register 323 41H What this Part is about...................................................................323
41HA Devices exempted from inclusion in the Register..........................323
41HB Exemptions for special and experimental uses ..............................324
41HC Exemptions for medical practitioners ............................................325
41HD Approvals if substitutes for medical devices are unavailable
or in short supply...........................................................................326
Part 4-8—Obtaining information 330 41J What this Part is about...................................................................330
Division 1—Information relating to compliance with
requirements and other matters 331
41JA Secretary may require information ................................................331
41JB Complying with the Secretary’s requirements ...............................333
41JBA Civil penalty for giving false or misleading information in
purported compliance with a notice...............................................335
41JC Self-incrimination..........................................................................335
Division 2—Information relating to medical devices covered by
exemptions 336
41JCA Secretary may require information etc. about medical
devices exempt under Part 4-6A....................................................336
41JD Secretary may require information etc. about devices
exempted under section 41HA from inclusion in the Register ......336
41JE Secretary may require information relating to approvals
under section 41HB .......................................................................337
41JF Secretary may require information relating to authorities
under section 41HC .......................................................................339
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41JFA Secretary may require information relating to approvals
under section 41HD.......................................................................339
41JG Criminal offences for failing to give information or
documents sought under this Division...........................................340
41JH False or misleading information ....................................................340
41JI False or misleading documents......................................................341
41JJ Self-incrimination..........................................................................341
Part 4-9—Public notification and recovery of medical devices 343 41K What this Part is about...................................................................343
41KA Public notification and recovery of medical devices .....................343
41KB Publication of requirements...........................................................345
41KC Criminal offences for failing to comply with requirements
relating to a kind of medical device...............................................346
41KCA Civil penalty for failing to comply with requirements relating
to a kind of medical device............................................................347
41KD Powers of suspension and cancellation unaffected ........................347
Part 4-10—Assessment fees 348 41L What this Part is about...................................................................348
41LA Assessment fees.............................................................................348
41LB When assessment fee due for payment ..........................................349
41LC Payment of assessment fee by instalments ....................................349
41LD Recovery of assessment fee ...........................................................349
41LE Reduction of conformity assessment fee where decision not
made within prescribed period.......................................................349
Part 4-11—Offences and civil penalty provisions relating to
medical devices 351 41M What this Part is about...................................................................351
Division 1—Non-compliance with essential principles 352
41MA Criminal offences for importing, supplying or exporting a
medical device that does not comply with essential principles......352
41MAA Civil penalties for importing, supplying or exporting a
medical device that does not comply with essential principles......356
41MB Exceptions .....................................................................................357
41MC Criminal offences relating to breaching a condition of a
consent...........................................................................................358
41MCA Civil penalty relating to breaching a condition of a consent ..........359
41MD Treating medical devices as prohibited imports or exports............359
Division 2—Failure to apply conformity assessment procedures 360
41ME Criminal offences for failing to apply conformity assessment
procedures—manufacturers ...........................................................360
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41MEA Civil penalties for failing to apply conformity assessment
procedures—manufacturers ...........................................................363
41MF Criminal offences for failing to apply conformity assessment
procedures—sponsors....................................................................363
41MG Exceptions .....................................................................................365
41MH Criminal offence for making false statements in declarations .......366
41MHA Civil penalty for making false statements in declarations..............366
Division 3—Medical devices not included in the Register and
related matters 367
41MI Criminal offences for importing, exporting, supplying or
manufacturing a medical device not included in the Register........367
41MIA Notice required to adduce evidence in support of exception
under subsection 41MI(7)..............................................................370
41MIB Civil penalty for importing, exporting, supplying or
manufacturing a medical device not included in the Register........371
41MJ Treating medical devices as prohibited imports or exports............372
41MK Wholesale supply of medical devices not included in the
Register..........................................................................................373
41ML False advertising about medical devices........................................373
41MLA Civil penalty for making misrepresentations about medical
devices...........................................................................................373
41MM Claims about arranging supplies of medical devices not
included in the Register .................................................................374
41MN Criminal offences relating to breaches of conditions.....................374
41MNA Civil penalties for breaching conditions ........................................377
Division 3A—Offences and civil penalties related to exemptions
under Part 4-6A 378
41MNB Criminal offences for breaching a condition of an exemption .......378
41MNC Civil penalty for breaching a condition of an exemption...............379
41MND Civil penalty for making misrepresentations about medical
devices...........................................................................................379
Division 4—Other offences and civil penalty provisions 380
41MO Criminal offences for misusing medical devices exempted
for special or experimental uses ....................................................380
41MP Criminal offence for failing to notify adverse events etc. ..............382
41MPA Civil penalty for failing to notify adverse events etc. ....................384
41MPB Relief from liability for contraventions for failing to notify
adverse events etc. .........................................................................385
41MQ Notification of adverse events etc. where application
withdrawn or lapses.......................................................................386
41MR Civil penalties for failing to notify adverse effects etc. where
application withdrawn or lapses ....................................................386
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Chapter 5—Advertising, counterfeit therapeutic goods
and product tampering 388
Part 5-1—Advertising and generic information 388
Division 1—Preliminary 388
42AA This Part not to apply to advertisements directed at health
professionals etc. ...........................................................................388
42AB This Part not to apply to advertisements for goods not for
human use......................................................................................389
42AC This Part not to apply to advertisements for exported goods .........389
42B Definitions.....................................................................................389
42BAA Therapeutic Goods Advertising Code............................................391
Division 2—Therapeutic goods advertisements for which an
approval is required 392
42BA Application of Division .................................................................392
42C Offences relating to publication of advertisements........................392
Division 3—General provisions about advertising therapeutic
goods 395
42DA Simplified outline ..........................................................................395
42DB Definitions.....................................................................................395
42DD Restricted representations..............................................................395
42DE Applications for approval of use of restricted representation ........396
42DF Approval of use of restricted representation ..................................396
42DG Notice of approval or refusal .........................................................396
42DH Variation of conditions of approval ...............................................397
42DI Withdrawal of approval .................................................................397
42DJ Prohibited and required representations.........................................398
42DK Use of restricted or prohibited representations ..............................398
Division 3A—Therapeutic goods advertisements for which an
approval is not required 399
42DKA Application of Division .................................................................399
42DKB Certain representations not to be published or broadcast...............399
42DL Advertising offences......................................................................399
42DM Compliance with Code ..................................................................401
Division 4—Generic information about ingredients or
components of therapeutic goods 402
42DN Application of Division .................................................................402
42DO Compliance with the Code ............................................................402
42DP Offences—publication of generic information ..............................402
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Part 5-2—Counterfeit therapeutic goods 403 42E Offence of dealing with counterfeit therapeutic goods ..................403
42EA Civil penalty relating to dealing with counterfeit therapeutic
goods .............................................................................................404
42EB Relief from liability for certain contraventions relating to
dealing with counterfeit therapeutic goods ....................................404
42F Customs treatment of counterfeit therapeutic goods......................405
Part 5-3—Product tampering 406 42T Notifying of actual or potential tampering.....................................406
42U Meaning of actual or potential tampering etc. ..............................407
42V Recovery of therapeutic goods because of actual or potential
tampering.......................................................................................408
42VA Civil penalty relating to the recovery of therapeutic goods
because of actual or potential tampering .......................................410
42VB Relief from liability for contraventions relating to the
recovery of therapeutic goods because of actual or potential
tampering.......................................................................................410
42W Supply etc. of therapeutic goods that are subject to recovery
requirements ..................................................................................411
42X Saving of other laws ......................................................................412
Chapter 5A—Enforcement 413
Part 5A-1—Civil penalties 413
Division 1—Obtaining an order for a civil penalty 413
42Y Federal Court may order person to pay pecuniary penalty for
contravening civil penalty provision..............................................413
42YA What is a civil penalty provision?..................................................414
42YB Meaning of penalty unit.................................................................414
42YC Persons involved in contravening civil penalty provision .............414
42YD Recovery of a pecuniary penalty ...................................................414
42YE Gathering information for application for pecuniary penalty ........415
Division 2—Civil penalty proceedings and criminal proceedings 416
42YF Civil proceedings after criminal proceedings ................................416
42YG Criminal proceedings during civil proceedings .............................416
42YH Criminal proceedings after civil proceedings ................................416
42YI Evidence given in proceedings for civil penalty not
admissible in criminal proceedings................................................416
Part 5A-2—Infringement notices 418 42YJ Infringement notices in respect of offences ...................................418
42YK Infringement notices in respect of civil penalty provisions ...........418
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Part 5A-3—Enforceable undertakings 419 42YL Enforcement of undertakings.........................................................419
Chapter 6—Administration 420
Part 6-1—Payment of charges 420 43 By whom charges payable .............................................................420
44 Time for payment of charges .........................................................420
44A Exemptions from liability to pay charges ......................................421
44B Recovery of unpaid charges...........................................................422
45 Therapeutic Goods Administration Account .................................423
Part 6-2—Entry, searches and warrants 424 45A Definitions.....................................................................................424
46 Searches to monitor compliance with Act .....................................425
46A Searches of certain premises to monitor compliance with Act ......425
46B Searches and seizures on public health grounds ............................427
47 Searches and seizures related to offences and civil penalty
provisions ......................................................................................427
48 General powers of authorised persons in relation to premises .......428
48A Details of warrant to be given to occupier etc. ..............................429
48B Announcement before entry ..........................................................430
48C Use of electronic equipment at premises .......................................430
48D Compensation for damage to electronic equipment.......................432
48E Copies of seized things to be provided ..........................................432
48F Occupier entitled to be present during search ................................433
48G Receipts for things seized under warrant .......................................433
48H Retention of seized things..............................................................433
48J Magistrate may permit a thing to be retained ................................434
49 Monitoring warrants ......................................................................434
50 Offence and civil penalty provision related warrants ....................435
51 Offence and civil penalty provision related warrants by
telephone .......................................................................................436
51A Searches at request of manufacturer ..............................................438
51B Offences relating to warrants.........................................................438
52 Identity cards .................................................................................439
Part 6-3—Scheduling of substances 440 52AA Overview .......................................................................................440
52A Definitions.....................................................................................440
52B Advisory Committee on Medicines Scheduling ............................441
52C Advisory Committee on Chemicals Scheduling ............................442
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52CA Joint meetings................................................................................442
52D Poisons Standard ...........................................................................443
52E Secretary to take certain matters into account in exercising
powers ...........................................................................................443
52EAA Application for amendment of the Poisons Standard.....................444
52EA Poisons Standard—validation etc. .................................................445
52EB Compensation for acquisition of property .....................................446
52EC Review of scheduling regime ........................................................447
Chapter 7—Miscellaneous 449 53 Retention of material on withdrawal of application.......................449
53A Alternative verdicts for various offences .......................................449
54 Offences and forfeiture ..................................................................451
54AA Offences for contravening conditions or requirements
imposed under the regulations .......................................................451
54AB Criminal offence for damaging etc. documents .............................452
54AC Civil penalty for damaging etc. documents ...................................452
54A Time for bringing prosecutions .....................................................453
54B Personal liability of an executive officer of a body
corporate—general ........................................................................453
54BA Personal liability of an executive officer of a body
corporate—offences covered .........................................................454
54C Establishing whether an executive officer took reasonable
steps to prevent the commission of an offence or the
contravention of a civil penalty provision .....................................456
55 Conduct by directors, servants and agents .....................................457
56 Judicial notice................................................................................458
56A Certificates to provide evidence of certain matters ........................458
57 Delegation .....................................................................................461
58 Export certifications ......................................................................463
59 Fees ...............................................................................................463
60 Review of decisions.......................................................................463
60A New information on review—discretion to remit ..........................466
61 Release of information...................................................................469
61A Immunity from civil actions ..........................................................475
63 Regulations....................................................................................476
Chapter 8—Repeal and transitional provisions 479 66 Transitional arrangements for goods required to be registered
or listed..........................................................................................479
67 Transitional provision for therapeutic goods for export only.........481
68 Transitional arrangements for Part 3-3 ..........................................481
69 Continuation of standards and requirements..................................482
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Endnotes 483
Endnote 1—Legislation history 483
Endnote 2—Amendment history 494
Endnote 3—Application, saving and transitional provisions 528
Therapeutic Goods Amendment Act (No. 2) 2000 (No. 56, 2000) 528
Therapeutic Goods Amendment Act (No. 3) 2000 (No. 120, 2000) 528
Therapeutic Goods Amendment Act 2001 (No. 14, 2001) 529
Australia New Zealand Food Authority Amendment Act 2001
(No. 81, 2001) 530
Health and Aged Care Legislation Amendment (Application of
Criminal Code) Act 2001 (No. 111, 2001) 530
Therapeutic Goods Amendment (Medical Devices) Act 2002 (No. 24,
2002) 530
Therapeutic Goods and Other Legislation Amendment Act 2002
(No. 56, 2002) 532
Therapeutic Goods Amendment Act (No. 1) 2003 (No. 39, 2003) 532
US Free Trade Agreement Implementation Act 2004 (No. 120, 2004) 533
Financial Framework Legislation Amendment Act 2005 (No. 8, 2005) 534
Therapeutic Goods Amendment Act (No. 2) 2006 (No. 2, 2006) 534
Therapeutic Goods Amendment (Repeal of Ministerial responsibility
for approval of RU486) Act 2006 (No. 5, 2006) 535
Therapeutic Goods Legislation Amendment (Annual Charges) Act
2008 (No. 96, 2008) 535
Therapeutic Goods Amendment (Medical Devices and Other
Measures) Act 2009 (No. 38, 2009) 535
Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009
(No. 76, 2009) 538
Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009
(No. 96, 2009) 544
Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010
(No. 54, 2010) 545
Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010
(No. 141, 2010) 548
Acts Interpretation Amendment Act 2011 (No. 46, 2011) 550
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Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011
(No. 77, 2011) 550
Endnote 4—Uncommenced amendments 552
Endnote 5—Misdescribed amendments 553
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Preliminary Chapter 1
Section 1
Therapeutic Goods Act 1989 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.
advertisement, in relation to therapeutic goods, includes any
statement, pictorial representation or design, however made, that is
intended, whether directly or indirectly, to promote the use or
supply of the goods.
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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.
authorised person means:
(a) in relation to any provision of this Act, 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.
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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.
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
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(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).
conformity assessment certificate means a certificate issued under
section 41EE.
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.
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.
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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).
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.
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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.
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 Court means the Federal Court of Australia.
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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.
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.
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).
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8 Therapeutic Goods Act 1989
included in the Register:
(a) in relation to a biological—means included in the Register
under Part 3-2A; and
(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 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.
listing number, in relation to listed goods, means any combination
of numbers, symbols and letters assigned to the goods under
section 27.
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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).
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.
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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).
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.
National Manager of the Therapeutic Goods Administration
means:
(a) the person holding the position of National Manager of the
Therapeutic Goods Administration; or
(b) if the position of National Manager of the Therapeutic Goods
Administration ceases to exist, or ceases to be referred to by
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that name—the person holding a position determined in
writing by the Secretary.
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.
penalty unit, in relation to a civil penalty provision, has the
meaning given by section 42YB.
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.
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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.
Register means the Australian Register of Therapeutic Goods
maintained under section 9A.
registered goods means therapeutic goods included in the part of
the Register for goods known as registered goods.
registration number, in relation to registered goods, means any
combination of numbers, symbols and letters assigned to the goods
under section 27.
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.
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
(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
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(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;
(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.
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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
Secretary, by order published in the Gazette, 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
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(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.
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.
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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.
(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 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
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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
(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 or an
annual licensing 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
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(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.
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.
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.
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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 Legislative Instruments 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
(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.
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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
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 Legislative Instruments 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:
(a) the European Community; or
(b) the European Free Trade Association.
(2) A declaration under subsection (1) must be published in the
Gazette.
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.
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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 Legislative Instruments 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).
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
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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
subsections 21A(1), (2) and (4) and sections 22A, 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.
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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
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:
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(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).
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.
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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
(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:
(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
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(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.
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, declare that
the goods, or the goods when used, advertised, or presented for
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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 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.
7A Authorised persons
The Secretary may, in writing, authorise any of the following
persons to exercise powers under a specified provision of this Act:
(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.
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7B Kits
(1) A package and therapeutic goods in the package together constitute
a kit for the purposes of this Act if:
(a) the package and the therapeutic goods are for use as a unit;
and
(b) each item of the therapeutic goods consists of goods that are
registered or listed, are exempt goods in relation to Part 3-2,
are included in the Register under Part 3-2A or are exempt
under subsection 32CA(2) or section 32CB; and
(c) the package and therapeutic goods do not constitute a
composite pack or a system or procedure pack.
(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.
(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.
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30 Therapeutic Goods Act 1989
(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
(b) goods in relation to which the Secretary is considering
making a declaration under section 7;
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.
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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
(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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32 Therapeutic Goods Act 1989
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 4 parts:
(a) a part for goods to be known as 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
(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.
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(5) The Minister may, by notice published in the Gazette:
(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 Gazette 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:
Time of cancellation of registration or listing
Circumstances Time
1 That kind of medical device is
included in the Register under
Chapter 4 before 4 October 2007
because of an application finally
determined before that day
When that kind of medical device is included
in the Register under Chapter 4
2 An effective application for a
conformity assessment
certificate relating to that kind of
medical device is made, but not
finally determined, before
4 October 2007
The end of 30 days after the application is
finally determined or, if the application
lapses, the later of the following times (or
either of them if they are the same):
(a) the time the application lapses;
(b) the start of 4 October 2007
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Time of cancellation of registration or listing
Circumstances Time
3 An effective application to
include that kind of medical
device in the Register under
Chapter 4 is made, but not
finally determined, before
4 October 2007, and item 2 does
not apply
Whichever one of the following times
applies, or the earlier of them:
(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);
(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
4 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:
(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.
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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.
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.
(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.
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(2A) Subsection (2), to the extent to which it relates to
subparagraph (2)(b)(i), 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
(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.
(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
(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.
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(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;
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
(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;
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38 Therapeutic Goods Act 1989
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).
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.
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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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 Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
(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
(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
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(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 Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
(4) The Minister must not make an order under subsection (1), or vary
or revoke an order made under subsection (1), unless the Minister
has consulted with respect to the proposed action with a committee
established by the regulations to advise the Minister on standards.
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.
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
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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
(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;
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42 Therapeutic Goods Act 1989
the Minister may, by order published in the Gazette, 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.
(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:
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(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; and
(d) either:
(i) the use of the goods has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would 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.
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 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; and
(d) the use of the goods, if the goods were used, would be likely
to result in harm or injury to any person; and
(e) the harm or injury would be likely to result because the
goods do not conform with the standard.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(4) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
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(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.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Exceptions
(5) Paragraphs (1)(a), (2)(a) and (4)(a) do not apply to goods that do
not conform with a standard applicable to the goods by reason only
of matters relating to labelling or packaging.
Note: A defendant bears an evidential burden in relation to the matters in subsection (5): see subsection 13.3(3) of the Criminal Code.
(5A) Subsection (1), (2) or (4) 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:
(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, or will result in,
harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would result,
because the goods do not conform with the standard.
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 (9) 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 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) the use of the goods, if the goods were used, would be likely
to result in harm or injury to any person; and
(e) the harm or injury would be likely to result because the
goods do not conform with the standard.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(8) Subsection (7) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
Exception
(9A) Subsection (6), (7) or (9) does not apply if:
(a) the therapeutic goods are a biological; and
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(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, or will result in,
harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would 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 (13) instead: see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(11) 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) the use of the goods, if the goods were used, would be likely
to result in harm or injury to any person; and
(e) the harm or injury would be likely to result because the
goods do not conform with the standard.
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Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(12) Subsection (11) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
Exception
(13A) Subsection (10), (11) or (13) 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.
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.
(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.
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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.
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:
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(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.
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.
(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:
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(a) the importation or exportation of goods is an offence under
subsection 14(1), (2), (4), (10), (11) or (13) or a
contravention of subsection 14A(1) or (3); and
(b) the Secretary notifies the Chief Executive Officer 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:
(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, or will 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.
(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 breaches a condition of a consent; and
(c) the act or omission is likely to result in harm or injury to any
person.
Penalty: 1,000 penalty units.
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Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(4) Subsection (3) is an offence of strict liability.
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; and
(b) the act or omission breaches a condition of a consent.
Penalty: 500 penalty units.
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
(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
or appeals arising out of it, have been finally determined or
otherwise disposed of.
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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.
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.
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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;
(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.
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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).
(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.
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(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.
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.
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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
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.
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(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.
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.
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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
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
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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);
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 special and experimental 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.
(1A) An approval for the purpose mentioned in paragraph (1)(b) is
subject to the conditions (if any) specified in the regulations. Those
conditions (if any) are in addition to any conditions imposed on the
approval under subsection (1).
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(2) An application for an approval must be made to the Secretary and
must:
(a) in the case of an application for use of the kind referred to in
paragraph (1)(a)—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;
(d) the circumstances in which the person must cease the use of
the goods for those purposes.
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(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.
(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).
(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
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(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 that complies with section 23 has been
made under that section for registration of the goods;
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.
(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 that complies with section 23 has been made
under that section for registration of the goods; 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 this section.
(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.
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(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 section 25 in relation to the
goods.
(9) The approval lapses if:
(a) the Secretary is satisfied that paragraph (1)(a), (b), (c) or (d),
or paragraph (2)(a), (b), (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.
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
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(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, or will result in,
harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
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: 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.
(2) 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;
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(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) the use of the goods, if the goods were used, would be likely
to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note 1: 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 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
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Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Defence if person was not the sponsor of the goods
(5) It is a defence to a prosecution under subsection (1), (2) or (4) 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, or will not, 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; or
(b) harm or injury would not 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), (2) or (4); and
(b) the Secretary notifies the Chief Executive Officer 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;
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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:
(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
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(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.
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:
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(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;
(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
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(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.
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 Chief Executive Officer 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 is guilty of 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.
(1C) For the purposes of paragraph (1B)(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.
(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:
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(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:
(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:
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(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.
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); and
(c) the statement is false or misleading in a material particular;
and
(d) either:
(i) the use of the medicine has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the medicine, if the medicine were used,
would 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.
(2) 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); and
(c) the statement is false or misleading in a material particular;
and
(d) the use of the medicine, if the medicine were used, would be
likely to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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); and
(c) the statement is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
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, or will 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 (8) 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) 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 is likely to result in harm or injury to any
person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(7) Subsection (6) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
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
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(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:
(i) the use of the goods has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would 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.
Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(7A) instead: see section 53A.
(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; 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) the use of the goods, if goods were used, would be likely to
result in harm or injury to any person; and
(e) the harm or injury 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).
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Penalty: 2,000 penalty units.
(11) Subsection (10) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
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, or will
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, or will result in, harm or injury to any of those
persons.
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 22(8) instead: see section 53A.
(13) A person commits an offence if:
(a) the person uses therapeutic goods; and
(b) the goods are used:
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(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, if the goods were used, 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, if the goods
were used, is likely to result in harm or injury to any of
those persons.
Penalty: 2,000 penalty units.
(14) Subsection (13) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
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), 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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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
(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.
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
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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.
(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: 60 penalty units.
(6) A person must not make a claim, by any means, that the person or
another person can arrange the supply of therapeutic goods (not
being exempt goods or goods exempt under section 18A) that are
not registered goods or listed goods.
Penalty: 60 penalty units.
(7) A person is guilty of 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.
(7A) A person to whom an authority under subsection 19(5) has been
granted must not supply the therapeutic goods to which the
authority relates except in accordance with:
(a) the authority; and
(aa) the conditions (if any) to which the authority is subject; and
(b) any regulations made for the purpose of subsection 19(7).
Penalty: 500 penalty units.
(8) A person must not use therapeutic goods, other than exempt goods,
listed goods, registered goods, goods exempt under section 18A or
goods that are the subject of an approval under section 19A:
(a) for use in the treatment of another person; or
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(b) for use solely for experimental purposes in humans;
except in accordance with an approval or authority under
section 19 or a condition applicable under regulations made for the
purposes of subsection 19(4A).
Penalty: 500 penalty units.
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:
(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, or will result in,
harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
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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(2) 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) the use of the goods, if the goods were used, would be likely
to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
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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Division 2—Registration and listing
23 Applications generally
(1) An application for registration or listing of therapeutic goods 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.
(2) An application is not effective unless:
(a) the prescribed application fee has been paid; and
(b) 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
(ba) if the application is for the registration of restricted
medicine—the application is accompanied by product
information, in relation to the medicine, that is in the form
approved under section 7D in relation to the medicine; and
(c) 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.
(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.
24 Applications for registration
(1) Where an application is made for the registration of therapeutic
goods in accordance with section 23 and the goods are goods that
are required to be registered, 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.
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(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.
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;
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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.
(3) For the purposes of subsection (2), the evaluation is taken to be
completed when the applicant is notified under subsection 25(4) of
the Secretary’s decision on the evaluation.
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:
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(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 and registration of therapeutic goods
(1) If an application is made for the registration of therapeutic goods in
relation to a person in accordance with section 23, the Secretary
must evaluate the goods for registration having regard to:
(d) whether the quality, safety and efficacy of the goods for the
purposes for which they are to be used have been
satisfactorily established; 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, or any requirements relating to advertising applicable
under Part 5-1 or under the regulations; and
(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
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(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
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.
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(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.
(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) If:
(a) the therapeutic goods are therapeutic devices; and
(b) the evaluation of the goods for registration has been
completed;
the Secretary must:
(c) notify the applicant in writing of his or her decision on the
evaluation within 28 days of the making of the decision and,
in the case of a decision not to register the goods, of the
reasons for the decision; and
(d) if the decision is to register the goods—include the goods in
the Register and give the applicant a certificate of
registration.
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(4) If:
(a) the therapeutic goods are not therapeutic devices; and
(b) the evaluation of the goods for registration has been
completed;
the Secretary must:
(c) notify the applicant in writing of his or her decision on the
evaluation within 28 days of the making of the decision and,
in the case of a decision not to register the goods, of the
reasons for the decision; and
(d) if the decision is to register the goods:
(i) notify the applicant in writing that the goods will be
included in the Register if the applicant gives the
Secretary either the certificate required under
subsection 26B(1) or 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
(ia) if the goods are restricted medicine or the goods are
medicine in respect of which the applicant has been
given a notice of the kind referred to in
subparagraph (1)(da)(ii)—notify the applicant in writing
of the product information that is approved in relation to
the medicine; and
(ii) include the goods in the Register and give the applicant
a certificate of registration if the applicant gives the
Secretary either the certificate required under
subsection 26B(1) or 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.
