This compilation was prepared on 12 January 2011 taking into account amendments up to Act No. 141 of 2010
The text of any of those amendments not in force on that date is appended in the Notes section
The operation of amendments that have been incorporated may be affected by application provisions that are set out in the Notes section
Prepared by the Office of Legislative Drafting and Publishing, Attorney-General’s Department, Canberra
Chapter 1—Preliminary
1 Short title [see Note 1].......................................................................1
2 Commencement [see Note 1].............................................................1
3 Interpretation.....................................................................................1
3A Declaration—member of European Community.............................16
3B Declaration—country covered by non-EC/EFTA MRA..................17
3C Exempting monographs in pharmacopoeias....................................17
4 Objects of Act..................................................................................17
5 Act to bind Crown...........................................................................18
5A Application of the Criminal Code—extended geographical
jurisdiction.......................................................................................18
6 Operation of Act..............................................................................18
6AAA Commonwealth consent to conferral of functions etc. on its
officers and authorities by corresponding State laws.......................19
6AAB When duty imposed.........................................................................20
6AAC Imposing duty under State law........................................................21
6AAD Conferral of jurisdiction on federal courts.......................................22
6AAE Consequences of State law conferring duty, function or
power on Commonwealth officer or Commonwealth
authority ..........................................................................................22
6B Review of certain decisions under State laws..................................23
6C Fees payable to Commonwealth under State laws...........................23
7 Declaration that goods are/are not therapeutic goods ......................24
7A Authorised persons..........................................................................24
7B Kits..................................................................................................25
7C Secretary may arrange for use of computer programs to
make decisions ................................................................................25
7D Form for product information for medicine.....................................26
8 Power to obtain information with respect to therapeutic
goods ...............................................................................................26
9 Arrangements with States etc. .........................................................27
Chapter 2—Australian Register of Therapeutic Goods 28 9A Australian Register of Therapeutic Goods.......................................28 9B When registrations or listings of medical devices are taken to be cancelled.....................................................................................29 9C Inspectionof entries in Register......................................................31 9D Variation of entries in Register........................................................31 9E Publication of list of goods on Register...........................................33
Part 3-1—Standards 34 10 Determination of standards..............................................................34 10A Application of standards to medical devices....................................35 13 Special provisions relating to standards...........................................35 14 Criminal offences for importing, supplying or exporting
goods that do not comply with standards.........................................37 14A Civil penalties for importing, supplying or exporting goods
that do not comply with standards...................................................41
14B Application of Customs Act 1901 ....................................................42
15 Criminal offences relating to breaching a condition of a
consent.............................................................................................43 15AA Civil penalty relating to breaching a condition of a consent............43
Division 1—Preliminary 45 15A Application of this Part to medical devices .....................................45 16 Therapeutic goods and gazetted groups...........................................47 18 Exempt goods..................................................................................48 18A Exemption because of emergency ...................................................48 19 Exemptionsforspecialand experimental uses................................52 19A Exemptions where unavailability etc. of therapeutic goods.............54 19B Criminal offences relating to registration or listing etc. of
imported, exported, manufactured and supplied therapeutic goods ...............................................................................................56
19C Notice required to adduce evidence in support of exception under subsection 19B(6)..................................................................59
19D Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods ...............................................................................................61
20 Criminal offences relating to notifying the Secretary and to importing goods exemptunder section 18A....................................63
20A Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification ......................................................................................65
21 Offence relating to wholesale supply...............................................66 21A General criminal offences relating to this Part.................................66 21B General civil penalties relating to this Part......................................71 22 General offences relating to this Part...............................................72 22AA Civil penalty for breaching a condition of an exemption.................74 22A Criminal offences for false statements in applications for
registration.......................................................................................75
22B Civil penalty for false statements in applications for registration.......................................................................................76
Division 2—Registration and listing
23 Applications generally.....................................................................77
24 Applications for registration............................................................77
24A When evaluation fee due for payment.............................................78
24B Payment of evaluation fee by instalments .......................................78