To avoid doubt, if the applicant gives the Secretary the certificate
required under subsection 26B(1) or a notice that a certificate
under that subsection is not required in relation to the application,
the Secretary must include the goods in the Register under
subparagraph (d)(ii) without inquiring into the correctness of the
certificate or the notice.
(5) The registration of therapeutic goods commences on the day
specified for the purpose in the certificate of registration.
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25AA Approved product information for medicine
(1) If:
(a) the Secretary includes restricted medicine in the Register in
relation to a person under subparagraph 25(4)(d)(ii); or
(b) an applicant for the registration of medicine (other than
restricted medicine) is given a notice of the kind referred to
in subparagraph 25(1)(da)(ii) and the Secretary includes the
medicine in the Register in relation to the applicant under
subparagraph 25(4)(d)(ii);
the product information that is approved under this section in
relation to the medicine is the product information referred to in
subparagraph 25(4)(d)(ia).
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) 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) 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 under subparagraph 25(4)(d)(ii);
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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.
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.
(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.
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
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(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.
25B Registration of therapeutic device to which EC/EFTA
attestation of conformity applies
(1) If:
(a) an application is made in accordance with section 23 for the
registration of a therapeutic device in relation to a person;
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.
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(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 in accordance with section 23; and
(aa) if goods are not therapeutic devices—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
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;
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 to a requirement relating to advertising applicable
under Part 5-1 or under 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
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(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:
(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
(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 in accordance with section 23; 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
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(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.
(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.
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(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.
26AA Listing of therapeutic device to which EC/EFTA attestation of
conformity applies
(1) If:
(a) an application is made in accordance with section 23 for the
listing of a therapeutic device in relation to a person; and
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(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 in accordance with section 23; 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
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
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(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 to every requirement (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
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(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
(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) the applicant holds information or evidence to support any
claim that the applicant makes relating to the medicine; 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.
(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.
(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
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(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.
(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.
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:
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(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 is guilty of 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.
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.
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(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 25(4), 26(1) or 26A(1) 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 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.
(3) The requirements referred to in paragraph (1)(b) may relate to
permitted concentrations or permitted total amounts of ingredients.
(4) Subsections (2) 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:
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(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 Legislative Instruments 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.
26BD Variation of determination under section 26BB—application
by person
(1) A person may apply to the Minister for a variation of a
determination under subsection 26BB(1).
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved by the
Secretary; and
(b) set out the variation sought; and
(c) be delivered to an office of the Department specified in the
form; and
(d) be accompanied by the prescribed application fee.
(3) If an application is made under subsection (1) and any applicable
prescribed evaluation fee has been paid, the Minister may, by
legislative instrument, vary the determination.
(3A) In deciding whether to vary the determination, the Minister must
have regard to the quality and safety of the ingredients concerned.
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This subsection does not limit the matters to which the Minister
may have regard to in deciding whether to vary the determination.
Further information
(4) The Minister may, by notice in writing given to the person, require
the person to give to the Minister, 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
(5) An approval of a form mentioned in paragraph (2)(a), or a notice
mentioned in subsection (4), 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
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.
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(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:
(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).
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(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:
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
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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
(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
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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.
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.
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(2A) Without limiting subsection (2), different conditions may be
specified for:
(a) the registration of therapeutic goods; 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.
(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
(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.
(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
(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; and
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(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
(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
(d) if requested to do so by an authorised person, make any such
record available to the authorised person for inspection:
(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.
(5A) In addition to any conditions imposed under subsection (1), (2B),
(3) or (5), the listing of a medicine under section 26A is subject to
a condition that the person in relation to whom the medicine is
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listed will deliver a reasonable number of samples of the medicine
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.
(5B) The listing of a medicine under section 26A 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) or 28A(2).
(5C) Subsection (5B) does not apply if the medicine is exempt from the
operation of Part 3-3.
(6) If:
(a) in, or in connection with, an application for the listing of
therapeutic goods, a claim is made by the applicant in
relation to the goods; and
(b) the claim is included in the Register in respect of the goods;
the listing of the goods is subject to the following conditions:
(c) 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) of the regulations;
(d) a condition that the sponsor retains the information or
evidence at all times while the goods remain listed;
(e) 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) The regulations may prescribe the amount, standard or type of
information or evidence required for the purposes of
paragraph (6)(c).
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28A Certification of manufacturing steps outside Australia following
application for listing
(1) The person in relation to whom medicine is listed under
section 26A 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, subsection 26A(4)
applies in a way corresponding to the way in which it applies for
the purposes of subsection 26A(3).
29 Duration of registration or listing
Where 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.
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:
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(a) information that contradicts information already furnished 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 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;
(d) information that indicates that the quality, safety or efficacy
of the goods is unacceptable.
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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.
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:
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(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
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) or (f) or subsection 30(1A), (1C) 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
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(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 in Gazette
(5) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette a notice
setting out particulars of the suspension.
29E When suspension takes effect etc.
(1) A suspension under section 29D takes effect:
(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.
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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 in Gazette
(4) As soon as practicable after giving a notice under subsection (3),
the Secretary must cause to be published in the Gazette 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
(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 in Gazette
(3) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette 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.
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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.
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) or (g) are incorrect or (if
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applicable) the requirements under subsection 26A(3) or
(4A) are not fulfilled; or
(f) both of the following apply:
(i) under the regulations, an authority constituted by or
under the regulations gives a direction to, or makes a
requirement of, the person in relation to an
advertisement of the goods to ensure that advertising
complies with the Therapeutic Goods Advertising Code;
(ii) the person does not comply with the direction or
requirement.
(1A) 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 medicine is not eligible for listing; or
(b) the medicine is exempt; or
(c) there is a serious breach, involving the medicine, of the
requirements 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
medicine is misleading to a significant extent.
(1B) However, paragraph (1A)(c) does not apply to medicines that are
manufactured in Australia for export only, or are imported into
Australia for export only.
(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
(b) the notice is given for the purposes of ascertaining whether
the medicine should have been listed; and
(c) the person fails to comply with the notice within 20 working
days after the notice is given.
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(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
(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), (f), (fa), (fb), (fc), (h), (i), (j) or
(k) or subsection 26A(2A) 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
(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 to a requirement relating to advertising applicable to
the goods under Part 5-1 or under the regulations; or
(f) the annual registration or listing charge is not paid within 28
days after it becomes payable.
(3) Where the Secretary proposes to cancel the registration or listing of
goods in relation to a person under subsection (2) otherwise than as
a result of a failure to pay the annual registration or listing charge,
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.
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(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) or
(1C)—on the day on which the notice of cancellation is given
to the person; or
(b) in any other case—on such later day as is specified in the
notice.
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
(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.
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 the therapeutic good 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
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(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
(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.
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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 recovery of
therapeutic goods
30EA Public notification and recovery 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 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
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 they do not conform with a standard
applicable to the goods
The person supplying the
goods
4. 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;
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
but the manufacturing principles have not been
observed in the manufacture of the goods
5. The goods are supplied in contravention of
subsection 19B(1), (2) or (4), 19D(1) or 42E(1)
or section 42EA
The person supplying the
goods
5A. The goods are supplied while they are
registered goods or listed goods, but it appears
to the Secretary that the quality, safety or
efficacy of the goods is unacceptable or that 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
7. The registration or listing of the goods has been
cancelled under this Part
The person in relation to
whom the goods were
included in the Register
(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 recover 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;
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(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.
(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.
(4) A requirement to recover therapeutic goods under this section does
not apply to therapeutic goods that cannot be recovered 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, 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, or will 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.
(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 requirement imposed on the
person under section 30EA; and
(c) the act or omission is likely to result in harm or injury to any
person.
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Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
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.
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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 recover the goods included in that batch
(except any of those goods that cannot be recovered 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 recover 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.
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 for the purposes of the
Legislative Instruments Act 2003.
Offences
(4B) 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; and
(d) either:
(i) the use of the goods has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would 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.
(4C) 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) the use of the goods, if the goods were used, would be likely
to result in harm or injury to any person; and
(e) the harm or injury would be likely to result because the
person failed to comply with that requirement.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(4D) Subsection (4C) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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
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(c) the person fails to comply with that requirement.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(6) For the purposes of an offence against subsection (5), strict liability
applies to the following physical elements of circumstances:
(a) that the notice concerned is given under subsection (2);
(b) that the particular requirement concerned is a requirement
mentioned in subsection (3).
Note: For strict liability, see section 6.1 of the Criminal Code.
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.
(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.
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(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
(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.
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31 Secretary may require information
(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;
(ga) whether the goods comply with conditions (if any) on the
registration of the goods;
(h) the conformity of the goods to a requirement relating to
advertising applicable under Part 5-1 or under 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;
(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
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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:
(a) a person makes an application under section 23 for the
registration of therapeutic goods in accordance with a form
referred to in paragraph 23(1)(a); 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 medicine—the matters covered by a
certification by the person under paragraph 26A(2)(j) in
relation to the medicine;
(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, or to a requirement relating to advertising applicable
to the goods under Part 5-1 or under the regulations;
(ga) if the goods are listed in relation to the person—whether the
goods are being:
(i) supplied in Australia; or
(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.
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(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.
(5) An offence under subsection (4) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(5A) A person commits an offence if:
(a) a medicine is listed under section 26A in relation to the
person; and
(b) the person provides information in purported compliance
with a notice under section 31 relating to the medicine; and
(c) the information is false or misleading in a material particular;
and
(d) either:
(i) the use of the medicine has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the medicine, if the medicine were used,
would 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.
(5B) A person commits an offence if:
(a) a medicine is listed under section 26A in relation to the
person; and
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(b) the person provides information in purported compliance
with a notice under section 31 relating to the medicine; and
(c) the information is false or misleading in a material particular;
and
(d) the use of the medicine, if the medicine were used, would be
likely to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(5C) Subsection (5B) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(6) A person in relation to whom a medicine is listed under
section 26A must not, in purported compliance with a notice under
this section relating to the medicine, provide information that is
false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
31AAA Civil penalty for providing false or misleading information
in relation to medicines listed under section 26A
A person contravenes this section if:
(a) a medicine is listed under section 26A in relation to the
person; and
(b) the person provides information in purported compliance
with a notice under section 31 relating to the medicine; 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.
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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.
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
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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.
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.
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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.
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.
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Compliance period
(4) A notice under subsection (1), (2) or (3) 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
(5) A notice under subsection (1), (2) or (3) 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.
31C Criminal offence for failing to give information or documents
sought under section 31A, 31AA or 31B
A person commits an offence if:
(a) the person is given a notice under section 31A, 31AA or 31B;
and
(b) the person fails to comply with the notice.
Penalty: 400 penalty units.
Note: The privilege against self incrimination is not a reasonable excuse for the purposes of this section. However, the information given, and the fact that a document was given under this section (and other information, documents or things obtained because of giving the information or document) generally cannot be used in a prosecution (see section 31F).
31D False or misleading information
(1) A person to whom a notice is given under section 31A, 31AA or
31B is guilty of 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.
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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) Subsection (1) does not apply as a result of subparagraph (1)(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).
(3) Subsection (1) does not apply as a result of subparagraph (1)(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).
31E False or misleading documents
(1) A person is guilty of 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 or
31B.
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) 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).
(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
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(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).
31F Self-incrimination
(1) A person is not excused from giving information or a document
under a notice given under section 31A, 31AA or 31B 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:
(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 31D or 31E; or
(e) proceedings for a pecuniary penalty order against the
individual for a contravention of a civil penalty provision.
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Biologicals Part 3-2A
Preliminary Division 1
Section 32
Therapeutic Goods Act 1989 145
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 recovery 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
(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
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146 Therapeutic Goods Act 1989
(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 Legislative Instruments 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 Legislative Instruments 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 32DD.
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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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) or (2) that is held by the person;
and
(c) either:
(i) the use of the biological has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would 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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Part 3-2A Biologicals
Division 2 Main criminal offences and civil penalties
Section 32BA
148 Therapeutic Goods Act 1989
(2) 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) or (2) that is held by the person;
and
(c) the use of the biological, if the biological were used, would
be likely to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) An offence against subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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
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approval covering the importation into Australia of the
biological;
(v) the biological is the subject of an approval under
subsection 32CO(1) or (2) that is held by the person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Defences
(5) Subsection (1), (2) or (4) 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, or will not, 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 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.
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);
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(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, or will result in,
harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would 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.
(2) 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) the use of the biological, if the biological were used, would
be likely to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) An offence against subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
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(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;
(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.
Defences
(5) Subsection (1), (2) or (4) 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.
(6) Subsection (1) does not apply if:
(a) harm or injury did not, or will not, 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 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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Part 3-2A Biologicals
Division 2 Main criminal offences and civil penalties
Section 32BC
152 Therapeutic Goods Act 1989
32BC Criminal offences for manufacturing a biological
(1) 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; and
(c) either:
(i) the use of the biological has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would 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.
(2) 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; and
(c) the use of the biological, if the biological were used, would
be likely to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
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(3) An offence against subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
Defences
(5) Subsection (1), (2) or (4) 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, or will not, 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 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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Part 3-2A Biologicals
Division 2 Main criminal offences and civil penalties
Section 32BD
154 Therapeutic Goods Act 1989
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) that is held by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1) 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, or will result in,
harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would 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.
(2) 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;
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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 supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) that is held by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1) or (2) that is held by the person,
being an approval covering the supply in Australia of
the biological; and
(c) the use of the biological, if the biological were used, would
be likely to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) An offence against subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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) that is held by the person;
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(vi) the biological is the subject of an approval under
subsection 32CO(1) 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.
Defences
(5) Subsection (1), (2) or (4) 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, or will not, 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 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.
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
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(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
(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.
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(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.
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) or (2) that is held by the person.
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.
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;
(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.
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Section 32BF
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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
(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) that is held by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1) 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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(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.
32BG Criminal offence and civil penalty relating to a failure to
notify the Secretary about manufacturing
Criminal offence
(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
(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.
Civil penalty
(2) A person contravenes this subsection if:
(a) the person:
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 2 Main criminal offences and civil penalties
Section 32BG
162 Therapeutic Goods Act 1989
(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:
(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.
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Medicines and other therapeutic goods that are not medical devices Chapter 3
Biologicals Part 3-2A
Main criminal offences and civil penalties Division 2
Section 32BH
Therapeutic Goods Act 1989 163
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) that is held by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1) 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.
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;
ComLaw Authoritative Act C2013C00132
Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 2 Main criminal offences and civil penalties
Section 32BI
164 Therapeutic Goods Act 1989
(iv) the biological is the subject of an approval under
subsection 32CO(1) 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); 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,
or will 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, or will result in, harm or injury to any of
those humans.
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.
(2) 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) or (2);
(v) the person uses the biological in accordance with an
approval under subsection 32CK(1);
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Medicines and other therapeutic goods that are not medical devices Chapter 3
Biologicals Part 3-2A
Main criminal offences and civil penalties Division 2
Section 32BI
Therapeutic Goods Act 1989 165
(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); and
(d) either:
(i) if the person used the biological in the treatment of
another person—the use of the biological 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 is likely
to result in harm or injury to any of those humans.
Penalty: 2,000 penalty units.
(3) An offence against subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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) 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).
Penalty for contravention of this subsection:500 penalty units.
ComLaw Authoritative Act C2013C00132
Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 2 Main criminal offences and civil penalties
Section 32BJ
166 Therapeutic Goods Act 1989
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.
Advertising biological for an indication
(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: 60 penalty units.
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 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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Medicines and other therapeutic goods that are not medical devices Chapter 3
Biologicals Part 3-2A
Main criminal offences and civil penalties Division 2
Section 32BK
Therapeutic Goods Act 1989 167
(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) that is held by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1) or (2) that is held by the 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:
(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);
(f) representations that a biological is the subject of an approval
under subsection 32CO(1) or (2).
ComLaw Authoritative Act C2013C00132
Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 3 Exemptions
Section 32C
168 Therapeutic Goods Act 1989
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 Legislative Instruments 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 Legislative Instruments Act 2003.
(3) An exemption under this section may be subject to conditions that
are prescribed in the regulations.
(4) A person commits an offence if:
(a) the person does an act or omits to do an act; and
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Biologicals Part 3-2A
Exemptions Division 3
Section 32CB
Therapeutic Goods Act 1989 169
(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:
(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.
ComLaw Authoritative Act C2013C00132
Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 3 Exemptions
Section 32CC
170 Therapeutic Goods Act 1989
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.
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.
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Medicines and other therapeutic goods that are not medical devices Chapter 3
Biologicals Part 3-2A
Exemptions Division 3
Section 32CD
Therapeutic Goods Act 1989 171
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
(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.
ComLaw Authoritative Act C2013C00132
Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 3 Exemptions
Section 32CF
172 Therapeutic Goods Act 1989
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);
(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.
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Medicines and other therapeutic goods that are not medical devices Chapter 3
Biologicals Part 3-2A
Exemptions Division 3
Section 32CH
Therapeutic Goods Act 1989 173
(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
(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.
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 3 Exemptions
Section 32CI
174 Therapeutic Goods Act 1989
(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.
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.
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Medicines and other therapeutic goods that are not medical devices Chapter 3
Biologicals Part 3-2A
Exemptions Division 3
Section 32CJ
Therapeutic Goods Act 1989 175
(2) The Secretary may, by written notice given to the person, require
the person to take steps to recover the biologicals included in that
batch (except any of those biologicals that cannot be recovered
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 recover 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.
(4) The Secretary must, as soon as practicable after giving the notice,
cause particulars of it to be published in the Gazette.
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, or will
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 harm or injury to
any person; and
(e) the harm or injury has resulted, will result, or would 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
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 3 Exemptions
Section 32CJ
176 Therapeutic Goods Act 1989
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement; and
(d) the use of any of the biologicals, if any of the biologicals
were used, would be likely to result in harm or injury to any
person; and
(e) the harm or injury would be likely to result because the
person failed to comply with that requirement.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(8) An offence against subsection (7) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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: 60 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.
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Medicines and other therapeutic goods that are not medical devices Chapter 3
Biologicals Part 3-2A
Exemptions Division 3
Section 32CK
Therapeutic Goods Act 1989 177
Subdivision D—Exempting biologicals for special and
experimental 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.
(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
(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
(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:
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 3 Exemptions
Section 32CL
178 Therapeutic Goods Act 1989
(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.
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;
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Biologicals Part 3-2A
Exemptions Division 3
Section 32CM
Therapeutic Goods Act 1989 179
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 medical 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.
Note: Section 32CN contains criminal offences relating to the giving an authority to a medical practitioner.
(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.
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Part 3-2A Biologicals
Division 3 Exemptions
Section 32CN
180 Therapeutic Goods Act 1989
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.
(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
medical 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:
(i) the use of the biological has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would 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
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Exemptions Division 3
Section 32CN
Therapeutic Goods Act 1989 181
(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.
(2) 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) the use of the biological, if the biological were used, would
be likely to result in harm or injury to any person; and
(e) the harm or injury 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: 2,000 penalty units.
(3) An offence against subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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;
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 3 Exemptions
Section 32CO
182 Therapeutic Goods Act 1989
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 32CM(6).
Penalty for contravention of this subsection:500 penalty units.
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) either:
(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); or
(ii) an application that complies with section 32DA or
32DD has been made for inclusion of the biological in
the Register; 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.
(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
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Exemptions Division 3
Section 32CO
Therapeutic Goods Act 1989 183
(d) an application that complies with section 32DA or 32DD has
been made for inclusion of the biological in the Register; 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.
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) or (2).
Penalty: 60 penalty units.
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 3 Exemptions
Section 32CO
184 Therapeutic Goods Act 1989
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),
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) or (2) is not a legislative
instrument.
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Biologicals Part 3-2A
Including biologicals in the Register Division 4
Section 32D
Therapeutic Goods Act 1989 185
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
(c) the biological conforms to every standard (if any) applicable
to it; and
(d) the biological complies with every requirement (if any)
relating to advertising applicable under Part 5-1 or under the
regulations; and
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Part 3-2A Biologicals
Division 4 Including biologicals in the Register
Section 32DB
186 Therapeutic Goods Act 1989
(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.
(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.
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Biologicals Part 3-2A
Including biologicals in the Register Division 4
Section 32DC
Therapeutic Goods Act 1989 187
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
(1) A person may make an application to the Secretary to include a
biological, other than a Class 1 biological, in the Register.
(2) An application is not effective unless:
(a) the application is made in accordance with a form that is
approved, in writing, by the Secretary and that relates to that
biological; and
(b) the application is accompanied by any documents that the
form requires; and
(c) the application is delivered to an office of the Department
specified in the form; and
(d) if the Secretary so requires—the applicant has delivered to
that office a reasonable number of samples of the biological;
and
(e) the application is accompanied by the prescribed application
fee.
Note: An evaluation fee is also payable: see sections 32DI to 32DM.
(3) The Secretary may approve different forms for different classes of
biologicals that are prescribed by the regulations for the purposes
of section 32AA.
(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.
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 4 Including biologicals in the Register
Section 32DE
188 Therapeutic Goods Act 1989
32DE Evaluation of biologicals
(1) If an application is made in accordance with section 32DD for a
biological to be included in the Register in relation to a person, 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
(c) whether the biological conforms to any standard applicable to
it; and
(d) whether the biological complies with every requirement (if
any) relating to advertising applicable under Part 5-1 or
under the regulations; 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).
32DF Inclusion of biological in the Register
(1) If:
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Section 32DG
Therapeutic Goods Act 1989 189
(a) an application is made in accordance with section 32DD for a
biological to be included in the Register in relation to a
person; 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.
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:
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 4 Including biologicals in the Register
Section 32DH
190 Therapeutic Goods Act 1989
(a) an application is made under subsection 32DD(1) to include
a 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.
32DH Lapsing of application
(1) An application under subsection 32DD(1) 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 in accordance with section 32DD for a
biological to be included in the Register, 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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Including biologicals in the Register Division 4
Section 32DJ
Therapeutic Goods Act 1989 191
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.
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
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Part 3-2A Biologicals
Division 4 Including biologicals in the Register
Section 32DN
192 Therapeutic Goods Act 1989
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.
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:
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Section 32DN
Therapeutic Goods Act 1989 193
(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:
(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.
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 4 Including biologicals in the Register
Section 32DN
194 Therapeutic Goods Act 1989
(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.
(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.
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Including biologicals in the Register Division 4
Section 32DO
Therapeutic Goods Act 1989 195
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:
(i) the use of the biological has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would 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.
(2) 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) the use of the biological, if the biological were used, would
be likely to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
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Part 3-2A Biologicals
Division 4 Including biologicals in the Register
Section 32DP
196 Therapeutic Goods Act 1989
(3) An offence against subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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 for contravention of this subsection:Imprisonment for 12
months or 1,000 penalty units, or both.
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.
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.
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Therapeutic Goods Act 1989 197
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:
(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
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 4 Including biologicals in the Register
Section 32DR
198 Therapeutic Goods Act 1989
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
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.
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Biologicals Part 3-2A
Including biologicals in the Register Division 4
Section 32DS
Therapeutic Goods Act 1989 199
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:
(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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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 4 Including biologicals in the Register
Section 32DT
200 Therapeutic Goods Act 1989
(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
(b) under section 32DT;
the Secretary must:
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Biologicals Part 3-2A
Including biologicals in the Register Division 4
Section 32DU
Therapeutic Goods Act 1989 201
(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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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 5 Conditions
Section 32E
202 Therapeutic Goods Act 1989
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; 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
(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.
(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.
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Conditions Division 5
Section 32EA
Therapeutic Goods Act 1989 203
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:
(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.
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 5 Conditions
Section 32EB
204 Therapeutic Goods Act 1989
(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.
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).
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Conditions Division 5
Section 32EC
Therapeutic Goods Act 1989 205
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:
(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
(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.
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 5 Conditions
Section 32EF
206 Therapeutic Goods Act 1989
(3) The imposition or variation or removal of a condition under
subsection (1) 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 a later day specified in the notice,
being a day not earlier than 28 days after 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, or will 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.
(2) 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 is likely to result in harm or injury to any
person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
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Conditions Division 5
Section 32EG
Therapeutic Goods Act 1989 207
(3) An offence against subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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 for contravention of this subsection:Imprisonment for 12
months or 1,000 penalty units, or both.
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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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 6 Suspension from the Register
Section 32F
208 Therapeutic Goods Act 1989
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) or (d)).
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:
(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
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Suspension from the Register Division 6
Section 32FB
Therapeutic Goods Act 1989 209
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 in Gazette
(5) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette 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.
(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.
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 6 Suspension from the Register
Section 32FC
210 Therapeutic Goods Act 1989
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 in Gazette
(4) As soon as practicable after giving a notice under subsection (3),
the Secretary must cause to be published in the Gazette 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
(b) on the Secretary’s own initiative.
Publication in Gazette
(3) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette 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
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Biologicals Part 3-2A
Suspension from the Register Division 6
Section 32FD
Therapeutic Goods Act 1989 211
(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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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 7 Cancellation from the Register
Section 32G
212 Therapeutic Goods Act 1989
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
(h) the person has failed to comply with a condition mentioned
in subsection 32EA(1) or (3); or
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Biologicals Part 3-2A
Cancellation from the Register Division 7
Section 32GB
Therapeutic Goods Act 1989 213
(i) both of the following apply:
(i) under the regulations, an authority constituted by or
under the regulations gives a direction to, or makes a
requirement of, the person in relation to an
advertisement of the biological to ensure that
advertising complies with the Therapeutic Goods
Advertising Code;
(ii) the person does not comply with the direction or
requirement; or
(j) there is a breach, involving the biological, of the
requirements relating to advertising applicable under Part 5-1
or under the regulations.
(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 the biological should have been
included in the Register; and
(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
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Chapter 3 Medicines and other therapeutic goods that are not medical devices
Part 3-2A Biologicals
Division 7 Cancellation from the Register
Section 32GC
214 Therapeutic Goods Act 1989
(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 unacceptable; 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.
(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
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Cancellation from the Register Division 7
Section 32GD
Therapeutic Goods Act 1989 215
(g) the biological does not comply with a requirement relating to
advertising applicable to it 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
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.
32GE Publication of cancellation of entry from Register
The Secretary must cause to be published in the Gazette, as soon as
practicable after cancelling an entry of a biological from the
Register, a notice setting out particulars of the cancellation.
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Part 3-2A Biologicals
Division 7 Cancellation from the Register
Section 32GF
216 Therapeutic Goods Act 1989
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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Public notification and recovery of biologicals Division 8
Section 32H
Therapeutic Goods Act 1989 217
Division 8—Public notification and recovery of biologicals
32H What this Division is about
The Secretary may require a person to recover 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 recovery 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 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 manufacturing
principles have not been observed in its
manufacture
The person in relation to
whom it is included in the
Register
3 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
The person supplying it
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Part 3-2A Biologicals
Division 8 Public notification and recovery of biologicals
Section 32HA
218 Therapeutic Goods Act 1989
Circumstances in which requirements may be imposed
Item Circumstance relating to biological Person subject to
requirements
subsection 32CM(1); or
(e) it is the subject of an approval under
subsection 32CO(1) or (2);
but it does not conform with a standard
applicable to it
4 It is a biological, other than a Class 1
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
(e) it is the subject of an approval under
subsection 32CO(1) or (2);
but the manufacturing principles have not been
observed in its manufacture
The person supplying it
5 It is supplied while:
(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); and
(f) it is not the subject of an approval under
subsection 32CO(1) or (2)
The person supplying it
6 It is supplied while it is exempt under
section 32CB, and the Secretary is satisfied that
it is not fit to be used for its intended purpose
The person supplying it
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Section 32HA
Therapeutic Goods Act 1989 219
Circumstances in which requirements may be imposed
Item Circumstance relating to biological Person subject to
requirements
7 It is supplied in contravention of
subsection 42E(1) or section 42EA
The person supplying it
8 It is a biological, other than a Class 1
biological, and it is supplied while it is included
in the Register, but there is a breach of the
condition set out in subsection 32EA(5)
The person in relation to
whom it is included in the
Register
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 unacceptable
The person in relation to
whom the biological is
included in the Register
10 It has been suspended from the Register The person in relation to
whom it is included in the
Register
11 Its entry has been cancelled from the Register The person in relation to
whom it is included in the
Register
(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 recover 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;
(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.
(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 recover a biological under this section does not
apply to a biological that cannot be recovered because it has been
administered to, or applied in the treatment of, a person.
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Part 3-2A Biologicals
Division 8 Public notification and recovery of biologicals
Section 32HB
220 Therapeutic Goods Act 1989
(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, as soon as
practicable after imposing a 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, or will 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.
(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 requirement imposed on the
person under section 32HA; and
(c) the act or omission is likely to result in harm or injury to any
person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) An offence against subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
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Public notification and recovery of biologicals Division 8
Section 32HD
Therapeutic Goods Act 1989 221
Penalty for contravention of this subsection:Imprisonment for 12
months or 1,000 penalty units, or both.
32HD 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 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.
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Part 3-2A Biologicals
Division 9 Obtaining information or documents
Section 32J
222 Therapeutic Goods Act 1989
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;
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;
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Section 32JA
Therapeutic Goods Act 1989 223
(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 the biological complies with every requirement (if
any) 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.
(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
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Part 3-2A Biologicals
Division 9 Obtaining information or documents
Section 32JB
224 Therapeutic Goods Act 1989
(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
(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).
(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, or will result in,
harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would 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.
(3) A person commits an offence if:
(a) the person is given a notice under section 32JA in relation to
a biological; and
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Obtaining information or documents Division 9
Section 32JC
Therapeutic Goods Act 1989 225
(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) the use of the biological, if the biological were used, would
be likely to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(4) An offence against subsection (3) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(5) 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 for contravention of this subsection:Imprisonment for 12
months or 1,000 penalty units, or both.
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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Part 3-2A Biologicals
Division 9 Obtaining information or documents
Section 32JE
226 Therapeutic Goods Act 1989
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), (2), (3) or (5); 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
produce to the Secretary specified documents, relating to one or
more of the following:
(a) the supply of the biological;
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Section 32JF
Therapeutic Goods Act 1989 227
(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:
(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;
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Part 3-2A Biologicals
Division 9 Obtaining information or documents
Section 32JG
228 Therapeutic Goods Act 1989
(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;
(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:
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Section 32JG
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(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.
Compliance
(4) A person given a notice under subsection (1), (2) or (3) 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:
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Part 3-2A Biologicals
Division 9 Obtaining information or documents
Section 32JH
230 Therapeutic Goods Act 1989
(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) or (2) 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.
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:
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(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.
(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 for contravention of this subsection: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.
32JJ 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 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:
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Section 32JL
232 Therapeutic Goods Act 1989
(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) or (2); 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.
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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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;
(ii) the person is an exempt person in relation to the
manufacture of the goods;
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(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, or will result in,
harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would 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.
(2) 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; and
(d) the use of the goods, if the goods were used, would be likely
to result in harm or injury to any person; and
(e) the harm or injury would be likely to result because the
person carried out the step in the manufacture of the goods.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
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Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
(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, or will result in,
harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in harm or injury to any person; and
(f) the harm or injury has resulted, will result, or would 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 (9) 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.
(6) Strict liability applies to paragraph (5)(c).
Note: For strict liability, see section 6.1 of the Criminal Code.
(7) 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) the use of the goods, if the goods were used, would be likely
to result in harm or injury to any person; and
(f) the harm or injury would be likely to result because the
person carried out the step in the manufacture of the goods.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(8) Subsection (7) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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) Strict liability applies to paragraph (9)(c).
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Note: For strict liability, see section 6.1 of the Criminal Code.
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
(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
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(c) the act or omission breaches a condition of the licence; and
(d) the act or omission has resulted in, or will 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.
(2) 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 is likely to result in harm or injury to any
person.
Penalty: 2,000 penalty units.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
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.
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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.
(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.
(3) The Minister may, before taking action under subsection (1) in
relation to the manufacturing principles, obtain advice from a
committee established by the regulations on the action that should
be taken under that subsection as to the principles to be observed in
the manufacture of therapeutic goods for use in humans.
(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
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(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
(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
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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.
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 in Gazette
(4) Where the Secretary grants a licence, the Secretary must cause
particulars of the decision to be published in the Gazette as soon as
is practicable after the decision is made.
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.
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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.
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.
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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.
(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.
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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;
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 or variation 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
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(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.
(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:
(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
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(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
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.
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(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).
(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
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(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
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.
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) or (6),
require the holder:
(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 therapeutic
goods at that site.
Applications or information may be given electronically
(11) An approval of a form mentioned in paragraph (2)(a) or (7)(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;
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(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
(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
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(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:
(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.
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(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.
(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 as soon as is practicable after the decision is made.
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).
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).
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
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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
256 Therapeutic Goods Act 1989
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).
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:
(a) issuing conformity assessment certificates for some
manufacturers of medical devices; and
(b) including medical devices in the Register; and
(c) suspending or cancelling entries of medical devices from the
Register; and
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Therapeutic Goods Act 1989 257
(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 recovery 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
258 Therapeutic Goods Act 1989
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
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;
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Therapeutic Goods Act 1989 259
(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, 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, 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 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
(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.
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Part 4-1 Introduction
Division 2 Interpretation
Section 41BEA
260 Therapeutic Goods Act 1989
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.
(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
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Therapeutic Goods Act 1989 261
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;
(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.
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Division 2 Interpretation
Section 41BI
262 Therapeutic Goods Act 1989
(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.
(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.
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Introduction Part 4-1
Application provisions Division 3
Section 41BJ
Therapeutic Goods Act 1989 263
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.
Note: Section 32DN deals with including the biological under Part 3-2A.
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Part 4-1 Introduction
Division 3 Application provisions
Section 41BJA
264 Therapeutic Goods Act 1989
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,
or omitted to be done, in relation to the biological during that
period.
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Introduction Part 4-1
Application provisions Division 3
Section 41BK
Therapeutic Goods Act 1989 265
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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Chapter 4 Medical devices
Part 4-2 Essential principles and medical device standards
Section 41C
266 Therapeutic Goods Act 1989
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 and medical device standards Part 4-2
Essential principles Division 1
Section 41CA
Therapeutic Goods Act 1989 267
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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Chapter 4 Medical devices
Part 4-2 Essential principles and medical device standards
Division 2 Medical device standards
Section 41CB
268 Therapeutic Goods Act 1989
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 Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
(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:
(a) Standards Australia;
(b) the International Organisation for Standardization;
(c) the International Electrotechnical Commission;
(d) the European Committee for Standardization;
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Essential principles and medical device standards Part 4-2
Medical device standards Division 2
Section 41CD
Therapeutic Goods Act 1989 269
(e) the European Committee for Electrotechnical
Standardization;
(f) any other organisation declared by the Minister by notice
published in the Gazette.
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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Chapter 4 Medical devices
Part 4-3 Conformity assessment procedures
Section 41D
270 Therapeutic Goods Act 1989
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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Conformity assessment procedures Part 4-3
Conformity assessment procedures Division 1
Section 41DA
Therapeutic Goods Act 1989 271
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;
(h) corrective action required in relation to the design,
manufacture, packaging, labelling and supply of medical
devices;
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Section 41DB
272 Therapeutic Goods Act 1989
(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 procedures Part 4-3
Conformity assessment standards Division 2
Section 41DC
Therapeutic Goods Act 1989 273
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 Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
(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;
(c) the European Committee for Standardization;
(d) any other organisation declared by the Minister by notice
published in the Gazette.
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Part 4-3 Conformity assessment procedures
Division 2 Conformity assessment standards
Section 41DE
274 Therapeutic Goods Act 1989
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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Conformity assessment certificates Part 4-4
Section 41E
Therapeutic Goods Act 1989 275
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 before a valid application can be made for including a kind of medical device in the Register under this Chapter: see subsection 41FC(2).
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Part 4-4 Conformity assessment certificates
Division 1 Issuing conformity assessment certificates
Section 41EA
276 Therapeutic Goods Act 1989
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.
(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
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Conformity assessment certificates Part 4-4
Issuing conformity assessment certificates Division 1
Section 41EC
Therapeutic Goods Act 1989 277
(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;
(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
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Part 4-4 Conformity assessment certificates
Division 1 Issuing conformity assessment certificates
Section 41ED
278 Therapeutic Goods Act 1989
(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
certificate; or
(ix) had a conformity assessment certificate 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.
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).
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.
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Conformity assessment certificates Part 4-4
Issuing conformity assessment certificates Division 1
Section 41EE
Therapeutic Goods Act 1989 279
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.
41EF Duration of certificate
(1) The conformity assessment certificate commences on the day
specified for the purpose in the certificate.
(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 (if any) specified in the certificate;
or
(c) until the certificate is revoked under Division 4.
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
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Division 1 Issuing conformity assessment certificates
Section 41EH
280 Therapeutic Goods Act 1989
(b) the applicant does not comply with a requirement by the
Secretary 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 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
(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.
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Medical devices Chapter 4
Conformity assessment certificates Part 4-4
Issuing conformity assessment certificates Division 1
Section 41EI
Therapeutic Goods Act 1989 281
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, or
will 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 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.
(2) 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;
and
(d) the use of the kind of medical device, if the kind of medical
device were used, would be likely to result in harm or injury
to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(4) A person commits an offence if:
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Division 1 Issuing conformity assessment certificates
Section 41EIA
282 Therapeutic Goods Act 1989
(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.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
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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Conformity assessment certificates Part 4-4
Conditions Division 2
Section 41EJ
Therapeutic Goods Act 1989 283
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), (6) and (8)), 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.
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
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Section 41EJ
284 Therapeutic Goods Act 1989
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.
Conditions do not limit other conditions
(6) A condition imposed under this section is in addition to any
conditions imposed under this Division.
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Conformity assessment certificates Part 4-4
Conditions Division 2
Section 41EK
Therapeutic Goods Act 1989 285
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 or variation 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
(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.
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Chapter 4 Medical devices
Part 4-4 Conformity assessment certificates
Division 3 Suspension of conformity assessment certificates
Section 41EM
286 Therapeutic Goods Act 1989
Division 3—Suspension of conformity assessment
certificates
Note: Suspension of a conformity assessment certificate leads to suspension from the Register of the kinds of medical devices to which the certificate applied (see subsection 41GF(1)). Applications to include such devices in the Register are not effective (see paragraph 41FC(2)(c)).
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.
41EO Duration of suspension
(1) The suspension takes effect:
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Conformity assessment certificates Part 4-4
Suspension of conformity assessment certificates Division 3
Section 41EP
Therapeutic Goods Act 1989 287
(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:
(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
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Division 3 Suspension of conformity assessment certificates
Section 41EQ
288 Therapeutic Goods Act 1989
(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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Revocation of conformity assessment certificates Division 4
Section 41ER
Therapeutic Goods Act 1989 289
Division 4—Revocation of conformity assessment
certificates
Note: Revocation of a conformity assessment certificate leads to cancellation of the entry from the Register of the kinds of medical devices to which the certificate applied (see paragraph 41GK(b)). Applications to include such devices in the Register are not effective (see paragraph 41FC(2)(c)).
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
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.
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
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Division 4 Revocation of conformity assessment certificates
Section 41ET
290 Therapeutic Goods Act 1989
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
(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
certificate; or
(ix) had a conformity assessment certificate 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.
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Revocation of conformity assessment certificates Division 4
Section 41EU
Therapeutic Goods Act 1989 291
(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.
(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.
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Chapter 4 Medical devices
Part 4-4 Conformity assessment certificates
Division 4 Revocation of conformity assessment certificates
Section 41EV
292 Therapeutic Goods Act 1989
(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, 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.
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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Medical devices Chapter 4
Including medical devices in the Register Part 4-5
Section 41F
Therapeutic Goods Act 1989 293
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 (and certain
other requirements are complied with).
Inclusions in the Register are subject to certain automatic
conditions and the Secretary may impose further conditions.
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-5 Including medical devices in the Register
Division 1 Including medical devices in the Register
Section 41FA
294 Therapeutic Goods Act 1989
Division 1—Including medical devices in the Register
41FA What this Division is about
Kinds of medical devices are usually included in the Register
automatically once a proper application is made, together with the
required certification. 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 be effective unless that kind of device is covered by a conformity assessment certificate under Part 4-4: see paragraph 41FC(2)(c).
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.
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Including medical devices in the Register Part 4-5
Including medical devices in the Register Division 1
Section 41FB
Therapeutic Goods Act 1989 295
41FB How this Division works
This diagram shows how this Division applies to an application for
a kind of medical device to be included in the Register.
Does the application comply with
Subdivision A?
Has the application been selected
for audit under Subdivision C?
Is the Secretary satisfied as to all
matters considered in the audit?
The Secretary will include
the kind of medical device
in the Register
The Secretary will refuse
the application
Yes
Yes
Yes No
No
No
Subdivision A—Applications
41FC Applications
(1) An application for a kind of medical device to be included in the
Register 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.
(2) An application is not effective if:
(a) the application is not made in accordance with
subsection (1); or
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-5 Including medical devices in the Register
Division 1 Including medical devices in the Register
Section 41FD
296 Therapeutic Goods Act 1989
(b) the prescribed application fee has not been paid; or
(c) 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 this section can be made, and no
such certificate is in force; or
(d) 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 41FE and 41FEA.
(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.
41FD Matters to be certified
The applicant must certify that:
(a) devices of the kind in question are medical devices; and
(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) an appropriate conformity assessment procedure has been
applied to devices of that kind; and
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Medical devices Chapter 4
Including medical devices in the Register Part 4-5
Including medical devices in the Register Division 1
Section 41FE
Therapeutic Goods Act 1989 297
(g) the applicant:
(i) has available sufficient information to substantiate the
application of those conformity assessment procedures;
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) devices of that kind comply with every requirement (if any)
relating to advertising applicable under Part 5-1 or under the
regulations; and
(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 on compliance with the essential principles and section 41BI on applying the conformity assessment procedures.
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, or
will 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 harm or
injury to any person.
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Chapter 4 Medical devices
Part 4-5 Including medical devices in the Register
Division 1 Including medical devices in the Register
Section 41FE
298 Therapeutic Goods Act 1989
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.
(2) 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; and
(d) the use of the kind of medical device, if the kind of medical
device were used, would be likely to result in harm or injury
to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Including medical devices in the Register Part 4-5
Including medical devices in the Register Division 1
Section 41FEA
Therapeutic Goods Act 1989 299
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 is made in accordance with section 41FC for a
kind of medical device to be included in the Register in
relation to a person; and
(b) the requirements of section 41FD have been complied with;
the Secretary must include the kind of device in the Register in
relation to the person, unless the application has been selected
under section 41FH for audit.
(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.
(2) As soon as practicable after the kind of device has been included in
the Register, the Secretary must give 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.
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Chapter 4 Medical devices
Part 4-5 Including medical devices in the Register
Division 1 Including medical devices in the Register
Section 41FG
300 Therapeutic Goods Act 1989
41FG Notification of unsuccessful applications
The Secretary must notify the applicant in writing, within 20
working days after receiving an application under
subsection 41FC(1), if an application for a kind of medical device
to be included in the Register is unsuccessful.
Subdivision C—Auditing of applications
41FH Selecting applications for auditing
(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, within 20 working days after the
application is made, give the applicant a written notice that:
(i) informs the applicant of the selection; and
(ii) requests the applicant to provide any further information
necessary for the auditing of the application; and
(b) the application must be dealt with under this Subdivision and
not under Subdivision B.
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.
(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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Medical devices Chapter 4
Including medical devices in the Register Part 4-5
Including medical devices in the Register Division 1
Section 41FJ
Therapeutic Goods Act 1989 301
(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.
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
(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 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 audit of the
application; or
(b) the applicant does not comply with a requirement by the
Secretary 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
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-5 Including medical devices in the Register
Division 1 Including medical devices in the Register
Section 41FL
302 Therapeutic Goods Act 1989
(e) the applicant fails to pay an assessment fee for the
application in accordance with section 41LB or 41LC.
Subdivision D—Miscellaneous
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.
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.
(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.
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Including medical devices in the Register Part 4-5
Conditions Division 2
Section 41FN
Therapeutic Goods Act 1989 303
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), (2) and (4)), 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:
(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
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
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Chapter 4 Medical devices
Part 4-5 Including medical devices in the Register
Division 2 Conditions
Section 41FN
304 Therapeutic Goods Act 1989
(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
(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
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
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Medical devices Chapter 4
Including medical devices in the Register Part 4-5
Conditions Division 2
Section 41FO
Therapeutic Goods Act 1989 305
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; 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 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
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-5 Including medical devices in the Register
Division 2 Conditions
Section 41FP
306 Therapeutic Goods Act 1989
(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:
(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 or variation 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
(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.
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Suspension and cancellation from the Register Part 4-6
Suspension from the Register Division 1
Section 41G
Therapeutic Goods Act 1989 307
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 certificate 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
Register under Division 2 (other than under
paragraph 41GL(a) or (d) or section 41GM).
(2) The suspension may be limited to some medical devices of that
kind, as specified in the notice.
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Chapter 4 Medical devices
Part 4-6 Suspension and cancellation from the Register
Division 1 Suspension from the Register
Section 41GB
308 Therapeutic Goods Act 1989
(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, 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
(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
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Medical devices Chapter 4
Suspension and cancellation from the Register Part 4-6
Suspension from the Register Division 1
Section 41GD
Therapeutic Goods Act 1989 309
(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, 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:
(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 a notice setting out particulars of the
revocation.
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Chapter 4 Medical devices
Part 4-6 Suspension and cancellation from the Register
Division 1 Suspension from the Register
Section 41GE
310 Therapeutic Goods Act 1989
(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
(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 under
Part 4-4
41GF 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 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.
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Medical devices Chapter 4
Suspension and cancellation from the Register Part 4-6
Suspension from the Register Division 1
Section 41GG
Therapeutic Goods Act 1989 311
(3) The Secretary must cause to be published in the Gazette, as soon as
practicable after the suspension, a notice setting out particulars of
the suspension.
41GG Duration of suspension
(1) The suspension 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 the suspension 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.
. (2) 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 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.
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Chapter 4 Medical devices
Part 4-6 Suspension and cancellation from the Register
Division 1 Suspension from the Register
Section 41GJ
312 Therapeutic Goods Act 1989
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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Medical devices Chapter 4
Suspension and cancellation from the Register Part 4-6
Cancellation of entries from the Register Division 2
Section 41GK
Therapeutic Goods Act 1989 313
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
(ii) the certification or purported certification under
section 41FD relating to the application;
was false or misleading in a material particular; or
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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
314 Therapeutic Goods Act 1989
(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) both of the following apply:
(i) under the regulations, an authority constituted by or
under the regulations gives a direction to, or makes a
requirement of, the person in relation to an
advertisement of the kind of device to ensure that
advertising complies with the Therapeutic Goods
Advertising Code;
(ii) the person does not comply with the direction or
requirement; or
(h) there is a serious breach, involving the kind of device, of the
requirements 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.
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 the kind of device should have been
included in the Register; 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
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Medical devices Chapter 4
Suspension and cancellation from the Register Part 4-6
Cancellation of entries from the Register Division 2
Section 41GN
Therapeutic Goods Act 1989 315
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.
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
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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
316 Therapeutic Goods Act 1989
application for inclusion of the kind of device in the Register
is incorrect, or is no longer correct, in a material particular.
Note: The matters that must be certified under section 41FD include compliance with the essential principles and the application of conformity assessment procedures, being able to substantiate the compliance and application, and compliance with advertising requirements.
(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.
(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, 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.
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Medical devices Chapter 4
Suspension and cancellation from the Register Part 4-6
Cancellation of entries from the Register Division 2
Section 41GQ
Therapeutic Goods Act 1989 317
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
318 Therapeutic Goods Act 1989
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 recovery 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
Therapeutic Goods Act 1989 319
(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;
(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);
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Chapter 4 Medical devices
Part 4-6A Exempting medical devices to deal with emergencies
Section 41GU
320 Therapeutic Goods Act 1989
(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
(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
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Medical devices Chapter 4
Exempting medical devices to deal with emergencies Part 4-6A
Section 41GV
Therapeutic Goods Act 1989 321
(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,
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
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Part 4-6A Exempting medical devices to deal with emergencies
Section 41GY
322 Therapeutic Goods Act 1989
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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Medical devices Chapter 4
Other exemptions from including medical devices in the Register Part 4-7
Section 41H
Therapeutic Goods Act 1989 323
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 particular medical 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.
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.
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Chapter 4 Medical devices
Part 4-7 Other exemptions from including medical devices in the Register
Section 41HB
324 Therapeutic Goods Act 1989
(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.
(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;
(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 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
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Other exemptions from including medical devices in the Register Part 4-7
Section 41HC
Therapeutic Goods Act 1989 325
(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;
(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 medical 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.
(2) An authority may be given subject to conditions specified in the
authority.
(3) The Secretary may impose conditions (or further conditions) on a
person’s authority by giving the person written notice of the
conditions.
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Chapter 4 Medical devices
Part 4-7 Other exemptions from including medical devices in the Register
Section 41HD
326 Therapeutic Goods Act 1989
(4) An authority 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.
(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:
(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
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Other exemptions from including medical devices in the Register Part 4-7
Section 41HD
Therapeutic Goods Act 1989 327
(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 Legislative Instruments 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
(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 Legislative Instruments 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.
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.
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Chapter 4 Medical devices
Part 4-7 Other exemptions from including medical devices in the Register
Section 41HD
328 Therapeutic Goods Act 1989
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:
(a) the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f),
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.
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Other exemptions from including medical devices in the Register Part 4-7
Section 41HD
Therapeutic Goods Act 1989 329
Approval not a legislative instrument
(12) An approval under subsection (1) or (2) is not a legislative
instrument.
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Chapter 4 Medical devices
Part 4-8 Obtaining information
Section 41J
330 Therapeutic Goods Act 1989
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;
• 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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Medical devices Chapter 4
Obtaining information Part 4-8
Information relating to compliance with requirements and other matters Division 1
Section 41JA
Therapeutic Goods Act 1989 331
Division 1—Information relating to compliance with
requirements and other matters
41JA Secretary may require information
(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 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 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;
(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 the devices comply with every requirement (if any)
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;
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Chapter 4 Medical devices
Part 4-8 Obtaining information
Division 1 Information relating to compliance with requirements and other matters
Section 41JA
332 Therapeutic Goods Act 1989
(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
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.
(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
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Obtaining information Part 4-8
Information relating to compliance with requirements and other matters Division 1
Section 41JB
Therapeutic Goods Act 1989 333
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.
(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
(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).
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, or
will result in, harm or injury to any person; or
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-8 Obtaining information
Division 1 Information relating to compliance with requirements and other matters
Section 41JB
334 Therapeutic Goods Act 1989
(ii) the use of the kind of medical device, if the kind of
medical device were used, would 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.
(5) 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) the use of the kind of medical device, if the kind of medical
device were used, would be likely to result in harm or injury
to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(6) Subsection (5) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Obtaining information Part 4-8
Information relating to compliance with requirements and other matters Division 1
Section 41JBA
Therapeutic Goods Act 1989 335
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), (5)
or (7); 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.
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-8 Obtaining information
Division 2 Information relating to medical devices covered by exemptions
Section 41JCA
336 Therapeutic Goods Act 1989
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,
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;
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Obtaining information Part 4-8
Information relating to medical devices covered by exemptions Division 2
Section 41JE
Therapeutic Goods Act 1989 337
(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.
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
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-8 Obtaining information
Division 2 Information relating to medical devices covered by exemptions
Section 41JE
338 Therapeutic Goods Act 1989
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.
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.