24C Recovery of evaluation fee..............................................................79
24D Reduction of evaluation fee where evaluation not completed
within prescribed period..................................................................79
24E Deemed refusal of application.........................................................80
25 Evaluation and registration of therapeutic goods.............................80
25AA Approved product information for medicine...................................84
25A When the Secretary must not use protected information .................86
25B Registration of therapeutic device to which EC/EFTA
attestation of conformity applies .....................................................87
26 Listing of therapeutic goods............................................................88
26AA Listing of therapeutic device to which EC/EFTA attestation
of conformity applies.......................................................................91
26A Listing of certain medicines ............................................................92
26B Certificates required in relation to patents.......................................95
26BA Approved form for notices ..............................................................97
26BB Permissible ingredients....................................................................97
26BC Variation of determination under section 26BB —Minister’s
initiative...........................................................................................98
26BD Variation of determination under section 26BB —application
by person.........................................................................................98
26C Certificates required in relation to patent infringement
proceedings......................................................................................99
26D Requirements for interlocutory injunction.....................................101
27 Registration orlisting number.......................................................103
28 Conditions of registration or listing...............................................103
28A Certification of manufacturing steps outside Australia
following application for listing ....................................................107
29 Duration of registration or listing..................................................107
29A Criminal offence for failing to notify adverse effects etc. of
goods .............................................................................................107
29AA Civil penalty for failing to notify adverse effects etc. of
goods .............................................................................................108
29B Notification of adverse effects etc. where application
withdrawn or lapses.......................................................................109
29C Civil penalties for failing to notify adverse effects etc. where
application withdrawn or lapses ....................................................109
29D Suspension of registration or listing..............................................110
29E When suspension takes effect etc..................................................111
29F Revocation of suspension..............................................................112 29G Effect of suspension ......................................................................112 30 Cancellation of registration or listing ............................................113 30A Revocation of cancellation of registration or listing upon
request ...........................................................................................116
30C Consultation with Gene Technology Regulator.............................116
30D Secretary may seek advice about classes of GM products or
genetically modified organisms.....................................................117 30E Secretary to take advice into account ............................................117
goods 119 30EA Public notification and recovery of therapeutic goods...................119 30EB Publication of requirements...........................................................121 30EC Criminal offences for non-compliance with requirements.............121 30ECA Civil penalty for non-compliance with requirements.....................122 30ED Powers of suspension and cancellationunaffected........................122
Division 3—General 123 30F Criminal offences for goods exempt under section 18A not conforming to standards etc...........................................................123 30FA Civil penalty for goods exempt under section 18A not
conforming to standards etc...........................................................125 30G Disposal of unused goods exempt under section 18A ...................125 30H Record for goods exempt under section 18A.................................126 31 Secretary may require information................................................126 31AAA Civil penalty for providing false or misleading information
in relation to medicineslisted under section 26A..........................131
31A Secretary may require information etc. about goods exempt under section 18.............................................................................131
31AA Secretary may require information etc. about goods exempt under section 18A..........................................................................133
31B Secretary may require information relating to approvals and authorities under section 19...........................................................133
31C Criminal offence for failing to give information or
documents sought under section 31A, 31AA or 31B.....................135 31D False or misleading information....................................................135 31E False or misleading documents......................................................136 31F Self-incrimination..........................................................................136
Part 3-3—Manufacturing of therapeutic goods 138 33A Application of this Part to medical devices ...................................138 34 Exempt goods and exempt persons................................................138 35 Criminal offences relating to manufacturing therapeutic
goods .............................................................................................138 35A Civil penalties relating to manufacturing therapeutic goods..........141