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Obtaining information Part 4-8
Information relating to medical devices covered by exemptions Division 2
Section 41JF
Therapeutic Goods Act 1989 339
41JF Secretary may require information relating to authorities
under section 41HC
(1) The Secretary may give to a person who is granted an authority
under section 41HC (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.
(2) 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.
(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.
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) 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.
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-8 Obtaining information
Division 2 Information relating to medical devices covered by exemptions
Section 41JG
340 Therapeutic Goods Act 1989
(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.
41JG Criminal offences for failing to give information or documents
sought under this Division
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.
Note: The privilege against self incrimination is not a reasonable excuse for the purposes of this section. However, section 41JJ limits the use in prosecutions of information etc. obtained under sections 41JCA, 41JD, 41JE, 41JF and 41JFA.
41JH False or misleading information
A person to whom a notice is given under section 41JCA, 41JD,
41JE, 41JF or 41JFA is guilty of 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.
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Obtaining information Part 4-8
Information relating to medical devices covered by exemptions Division 2
Section 41JI
Therapeutic Goods Act 1989 341
41JI False or misleading documents
(1) A person is guilty of 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.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(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.
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.
(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:
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-8 Obtaining information
Division 2 Information relating to medical devices covered by exemptions
Section 41JJ
342 Therapeutic Goods Act 1989
(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.
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Public notification and recovery of medical devices Part 4-9
Section 41K
Therapeutic Goods Act 1989 343
Part 4-9—Public notification and recovery of
medical devices
41K What this Part is about
The Secretary can require action to recover 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 recovery 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
device
Person subject to
requirements
1. It is supplied while it is included in the
Register, but 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 conformity assessment
procedures have not been applied to medical
devices of that kind
The person in relation to
whom it is included in the
Register
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
The person supplying the
kind of medical device
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-9 Public notification and recovery of medical devices
Section 41KA
344 Therapeutic Goods Act 1989
Circumstances in which requirements may be imposed
Item Circumstance relating to a kind of medical
device
Person subject to
requirements
subsection 41HD(1) or (2) relating to
devices of that kind;
but medical devices of that kind do not
comply with the essential principles
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) or (2) relating to
devices of that kind;
but the conformity assessment procedures
have not been applied to medical devices of
that kind
The person supplying the
kind of medical device
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) 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
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Public notification and recovery of medical devices Part 4-9
Section 41KB
Therapeutic Goods Act 1989 345
Circumstances in which requirements may be imposed
Item Circumstance relating to a kind of medical
device
Person subject to
requirements
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
(2) The requirements may be one or both of the following:
(a) to take specified steps, in the specified manner and within
such reasonable period as is specified, to recover 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.
(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 recover medical devices under this section does
not apply to a medical device that cannot be recovered 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, as soon as
practicable after imposing a requirement under section 41KA, a
notice setting out particulars of the requirement.
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-9 Public notification and recovery of medical devices
Section 41KC
346 Therapeutic Goods Act 1989
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, or will 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.
(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 requirement imposed on the
person under section 41KA; and
(c) the act or omission is likely to result in harm or injury to any
person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Public notification and recovery of medical devices Part 4-9
Section 41KCA
Therapeutic Goods Act 1989 347
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.
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-10 Assessment fees
Section 41L
348 Therapeutic Goods Act 1989
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;
(c) different levels of assessment of kinds of medical devices.
ComLaw Authoritative Act C2013C00132
Medical devices Chapter 4
Assessment fees Part 4-10
Section 41LB
Therapeutic Goods Act 1989 349
(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.
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
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Chapter 4 Medical devices
Part 4-10 Assessment fees
Section 41LE
350 Therapeutic Goods Act 1989
(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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Medical devices Chapter 4
Offences and civil penalty provisions relating to medical devices Part 4-11
Section 41M
Therapeutic Goods Act 1989 351
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 (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).
ComLaw Authoritative Act C2013C00132
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
352 Therapeutic Goods Act 1989
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, or will result in,
harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would 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.
(2) 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
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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
Therapeutic Goods Act 1989 353
(d) the use of the device, if the device were used, would be likely
to result in harm or injury to any person; and
(e) the harm or injury would be likely to result because the
device does not comply with the essential principles.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(4) 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: Imprisonment for 12 months or 1,000 penalty units, or
both.
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, or will result in,
harm or injury to any person; or
(ii) the use of the device, if device were used, would result
in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would result,
because the device does not comply with the essential
principles.
ComLaw Authoritative Act C2013C00132
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
354 Therapeutic Goods Act 1989
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.
(6) 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) the use of the device, if the device were used, would be likely
to result in harm or injury to any person; and
(e) the harm or injury would be likely to result because the
device does not comply with the essential principles.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(7) Subsection (6) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
Offences relating to exporting a medical device
(9) A person commits an offence if:
(a) the person exports a medical device from Australia; and
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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
Therapeutic Goods Act 1989 355
(b) the medical device does not comply with the essential
principles; 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, or will result in,
harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would 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.
(10) 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; 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) the use of the device, if the device were used, would be likely
to result in harm or injury to any person; and
(e) the harm or injury would be likely to result because the
device does not comply with the essential principles.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(11) Subsection (10) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(12) 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 41MAA
356 Therapeutic Goods Act 1989
(a) the person exports a medical device from Australia; and
(b) the medical device does not comply with the essential
principles; 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: Imprisonment for 12 months or 1,000 penalty units, or
both.
Exception
(13) Paragraphs (9)(b), (10)(b) and (12)(b) do not apply to the extent
that the essential principles in question relate to labelling medical
devices for supply in Australia.
Note: A defendant bears an evidential burden in relation to the matters in this subsection: see subsection 13.3(3) of the Criminal Code.
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:
(a) the person supplies a medical device for use in Australia; and
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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 41MB
Therapeutic Goods Act 1989 357
(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; 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.
(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).
ComLaw Authoritative Act C2013C00132
Chapter 4 Medical devices
Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 1 Non-compliance with essential principles
Section 41MC
358 Therapeutic Goods Act 1989
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, or will 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.
(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 breaches a condition of a consent; and
(c) the act or omission is likely to result in harm or injury to any
person.
Penalty: 1,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(4) Subsection (3) is an offence of strict liability.
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; and
(b) the act or omission breaches a condition of a consent.
Penalty: 500 penalty units.
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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 41MCA
Therapeutic Goods Act 1989 359
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), (2), (4), (9), (10) or (12)
or a contravention of subsection 41MAA(1) or (3); and
(b) the Secretary notifies the Chief Executive Officer 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.
ComLaw Authoritative Act C2013C00132
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 41ME
360 Therapeutic Goods Act 1989
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, or will result in,
harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would 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.
(2) 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
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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
Therapeutic Goods Act 1989 361
(d) the use of the device, if the device were used, would be likely
to result in harm or injury to any person; and
(e) the harm or injury would be likely to result because the
conformity assessment procedures have not been applied to
the device.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(4) 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: Imprisonment for 12 months or 1,000 penalty units, or
both.
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, or will result in,
harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would result,
because the conformity assessment procedures have not been
applied to the device.
ComLaw Authoritative Act C2013C00132
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 41ME
362 Therapeutic Goods Act 1989
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.
(6) 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) the use of the device, if the device were used, would be likely
to result in harm or injury to any person; and
(e) the harm or injury would be likely to result because the
conformity assessment procedures have not been applied to
the device.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(7) Subsection (6) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
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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 41MEA
Therapeutic Goods Act 1989 363
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:
(a) the person supplies a medical device in Australia; and
(b) the conformity assessment procedures have not been applied
to the device; and
ComLaw Authoritative Act C2013C00132
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
364 Therapeutic Goods Act 1989
(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, or will result in,
harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in harm or injury to any person; and
(d) the harm or injury has resulted, will result, or would 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
(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, or will result in,
harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in harm or injury to any person; and
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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
Therapeutic Goods Act 1989 365
(d) the harm or injury has resulted, will result, or would 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.
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.
ComLaw Authoritative Act C2013C00132
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 41MH
366 Therapeutic Goods Act 1989
(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.
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 is guilty of an offence if:
(a) the person makes a statement in or in connection with a
declaration, relating to the application of conformity
assessment procedures to a medical device that the person
has manufactured; and
(b) the statement 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.
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 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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Medical devices Chapter 4
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
Therapeutic Goods Act 1989 367
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) or (2) that is held by the person;
and
(c) either:
(i) the use of the device has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the device, if the device were used, would
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.
(2) 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 3 Medical devices not included in the Register and related matters
Section 41MI
368 Therapeutic Goods Act 1989
(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) or (2) that is held by the person;
and
(c) the use of the device, if the device were used, would be likely
to result in harm or injury to any person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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;
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Medical devices not included in the Register and related matters Division 3
Section 41MI
Therapeutic Goods Act 1989 369
(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) or (2) that is held by the person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) Strict liability applies to paragraph (4)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
Defence if person was not the sponsor of the goods
(6) It is a defence to a prosecution under subsection (1), (2) or (4) 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, or will not, 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 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.
Note: A defendant bears an evidential burden in relation to the matters in subsection (7): see subsection 13.3(3) of the Criminal Code.
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Chapter 4 Medical devices
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
370 Therapeutic Goods Act 1989
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
(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:
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Section 41MIB
Therapeutic Goods Act 1989 371
(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.
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
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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 41MJ
372 Therapeutic Goods Act 1989
(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) 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:
(a) the importation or exportation of a medical device is an
offence under subsection 41MI(1), (2) or (4) or a
contravention of section 41MIB; and
(b) the Secretary notifies the Chief Executive Officer 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
Medical devices not included in the Register and related matters Division 3
Section 41MK
Therapeutic Goods Act 1989 373
41MK Wholesale supply of medical devices not included in the
Register
A person is guilty of 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) 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.
41ML False advertising about medical devices
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: 60 penalty units.
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:
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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 41MM
374 Therapeutic Goods Act 1989
(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) or (2).
41MM Claims about arranging supplies of medical devices not
included in the Register
A person is guilty of an offence if:
(a) the person claims, by any means, that the person or another
person can arrange the supply of medical devices; and
(b) the devices are not:
(i) medical devices of a kind included in the Register; or
(ii) exempt devices.
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, or will result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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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 41MN
Therapeutic Goods Act 1989 375
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.
(2) 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 is likely to result in harm or injury to any
person.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
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
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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 41MN
376 Therapeutic Goods Act 1989
(d) the act or omission has resulted in, or will result in, harm or
injury to a 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.
(6) 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 is likely to result in harm or injury to a
person.
Penalty: 2,000 penalty units.
(7) Subsection (6) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
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
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Section 41MNA
Therapeutic Goods Act 1989 377
(iii) a condition applicable under regulations made for the
purposes of subsection 41HB(7); or
(iv) a condition of an approval under subsection 41HD(1) or
(2).
Penalty: 60 penalty units.
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
(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.
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Chapter 4 Medical devices
Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 3A Offences and civil penalties related to exemptions under Part 4-6A
Section 41MNB
378 Therapeutic Goods Act 1989
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.
(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
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Section 41MNC
Therapeutic Goods Act 1989 379
(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:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 4 Other offences and civil penalty provisions
Section 41MO
380 Therapeutic Goods Act 1989
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 section 41HC
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, or will result in,
harm or injury to any person; or
(ii) the use of the device, if the device were used, would
result in harm or injury to any person; and
(d) the harm or injury has resulted, will result, or would 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.
(2) A person commits an offence if:
(a) the person has been granted an authority under section 41HC
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
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Section 41MO
Therapeutic Goods Act 1989 381
(iii) otherwise than in accordance with any regulations made
for the purpose of subsection 41HC(5); and
(c) the use of the device, if the device were used, would be likely
to result in harm or injury to any person; and
(d) the harm or injury 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: 2,000 penalty units.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(4) A person commits an offence if:
(a) the person has been granted an authority under section 41HC
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.
(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, or will result in,
harm or injury to any person; or
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Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 4 Other offences and civil penalty provisions
Section 41MP
382 Therapeutic Goods Act 1989
(ii) the use of the device, if the device were used, would
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.
(6) 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) the use of the device, if the device were used, would be likely
to result in harm or injury to any person.
Penalty: 2,000 penalty units.
(7) Subsection (6) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(8) 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: 500 penalty units.
41MP Criminal offence for failing to notify adverse events etc.
(1) A person is guilty of an offence if:
(a) the person is a person in relation to whom a kind of medical
device is included in the Register; and
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Other offences and civil penalty provisions Division 4
Section 41MP
Therapeutic Goods Act 1989 383
(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.
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 recover 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 (other than one
issued 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 particular device;
has been restricted, suspended, revoked or is no longer in
effect.
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Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 4 Other offences and civil penalty provisions
Section 41MPA
384 Therapeutic Goods Act 1989
41MPA Civil penalty for failing to notify adverse events etc.
(1) A person contravenes this section if:
(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 recover 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 (other than one
issued 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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Other offences and civil penalty provisions Division 4
Section 41MPB
Therapeutic Goods Act 1989 385
(ii) the application of relevant conformity assessment
procedures to a particular device;
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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Chapter 4 Medical devices
Part 4-11 Offences and civil penalty provisions relating to medical devices
Division 4 Other offences and civil penalty provisions
Section 41MQ
386 Therapeutic Goods Act 1989
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 is guilty of 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 is guilty of 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.
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
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Section 41MR
Therapeutic Goods Act 1989 387
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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Chapter 5 Advertising, counterfeit therapeutic goods and product tampering
Part 5-1 Advertising and generic information
Division 1 Preliminary
Section 42AA
388 Therapeutic Goods Act 1989
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
if, the person has the qualifications and training that are necessary
or appropriate for membership of the relevant body.
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Preliminary Division 1
Section 42AB
Therapeutic Goods Act 1989 389
(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) Section 42DKB applies 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
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
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Part 5-1 Advertising and generic information
Division 1 Preliminary
Section 42B
390 Therapeutic Goods Act 1989
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.
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:
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Advertising and generic information Part 5-1
Preliminary Division 1
Section 42BAA
Therapeutic Goods Act 1989 391
(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
The Minister may, by legislative instrument, make a code relating
to advertisements about therapeutic goods.
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Part 5-1 Advertising and generic information
Division 2 Therapeutic goods advertisements for which an approval is required
Section 42BA
392 Therapeutic Goods Act 1989
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 is guilty of 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 is guilty of 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.
Note: Advertising that requires approval under Part 2 of the Therapeutic Goods Regulations 1990 must also comply with the Therapeutic Goods Advertising Code.
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Advertising and generic information Part 5-1
Therapeutic goods advertisements for which an approval is required Division 2
Section 42C
Therapeutic Goods Act 1989 393
(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 is guilty of 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
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.
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Chapter 5 Advertising, counterfeit therapeutic goods and product tampering
Part 5-1 Advertising and generic information
Division 2 Therapeutic goods advertisements for which an approval is required
Section 42C
394 Therapeutic Goods Act 1989
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 is guilty of 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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Advertising and generic information Part 5-1
General provisions about advertising therapeutic goods Division 3
Section 42DA
Therapeutic Goods Act 1989 395
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 about therapeutic
goods.
Note: Under subsection 42DL(1) it is an offence for a person to publish or broadcast an advertisement about therapeutic goods that contains a restricted representation, about those goods, the use of which has not been approved under subsection 42DF(1) or permitted under subsection 42DK(1).
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Chapter 5 Advertising, counterfeit therapeutic goods and product tampering
Part 5-1 Advertising and generic information
Division 3 General provisions about advertising therapeutic goods
Section 42DE
396 Therapeutic Goods Act 1989
42DE Applications for approval of use of restricted representation
An application for approval of the use of a restricted representation
must be:
(a) made to the Secretary in writing, in a form approved by the
Secretary; and
(b) signed by or on behalf of the applicant.
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.
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.
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General provisions about advertising therapeutic goods Division 3
Section 42DH
Therapeutic Goods Act 1989 397
(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:
(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
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Part 5-1 Advertising and generic information
Division 3 General provisions about advertising therapeutic goods
Section 42DJ
398 Therapeutic Goods Act 1989
(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.
(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.
42DK Use of restricted or prohibited representations
(1) The Secretary may, by notice in writing published in the Gazette or
on the Department’s website, permit, in relation to therapeutic
goods, the use of a restricted representation (including its use on
the label of the goods or in information included in the package in
which the goods are contained).
(2) The Secretary may, by notice in writing published in the Gazette or
on the Department’s website, permit a prohibited representation to
be included on the label of therapeutic goods, or in information
included in the package in which therapeutic goods are contained,
if the representation is necessary for the appropriate use of the
goods.
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Advertising and generic information Part 5-1
Therapeutic goods advertisements for which an approval is not required Division 3A
Section 42DKA
Therapeutic Goods Act 1989 399
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 published or broadcast
(1) If a representation in an advertisement about therapeutic goods is
false or misleading, the Secretary may, by notice given to the
person apparently responsible for publishing or broadcasting the
advertisement, prevent that person from publishing or
broadcasting, or causing to be published or broadcast, an
advertisement containing that representation (whether express or
implied) about those goods.
(2) A notice under subsection (1) is not a legislative instrument.
42DL Advertising offences
(1) A person must not publish or broadcast an advertisement about
therapeutic goods:
(a) that contains a prohibited representation (whether in express
terms or by necessary implication) about those goods; or
(b) that does not contain a required representation about those
goods; or
(c) that contains a restricted representation, about those goods,
the use of which has not been approved under
subsection 42DF(1) or permitted under subsection 42DK(1);
or
(d) that is in contravention of a notice referred to in
section 42DKB that was given to the person; or
(e) that contains:
(i) a reference to the Act other than in a statement of the
registration number, listing number or device number of
the goods; or
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Part 5-1 Advertising and generic information
Division 3A Therapeutic goods advertisements for which an approval is not required
Section 42DL
400 Therapeutic Goods Act 1989
(ii) a statement 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 statement of their availability as a
pharmaceutical benefit or a statement authorised or
required by a government or government authority
(including a foreign government or foreign government
authority); or
(f) that contains a statement referring to goods, or substances or
preparations containing goods, included in Schedule 3, 4 or 8
to the current Poisons Standard, other than a statement
authorised or required by a government or government
authority (including a foreign government or foreign
government authority); or
(fa) that contains a statement referring to a biological, other than
a statement authorised or required by a government or
government authority (including a foreign government or
foreign government authority); or
(g) that are not entered in the Register; or
(h) if the goods are therapeutic goods, or come within a class of
therapeutic goods, that:
(i) are exempt goods or exempt devices prescribed in the
regulations for the purposes of this provision; or
(ii) have been approved under subsection 19(1) or
section 41HB of this Act for importation into,
exportation from, or supply within, Australia.
Penalty: 60 penalty units.
(2) For the purposes of an offence against subsection (1), strict liability
applies to the following physical elements:
(a) that the use of a restricted representation, as referred to in
paragraph (1)(c), has not been approved under
subsection 42DF(1) or permitted under subsection 42DK(1);
(b) that the notice referred to in paragraph (1)(d) is a notice
referred to in section 42DKB;
(c) that goods, substances or preparations referred to in
paragraph (1)(f) are included in Schedule 3, 4 or 8 to the
current Poisons Standard;
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Therapeutic goods advertisements for which an approval is not required Division 3A
Section 42DM
Therapeutic Goods Act 1989 401
(d) that the therapeutic goods, or class of therapeutic goods,
referred to in paragraph (1)(h):
(i) are exempt goods or exempt devices prescribed in the
regulations made for the purposes of
subparagraph (1)(h)(i); or
(ii) have been approved under subsection 19(1) or
section 41HB of the Act for importation into,
exportation from or supply within, Australia.
(3) It is a defence to a prosecution under subsection (1) if:
(a) in relation to an advertisement mentioned in paragraph (1)(a)
or (f)—the advertisement is made by, or on behalf of, the
Commonwealth; and
(b) in relation to an advertisement mentioned in
paragraph (1)(f)—the goods, substances or preparations are
mentioned in Appendix H of the current Poisons Standard;
and
(c) in relation to goods mentioned in paragraph (1)(g)—the
goods are exempt goods or exempt devices other than goods
of a kind mentioned in paragraph (1)(h).
Note: A defendant bears an evidential burden in relation to the matters mentioned in subsection (3) (see section 13.3 of the Criminal Code).
42DM Compliance with Code
(1) A person is guilty of an offence if:
(a) the person publishes or broadcasts an advertisement about
therapeutic goods; and
(b) the advertisement does not comply with the Therapeutic
Goods Advertising Code.
Penalty: 60 penalty units.
(2) An offence against this section is an offence of strict liability.
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Part 5-1 Advertising and generic information
Division 4 Generic information about ingredients or components of therapeutic goods
Section 42DN
402 Therapeutic Goods Act 1989
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 principles of the Therapeutic Goods Advertising Code
specified in regulations made for the purposes of this section as if
those principles applied to generic information in the same way as
they apply to advertisements.
42DP Offences—publication of generic information
(1) A person is guilty of an offence if:
(a) the person publishes or broadcasts generic information about
therapeutic goods; and
(b) the publication or broadcasting of that generic information
does not comply with principles contained in the part of the
Therapeutic Goods Advertising Code that are specified in
Regulations.
Penalty: 60 penalty units.
(2) An offence against this section is an offence of strict liability.
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Counterfeit therapeutic goods Part 5-2
Section 42E
Therapeutic Goods Act 1989 403
Part 5-2—Counterfeit therapeutic goods
42E Offence of dealing with counterfeit therapeutic goods
(1) A person is guilty of 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);
(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.
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Part 5-2 Counterfeit therapeutic goods
Section 42EA
404 Therapeutic Goods Act 1989
(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;
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.
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Advertising, counterfeit therapeutic goods and product tampering Chapter 5
Counterfeit therapeutic goods Part 5-2
Section 42F
Therapeutic Goods Act 1989 405
(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 Chief Executive Officer 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.
Exported counterfeit therapeutic goods
(2) If the Secretary notifies the Chief Executive Officer 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.
ComLaw Authoritative Act C2013C00132
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering
Part 5-3 Product tampering
Section 42T
406 Therapeutic Goods Act 1989
Part 5-3—Product tampering
42T Notifying of actual or potential tampering
(1) A person is guilty of 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 or the National
Manager of the Therapeutic Goods Administration.
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 is guilty of 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
(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
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Advertising, counterfeit therapeutic goods and product tampering Chapter 5
Product tampering Part 5-3
Section 42U
Therapeutic Goods Act 1989 407
therapeutic goods, and the person is negligent as to that
fact; and
(d) the person fails to notify the Secretary or the National
Manager of the Therapeutic Goods Administration 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
(d) proposing to cause the therapeutic goods to be tampered
with.
ComLaw Authoritative Act C2013C00132
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering
Part 5-3 Product tampering
Section 42V
408 Therapeutic Goods Act 1989
42V Recovery 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 recover 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 recovered 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, as soon as
practicable after imposing such requirements, a notice setting out
particulars of the requirements.
(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
ComLaw Authoritative Act C2013C00132
Advertising, counterfeit therapeutic goods and product tampering Chapter 5
Product tampering Part 5-3
Section 42V
Therapeutic Goods Act 1989 409
(b) either:
(i) the use of the goods has resulted in, or will result in,
harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in harm or injury to any person; and
(c) the harm or injury has resulted, will result, or would 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.
(6A) 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) the use of the goods, if the goods were used, would be likely
to result in harm or injury to any person; and
(c) the harm or injury would be likely to result because the
person failed to comply with the requirement.
Penalty: 2,000 penalty units.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(6B) Subsection (6A) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(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.
(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.
ComLaw Authoritative Act C2013C00132
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering
Part 5-3 Product tampering
Section 42VA
410 Therapeutic Goods Act 1989
42VA Civil penalty relating to the recovery 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
recovery 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.
(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
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Advertising, counterfeit therapeutic goods and product tampering Chapter 5
Product tampering Part 5-3
Section 42W
Therapeutic Goods Act 1989 411
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 recovery
requirements
(1) A person is guilty of 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 recover 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 is guilty of 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
that person or another person, to recover 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.
ComLaw Authoritative Act C2013C00132
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering
Part 5-3 Product tampering
Section 42X
412 Therapeutic Goods Act 1989
(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.
ComLaw Authoritative Act C2013C00132
Enforcement Chapter 5A
Civil penalties Part 5A-1
Obtaining an order for a civil penalty Division 1
Section 42Y
Therapeutic Goods Act 1989 413
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.
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.
ComLaw Authoritative Act C2013C00132
Chapter 5A Enforcement
Part 5A-1 Civil penalties
Division 1 Obtaining an order for a civil penalty
Section 42YA
414 Therapeutic Goods Act 1989
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).
42YB Meaning of penalty unit
In this Act, penalty unit, in relation to a civil penalty provision, has
the same meaning as given by section 4AA of the Crimes Act
1914.
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.
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
ComLaw Authoritative Act C2013C00132
Enforcement Chapter 5A
Civil penalties Part 5A-1
Obtaining an order for a civil penalty Division 1
Section 42YE
Therapeutic Goods Act 1989 415
(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.
(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.
ComLaw Authoritative Act C2013C00132
Chapter 5A Enforcement
Part 5A-1 Civil penalties
Division 2 Civil penalty proceedings and criminal proceedings
Section 42YF
416 Therapeutic Goods Act 1989
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:
(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
ComLaw Authoritative Act C2013C00132
Enforcement Chapter 5A
Civil penalties Part 5A-1
Civil penalty proceedings and criminal proceedings Division 2
Section 42YI
Therapeutic Goods Act 1989 417
(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.
ComLaw Authoritative Act C2013C00132
Chapter 5A Enforcement
Part 5A-2 Infringement notices
Section 42YJ
418 Therapeutic Goods Act 1989
Part 5A-2—Infringement notices
42YJ Infringement notices in respect of offences
(1) The regulations may make provision enabling a person who is
alleged to have committed an offence against this Act to pay to the
Commonwealth, as an alternative to prosecution, a specified
penalty.
Note: An offence against this Act includes an offence against the regulations: see subsection 3(7).
(2) If an individual is alleged to have committed an offence against
this Act, the penalty must not exceed an amount equal to one-fifth
of the maximum penalty that could have been imposed on the
individual for that offence.