35B Criminal offences relating to breaching a condition of a licence ...........................................................................................142 35C Civil penalty relating to breaching a condition of a licence...........143 36 Manufacturing principles...............................................................143 37 Application for licence..................................................................144 38 Grant oflicence.............................................................................145 38A Guidelines for multi-site licences..................................................148 38B Splitting multi-site licences...........................................................148 39 Term of licence..............................................................................150 40 Conditions of licences ...................................................................150 40A Variation of manufacturing site authorisations—Secretary’s own initiative.................................................................................153 40B Variation of licences—application by licence holder....................153 41 Revocation and suspension of licences..........................................155 41AA Spent convictions scheme..............................................................158 41AAA Transfer of licences .......................................................................158 41A Publication of listof manufacturers etc.........................................158
Chapter 4—Medical devices 159
Division 1—Overview of this Chapter 159 41B General..........................................................................................159 41BA Requirements for medical devices (Parts 4-2 and 4-3)..................159 41BB Administrative processes (Parts 4-4 to 4-10).................................159 41BC Enforcement(Part 4-11)................................................................160
Division 2—Interpretation 161 41BD What is a medical device ...............................................................161 41BE Kinds of medical devices...............................................................162 41BEA Excluded purposes.........................................................................163 41BF System or procedure packs............................................................163 41BG Manufacturersofmedical devices.................................................163 41BH Meaning of compliance with essential principles..........................164 41BI Meaning of non-application of conformity assessment procedures .....................................................................................165
Division 3—Application provisions 166 41BJ Application of this Chapter to medical devices covered by Part 3-2..........................................................................................166 41BK Application of the Criminal Code .................................................166
Part 4-2—Essential principles and medical device standards 167 41C What this Part is about...................................................................167
Division 1—Essential principles 168 41CA Essential principles........................................................................168
41CB | Medical device standards...............................................................169 |
41CC | Content of medical device standards .............................................169 |
41CD | Inconsistencies between medical device standards........................170 |
Part 4-3—Conformity assessment procedures 171 41D What this Part is about...................................................................171
Division 1—Conformity assessment procedures 172 41DA Conformity assessment procedures ...............................................172 41DB Medical device classifications.......................................................173
Division 2—Conformity assessment standards 174 41DC Conformity assessment standards..................................................174 41DD Content of conformity assessment standards.................................174 41DE Inconsistencies between conformity assessment standards ...........175
Part 4-4—Conformity assessment certificates 176 41E What this Part is about...................................................................176
Division 1—Issuing conformity assessment certificates 177 41EA When conformity assessment certificates are required..................177 41EB Applications ..................................................................................177 41EC Considering applications ...............................................................178 41ED Time for making decisions on applications...................................179 41EE Procedure following making a decision whether to issue
certificate.......................................................................................180 41EF Duration of certificate....................................................................180 41EG Lapsing of applications..................................................................180 41EH Treating applicationsas having been refused................................181 41EI Criminal offences for making a false statement.............................182 41EIA Civil penalty for making a false statement ....................................183
Division 2—Conditions 184 41EJ Automatic conditions on conformity assessment certificates ........184 41EK Conditions imposed when conformity assessment certificates
are issued.......................................................................................186 41EL Conditions imposed after issuing a conformity assessment certificate.......................................................................................186
Division 3—Suspension of conformity assessment certificates 187 41EM Suspension of conformity assessment certificates.........................187 41EN Notice of proposed suspension......................................................187 41EO Duration of suspension..................................................................188 41EP Revocation of suspension..............................................................188 41EQ Powers of revocation of conformity assessment certificates
unaffected......................................................................................189
Division 4—Revocation of conformity assessment certificates 190 41ER Automatic revocation of conformity assessment certificates.........190 41ES Immediate revocation of conformity assessment certificates.........190 41ET Revocation of conformity assessment certificates after notice of proposed revocation..................................................................190 41EU Limiting revocation of conformity assessment certificates to some medical devices of a particular kind.....................................192 41EV Publication of revocation etc. of conformity assessment certificates .....................................................................................193 41EW Date of effect of revocation etc. of conformity assessment certificates .....................................................................................193
Part 4-5—Including medical devices in the Register 194 41F What this Part is about...................................................................194
Division 1—Including medical devices in the Register 195 41FA What this Division is about ...........................................................195 41FB How this Division works...............................................................196