(3) If a body corporate is alleged to have committed an offence against
this Act, the penalty must not exceed an amount equal to 5 times
the amount specified under subsection (2) in relation to that
offence.
42YK Infringement notices in respect of civil penalty provisions
(1) The regulations may make provision enabling a person who is
alleged to have contravened a civil penalty provision to pay to the
Commonwealth, as an alternative to civil penalty proceedings
against the person, a specified penalty.
(2) The penalty must not exceed an amount equal to one-tenth of the
maximum penalty prescribed for contravening that provision.
ComLaw Authoritative Act C2013C00132
Enforcement Chapter 5A
Enforceable undertakings Part 5A-3
Section 42YL
Therapeutic Goods Act 1989 419
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.
ComLaw Authoritative Act C2013C00132
Chapter 6 Administration
Part 6-1 Payment of charges
Section 43
420 Therapeutic Goods Act 1989
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.
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).
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.
ComLaw Authoritative Act C2013C00132
Administration Chapter 6
Payment of charges Part 6-1
Section 44A
Therapeutic Goods Act 1989 421
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) or (2)
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:
(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.
ComLaw Authoritative Act C2013C00132
Chapter 6 Administration
Part 6-1 Payment of charges
Section 44B
422 Therapeutic Goods Act 1989
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.
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 or an annual
licensing 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.
ComLaw Authoritative Act C2013C00132
Administration Chapter 6
Payment of charges Part 6-1
Section 45
Therapeutic Goods Act 1989 423
Note: Section 44 sets out the day on which a charge becomes payable.
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 Financial
Management and Accountability Act 1997.
(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 and annual licensing 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 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
(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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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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46 Searches to monitor compliance with Act
(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).
(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;
(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.
(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.
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(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
section 19; 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) 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
section 41HB or 41HC; or
(iib) who has been granted an approval under
subsection 41HD(1) or (2); or
(iii) in relation to whom therapeutic goods are registered,
listed or included in the Register;
being premises connected with the importation, export,
manufacture or supply of therapeutic goods, or the keeping of
records relating to the importation, export, manufacture or
supply of therapeutic goods; 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
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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.
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:
(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) and
subsection 48(1); and
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(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:
(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;
(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;
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(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;
(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.
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(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.
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.
48C Use of electronic equipment at premises
(1) The 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 if he or she
believes on reasonable grounds that the operation of the equipment
can be carried out without damage to the equipment.
(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) if the material can, by using facilities at the premises, be put
in documentary form—operate the facilities to put the
material in that form and seize the documents so produced; or
(c) if the material can be transferred to a disk, tape or other
storage device that:
(i) is brought to the premises; or
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(ii) is at the premises and the use of which for the purpose
has been agreed to in writing by the occupier of the
premises;
operate the equipment or other facilities to copy the material to the
storage device and take the storage device from the premises.
(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 copy 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) If the authorised person believes on reasonable grounds that the
expert assistance will not be available within 24 hours, he or she
may apply to the magistrate for an extension of 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.
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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 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
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:
(a) the thing that has been seized was seized under
paragraph 48C(2)(b) or (c); or
(b) possession by the occupier of the document, film, computer
file, thing or information could constitute an offence or the
contravention of a civil penalty provision.
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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.
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.
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(3) The thing may be returned under subsection (2) either
unconditionally or on such terms and conditions as the Secretary
sees fit.
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.
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(2) Subject to subsection (3), the magistrate may issue the warrant if
the magistrate is satisfied, by information on oath, that it is
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) 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
orally or by affidavit, such further information (if any) as the
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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
(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
(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.
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(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
(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
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(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 Searches at request of manufacturer
(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:
(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
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(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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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
(b) an ingredient, compound, material or preparation specified
under subsection (2);
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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 Legislative Instruments 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;
(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.
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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.
(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.
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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 Legislative Instruments Act 2003
does not apply to the instrument.
(4B) Despite subsection 14(2) of the Legislative Instruments 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:
(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;
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(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:
(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
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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.
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.
52EA Poisons Standard—validation etc.
Scope
(1) This section applies to the following instruments:
(a) the first Poisons Standard;
(b) an instrument made under paragraph 52D(2)(a) or (b) before
the commencement of this section;
whether or not the instrument is in force as at the commencement
of this section.
Disallowance
(2) Section 42 (disallowance) of the Legislative Instruments Act 2003
does not apply, and is taken never to have applied, to the
instrument.
Deemed registration etc.
(3) If:
(a) the instrument was required to be registered under Division 2
of Part 4 of the Legislative Instruments Act 2003; and
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(b) the instrument was not registered;
that Act has effect, and is taken always to have had effect, as if:
(c) the instrument had been lodged for registration immediately
after the instrument was made; and
(d) the instrument had been registered immediately after it was
lodged for registration; and
(e) any other requirement imposed by that Act in relation to the
instrument had been met.
(4) If:
(a) the instrument was required to be registered under Division 3
of Part 4 of the Legislative Instruments Act 2003; and
(b) the instrument was not lodged for registration on or before
the last day for lodging the instrument for registration (the
last lodgment day) worked out under section 29 of that Act;
that Act has effect, and is taken always to have had effect, as if:
(c) the instrument had been lodged for registration on the last
lodgment day; and
(d) the instrument had been registered immediately after it was
lodged for registration; and
(e) any other requirement imposed by that Act in relation to the
instrument had been met.
Definition
(5) In this section:
register has the same meaning as in the Legislative Instruments Act
2003.
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.
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(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;
(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.
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(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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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
an offence against...
the jury may instead
convict the person of an
offence against...
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)
6 subsection 21A(1) subsection 21A(4)
7 subsection 21A(5) subsection 21A(8)
8 subsection 21A(9) subsection 22(7A)
9 subsection 21A(12) subsection 22(8)
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Alternative verdicts for various offences
Column 1 Column 2 Column 3
Item If a prosecution is for
an offence against...
the jury may instead
convict the person of an
offence against...
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)
13F subsection 32CN(1) subsection 32CN(4)
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)
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)
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Alternative verdicts for various offences
Column 1 Column 2 Column 3
Item If a prosecution is for
an offence against...
the jury may instead
convict the person of an
offence against...
29 subsection 41MI(1) subsection 41MI(4)
30 subsection 41MN(1) subsection 41MN(4)
31 subsection 41MN(5) subsection 41MN(8)
32 subsection 41MO(1) subsection 41MO(4)
33 subsection 41MO(5) subsection 41MO(8)
34 subsection 42V(6) subsection 42V(6C)
54 Offences and forfeiture
(3) If a court:
(a) convicts a person of 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.
(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;
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the person is guilty of 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.
(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 is guilty of 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:
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(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
(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 the
maximum penalty that a Court could impose in respect of an
individual for the offence committed by the body corporate.
(3) An executive officer of a body corporate contravenes this
subsection if:
(a) the body corporate contravenes a civil penalty provision; and
(b) the officer knew that the contravention would occur; and
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(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
the maximum civil penalty that a Court could impose in respect of
an individual for the civil penalty provision contravened by the
body corporate.
(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.
Corporate offences for which executive officers may be personally liable
Item Provisions of this Act
1 Subsection 14(1), (2), (6), (7), (10) or (11)
2 Subsection 15(2) or (3)
3 Subsection 19B(1) or (2)
4 Subsection 21A(1), (2), (5) or (6)
5 Subsection 22(7AB)
6 Subsection 22A(1) or (2)
7 Subsection 29A(1)
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Corporate offences for which executive officers may be personally liable
Item Provisions of this Act
8 Subsection 29B(3) or (4)
9 Subsection 30EC(1) or (2)
10 Subsection 30F(4B) or (4C)
11 Subsection 31(5A) or (5B)
12 Subsection 31D(1)
13 Subsection 31E(1)
14 Subsection 32BA(1) or (2)
15 Subsection 32BB(1) or (2)
16 Subsection 32BC(1) or (2)
17 Subsection 32BD(1) or (2)
18 Subsection 32CH(1)
19 Subsection 32CJ(6) or (7)
20 Subsection 32DO(1) or (2)
21 Subsection 32DQ(1)
22 Subsection 32DR(3) or (4)
23 Subsection 32EF(1) or (2)
24 Subsection 32HC(1) or (2)
25 Subsection 32JB(2) or (3)
26 Subsection 32JI(2)
27 Subsection 35(1), (2), (5) or (7)
28 Subsection 41EI(1) or (2)
29 Subsection 41FE(1) or (2)
30 Subsection 41JB(4) or (5)
31 Section 41JH
32 Subsection 41JI(1)
33 Subsection 41KC(1) or (2)
34 Subsection 41MA(1), (2), (5), (6), (9) or (10)
35 Subsection 41MC(2) or (3)
36 Subsection 41ME(1), (2), (5) or (6)
37 Subsection 41MF(1) or (3)
38 Section 41MH
39 Subsection 41MI(1) or (2)
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Corporate offences for which executive officers may be personally liable
Item Provisions of this Act
40 Subsection 41MN(1) or (2)
41 Subsection 41MNB(1)
42 Subsection 41MP(1)
43 Subsection 41MQ(3) or (4)
44 Subsection 42E(1)
45 Subsection 42T(1) or (2)
46 Subsection 42V(6) or (6A)
47 Subsection 42W(1) or (2)
48 Subsection 54AB(1)
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.
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55 Conduct by directors, servants 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, servant or
agent of the body corporate within the scope of his or her
actual or apparent authority; and
(b) that the director, servant or agent had the state of mind.
(2) Any conduct engaged in on behalf of a body corporate by a
director, servant or agent of the body corporate 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 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 a servant or agent of the
person within the scope of his or her actual or apparent
authority; and
(b) the servant 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 a servant 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
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(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.
(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
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(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 or authority under section 19 granted
to a particular person in relation to particular therapeutic
goods; or
(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 41HC granted to a particular person in
relation to particular medical devices;
(bb) there was no approval under subsection 41HD(1) 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) 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
(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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(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
(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).
(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;
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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:
(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)
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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;
(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 either or both of the following persons:
(a) the National Manager of the Therapeutic Goods
Administration;
(b) a person who holds, occupies or performs the duties of a
position in the Therapeutic Goods Administration prescribed
by the regulations for the purposes of this paragraph.
(9) The powers of the Secretary under section 41HD may be delegated
only to either or both of the following persons:
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(a) the National Manager of the Therapeutic Goods
Administration;
(b) a person who holds, occupies or performs the duties of a
position in the Therapeutic Goods Administration prescribed
by the regulations for the purposes of this paragraph.
(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.
(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:
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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 or 9D; or
(b) refusing to grant 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
(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.
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:
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(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.
(2) A person whose interests are affected by an initial decision may, by
notice in writing given to the Minister:
(a) in the case of a decision particulars of which are required to
be notified in the Gazette—within 90 days after those
particulars are so notified; or
(b) in any other case—within 90 days after the decision first
comes 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.
(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
(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.
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(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.
(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
(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
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(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
(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.
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(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
(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).
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(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.
(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.
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(3A) The Secretary may release information obtained in response to a
notice under section 31A, 31AA, 31B, 32JE, 32JF, 32JG, 32JH,
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
(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:
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(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 recovery of therapeutic goods);
(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 1(d) of Information Privacy Principle 11 in section 14 of
the Privacy Act 1988, to be authorised by law.
(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
co-operative arrangements relating to the assessment or regulation
of therapeutic goods, therapeutic goods information the release of
which is consistent with those arrangements.
(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 1(d) of
Information Privacy Principle 11 in section 14 of the Privacy Act
1988, to be authorised by law.
(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:
(a) the release of which is necessary to ensure the safe use of
particular therapeutic goods; or
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(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
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.
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(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);
(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.
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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
(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
ComLaw Authoritative Act C2013C00132
Miscellaneous Chapter 7
Section 63
Therapeutic Goods Act 1989 477
Register are to be made, in cases where applications for
revocation have been made under paragraph 41GD(2)(a); 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
(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.
ComLaw Authoritative Act C2013C00132
Chapter 7 Miscellaneous
Section 63
478 Therapeutic Goods Act 1989
(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
come into effect on a day earlier than the day on which this Act
commences.
ComLaw Authoritative Act C2013C00132
Repeal and transitional provisions Chapter 8
Section 66
Therapeutic Goods Act 1989 479
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
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
ComLaw Authoritative Act C2013C00132
Chapter 8 Repeal and transitional provisions
Section 66
480 Therapeutic Goods Act 1989
(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
(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.
ComLaw Authoritative Act C2013C00132
Repeal and transitional provisions Chapter 8
Section 67
Therapeutic Goods Act 1989 481
(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.
(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
ComLaw Authoritative Act C2013C00132
Chapter 8 Repeal and transitional provisions
Section 69
482 Therapeutic Goods Act 1989
(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.
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
Therapeutic Goods Act 1989 483
Endnotes
Endnote 1—Legislation history
This endnote sets out details of the legislation history of the Therapeutic Goods
Act 1989.
Act Number
and year
Assent
date
Commencement
date
Application,
saving and
transitional
provisions
Therapeutic Goods Act
1989
21, 1990 17 Jan 1990 15 Feb 1991
Community Services and
Health Legislation
Amendment Act (No. 2)
1990
141, 1990 28 Dec
1990
Part 8 (ss. 78–81): (a) —
Community Services and
Health Legislation
Amendment Act 1991
84, 1991 26 June
1991
s. 14: 1 Aug 1991 (see s.
2(2) and Gazette 1991,
No. S207)
Remainder: Royal
Assent
ss. 33–36
Therapeutic Goods
Amendment Act 1991
204, 1991 24 Dec
1991
24 Dec 1991 ss. 4(2), 10(2) and
13(2)
Health, Housing and
Community Services
Legislation Amendment
Act 1992
88, 1992 30 June
1992
ss. 82–88: Royal Assent
(b)
s. 83(2)
Health and Community
Services Legislation
Amendment Act (No. 2)
1993
76, 1993 25 Nov
1993
ss. 29(h) and 30–32: 14
Feb 1994 (see Gazette
1994, No. GN5)
ss. 29(i), 37(b), 38(b), 47
and 50(1)(d): 2 May
1994 (see Gazette 1994,
No. S149)
Remainder: Royal
Assent
ss. 33(2), 36(2),
41(2), 49(2), 50(2)
and 51(2)
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
484 Therapeutic Goods Act 1989
Act Number
and year
Assent
date
Commencement
date
Application,
saving and
transitional
provisions
Customs, Excise and
Bounty Legislation
Amendment Act 1995
85, 1995 1 July 1995 s. 12 (items 5, 6): 1 July
1995 (c)
s. 18: Royal Assent (c)
s. 18
Therapeutic Goods
Amendment Act 1996
6, 1996 11 June
1996
11 June 1996 s. 84
Therapeutic Goods
Amendment Act 1997
116, 1997 7 July 1997 Schedule 1 (Part 2
[items 2–14]): 1 Jan
1999 (see Gazette 1998,
No. S609)
Remainder: Royal
Assent
—
as amended by
Therapeutic Goods
Legislation
Amendment Act 1999
3, 1999 29 Mar
1999
(see 3, 1999 below) —
Audit (Transitional and
Miscellaneous)
Amendment Act 1997
152, 1997 24 Oct
1997
Schedule 2 (item 1249):
1 Jan 1998 (see Gazette
1997, No. GN49) (d)
—
Therapeutic Goods
Legislation Amendment
Act 1998
34, 1998 17 Apr
1998
17 Apr 1998 —
Therapeutic Goods
Legislation Amendment
Act 1999
3, 1999 29 Mar
1999
Schedule 2: (e)
Remainder: 1 Apr 1999
(see Gazette 1999, No.
S143)
—
Public Employment
(Consequential and
Transitional)
Amendment Act 1999
146, 1999 11 Nov
1999
Schedule 1 (items 936–
938): 5 Dec 1999 (see
Gazette 1999, No. S584)
(f)
—
Therapeutic Goods
Amendment Act 2000
12, 2000 31 Mar
2000
31 Mar 2000 —
Therapeutic Goods
Amendment Act (No. 2)
2000
56, 2000 30 May
2000
30 May 2000 Sch. 1 (item 5)
[see Endnote 3]
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
Therapeutic Goods Act 1989 485
Act Number
and year
Assent
date
Commencement
date
Application,
saving and
transitional
provisions
Therapeutic Goods
Amendment Act (No. 3)
2000
120, 2000 12 Sept
2000
Schedule 1: 10 Oct 2000
Remainder: Royal
Assent
Sch. 1 (items 4, 6,
8, 10, 17) [see
Endnote 3]
Gene Technology
(Consequential
Amendments) Act 2000
170, 2000 21 Dec
2000
22 June 2001 (see s. 2) —
Therapeutic Goods
Amendment Act 2001
14, 2001 22 Mar
2001
22 Sept 2001 Sch. 1 (item 36)
[see Endnote 3]
Australia New Zealand
Food Authority
Amendment Act 2001
81, 2001 10 July
2001
s. 2(6): Royal Assent (g)
Schedule 3 (item 8):
1 July 2002 (see Gazette
2002, No. GN30) (g)
s. 2(6) [see
Endnote 3]
Health and Aged Care
Legislation Amendment
(Application of Criminal
Code) Act 2001
111, 2001 17 Sept
2001
17 Sept 2001 s. 4 [see Endnote
3]
Therapeutic Goods
Amendment Act (No. 1)
2002
23, 2002 4 Apr 2002 4 Apr 2002 —
Therapeutic Goods
Amendment (Medical
Devices) Act 2002
24, 2002 4 Apr 2002 Schedule 1: 4 Oct 2002
Schedule 2: (h)
Remainder: Royal
Assent
Sch. 1 (items 38,
46, 55) [see
Endnote 3]
s. 2(1) (item 3)
(rep. by 140,
2007, Sch. 1
[item 7])
as amended by
Therapeutic Goods
and Other Legislation
Amendment Act 2002
56, 2002 3 July 2002 Schedule 3 (item 22):
(see 56, 2002 below)
—
Therapeutic Goods
Amendment Act
(No. 1) 2006
39, 2006 3 May 2006 Schedule 1 (item 158):
(h)
—
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
486 Therapeutic Goods Act 1989
Act Number
and year
Assent
date
Commencement
date
Application,
saving and
transitional
provisions
Therapeutic Goods
Amendment Act 2007
140, 2007 14 Sept
2007
Schedule 1 (items 7, 8):
3 Oct 2007
—
Therapeutic Goods and
Other Legislation
Amendment Act 2002
56, 2002 3 July 2002 Schedule 1 (items 6, 7),
Schedule 3 (items 4, 22)
and Schedule 4 (item 1):
(i)
Remainder: Royal
Assent
Sch. 3 (items 20,
21) [see Endnote
3]
Therapeutic Goods
Amendment Act (No. 1)
2003
39, 2003 27 May
2003
Schedule 1 (items 1–19)
and Schedule 2: 27 Nov
2003
Schedule 1 (item 79): (j)
Remainder: Royal
Assent
Sch. 1 (items 41,
55, 60) [see
Endnote 3]
US Free Trade
Agreement
Implementation Act
2004
120, 2004 16 Aug
2004
Schedule 7: 1 Jan 2005 Sch. 7 (item 7)
[see Endnote 3]
Financial Framework
Legislation Amendment
Act 2005
8, 2005 22 Feb
2005
s. 4 and Schedule 1
(items 493, 496): Royal
Assent
s. 4 and Sch. 1
(item 496) [see
Endnote 3]
Therapeutic Goods
Amendment Act (No. 2)
2006
2, 2006 1 Mar 2006 Schedule 1: 3 Apr 2006
(see F2006L00889)
Remainder: Royal
Assent
Sch. 1 (item 15)
[see Endnote 3]
Therapeutic Goods
Amendment (Repeal of
Ministerial responsibility
for approval of RU486)
Act 2006
5, 2006 3 Mar 2006 3 Mar 2006 s. 3 [see Endnote
3]
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
Therapeutic Goods Act 1989 487
Act Number
and year
Assent
date
Commencement
date
Application,
saving and
transitional
provisions
Therapeutic Goods
Amendment Act (No. 1)
2006
39, 2006 3 May 2006 Schedule 1 (items 1–117,
119–157): 31 May 2006
Schedule 1 (item 118):
27 Nov 2003
Remainder: Royal
Assent
s. 2(1) (item 5)
(rep. by 140,
2007, Sch. 1
[item 4])
as amended by
Therapeutic Goods
Amendment Act 2007
140, 2007 14 Sept
2007
Schedule 1 (items 4–6):
3 Oct 2007
—
National Health and
Medical Research
Council Amendment Act
2006
50, 2006 9 June 2006 Schedule 1: 1 July 2006
Remainder: Royal
Assent
—
Therapeutic Goods
Amendment Act (No. 3)
2006
96, 2006 5 Sept 2006 5 Sept 2006 —
Therapeutic Goods
Amendment Act 2007
140, 2007 14 Sept
2007
3 Oct 2007 —
Therapeutic Goods
Amendment (Poisons
Standard) Act 2008
9, 2008 20 Mar
2008
20 Mar 2008 —
Statute Law Revision
Act 2008
73, 2008 3 July 2008 Schedule 1 (item 47): (k) —
Therapeutic Goods
Legislation Amendment
(Annual Charges) Act
2008
96, 2008 3 Oct 2008 Schedule 1 (items 1–3):
1 Jan 2009 (see
F2008L04263)
Sch. 1 (item 3)
[see Endnote 3]
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
488 Therapeutic Goods Act 1989
Act Number
and year
Assent
date
Commencement
date
Application,
saving and
transitional
provisions
Therapeutic Goods
Amendment (Medical
Devices and Other
Measures) Act 2009
38, 2009 17 June
2009
Schedules 1, 2 and 5–7:
18 June 2009
Schedule 3: 1 Dec 2009
(see F2009L03387)
Schedule 4: 1 July 2009
Remainder: Royal
Assent
Sch. 2 (item 4),
Sch. 3 (item 23),
Sch. 4 (item 20),
Sch. 5 (item 3)
and Sch. 6
(item 12) [see
Endnote 3]
Therapeutic Goods
Amendment (2009
Measures No. 1) Act
2009
76, 2009 27 Aug
2009
Schedules 1, 3, 6 and
Schedule 7 (items 1–28):
28 Aug 2009
Schedule 2: 25 Feb 2010
(see F2009L03994)
Schedule 4: 1 July 2011
Schedule 5: 8 Feb 2010
(see F2009L03994)
Schedule 7 (items 29–
58): 25 Jan 2010 (see
F2009L03994)
Remainder: Royal
Assent
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) [see
Endnote 3]
Therapeutic Goods
Amendment (2009
Measures No. 2) Act
2009
96, 2009 29 Sept
2009
Schedule 1: 1 July 2010
Schedule 2 and
Schedule 3 (items 1–7):
30 Sept 2009
Schedule 3 (items 8–10):
29 Mar 2010
Remainder: Royal
Assent
Sch. 1 (item 13),
Sch. 2 (item 4)
and Sch. 3
(items 7, 10) [see
Endnote 3]
Statute Law Revision
Act 2010
8, 2010 1 Mar 2010 Schedule 5 (item 124):
Royal Assent
Schedule 5
(item 137(a)): (l)
—
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
Therapeutic Goods Act 1989 489
Act Number
and year
Assent
date
Commencement
date
Application,
saving and
transitional
provisions
Therapeutic Goods
Amendment (2009
Measures No. 3) Act
2010
54, 2010 31 May
2010
Schedule 1: 31 May
2011
Schedules 2–6: 1 June
2010
Remainder: Royal
Assent
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) [see
Endnote 3]
Therapeutic Goods
Amendment (2010
Measures No. 1) Act
2010
141, 2010 15 Dec
2010
Schedule 1 and
Schedule 2 (items 7A–
21): 16 Dec 2010
Schedule 1A and
Schedule 2 (items 1A–
7): 12 Jan 2011
Schedule 2 (items 22,
23): (m)
Remainder: Royal
Assent
Sch. 1A (item 10)
and Sch. 2
(items 7, 21) [see
Endnote 3]
Statute Law Revision
Act 2011
5, 2011 22 Mar
2011
Schedule 7 (item 140):
19 Apr 2011
—
Acts Interpretation
Amendment Act 2011
46, 2011 27 June
2011
Schedule 2 (items 1150–
1156) and Schedule 3
(items 10, 11): 27 Dec
2011
Sch. 3 (items 10,
11) [see Endnote
3]
Therapeutic Goods
Amendment (2011
Measures No. 1) Act
2011
77, 2011 25 July
2011
26 July 2011 Sch. 1 (items 6–8)
[see Endnote 3]
Statute Law Revision
Act 2012
136, 2012 22 Sept
2012
Schedule 6 (items 85–
88): Royal Assent
—
Personal Liability for
Corporate Fault Reform
Act 2012
180, 2012 10 Dec
2012
Schedule 5: 11 Dec 2012 —
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
490 Therapeutic Goods Act 1989
(a) The Therapeutic Goods Act 1989 was amended by Part 8 (sections 78–81)
only of the Community Services and Health Legislation Amendment Act
(No. 2) 1990, subsection 2(6) of which provides as follows:
(6) Part 8 commences immediately after the commencement of the
Therapeutic Goods Act 1989.
The Therapeutic Goods Act 1989 came into operation on 15 February 1991.
(b) The Therapeutic Goods Act 1989 was amended by sections 82–88 only of the
Health, Housing and Community Services Legislation Amendment Act 1992,
subsection 2(1) of which provides as follows:
(1) Subject to this section, this Act commences on the day on which it
receives the Royal Assent.
(c) The Therapeutic Goods Act 1989 was amended by the Customs, Excise and
Bounty Legislation Amendment Act 1995, subsections 2(1) and (5) of which
provide as follows:
(1) Subject to subsections (2), (3), (4), (5) and (6), this Act commences on
the day on which it receives the Royal Assent.
(5) Schedules 2 and 3, items 1, 26 to 45, 49 to 53 and 56 and 67 of
Schedule 4, Schedule 6, items 6 to 11 of Schedule 7 and Schedules 8 and
10 commence on 1 July 1995.
(d) The Therapeutic Goods Act 1989 was amended by Schedule 2 (item 1249)
only of the Audit (Transitional and Miscellaneous) Amendment Act 1997,
subsection 2(2) of which provides as follows:
(2) Schedules 1, 2 and 4 commence on the same day as the Financial
Management and Accountability Act 1997.
(e) Subsection 2(3) of the Therapeutic Goods Legislation Amendment Act 1999
provides as follows:
(3) Schedule 2 is taken to have commenced immediately after the
commencement of Part 2 of Schedule 1 to the Therapeutic Goods
Amendment Act 1997.
Part 2 of Schedule 1 commenced on 1 January 1999 (see Gazette 1998, No.
S609). .
(f) The Therapeutic Goods Act 1989 was amended by Schedule 1 (items 936–
938) only of the Public Employment (Consequential and Transitional)
Amendment Act 1999, subsections 2(1) and (2) of which provide as follows:
(1) In this Act, commencing time means the time when the Public Service
Act 1999 commences.
(2) Subject to this section, this Act commences at the commencing time.
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
Therapeutic Goods Act 1989 491
(g) The Therapeutic Goods Act 1989 was amended by Schedule 3 (item 8) only
of the Australia New Zealand Food Authority Amendment Act 2001,
subsections 2(1)(a), (2) and (5) of which provide as follows:
(1) The following provisions commence on the day on which this Act
receives the Royal Assent:
(a) sections 1, 2 and 3;
(2) Part 1 of Schedule 1 (other than item 120A), and Schedule 3, commence
on the first day after the commencement of this section on which an
amendment of the Australia New Zealand Joint Food Standards
Agreement comes into force in accordance with Article 10 of that
Agreement.
(5) As soon as practicable after the commencement of the following
provisions:
(a) Part 1 of Schedule 1 (other than item 120A);
(b) Schedule 3;
the Minister must cause to be published in the Gazette a notice
specifying the day on which those provisions commenced.
(h) The proposed amendments made by Schedule 2 (items 1–11 and 13–23) of
the Therapeutic Goods Amendment (Medical Devices) Act 2002 and
Schedule 2 (item 12) of the Therapeutic Goods Amendment (Medical
Devices) Act 2002 as amended by Schedule 1 (item 158) of the Therapeutic
Goods Amendment Act (No. 1) 2006 were repealed by Schedule 1 (item 8) of
the Therapeutic Goods Amendment Act 2007 before they commenced.
(i) Subsection 2(1) (items 2(b), 4, 6 and 7) of the Therapeutic Goods and Other
Legislation Amendment Act 2002 provides as follows:
(1) Each provision of this Act specified in column 1 of the table commences,
or is taken to have commenced, on the day or at the time specified in
column 2 of the table.
Commencement information
Column 1 Column 2 Column 3
Provision(s) Commencement Date/Details
2. Schedule 1,
items 6 and 7
The later of:
(b) immediately after Schedule 1 to the Therapeutic Goods Amendment (Medical Devices) Act 2002 commences
4 October 2002
4. Schedule 3,
item 4
Immediately after item 22 of Schedule 3
commences, subject to subsection (3)
4 October 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
492 Therapeutic Goods Act 1989
Commencement information
Column 1 Column 2 Column 3
Provision(s) Commencement Date/Details
6. Schedule 3,
item 22
Immediately after Schedule 1 to the Therapeutic
Goods Amendment (Medical Devices) Act 2002
commences, subject to subsection (3)
4 October 2002
7. Schedule 4,
item 1
Immediately after Schedule 1 to the Therapeutic
Goods Amendment (Medical Devices) Act 2002
commences
4 October 2002
(j) Subsection 2(1) (item 4) of the Therapeutic Goods Amendment Act (No. 1)
2003 provides as follows:
(1) Each provision of this Act specified in column 1 of the table commences,
or is taken to have commenced, on the day or at the time specified in
column 2 of the table.
Provision(s) Commencement Date/Details
4. Schedule 1,
item 79
Immediately after the commencement of the
Health and Aged Care Legislation Amendment
(Application of Criminal Code) Act 2001
17 September
2001
(k) Subsection 2(1) (item 31) of the Statute Law Revision Act 2008 provides as
follows:
(1) Each provision of this Act specified in column 1 of the table commences,
or is taken to have commenced, in accordance with column 2 of the table.
Any other statement in column 2 has effect according to its terms.
Provision(s) Commencement Date/Details
31. Schedule 1,
item 47
Immediately after the commencement of item 79 of
Schedule 1 to the Therapeutic Goods Amendment
Act (No. 1) 2003.
17 September
2001
(l) Subsection 2(1) (items 31 and 38) of the Statute Law Revision Act 2010
provides as follows:
(1) Each provision of this Act specified in column 1 of the table commences,
or is taken to have commenced, in accordance with column 2 of the table.
Any other statement in column 2 has effect according to its terms.
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 1—Legislation history
Therapeutic Goods Act 1989 493
Provision(s) Commencement Date/Details
31. Schedule 5,
items 1 to 51
The day this Act receives the Royal Assent. 1 March 2010
38. Schedule 5,
Parts 2 and 3
Immediately after the provision(s) covered by table
item 31.
1 March 2010
(m) Subsection 2(1) (item 5) of the Therapeutic Goods Amendment (2010
Measures No. 1) Act 2010 provides as follows:
(1) Each provision of this Act specified in column 1 of the table commences,
or is taken to have commenced, in accordance with column 2 of the table.
Any other statement in column 2 has effect according to its terms.
Provision(s) Commencement Date/Details
5. Schedule 2,
Part 3
The later of:
(a) immediately after the commencement of the provision(s) covered by table item 2; and
(b) immediately after the commencement of Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010.
31 May 2011
(paragraph (b)
applies)
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
494 Therapeutic Goods Act 1989
Endnote 2—Amendment history
This endnote sets out the amendment history of the Therapeutic Goods Act
1989.
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Chapter 1
Heading to Part 1 ...........................rep. No. 24, 2002
Heading to Chapt. 1.......................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; Nos. 14, 81 and 111, 2001; No. 24, 2002 (as am. by No. 56,
2002); No. 56, 2002; No. 39, 2003; Nos. 5, 39 and 50, 2006; No. 9, 2008;
Nos. 38, 76 and 96, 2009; Nos. 54 and 141, 2010; No. 5, 2011
ss. 3AA, 3AB ................................ad. No. 76, 2009
s. 3A ..............................................ad. No. 116, 1997
am. No. 12, 2000
s. 3B ..............................................ad. No. 56, 2002
s. 3C ..............................................ad. No. 38, 2009
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
s. 6 .................................................am. No. 76, 1993
s. 6AA ...........................................ad. No. 6, 1996
am. No. 111, 2001
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
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 495
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
ss. 6AAA–6AAD...........................ad. No. 56, 2002
s. 6AAE.........................................ad. No. 56, 2002
am. No. 56, 2002; No. 54, 2010
ss. 6B, 6C ......................................ad. No. 76, 1993
s. 7 .................................................am. No. 76, 1993; No. 24, 2002; No. 141, 2010
s. 7A ..............................................ad. No. 76, 1993
s. 7B ..............................................ad. No. 76, 1993
am. No. 24, 2002; No. 54, 2010
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
s. 9 .................................................am. No. 54, 2010
Chapter 2
Chapt. 2 .........................................ad. No. 24, 2002
s. 9A ..............................................ad. No. 24, 2002
am. No. 56, 2002; No. 54, 2010
s. 9B ..............................................ad. No. 24, 2002
am. No. 140, 2007
s. 9C ..............................................ad. No. 24, 2002
am. No. 38, 2009
s. 9D ..............................................ad. No. 24, 2002
am. Nos. 54 and 141, 2010; No. 77, 2011
s. 9E...............................................ad. No. 24, 2002
Chapter 3
Heading to Part 2 ...........................rep. No. 24, 2002
Heading to Chapt. 3.......................ad. No. 24, 2002
Note to Chapt. 3.............................ad. No. 24, 2002
rs. No. 140, 2007
Part 3-1
Heading to Part 3-1........................ad. No. 24, 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
496 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
s. 10 ...............................................am. No. 24, 2002; Nos. 38 and 76, 2009; No. 46, 2011
Note to s. 10(1)..............................ad. No. 76, 2009
s. 10A ............................................ad. No. 24, 2002
ss. 11, 12........................................rep. No. 76, 2009
Heading to s. 13.............................am. No. 76, 2009
s. 13 ...............................................rs. No. 38, 2009
s. 13A ............................................ad. No. 76, 2009
Subhead. to s. 14(5) .......................rs. No. 54, 2010
s. 14 ...............................................am. No. 85, 1995; No. 6, 1996; No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009; No. 54, 2010
Note to s. 14(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 14(1) ...........................ad. No. 180, 2012
Note to s. 14(2)..............................ad. No. 180, 2012
Note to s. 14(6)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 14(6) ...........................ad. No. 180, 2012
Note to s. 14(7)..............................ad. No. 180, 2012
Note to s. 14(10)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 14(10) .........................ad. No. 180, 2012
Note to s. 14(11)............................ad. No. 180, 2012
s. 14A ............................................ad. No. 39, 2006
am. No. 54, 2010
s. 14B ............................................ad. No. 39, 2006
s. 15 ...............................................am. No. 6, 1996; No. 111, 2001
rs. No. 39, 2006
am. No. 38, 2009
Note to s. 15(2)
Renumbered Note 1 ...................No. 180, 2012
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 497
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Note 2 to s. 15(2) ...........................ad. No. 180, 2012
Note to s. 15(3)..............................ad. No. 180, 2012
s. 15AA .........................................ad. No. 39, 2006
s. 15AB..........................................ad. No. 54, 2010
Part 3-2
Heading to Part 3 ...........................rep. No. 24, 2002
Heading to Part 3-2........................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. 38, 2009; No. 54, 2010
Note to s. 18A(7)
Renumbered Note 1 ...................No. 39, 2006
Note 2 to s. 18A(7) ........................ad. No. 39, 2006
Note to s. 18A(12) .........................am. No. 39, 2006
s. 19 ...............................................am. No. 204, 1991; No. 6, 1996; No. 120, 2000; No. 54, 2010
s. 19A ............................................ad. No. 6, 1996
am. No. 76, 2009
s. 19B ............................................ad. No. 39, 2006
am. No. 38, 2009
Note 3 to s. 19B(1) ........................ad. No. 180, 2012
Note to s. 19B(2)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 19B(2) ........................ad. No. 180, 2012
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
498 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
ss. 19C, 19D ..................................ad. No. 39, 2006
Heading to s. 20.............................rs. No. 6, 1996; No. 39, 2006
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
Note to s. 20(1)..............................ad. No. 23, 2002
rep. No. 39, 2006
Note to s. 20(1A) ...........................ad. No. 111, 2001
rep. No. 39, 2006
s. 20A ............................................ad. No. 39, 2006
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
Note to s. 21A(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 21A(1) ........................ad. No. 180, 2012
Note to s. 21A(2) ...........................ad. No. 180, 2012
Note to s. 21A(5)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 21A(5) ........................ad. No. 180, 2012
Note to s. 21A(6) ...........................ad. No. 180, 2012
s. 21B ............................................ad. No. 39, 2006
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; Nos. 38 and 96, 2009
Note 1 to s. 22(7AB) .....................rs. No. 39, 2006
Note 3 to s. 22(7AB) .....................ad. No. 180, 2012
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
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 499
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Note to s. 22A(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 22A(1) ........................ad. No. 180, 2012
Note to s. 22A(2) ...........................ad. No. 180, 2012
s. 22B ............................................ad. No. 39, 2006
Division 2
s. 23AA .........................................ad. No. 6, 1996
rep. No. 5, 2006
s. 23 ...............................................am. No. 84, 1991; No. 76, 1993; No. 141, 2010
s. 24 ...............................................am. Nos. 84 and 204, 1991; No. 77, 2011
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
Heading to s. 24D..........................am. No. 77, 2011
s. 24D ............................................ad. No. 204, 1991
am. No. 56, 2002; No. 76, 2009; No. 77, 2011
s. 24E.............................................ad. No. 88, 1992
Heading to s. 25.............................rs. No. 6, 1996
s. 25 ...............................................am. Nos. 84 and 204, 1991; No. 76, 1993; No. 116, 1997; No. 12, 2000;
Nos. 24 and 56, 2002; No. 39, 2003; No. 120, 2004; No. 2, 2006; Nos. 54
and 141, 2010
Note to s. 25(1)..............................ad. No. 34, 1998
s. 25AA .........................................ad. No. 141, 2010
s. 25A ............................................ad. No. 34, 1998
am. No. 54, 2010
Heading to s. 25B ..........................am. No. 56, 2002
s. 25B ............................................ad. No. 116, 1997 (as am. by No. 3, 1999)
am. No. 56, 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
500 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
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
Heading to s. 26AA .......................am. No. 56, 2002
s. 26AA .........................................ad. No. 116, 1997
am. No. 56, 2002
Heading to s. 26A..........................rs. No. 14, 2001
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
s. 26B ............................................ad. No. 120, 2004
am. No. 2, 2006; No. 38, 2009
s. 26BA..........................................ad. No. 2, 2006
s. 26BB..........................................ad. No. 76, 2009
rs. No. 141, 2010
Heading to s. 26BC........................am. No. 141, 2010
s. 26BC..........................................ad. No. 76, 2009
Heading to s. 26BD .......................am. No. 141, 2010
s. 26BD..........................................ad. No. 76, 2009
am. No. 141, 2010
s. 26BE..........................................ad. No. 76, 2009
rep. No. 141, 2010
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
s. 28A ............................................ad. No. 76, 2009
Note to s. 29 ..................................ad. No. 76, 2009
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 501
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Heading to s. 29A..........................rs. No. 39, 2006
s. 29A ............................................ad. No. 88, 1992
am. No. 6, 1996; No. 39, 2003; No. 39, 2006; No. 38, 2009
Note to s. 29A(1) ...........................ad. 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
Note to s. 29B(3) ...........................ad. No. 180, 2012
Note to s. 29B(4) ...........................ad. No. 180, 2012
s. 29C ............................................ad. No. 39, 2006
ss. 29D–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
s. 30A ............................................ad. No. 6, 1996
am. No. 111, 2001; No. 23, 2002
rep. No. 39, 2003
ad. No. 76, 2009
s. 30B ............................................ad. No. 116, 1997
rep. No. 39, 2003
s. 30C ............................................ad. No. 170, 2000
am. No. 96, 2009
Heading to s. 30D..........................am. No. 96, 2009
s. 30D ............................................ad. No. 170, 2000
am. No. 96, 2009
s. 30E.............................................ad. No. 170, 2000
Division 2A
Div. 2A of Part 3-2 ........................ad. No. 39, 2003
s. 30EA..........................................ad. No. 39, 2003
am. No. 39, 2006; No. 76, 2009; No. 54, 2010
s. 30EB ..........................................ad. No. 39, 2003
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
502 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
s. 30EC ..........................................ad. No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009
Note to s. 30EC(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 30EC(1)......................ad. No. 180, 2012
Note to s. 30EC(2).........................ad. No. 180, 2012
s. 30ECA .......................................ad. No. 39, 2006
Heading to s. 30ED........................am. No. 76, 2009
s. 30ED..........................................ad. No. 39, 2003
am. No. 76, 2009
Division 3
Heading to s. 30F...........................am. No. 39, 2006
s. 30F.............................................ad. No. 23, 2002
am. No. 39, 2006; No. 38, 2009
Note to s. 30F(4B)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 30F(4B) ......................ad. No. 180, 2012
Note to s. 30F(4C) .........................ad. No. 180, 2012
s. 30FA ..........................................ad. No. 39, 2006
s. 30G ............................................ad. No. 23, 2002
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; Nos. 14 and
111, 2001; No. 39, 2003; No. 39, 2006; No. 38, 2009; Nos. 54 and 141,
2010; No. 77, 2011
Note to s. 31(5A)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 31(5A) ........................ad. No. 180, 2012
Note to s. 31(5B) ...........................ad. No. 180, 2012
s. 31AAA.......................................ad. No. 39, 2006
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 503
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Heading to s. 31A..........................rs. No. 23, 2002
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
Heading to s. 31C ..........................am. No. 23, 2002
rs. No. 39, 2006
s. 31C ............................................ad. No. 120, 2000
am. No. 23, 2002
rs. No. 39, 2006
am. No. 38, 2009
s. 31D ............................................ad. No. 120, 2000
am. No. 23, 2002; No. 39, 2006; No. 38, 2009
Note to s. 31D(1) ...........................ad. No. 180, 2012
s. 31E.............................................ad. No. 120, 2000
am. No. 39, 2006; No. 38, 2009
Note to s. 31E(1) ...........................ad. No. 180, 2012
s. 31F.............................................ad. No. 120, 2000
am. No. 39, 2006
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
ad. No. 54, 2010
s. 32A ............................................ad. No. 54, 2010
ss. 32AA, 32AB.............................ad. No. 54, 2010
Division 2
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
504 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
s. 32B ............................................ad. No. 54, 2010
s. 32BA..........................................ad. No. 54, 2010
Note to s. 32BA(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 32BA(1) .....................ad. No. 180, 2012
Note to s. 32BA(2) ........................ad. No. 180, 2012
s. 32BB..........................................ad. No. 54, 2010
Note to s. 32BB(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 32BB(1)......................ad. No. 180, 2012
Note to s. 32BB(2).........................ad. No. 180, 2012
s. 32BC..........................................ad. No. 54, 2010
Note to s. 32BC(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 32BC(1)......................ad. No. 180, 2012
Note to s. 32BC(2).........................ad. No. 180, 2012
s. 32BD..........................................ad. No. 54, 2010
Note to s. 32BD(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 32BD(1) .....................ad. No. 180, 2012
Note to s. 32BD(2) ........................ad. No. 180, 2012
s. 32BE..........................................ad. No. 54, 2010
s. 32BF ..........................................ad. No. 54, 2010
s. 32BG..........................................ad. No. 54, 2010
s. 32BH..........................................ad. No. 54, 2010
s. 32BI ...........................................ad. No. 54, 2010
s. 32BJ...........................................ad. No. 54, 2010
s. 32BK..........................................ad. No. 54, 2010
Division 3
Subdivision A
s. 32C ............................................ad. No. 54, 2010
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 505
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Subdivision B
s. 32CA..........................................ad. No. 54, 2010
Subdivision C
s. 32CB..........................................ad. No. 54, 2010
Note 1 to s. 32CB(1)......................am. No. 46, 2011
ss. 32CC, 32CD.............................ad. No. 54, 2010
Note to s. 32CD(1) ........................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
Note to s. 32CH(1) ........................ad. No. 180, 2012
s. 32CI ...........................................ad. No. 54, 2010
s. 32CJ...........................................ad. No. 54, 2010
Note to s. 32CJ(6)..........................ad. No. 180, 2012
Note to s. 32CJ(7)..........................ad. No. 180, 2012
Subdivision D
ss. 32CK–32CN.............................ad. No. 54, 2010
Subdivision E
s. 32CO..........................................ad. No. 54, 2010
Division 4
Subdivision A
s. 32D ............................................ad. No. 54, 2010
Subdivision B
ss. 32DA–32DC.............................ad. No. 54, 2010
Subdivision C
ss. 32DD–32DM............................ad. No. 54, 2010
Subdivision D
s. 32DN .........................................ad. No. 54, 2010
Subdivision E
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
506 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
s. 32DO .........................................ad. No. 54, 2010
Note to s. 32DO(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 32DO(1) .....................ad. No. 180, 2012
Note to s. 32DO(2) ........................ad. No. 180, 2012
s. 32DP..........................................ad. No. 54, 2010
s. 32DQ .........................................ad. No. 54, 2010
Note to s. 32DQ(1) ........................ad. No. 180, 2012
s. 32DR..........................................ad. No. 54, 2010
Note to s. 32DR(3) ........................ad. No. 180, 2012
Note to s. 32DR(4) ........................ad. No. 180, 2012
Subdivision F
ss. 32DS–32DU.............................ad. No. 54, 2010
Division 5
s. 32E.............................................ad. No. 54, 2010
s. 32EA..........................................ad. No. 54, 2010
s. 32EB ..........................................ad. No. 54, 2010
s. 32EC ..........................................ad. No. 54, 2010
s. 32ED..........................................ad. No. 54, 2010
s. 32EE ..........................................ad. No. 54, 2010
s. 32EF ..........................................ad. No. 54, 2010
Note to s. 32EF(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 32EF(1) ......................ad. No. 180, 2012
Note to s. 32EF(2) .........................ad. No. 180, 2012
s. 32EG..........................................ad. No. 54, 2010
Division 6
s. 32F.............................................ad. No. 54, 2010
ss. 32FA–32FD..............................ad. No. 54, 2010
Division 7
s. 32G ............................................ad. No. 54, 2010
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 507
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
ss. 32GA–32GF.............................ad. No. 54, 2010
Division 8
s. 32H ............................................ad. No. 54, 2010
s. 32HA .........................................ad. No. 54, 2010
s. 32HB..........................................ad. No. 54, 2010
s. 32HC..........................................ad. No. 54, 2010
Note to s. 32HC(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 32HC(1) .....................ad. No. 180, 2012
Note to s. 32HC(2) ........................ad. No. 180, 2012
s. 32HD .........................................ad. No. 54, 2010
s. 32HE..........................................ad. No. 54, 2010
Division 9
Subdivision A
s. 32J..............................................ad. No. 54, 2010
Subdivision B
s. 32JA...........................................ad. No. 54, 2010
s. 32JB...........................................ad. No. 54, 2010
Note to s. 32JB(2)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 32JB(2).......................ad. No. 180, 2012
Note to s. 32JB(3)..........................ad. No. 180, 2012
s. 32JC...........................................ad. No. 54, 2010
s. 32JD...........................................ad. No. 54, 2010
Subdivision C
s. 32JE ...........................................ad. No. 54, 2010
s. 32JF ...........................................ad. No. 54, 2010
s. 32JG...........................................ad. No. 54, 2010
s. 32JH...........................................ad. No. 54, 2010
s. 32JI ............................................ad. No. 54, 2010
Note to s. 32JI(2) ...........................ad. No. 180, 2012
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
508 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
s. 32JJ ............................................ad. No. 54, 2010
s. 32JK...........................................ad. No. 54, 2010
Subdivision D
ss. 32JL, 32JM...............................ad. No. 54, 2010
s. 33 ...............................................rep. No. 24, 2002
Part 3-3
Heading to Part 4 ...........................rep. No. 24, 2002
Heading to Part 3-3........................ad. No. 24, 2002
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
Note to s. 35(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 35(1) ...........................ad. No. 180, 2012
Note to s. 35(2)..............................ad. No. 180, 2012
Note to s. 35(5)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 35(5) ...........................ad. No. 180, 2012
Note to s. 35(7)..............................ad. No. 180, 2012
s. 35A ............................................ad. No. 39, 2006
am. No. 54, 2010
s. 35B ............................................ad. No. 39, 2006
am. No. 38, 2009
s. 35C ............................................ad. No. 39, 2006
s. 36 ...............................................am. No. 76, 2009
Subheads. to s. 37(2), (3) ...............ad. No. 76, 2009
s. 37 ...............................................am. No. 76, 1993; No. 56, 2002; No. 96, 2006; No. 76, 2009
Subhead. to s. 38(1A) ....................ad. No. 76, 2009
Subhead. to s. 38(2) .......................ad. No. 76, 2009
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 509
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Subheads. to s. 38(3), (4) ...............ad. No. 76, 2009
s. 38 ...............................................am. No. 76, 1993; No. 34, 1998; No. 39, 2003; No. 39, 2006; Nos. 38 and
76, 2009
Note 1 to s. 38(2B) ........................am. No. 46, 2011
ss. 38A, 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
ss. 40A, 40B ..................................ad. No. 76, 2009
Note 1 to s. 40B(4) ........................am. No. 46, 2011
s. 41 ...............................................am. No. 34, 1998; No. 23, 2002; No. 39, 2003; No. 39, 2006; Nos. 38 and
76, 2009; No. 54, 2010
s. 41AA .........................................ad. No. 38, 2009
s. 41AAA.......................................ad. No. 76, 2009
s. 42 ...............................................
Renumbered s. 41A....................
am. No. 76, 1993
No. 24, 2002
s. 41A ............................................am. No. 76, 2009
Chapter 4
Chapt. 4 .........................................ad. No. 24, 2002
Note to Chapt. 4.............................rs. No. 140, 2007
Part 4-1
Division 1
s. 41B ............................................ad. No. 24, 2002
am. No. 39, 2006
s. 41BA..........................................ad. No. 24, 2002
s. 41BB..........................................ad. No. 24, 2002
am. No. 38, 2009
s. 41BC..........................................ad. No. 24, 2002
am. No. 39, 2006
Note to s. 41BC .............................am. No. 39, 2006
Division 2
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
510 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
ss. 41BD, 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
ss. 41BH, 41BI ..............................ad. No. 24, 2002
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
Note to s. 41C................................am. No. 39, 2006
Division 1
s. 41CA..........................................ad. No. 24, 2002
Division 2
s. 41CB..........................................ad. No. 24, 2002
am. No. 76, 2009
Note to s. 41CB(1).........................ad. No. 76, 2009
s. 41CC..........................................ad. No. 24, 2002
am. No. 38, 2009; No. 46, 2011
s. 41CD..........................................ad. No. 24, 2002
Part 4-3
s. 41D ............................................ad. No. 24, 2002
Note 1 to s. 41D.............................am. No. 39, 2006
Division 1
ss. 41DA, 41DB.............................ad. No. 24, 2002
Division 2
s. 41DC..........................................ad. No. 24, 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 511
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
am. No. 76, 2009
Note to s. 41DC(1) ........................ad. No. 76, 2009
s. 41DD .........................................ad. No. 24, 2002
am. No. 46, 2011
s. 41DE..........................................ad. No. 24, 2002
Part 4-4
s. 41E.............................................ad. No. 24, 2002
Division 1
ss. 41EA, 41EB .............................ad. No. 24, 2002
Note to s. 41EB(2).........................rs. No. 39, 2006
s. 41EC ..........................................ad. No. 24, 2002
am. No. 39, 2003; No. 39, 2006; No. 38, 2009
s. 41ED..........................................ad. No. 24, 2002
am. No. 54, 2010
ss. 41EE, 41EF ..............................ad. No. 24, 2002
s. 41EG..........................................ad. No. 24, 2002
am. No. 38, 2009; No. 141, 2010
s. 41EH..........................................ad. No. 24, 2002
s. 41EI ...........................................ad. No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009
Note to s. 41EI(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41EI(1) .......................ad. No. 180, 2012
Note to s. 41EI(2) ..........................ad. No. 180, 2012
s. 41EIA.........................................ad. No. 39, 2006
Division 2
Note to heading of Div. 2 ..............rs. No. 39, 2006
s. 41EJ ...........................................ad. No. 24, 2002
am. Nos. 38 and 76, 2009
ss. 41EK, 41EL..............................ad. No. 24, 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
512 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Division 3
ss. 41EM–41EQ.............................ad. No. 24, 2002
Division 4
ss. 41ER, 41ES..............................ad. No. 24, 2002
s. 41ET ..........................................ad. No. 24, 2002
am. No. 39, 2003; No. 39, 2006; No. 38, 2009
ss. 41EU–41EW ............................ad. No. 24, 2002
Part 4-5
s. 41F.............................................ad. No. 24, 2002
Division 1
s. 41FA ..........................................ad. No. 24, 2002
Note 2 to s. 41FA ..........................am. No. 39, 2006
s. 41FB ..........................................ad. No. 24, 2002
Subdivision A
s. 41FC ..........................................ad. No. 24, 2002
Note to s. 41FC(2) .........................rs. No. 39, 2006
s. 41FD ..........................................ad. No. 24, 2002
am. No. 39, 2003; No. 96, 2009
s. 41FE ..........................................ad. No. 24, 2002
am. No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009
Note to s. 41FE(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41FE(1) ......................ad. No. 180, 2012
Note to s. 41FE(2) .........................ad. No. 180, 2012
s. 41FEA........................................ad. No. 39, 2006
Subdivision B
s. 41FF...........................................ad. No. 24, 2002
am. No. 96, 2009
s. 41FG ..........................................ad. No. 24, 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 513
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Subdivision C
ss. 41FH–41FJ...............................ad. No. 24, 2002
s. 41FK ..........................................ad. No. 24, 2002
am. No. 141, 2010
Subdivision D
ss. 41FL, 41FM .............................ad. No. 24, 2002
Division 2
Note to heading of Div. 2 ..............rs. No. 39, 2006
s. 41FN ..........................................ad. No. 24, 2002
am. No. 39, 2006; No. 76, 2009
ss. 41FO, 41FP ..............................ad. No. 24, 2002
Part 4-6
Division 1
Subdivision A
s. 41G ............................................ad. No. 24, 2002
ss. 41GA–41GE.............................ad. No. 24, 2002
Subdivision B
ss. 41GF–41GH.............................ad. No. 24, 2002
Subdivision C
s. 41GI...........................................ad. No. 24, 2002
Note to s. 41GI ..............................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
s. 41GM.........................................ad. No. 24, 2002
s. 41GN .........................................ad. No. 24, 2002
am. No. 39, 2006
ss. 41GO–41GQ ............................ad. No. 24, 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
514 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Part 4-6A
Part 4-6A .......................................ad. No. 38, 2009
ss. 41GR–41GW............................ad. No. 38, 2009
s. 41GX .........................................ad. No. 38, 2009
rep. No. 54, 2010
s. 41GY .........................................ad. No. 38, 2009
Part 4-7
Heading to Part 4-7........................rs. No. 38, 2009
s. 41H ............................................ad. No. 24, 2002
am. No. 38, 2009; No. 141, 2010
s. 41HA .........................................ad. No. 24, 2002
Notes to s. 41HA(1), (2) ................am. No. 39, 2006
s. 41HB..........................................ad. No. 24, 2002
Note to s. 41HB(2) ........................am. No. 39, 2006
Note to s. 41HB(7) ........................am. No. 39, 2006
s. 41HC..........................................ad. No. 24, 2002
am. No. 54, 2010
s. 41HD .........................................ad. No. 141, 2010
Part 4-8
s. 41J..............................................ad. No. 24, 2002
am. No. 38, 2009
Note to s. 41J.................................am. No. 39, 2006
Division 1
s. 41JA...........................................ad. No. 24, 2002
am. No. 39, 2003; Nos. 38 and 76, 2009
s. 41JB...........................................ad. No. 24, 2002
am. No. 39, 2006; No. 38, 2009
Note to s. 41JB(4)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41JB(4).......................ad. No. 180, 2012
Note to s. 41JB(5)..........................ad. No. 180, 2012
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 515
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
s. 41JBA ........................................ad. No. 39, 2006
s. 41JC...........................................ad. No. 24, 2002
am. No. 39, 2006
Division 2
s. 41JCA ........................................ad. No. 38, 2009
ss. 41JD–41JF................................ad. No. 24, 2002
am. No. 39, 2006
s. 41JFA.........................................ad. No. 141, 2010
s. 41JG...........................................ad. No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009; No. 141, 2010
Note to s. 41JG..............................am. No. 38, 2009; No. 141, 2010
s. 41JH...........................................ad. No. 24, 2002
am. No. 39, 2006; No. 38, 2009; No. 141, 2010
Note to s. 41JH..............................ad. No. 180, 2012
s. 41JI ............................................ad. No. 24, 2002
am. No. 39, 2006; No. 38, 2009; No. 141, 2010
Note to s. 41JI(1) ...........................ad. No. 180, 2012
s. 41JJ ............................................ad. No. 24, 2002
am. No. 39, 2006; No. 38, 2009; No. 141, 2010
Part 4-9
s. 41K ............................................ad. No. 24, 2002
s. 41KA .........................................ad. No. 24, 2002
am. No. 38, 2009; Nos. 54, and 141, 2010
s. 41KB..........................................ad. No. 24, 2002
s. 41KC..........................................ad. No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009
Note to s. 41KC(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41KC(1) .....................ad. No. 180, 2012
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
516 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Note to s. 41KC(2) ........................ad. No. 180, 2012
s. 41KCA.......................................ad. No. 39, 2006
s. 41KD .........................................ad. No. 24, 2002
Part 4-10
s. 41L.............................................ad. No. 24, 2002
ss. 41LA–41LE..............................ad. No. 24, 2002
Part 4-11
Heading to Part 4-11......................rs. No. 39, 2006
s. 41M............................................ad. No. 24, 2002
am. No. 39, 2006; No. 38, 2009
Note to s. 41M...............................am. No. 39, 2006
Division 1
s. 41MA.........................................ad. No. 24, 2002
am. No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009
Note to s. 41MA(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41MA(1).....................ad. No. 180, 2012
Note to s. 41MA(2)........................ad. No. 180, 2012
Note to s. 41MA(5)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41MA(5).....................ad. No. 180, 2012
Note to s. 41MA(6)........................ad. No. 180, 2012
Note to s. 41MA(9)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41MA(9).....................ad. No. 180, 2012
Note to s. 41MA(10)......................ad. No. 180, 2012
s. 41MAA......................................ad. No. 39, 2006
am. No. 38, 2009
s. 41MB.........................................ad. No. 24, 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 517
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
am. No. 39, 2006
Note to s. 41MB(2)........................rep. No. 39, 2006
Notes 1, 2 to s. 41MB(2) ...............ad. No. 39, 2006
s. 41MC.........................................ad. No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009
Note to s. 41MC(2)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41MC(2).....................ad. No. 180, 2012
Note to s. 41MC(3)........................ad. No. 180, 2012
s. 41MCA ......................................ad. No. 39, 2006
s. 41MD.........................................ad. No. 24, 2002
am. No. 39, 2006
Division 2
s. 41ME .........................................ad. No. 24, 2002
am. No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009
Note to s. 41ME(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41ME(1) .....................ad. No. 180, 2012
Note to s. 41ME(2) ........................ad. No. 180, 2012
Note to s. 41ME(5)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41ME(5) .....................ad. No. 180, 2012
Note to s. 41ME(6) ........................ad. No. 180, 2012
s. 41MEA ......................................ad. No. 39, 2006
am. No. 38, 2009
s. 41MF .........................................ad. No. 24, 2002
am. No. 39, 2003
rs. No. 39, 2006
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
518 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
am. No. 38, 2009
Note to s. 41MF(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41MF(1) .....................ad. No. 180, 2012
Note to s. 41MF(3)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41MF(3) .....................ad. No. 180, 2012
s. 41MG.........................................ad. No. 24, 2002
am. No. 39, 2006
Note to s. 41MG(2)........................rep. No. 39, 2006
Notes 1, 2 to s. 41MG(2) ...............ad. No. 39, 2006
Heading to s. 41MH ......................rs. No. 39, 2006
s. 41MH.........................................ad. No. 24, 2002
am. No. 39, 2003; No. 38, 2009
Note to s. 41MH ............................ad. No. 180, 2012
s. 41MHA......................................ad. No. 39, 2006
Division 3
s. 41MI ..........................................ad. No. 24, 2002
am. No. 39, 2003
rs. No. 39, 2006
am. No. 38, 2009; No. 141, 2010
Note to s. 41MI(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41MI(1) ......................ad. No. 180, 2012
Note to s. 41MI(2) .........................ad. No. 180, 2012
s. 41MIA .......................................ad. No. 39, 2006
s. 41MIB........................................ad. No. 39, 2006
am. No. 38, 2009; No. 141, 2010
s. 41MJ ..........................................ad. No. 24, 2002
am. No. 39, 2006
s. 41MK.........................................ad. No. 24, 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 519
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
am. No. 38, 2009; No. 141, 2010
Heading to s. 41ML.......................rs. No. 39, 2006; No. 96, 2009
s. 41ML .........................................ad. No. 24, 2002
am. No. 39, 2006; No. 38, 2009
rs. No. 96, 2009
s. 41MLA ......................................ad. No. 39, 2006
am. No. 141, 2010
s. 41MM ........................................ad. No. 24, 2002
am. No. 38, 2009
s. 41MN.........................................ad. No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009; No. 141, 2010
Note to s. 41MN(1)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 41MN(1).....................ad. No. 180, 2012
Note to s. 41MN(2)........................ad. No. 180, 2012
s. 41MNA......................................ad. No. 39, 2006
Division 3A
Div. 3A of Part 4-11 ......................ad. No. 38, 2009
s. 41MNB ......................................ad. No. 38, 2009
Note to s. 41MNB(1).....................ad. No. 180, 2012
s. 41MNC ......................................ad. No. 38, 2009
s. 41MND......................................ad. No. 38, 2009
Division 4
Heading to Div. 4 of ......................
Part 4-11
rs. No. 39, 2006
s. 41MO.........................................ad. No. 24, 2002
rs. No. 39, 2006
am. No. 38, 2009
Heading to s. 41MP .......................rs. No. 39, 2006
s. 41MP .........................................ad. No. 24, 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
520 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
am. No. 39, 2006; No. 38, 2009
Note to s. 41MP(1) ........................ad. No. 180, 2012
ss. 41MPA, 41MPB.......................ad. No. 39, 2006
s. 41MQ.........................................ad. No. 24, 2002
am. No. 39, 2006; No. 38, 2009
Note to s. 41MQ(3)........................ad. No. 180, 2012
Note to s. 41MQ(4)........................ad. No. 180, 2012
s. 41MR.........................................ad. No. 39, 2006
Chapter 5
Heading to Part 4A ........................rep. No. 24, 2002
Heading to Chapt. 5.......................ad. No. 24, 2002
Part 4A ..........................................ad. No. 3, 1999
Part 5-1
Heading to Part 5-1........................ad. No. 24, 2002
rs. No. 39, 2003
Division 1
Heading to Div. 1 of ......................
Part 5-1
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
s. 42A ............................................ad. No. 3, 1999
rep. No. 39, 2003
s. 42B ............................................ad. No. 3, 1999
am. No. 39, 2003; No. 38, 2009
s. 42BAA.......................................ad. No. 76, 2009
Division 2
Heading to Div. 2 of ......................
Part 5-1
ad. No. 39, 2003
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 521
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
s. 42BA..........................................ad. No. 39, 2003
s. 42C ............................................ad. No. 3, 1999
rs. No. 39, 2003
am. No. 39, 2006
Notes to s. 42C(1), (2) ...................ad. No. 39, 2006
Note to s. 42C(4) ...........................ad. No. 39, 2006
Note to s. 42C(6) ...........................ad. No. 39, 2006
s. 42D ............................................ad. No. 3, 1999
rep. No. 39, 2003
Division 3
Div. 3 of Part 5-1...........................ad. No. 39, 2003
s. 42DA .........................................ad. No. 39, 2003
rs. No. 38, 2009
s. 42DB..........................................ad. No. 39, 2003
s. 42DC..........................................ad. No. 39, 2003
rep. No. 38, 2009
s. 42DD .........................................ad. No. 39, 2003
am. Nos. 38 and 76, 2009
Note to s. 42DD(1) ........................ad. No. 38, 2009
s. 42DE..........................................ad. No. 39, 2003
s. 42DF..........................................ad. No. 39, 2003
am. No. 76, 2009
ss. 42DG–42DJ..............................ad. No. 39, 2003
s. 42DK .........................................ad. No. 39, 2003
am. No. 8, 2010
Division 3A
Heading to Div. 3A of ...................
Part 5-1
ad. No. 38, 2009
ss. 42DKA, 42DKB.......................ad. No. 38, 2009
s. 42DL..........................................ad. No. 39, 2003
am. No. 38, 2009; No. 54, 2010
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
522 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
s. 42DM.........................................ad. No. 39, 2003
Division 4
Div. 4 of Part 5-1...........................ad. No. 39, 2003
ss. 42DN–42DP.............................ad. No. 39, 2003
Part 5-2
Heading to Part 4B ........................rep. No. 24, 2002
Heading to Part 5-2........................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
Note to s. 42E(1) ...........................ad. No. 180, 2012
ss. 42EA, 42EB .............................ad. No. 39, 2006
s. 42F.............................................ad. No. 56, 2000
Part 5-3
Heading to Part 4C ........................rep. No. 24, 2002
Heading to Part 5-3........................ad. No. 24, 2002
Part 4C...........................................ad. No. 120, 2000
s. 42T.............................................ad. No. 120, 2000
am. No. 39, 2006; No. 38, 2009
Note to s. 42T(1) ...........................ad. No. 180, 2012
Note to s. 42T(2) ...........................ad. No. 180, 2012
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
Note to s. 42V(6)
Renumbered Note 1 ...................No. 180, 2012
Note 2 to s. 42V(6) ........................ad. No. 180, 2012
Note to s. 42V(6A) ........................ad. No. 180, 2012
ss. 42VA, 42VB.............................ad. No. 39, 2006
s. 42W ...........................................ad. No. 120, 2000
am. No. 39, 2006; No. 38, 2009
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 523
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Note to s. 42W(1) ..........................ad. No. 180, 2012
Note to s. 42W(2) ..........................ad. No. 180, 2012
s. 42X ............................................ad. No. 120, 2000
Chapter 5A
Chapt. 5A ......................................ad. No. 39, 2006
Part 5A-1
Division 1
s. 42Y ............................................ad. No. 39, 2006
ss. 42YA–42YD ............................ad. No. 39, 2006
s. 42YE..........................................ad. No. 39, 2006
am. No. 38, 2009
Division 2
ss. 42YF–42YI...............................ad. No. 39, 2006
Part 5A-2
ss. 42YJ, 42YK..............................ad. No. 39, 2006
Part 5A-3
s. 42YL..........................................ad. No. 39, 2006
am. No. 8, 2010
Chapter 6
Heading to Part 5 ...........................rep. No. 24, 2002
Heading to Chapt. 6.......................ad. No. 24, 2002
Part 6-1
Heading to Part 6-1........................ad. No. 24, 2002
s. 43 ...............................................am. No. 24, 2002
s. 44 ...............................................am. No. 84, 1991; No. 24, 2002
rs. No. 96, 2008
s. 44A ............................................ad. No. 96, 2008
s. 44B ............................................ad. No. 54, 2010
s. 45 ...............................................rs. No. 152, 1997
am. No. 24, 2002
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
524 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
rs. No. 8, 2005
Part 6-2
Heading to Part 6 ...........................rep. No. 6, 1996
Heading to Part 5A ........................ad. No. 6, 1996
rep. No. 24, 2002
Heading to Part 6-2........................ad. No. 24, 2002
s. 45A ............................................ad. No. 6, 1996
am. No. 39, 2006
s. 46 ...............................................rs. No. 6, 1996
s. 46A ............................................ad. No. 6, 1996
am. Nos. 23 and 24, 2002; Nos. 38 and 76, 2009; Nos. 54 and 141, 2010
s. 46B ............................................ad. No. 6, 1996
Heading to s. 47.............................am. No. 39, 2006
s. 47 ...............................................am. No. 76, 1993
rs. No. 6, 1996
am. No. 39, 2006
s. 48 ...............................................am. No. 6, 1996; No. 111, 2001; Nos. 38 and 76, 2009
ss. 48A, 48B ..................................ad. No. 6, 1996
s. 48C ............................................ad. No. 6, 1996
am. No. 39, 2006
s. 48D ............................................ad. No. 6, 1996
s. 48E.............................................ad. No. 6, 1996
am. No. 39, 2006
ss. 48F–48H...................................ad. No. 6, 1996
s. 48J..............................................ad. No. 6, 1996
am. No. 39, 2006
s. 49 ...............................................am. No. 6, 1996
Heading to s. 50.............................am. No. 39, 2006
s. 50 ...............................................am. No. 6, 1996; No. 39, 2006
Heading to s. 51.............................am. No. 39, 2006
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 525
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
s. 51 ...............................................am. No. 6, 1996
s. 51A ............................................ad. No. 76, 1993
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
Heading to Part 5B ........................rep. No. 24, 2002
Heading to Part 6-3........................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
am. No. 96, 2009
ss. 52B, 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
s. 52E.............................................ad. No. 3, 1999
rs. No. 96, 2009
s. 52EAA.......................................ad. No. 96, 2009
ss. 52EA, 52EB .............................ad. No. 9, 2008
s. 52EC ..........................................ad. No. 96, 2009
Heading to Part 5C ........................rep. No. 24, 2002
Heading to Part 6-4........................ad. No. 24, 2002
rep. No. 76, 2009
Part 5C...........................................ad. No. 3, 1999
Part 6-4..........................................rep. No. 76, 2009
ss. 52F, 52G...................................ad. No. 3, 1999
rep. No. 76, 2009
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
526 Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
Chapter 7
Heading to Part 6 ...........................ad. No. 6, 1996
rep. No. 24, 2002
Heading to Chapt. 7.......................ad. No. 24, 2002
s. 53 ...............................................rs. No. 24, 2002
am. No. 54, 2010
s. 53A ............................................ad. No. 39, 2006
am. No. 54, 2010
Heading to s. 54.............................rs. No. 6, 1996; No. 39, 2006
s. 54 ...............................................am. No. 204, 1991; No. 76, 1993; No. 6, 1996; No. 24, 2002; No. 39,
2006
s. 54AA .........................................ad. No. 3, 1999
am. No. 111, 2001; No. 39, 2003; No. 73, 2008
Heading to s. 54AB .......................rs. No. 39, 2006
s. 54AB..........................................ad. No. 39, 2003
am. No. 39, 2006; No. 38, 2009
Note to s. 54AB(1) ........................ad. No. 180, 2012
s. 54A ............................................ad. No. 6, 1996
Heading to s. 54B ..........................rs. No. 180, 2012
s. 54B ............................................ad. No. 39, 2006
am. No. 180, 2012
s. 54BA..........................................ad. No. 180, 2012
s. 54C ............................................ad. No. 39, 2006
s. 55 ...............................................am. No. 6, 1996; No. 39, 2006
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
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
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 2—Amendment history
Therapeutic Goods Act 1989 527
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
exp. = expired or ceased to have effect
Provision affected How affected
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
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
s. 61A ............................................ad. No. 54, 2010
s. 62 ...............................................rep. No. 136, 2012
s. 63 ...............................................am. No. 204, 1991; No. 76, 1993; No. 6, 1996; No. 34, 1998; No. 24,
2002; No. 54, 2010
Chapter 8
Heading to Part 7 ...........................rep. No. 24, 2002
Heading to Chapt. 8.......................ad. No. 24, 2002
s. 64 ...............................................rep. No. 136, 2012
s. 65 ...............................................rep. No. 136, 2012
s. 66 ...............................................am. No. 76, 1993
Heading to s. 68.............................am. No. 24, 2002
s. 69 ...............................................am. No. 24, 2002; No. 136, 2012
Schedule ........................................am. No. 141, 1990
rep. No. 136, 2012
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
528 Therapeutic Goods Act 1989
Endnote 3—Application, saving and transitional provisions
This endnote sets out application, saving and transitional provisions for
amendments of the Therapeutic Goods Act 1989.
Application, saving and transitional provisions prior to 30 May 2000 are not
included in this endnote.
Therapeutic Goods Amendment Act (No. 2) 2000 (No. 56, 2000)
Schedule 1
5 Application
The amendment of section 30 of the Therapeutic Goods Act 1989
by this Schedule applies to directions given, and requirements
made, of persons after the commencement of the amendment.
Therapeutic Goods Amendment Act (No. 3) 2000 (No. 120, 2000)
Schedule 1
4 Saving
(1) Regulations in force for the purposes of subsection 18(1) of the
Therapeutic Goods Act 1989 immediately before the commencement of
the amendment of that subsection made by this Schedule have effect,
after that commencement, as if they had been made for the purposes of
that subsection after that commencement.
(2) Subitem (1) does not prevent the amendment or repeal of the
regulations.
6 Application
Conditions specified in regulations made for the purposes of
subsection 19(1A) of the Therapeutic Goods Act 1989 apply to an
approval for the purpose mentioned in paragraph 19(1)(b) of that Act
granted before or after the commencement of subsection 19(1A).
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 529
8 Application
Conditions specified in regulations made for the purposes of
subsection 19(4A) of the Therapeutic Goods Act 1989 apply to an
approval for the purpose mentioned in paragraph 19(1)(b) of that Act
granted before or after the commencement of subsection 19(4A).
10 Application
Subsection 19(5B) of the Therapeutic Goods Act 1989 applies to an
authority given under subsection 19(5) of that Act before or after the
commencement of subsection 19(5B).
17 Application
(1) Subsections 31B(1) and (2) of the Therapeutic Goods Act 1989 apply to
an approval granted under subsection 19(1) of that Act before or after
the commencement of section 31B of that Act.
(2) Subsection 31B(3) of the Therapeutic Goods Act 1989 applies to an
authority given under subsection 19(5) of that Act before or after the
commencement of section 31B of that Act.
Therapeutic Goods Amendment Act 2001 (No. 14, 2001)
Schedule 1
36 Application of amendments
(1) The amendments made by this Schedule do not apply, and the
Therapeutic Goods Act 1989 as in force immediately before the
commencement of this Schedule continues to apply, in relation to any
application made under that Act, before that commencement, for listing
of therapeutic goods.
(2) However, the amendment made by item 5 of this Schedule applies, after
that commencement, to therapeutic goods that were listed before that
commencement.
(3) The amendment made by item 31 of this Schedule applies, after that
commencement, to medicines listed under section 26A before that
commencement.
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
530 Therapeutic Goods Act 1989
Australia New Zealand Food Authority Amendment Act 2001 (No. 81,
2001)
2(6) In this section:
Australia New Zealand Joint Food Standards Agreement means
the Agreement between the Government of Australia and the
Government of New Zealand Establishing a System for the
Development of Joint Food Standards, signed at Wellington on
5 December 1995.
Health and Aged Care Legislation Amendment (Application of Criminal
Code) Act 2001 (No. 111, 2001)
4 Application of amendments
(1) Each amendment made by this Act applies to acts and omissions
that take place after the amendment commences.
(2) For the purposes of this section, if an act or omission is alleged to
have taken place between 2 dates, one before and one on or after
the day on which a particular amendment commences, the act or
omission is alleged to have taken place before the amendment
commences.
Therapeutic Goods Amendment (Medical Devices) Act 2002 (No. 24, 2002)
Schedule 1
38 Transitional for publication of list of goods on Register
The first list published under section 9E of the Therapeutic Goods Act
1989 after the commencement of this Schedule must be published
within 12 months after the last list published under section 33 of the
Therapeutic Goods Act 1989.
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 531
46 Saving of existing registrations and listings
(1) Despite the repeal of section 17 of the Therapeutic Goods Act 1989 by
item 45, any therapeutic goods that, immediately before the
commencement of this Schedule, were included in the Register are
taken to be included in the Register after that commencement.
(2) Despite the repeal of subsection 17(5) of the Therapeutic Goods Act
1989, any notices that were in force immediately before the
commencement of this Schedule, are taken to have been made under
section 9A after that commencement.
55 Saving of existing requests for inspection or variation of the Register
(1) A request for a copy of an entry in the Register under section 32 of the
Therapeutic Goods Act 1989:
(a) that was made before the commencement of this Schedule;
and
(b) that was not dealt with before that commencement;
is taken, after that commencement, to be a request made under
section 9C of the Therapeutic Goods Act 1989 as in force after that
commencement.
(2) A request for a variation of an entry in the Register under section 32 of
the Therapeutic Goods Act 1989:
(a) that was made before the commencement of this Schedule;
and
(b) that was not dealt with before that commencement;
is taken, after that commencement, to be a request made under
section 9D of the Therapeutic Goods Act 1989 as in force after that
commencement.
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
532 Therapeutic Goods Act 1989
Therapeutic Goods and Other Legislation Amendment Act 2002 (No. 56,
2002)
Schedule 3
20 Application
(1) The amendment made by item 12 applies in relation to applications
made on or after the commencement of that item.
(2) The amendment made by item 18 applies in relation to applications for
licences made on or after the commencement of that item.
(3) Paragraph 40(4)(a) of the Therapeutic Goods Act 1989 as amended by
this Schedule applies in relation to a request made under that paragraph
on or after the commencement of this item, even if the licence to which
the request relates was granted before that commencement.
21 Transitional
(1) An approval of a body as an approved conformity assessment body that
was in force under the Therapeutic Goods Act 1989 immediately before
the commencement time has effect after the commencement time as if it
were an approval of the body by the Secretary in writing for the
purposes of the definition of EC/EFTA attestation of conformity in
subsection 3(1) of the Therapeutic Goods Act 1989 as in force after the
commencement time.
(2) In subitem (1):
commencement time means the time at which this item commences.
Therapeutic Goods Amendment Act (No. 1) 2003 (No. 39, 2003)
Schedule 1
41 Saving provisions
(1) The repeal of subsections 30(6) and (7) of the Therapeutic Goods Act
1989 does not affect the application, after the commencement of this
item, of paragraph 30(6)(b) and subsection 30(7) of that Act in relation
to a requirement imposed under paragraph 30(6)(a) of that Act before
that commencement.
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 533
(2) The repeal of section 30A of the Therapeutic Goods Act 1989 does not
affect the application, after the commencement of this item, of
subsections 30A(3) and (4) of that Act in relation to a requirement
imposed under subsection 30A(2) of that Act before that
commencement.
(3) The repeal of section 30B of the Therapeutic Goods Act 1989 does not
affect the application, after the commencement of this item, of
subsections 30B(3), (4) and (5) of that Act in relation to a requirement
imposed under subsection 30B(2) of that Act before that
commencement.
55 Saving provision
The repeal and substitution of subsection 40(1) of the Therapeutic
Goods Act 1989 does not affect the application, after the
commencement of this item, of any condition that:
(a) was imposed on a licence under that subsection; and
(b) was in force immediately before that commencement.
60 Application provision
Subsection 40(4) of the Therapeutic Goods Act 1989 as amended by
this Act, and subsection 40(5) of that Act, apply to any licence in force
after the commencement of this item, whether or not the licence was
granted after that commencement.
US Free Trade Agreement Implementation Act 2004 (No. 120, 2004)
Schedule 7
7 Application of amendments
(1) The amendments made by this Schedule apply to applications for
registration or listing under section 23 of the Therapeutic Goods Act
1989 made on or after the day on which this Schedule commences.
(2) The amendments made by item 6 apply to legal proceedings
commenced on or after the day on which this Schedule commences.
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
534 Therapeutic Goods Act 1989
Financial Framework Legislation Amendment Act 2005 (No. 8, 2005)
4 Saving of matters in Part 2 of Schedule 1
(1) If:
(a) a decision or action is taken or another thing is made, given
or done; and
(b) the thing is taken, made, given or done under a provision of a
Part 2 Act that had effect immediately before the
commencement of this Act;
then the thing has the corresponding effect, for the purposes of the
Part 2 Act as amended by this Act, as if it had been taken, made,
given or done under the Part 2 Act as so amended.
(2) In this section:
Part 2 Act means an Act that is amended by an item in Part 2 of
Schedule 1.
Schedule 1
496 Saving provision—Finance Minister’s determinations
If a determination under subsection 20(1) of the Financial Management
and Accountability Act 1997 is in force immediately before the
commencement of this item, the determination continues in force as if it
were made under subsection 20(1) of that Act as amended by this Act.
Therapeutic Goods Amendment Act (No. 2) 2006 (No. 2, 2006)
Schedule 1
15 Application
The amendments made by this Schedule apply to applications for
registration or listing of therapeutic goods that are made on or after the
day on which this Schedule commences.
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 535
Therapeutic Goods Amendment (Repeal of Ministerial responsibility for
approval of RU486) Act 2006 (No. 5, 2006)
3 Purpose
The purpose of this Act is to remove the responsibility for approval
of RU486 from the Minister and to provide responsibility for
approval of RU486 to the Therapeutic Goods Administration.
Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008
(No. 96, 2008)
Schedule 1
3 Application
(1) The amendment made by item 1 applies in relation to the financial year
beginning on 1 July 2009 and all later financial years (regardless of
whether the registration, listing or inclusion in the Register of the
therapeutic goods, or whether the licence, commenced before, on or
after 1 July 2009).
(2) The amendment made by item 2 applies for the purposes of working out
whether a person is exempt from liability to pay annual registration
charge, annual listing charge or annual charge for inclusion in the
Register for the financial year beginning on 1 July 2009 and all later
financial years.
Therapeutic Goods Amendment (Medical Devices and Other Measures)
Act 2009 (No. 38, 2009)
Schedule 2
4 Application
(1) The amendment made by item 1 applies in relation to an exemption
made on or after the commencement of that item.
(2) The amendment made by item 2 applies in relation to a revocation or
variation made on or after the commencement of that item (whether the
exemption was made before, on or after that commencement).
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
536 Therapeutic Goods Act 1989
Schedule 3
23 Application and transitional
(1) The amendments of section 38 of the Therapeutic Goods Act 1989
made by this Schedule apply in relation to applications for licences
made on or after the commencement of this item.
(2) The amendments of sections 40 and 41 of the Therapeutic Goods Act
1989 made by this Schedule apply in relation to licences granted before,
on or after the commencement of this item.
(3) The amendments of section 41EC of the Therapeutic Goods Act 1989
made by this Schedule apply in relation to applications for conformity
assessment certificates made on or after the commencement of this
item.
(4) The amendment of section 41EG of the Therapeutic Goods Act 1989
made by this Schedule applies in relation to notices given on or after the
commencement of this item.
(5) The amendment of section 41EJ of the Therapeutic Goods Act 1989
made by this Schedule applies in relation to conformity assessment
certificates issued before, on or after the commencement of this item.
(6) The amendments of section 41ET of the Therapeutic Goods Act 1989
made by this Schedule apply in relation to conformity assessment
certificates issued before, on or after the commencement of this item.
(7) Paragraph 41ET(1)(c) of the Therapeutic Goods Act 1989, as in force
immediately before the commencement of this item, continues to apply
on and after that commencement in relation to a notice given before that
commencement.
(8) Subsection 41JA(1A) of the Therapeutic Goods Act 1989 applies in
relation to applications for conformity assessment certificates made on
or after the commencement of this item.
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 537
(9) Subsection 41JA(1C) of the Therapeutic Goods Act 1989 applies in
relation to conformity assessment certificates issued before, on or after
the commencement of this item.
Schedule 4
20 Application and transitional
(1) If:
(a) immediately before the commencement of this item,
therapeutic goods were registered goods or listed goods; and
(b) at a particular time within the period of 12 months beginning
on the day on which this item commences:
(i) a standard referred to in paragraph (c) or (d) of the
definition of standard in subsection 3(1) of the
Therapeutic Goods Act 1989 (as amended by this Act)
would, apart from this subitem, apply to the goods; and
(ii) the goods do not conform with that standard;
then that standard is taken not to apply to the goods at that time.
(2) To avoid doubt, paragraph (a) of the definition of standard in
subsection 3(1) of the Therapeutic Goods Act 1989 (as amended by this
Act) applies in relation to orders made under section 10 of the
Therapeutic Goods Act 1989 before, on or after the commencement of
this item.
(3) An order in force under paragraph 13(7)(c) of the Therapeutic Goods
Act 1989 immediately before the commencement of this item has effect,
on and after that commencement, as if it were an order in force under
subsection 13(5) of that Act.
Schedule 5
3 Application
The amendment made by item 2 applies in relation to information held
by the Department on or after the commencement of this item
(regardless of whether the information came into existence before, on or
after that commencement).
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
538 Therapeutic Goods Act 1989
Schedule 6
12 Saving and transitional
(1) A notice in force under section 42DC of the Therapeutic Goods Act
1989 immediately before the commencement of this item has effect, on
and after that commencement, as if it were a notice given and in force
under section 42DKB of that Act.
(2) Regulations in force for the purposes of subsection 42DD(1) of the
Therapeutic Goods Act 1989 immediately before the commencement of
this item continue in force on and after that commencement as if they
were regulations in force for the purposes of section 42DD of that Act.
Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009 (No. 76,
2009)
Schedule 1
7 Application
The amendment made by item 2 applies in relation to therapeutic goods
included in the Register before, on or after the commencement of that
item.
Schedule 2
25 Application and transitional—amendments made by this Schedule
(1) The amendments made by items 4 to 7 apply in relation to applications
for licences made on or after the commencement of those items.
(2) The amendments made by items 8 to 11 apply in relation to applications
for licences:
(a) made on or after the commencement of those items; and
(b) made before the commencement of those items that have not
been decided by the Secretary before that commencement.
(3) In relation to an application covered by paragraph (2)(b) of this item,
paragraph 38(1)(a) of the Therapeutic Goods Act 1989 applies on and
after the commencement of this item as if the application was in respect
ComLaw Authoritative Act C2013C00132
Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 539
of the one or more manufacturing sites constituted by the manufacturing
premises the subject of the application.
(4) The amendments made by items 13 to 22 apply in relation to licences
granted before, on or after the commencement of those items.
26 Transitional—existing licences
(1) This item applies to a licence that:
(a) was in force under Part 3-3 of the Therapeutic Goods Act
1989 immediately before the commencement of this item; or
(b) was suspended under that Part immediately before that
commencement.
(2) The Therapeutic Goods Act 1989 applies in relation to the licence on
and after that commencement as if the licence covered the one or more
manufacturing sites constituted by the manufacturing premises to which
the licence related immediately before that commencement.
(3) Subitem (2) is subject to section 38B of the Therapeutic Goods Act
1989 (about splitting multi-site licences).
(4) If section 38B of the Therapeutic Goods Act 1989 does not apply in
relation to the licence, that Act applies in relation to the licence on and
after the commencement of this item as if:
(a) the licence authorised the holder of the licence, at the
manufacturing site constituted by the manufacturing premises
to which the licence related immediately before that
commencement, to carry out the steps in the manufacture of
therapeutic goods that the licence allowed the holder to carry
out immediately before that commencement; and
(b) that authorisation were an authorisation referred to in
subsection 38(2B) of that Act.
(5) Subitem (4) does not prevent the variation of that authorisation under
section 40A or 40B of the Therapeutic Goods Act 1989.
Note: A contravention of that authorisation may lead to the licence being revoked or suspended: see paragraph 41(1)(ea) of the Therapeutic Goods Act 1989.
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Endnotes
Endnote 3—Application, saving and transitional provisions
540 Therapeutic Goods Act 1989
Schedule 3
16 Application
(1) The amendments made by items 1 to 9 apply in relation to the
registration or listing of therapeutic goods before, on or after the
commencement of those items.
(2) The amendments made by items 10 and 11 apply in relation to
conformity assessment certificates issued before, on or after the
commencement of those items.
(3) The amendments made by items 12 and 13 apply in relation to the
inclusion of a kind of medical device in the Register before, on or after
the commencement of those items.
Schedule 5
5 Application
The amendments made by items 1 and 2 apply in relation to
applications for listings made on or after the commencement of those
items.
Schedule 6
14 Saving and transitional
Standards
(1) The amendment made by item 1 does not affect the validity of an order
made under section 10 of the Therapeutic Goods Act 1989 before the
commencement of this item.
(2) The repeal of section 11 of the Therapeutic Goods Act 1989 by this
Schedule does not apply to an order made under section 10 of that Act
before the commencement of this item.
Medical device standards
(3) The amendment made by item 8 does not affect the validity of an order
made under section 41CB of the Therapeutic Goods Act 1989 before the
commencement of this item.
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Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 541
(4) Subsection 41CB(2) of the Therapeutic Goods Act 1989, as in force
immediately before the commencement of this item, continues to apply
on and after that commencement in relation to an order made under
section 41CB of that Act before that commencement.
Conformity assessment standards
(5) The amendment made by item 11 does not affect the validity of an order
made under section 41DC of the Therapeutic Goods Act 1989 before
the commencement of this item.
(6) Subsection 41DC(3) of the Therapeutic Goods Act 1989, as in force
immediately before the commencement of this item, continues to apply
on and after that commencement in relation to an order made under
section 41DC of that Act before that commencement.
Schedule 7
26 Application—listings of medicines
The amendments made by items 5 to 10 apply in relation to applications
for listings of medicines made on or after the commencement of those
items.
27 Application—revocation of cancellation of registration or listing upon request
The amendment made by item 14 applies in relation to cancellations
occurring before, on or after the commencement of that item.
28 Saving—device nomenclature codes
Despite the amendment made by item 22, regulations in force for the
purposes of subsection 41BE(3) of the Therapeutic Goods Act 1989
immediately before the commencement of this item continue in force,
after that commencement, until the first determination made under that
subsection (as inserted by this Act) takes effect.
56 Saving—Therapeutic Goods Advertising Code
(1) Despite the amendment made by item 29, the Therapeutic Goods
Advertising Code as in force immediately before the commencement of
this item continues in force, after that commencement, until the first
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Endnotes
Endnote 3—Application, saving and transitional provisions
542 Therapeutic Goods Act 1989
instrument made under section 42BAA of the Therapeutic Goods Act
1989, as inserted by this Act, takes effect.
(2) Despite the amendment made by item 52, regulations in force for the
purposes of section 42DD of the Therapeutic Goods Act 1989
immediately before the commencement of this item continue in force,
after that commencement, until the first instrument made under
section 42BAA of the Therapeutic Goods Act 1989, as inserted by this
Act, takes effect.
(3) Despite the amendment made by item 54, regulations in force for the
purposes of paragraph 42DF(4)(c) of the Therapeutic Goods Act 1989
immediately before the commencement of this item continue in force,
after that commencement, until the first instrument made under
section 42BAA of the Therapeutic Goods Act 1989, as inserted by this
Act, takes effect.
57 Application and transitional—registration or listing conditions
(1) Subsection 28(1) of the Therapeutic Goods Act 1989, as inserted by this
Act, applies in relation to the registration or listing of therapeutic goods
occurring before, on or after the commencement of this item.
(2) Subsection 28(2B) of the Therapeutic Goods Act 1989, as inserted by
this Act, applies in relation to the registration or listing of therapeutic
goods occurring on or after the commencement of this item.
(3) Conditions in force under subsection 28(1) of the Therapeutic Goods
Act 1989 immediately before the commencement of this item continue
in force, on and after that commencement, as if they had been imposed,
on that commencement, under subsection 28(2B) of the Therapeutic
Goods Act 1989.
(4) Subitem (3) does not prevent the variation or removal of the conditions
under subsection 28(3) of the Therapeutic Goods Act 1989 on or after
the commencement of this item.
(5) The amendment made by item 31 applies in relation to:
(a) conditions imposed under subsection 28(2B) of the
Therapeutic Goods Act 1989 on or after the commencement
of that item (including because of subitem (3)); and
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Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 543
(b) conditions imposed under subsection 28(3) of the
Therapeutic Goods Act 1989 before, on or after the
commencement of that item.
(6) The amendment made by item 34 applies in relation to the registration
or listing of therapeutic goods occurring before, on or after the
commencement of that item.
(7) The amendment made by item 36 applies in relation to the listing of
medicine occurring before, on or after the commencement of that item.
(8) This item does not affect the conditions to which the registration or
listing of therapeutic goods is subject before the commencement of this
item.
58 Application—information gathering
(1) The amendments made by items 38 and 40 apply in relation to periods
beginning before, on or after the commencement of those items.
(2) The amendment made by item 41 applies in relation to things occurring
before, on or after the commencement of that item.
(3) Regulations in force for the purposes of subsection 41JA(2) of the
Therapeutic Goods Act 1989 immediately before the commencement of
this item continue in force for the purposes of that subsection on and
after that commencement.
59 Application—advertisements
The amendments made by items 44 to 50 apply in relation to
advertisements published or broadcast on or after the commencement of
those items.
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Endnotes
Endnote 3—Application, saving and transitional provisions
544 Therapeutic Goods Act 1989
Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (No. 96,
2009)
Schedule 1
13 Saving and transitional
(1) The amendment made by item 10 does not affect the validity of an
instrument made under paragraph 52D(2)(a) or (b) of the Therapeutic
Goods Act 1989 before the commencement of that item.
(2) If:
(a) on or after 1 January 2010 and before the commencement of
this item, the Committee referred to in section 52B of the
Therapeutic Goods Act 1989 had proposed an amendment of
the current Poisons Standard; and
(b) before that commencement, that Committee had not amended
the current Poisons Standard as a result of that proposal;
then the Secretary must have regard to that proposal in relation to
making the first instrument under subsection 52D(2) of that Act on or
after that commencement.
(3) If:
(a) on or after 1 January 2010 and before the commencement of
this item, an application was made to the Committee referred
to in section 52B of the Therapeutic Goods Act 1989 for an
amendment of the current Poisons Standard; and
(b) the application had not been refused by that Committee
before that commencement; and
(c) before that commencement, that Committee had not proposed
an amendment of the current Poisons Standard as a result of
the application;
then the application has effect on and after that commencement as if it
were an application made to the Secretary in accordance with
section 52EAA of that Act.
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Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 545
Schedule 2
4 Application
The amendments made by items 2 and 3 apply in relation to
applications made after the day on which the first instrument made
under section 41BEA of the Therapeutic Goods Act 1989 takes effect.
Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
Schedule 3
7 Application and saving
(1) The amendments made by items 2 and 5 apply in relation to
advertisements occurring on or after the commencement of those items.
(2) The amendment made by item 3 applies in relation to applications made
on or after the commencement of that item.
(3) The amendment made by item 4 does not affect the validity of a request
made under subsection 30D(1) of the Therapeutic Goods Act 1989
before the commencement of that item.
10 Application
The amendment made by item 8 applies in relation to applications for
the registration or listing of medicine made on or after the
commencement of this Part.
Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010 (No. 54,
2010)
Schedule 1
58 Application—licences
The amendment made by item 31 applies in relation to licences granted
before, on or after the commencement of that item.
59 Transitional—exempt biologicals
(1) This item applies in relation to a class of biologicals that, immediately
before the commencement of this item, was covered by an exemption of
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Endnotes
Endnote 3—Application, saving and transitional provisions
546 Therapeutic Goods Act 1989
the kind referred to in paragraph 18(1)(c) of the Therapeutic Goods Act
1989.
(2) At the commencement of this item, there is taken to be an exemption
(the transitional exemption) in force under subsection 32CA(2) of that
Act covering that class of biologicals.
(3) Subject to this item, the transitional exemption ceases to be in force at
the end of the period (the transitional period) of 3 years beginning on
the day this item commences.
(4) If:
(a) before the end of the period of 18 months beginning on the
day this item commences, a person makes an application in
accordance with section 32DA or 32DD of that Act to
include in the Register a biological included in that class; and
(b) before the end of the transitional period, the person has not
been notified of the Secretary’s decision on the application;
the transitional exemption, in relation to that biological, continues in
force past the end of the transitional period until the person is notified
of the Secretary’s decision on the application.
(5) If:
(a) before the end of the transitional period, a person makes an
application in accordance with section 32DA or 32DD of that
Act to include in the Register a biological included in that
class; and
(b) before the end of that period, the person is notified of the
Secretary’s decision on the application;
the transitional exemption, in relation to that biological, ceases to be in
force immediately after that notification.
60 Transitional regulations
The Governor-General may make regulations prescribing matters of a
transitional nature (including prescribing any saving or application
provisions) relating to the amendments made by this Schedule.
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Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 547
Schedule 2
15 Application
The amendment made by item 14 applies in relation to anything done or
omitted to be done on or after the commencement of that item.
16 Saving
Despite the repeal of provisions of the Therapeutic Goods Act 1989
made by items 1, 2, 4 to 8 and 10 to 13, those provisions (as in force
immediately before the commencement of those items) continue to
apply on and after that commencement in relation to anything done or
omitted to be done before that commencement.
Schedule 3
3 Application
The amendments made by items 1 and 2 apply in relation to therapeutic
goods, and kinds of medical devices, included in the Register before, on
or after the commencement of those items.
Schedule 4
6 Application
(1) The amendments made by items 1 to 5 apply in relation to notices given
on or after the commencement of those items.
(2) Paragraphs 31(1)(ac) and (2)(ac) of the Therapeutic Goods Act 1989, as
inserted by this Act, apply in relation to the registration or listing of
therapeutic goods occurring before, on or after the commencement of
this item.
Schedule 5
2 Application
The amendment made by item 1 applies in relation to an annual
registration charge, an annual listing charge, an annual charge for
inclusion in the Register or an annual licensing charge that becomes
payable on or after the day on which that item commences.
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Endnotes
Endnote 3—Application, saving and transitional provisions
548 Therapeutic Goods Act 1989
Schedule 6
20 Application
(1) The amendment made by item 3 applies in relation to requests made on
or after the commencement of that item.
(2) The amendments made by items 4 and 5 apply in relation to
advertisements published or broadcast on or after the commencement of
those items.
(3) The amendments made by items 8 to 15 and 17 to 19 apply in relation
to requests made to the Minister to reconsider decisions, where the
requests are made on or after the commencement of those items
(regardless of whether the decisions were made before, on or after that
commencement).
Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010 (No. 141,
2010)
Schedule 1A
10 Application
(1) Paragraph 23(2)(ba) and subparagraph 25(1)(da)(i) of the Therapeutic
Goods Act 1989, as inserted by this Act, apply in relation to
applications for registration of medicine that are made after the day on
which the first instrument made under subsection 3(2A) or (2B) of that
Act takes effect.
(2) Subparagraph 25(1)(da)(ii) of the Therapeutic Goods Act 1989, as
inserted by this Act, applies in relation to applications for registration of
medicine that are made on or after the day on which the first instrument
made under subsection 3(2A) or (2B) of that Act takes effect.
(3) Subparagraph 25(4)(d)(ia) of the Therapeutic Goods Act 1989, as
inserted by this Act, applies on and after the day on which the first
instrument made under subsection 3(2A) or (2B) of that Act takes effect
(whether the application for registration was made before, on or after
that day).
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Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 549
(4) Subsection 25AA(1) of the Therapeutic Goods Act 1989, as inserted by
this Act, applies in relation to medicine included in the Register on or
after the day on which the first instrument made under subsection 3(2A)
or (2B) of that Act takes effect (where the notification (in relation to the
medicine) referred to in subparagraph 25(4)(d)(ia) of that Act also
occurred on or after that day).
Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
Schedule 2
7 Application
(1) The amendments made by items 1A to 1D apply in relation to requests
made on or after the commencement of those items.
(2) The amendment made by item 1E applies in relation to applications for
registration made on or after the commencement of that item.
(3) The amendments made by items 1 and 2 apply in relation to
applications for listings made on or after the commencement of those
items.
(4) The amendment made by item 6A applies in relation to a notice given
on or after the commencement of that item (whether the application or
request was made before, on or after that commencement).
21 Application
(1) The amendments made by items 8 and 9 apply in relation to
applications for listings made on or after the commencement of those
items.
(2) The amendments made by items 10 to 15 apply in relation to notices
given on or after the commencement of those items.
(2A) The amendment made by item 15A applies in relation to notices given
on or after the commencement of that item.
(3) The amendments made by items 16 and 17 apply in relation to
applications made on or after the commencement of those items.
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Endnotes
Endnote 3—Application, saving and transitional provisions
550 Therapeutic Goods Act 1989
(4) The amendments made by items 18 and 19 apply in relation to initial
decisions made on or after the commencement of those items.
Acts Interpretation Amendment Act 2011 (No. 46, 2011)
Schedule 3
10 Saving—appointments
The amendments made by Schedule 2 do not affect the validity of an
appointment that was made under an Act before the commencement of
this item and that was in force immediately before that commencement.
11 Transitional regulations
The Governor-General may make regulations prescribing matters of a
transitional nature (including prescribing any saving or application
provisions) relating to the amendments and repeals made by
Schedules 1 and 2.
Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011 (No. 77,
2011)
Schedule 1
6 Application
(1) The amendment made by item 1 applies in relation to requests made on
or after the commencement of that item.
(2) The amendments made by items 2 to 4 apply in relation to applications
made under section 23 of the Therapeutic Goods Act 1989 on or after
the commencement of those items.
(3) The amendment made by item 5 applies in relation to notices given on
or after the commencement of that item.
7 Transitional—approved forms
An approval in force under subsection 9D(6) of the Therapeutic Goods
Act 1989 immediately before the commencement of this item continues
in force on and after that commencement as if it were an approval in
force under paragraph 9D(6)(a) of that Act.
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Endnotes
Endnote 3—Application, saving and transitional provisions
Therapeutic Goods Act 1989 551
8 Transitional—registration or listing conditions
(1) If:
(a) on or after the day on which this item commences, the first
instrument made under subsection 28(2) of the principal Act
takes effect; and
(b) immediately before that first instrument takes effect, a
condition on the registration or listing of therapeutic goods
was in force under subsection 28(2B) of the principal Act;
and
(c) either:
(i) if that condition was in force because of subitem 57(3)
of Schedule 7 to the amending Act—that condition was
imposed in writing under subsection 28(1) of the
principal Act (as in force at any time before 25 January
2010) and was described as a standard condition; or
(ii) in any other case—that condition was imposed by notice
in writing under subsection 28(2B) of the principal Act
and was described as a standard condition;
then that condition ceases to be in force at the time that first instrument
takes effect.
Note 1: If, immediately before that first instrument takes effect, multiple conditions on the registration or listing of therapeutic goods were in force under subsection 28(2B) of the principal Act, this item has a separate application in relation to each of those conditions.
Note 2: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
(2) Subitem 57(1) of Schedule 7 to the amending Act is subject to an
instrument under subsection 28(2) of the principal Act providing that
specified conditions apply only to a specified class of therapeutic goods
that are registered or listed on or after that instrument takes effect.
(3) In this item:
amending Act means the Therapeutic Goods Amendment (2009
Measures No. 1) Act 2009.
principal Act means the Therapeutic Goods Act 1989.
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Endnotes
Endnote 4—Uncommenced amendments
552 Therapeutic Goods Act 1989
Endnote 4—Uncommenced amendments
This endnote sets out amendments of the Therapeutic Goods Act 1989 that have
not yet commenced.
There are no uncommenced amendments.
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Endnotes
Endnote 5—Misdescribed amendments
Therapeutic Goods Act 1989 553
Endnote 5—Misdescribed amendments
This endnote sets out amendments of the Therapeutic Goods Act 1989 that have
been misdescribed.
There are no misdescribed amendments.
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