Subdivision A—Applications 196 41FC Applications ..................................................................................196 41FD Matters to be certified....................................................................197 41FE Criminal offences for making a false statement.............................198 41FEA Civil penalty for making a false statement ....................................200
Subdivision B—Including kinds of medical devices in the Register 200 41FF Obligation to include kinds of medical devices in the Register..........................................................................................200 41FG Notification of unsuccessful applications......................................201
Subdivision C—Auditing of applications 201 41FH Selecting applications for auditing ................................................201 41FI Auditing ofapplications................................................................201 41FJ Procedure following audits............................................................202 41FK Lapsing of applications..................................................................202
Subdivision D—Miscellaneous 203 41FL Device number ..............................................................................203 41FM Duration of inclusion in the Register.............................................203
Division 2—Conditions 204 41FN Conditions applying automatically................................................204 41FO Conditions imposed when kinds of medical devices are included in the Register.................................................................206 41FP Conditions imposed after kinds of medical devices are included in the Register.................................................................207
Part 4-6—Suspension and cancellation from the Register | 208 |
Division 1—Suspension from the Register | 208 |
Subdivision A—General power of suspension | 208 |
41G What this Part is about...................................................................208 41GA Suspension of kinds of medical devices from the Register............208 41GB Notice of proposed suspension must be given in certain cases......209 41GC Duration of suspension..................................................................209 41GD Revocation of suspension..............................................................210 41GE Treating applications for revocation as having been refused.........211
Part 4-4 211 41GF Suspension of kinds of medical devices from the Register............211 41GG Duration of suspension..................................................................212 41GH Revocation of suspension..............................................................212
Subdivision C—Effect of suspension 212 41GI Effect of suspension ......................................................................212 41GJ Powers of cancellation from Register unaffected..........................213
Division 2—Cancellation of entries from the Register 214 41GK Automatic cancellation of entries of kinds of medical devices from the Register...........................................................................214 41GL Immediate cancellation of entries of kinds of medical devices from the Register..............................................................214 41GM Cancellation of entries of kinds of medical devices from the Register after section 41JA notice.................................................215 41GN Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation...............................216 41GO Limiting cancellation of entries from Register to some
medical devicesof a particular kind..............................................217 41GP Publication of cancellation of entry from Register........................217 41GQ Date of effect of cancellation ofentriesfrom Register..................218
Part 4-6A—Exempting medical devices to deal with emergencies 219 41GR What this Part is about...................................................................219 41GS Minister may make exemptions.....................................................219 41GT Conditions of exemptions..............................................................220 41GU Variation or revocation of exemption............................................221 41GV Informing persons of exemption etc..............................................222 41GW Notification and tabling.................................................................222 41GY Disposal of unused medical devices..............................................223
Part 4-7—Other exemptions from including medical devices in the Register 224 41H What this Part is about...................................................................224 41HA Devices exempted from inclusion in the Register..........................224 41HB Exemptionsforspecialand experimental uses..............................225 41HC Exemptions for medical practitioners............................................226 41HD Approvals if substitutes for medical devices are unavailable or in short supply...........................................................................227
Part 4-8—Obtaining information 231 41J What this Part is about...................................................................231
requirements and other matters 232 41JA Secretary may require information................................................232 41JB Complying with the Secretary’s requirements...............................234 41JBA Civil penalty for giving false or misleading information in
purported compliance with a notice...............................................235 41JC Self-incrimination..........................................................................236
Division 2—Information relating to medical devices covered by exemptions 237 41JCA Secretary may require information etc. about medical devices exempt under Part 4-6A....................................................237 41JD Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register ......237 41JE Secretary may require information relating to approvals under section 41HB.......................................................................238 41JF Secretary may require information relating to authorities under section 41HC.......................................................................240 41JFA Secretary may require information relating to approvals under section 41HD.......................................................................240 41JG Criminal offences for failing to give information or
documents sought under this Division...........................................241 41JH False or misleading information....................................................241 41JI False or misleading documents......................................................241 41JJ Self-incrimination..........................................................................242
Part 4-9—Public notification and recovery of medical devices 243 41K What this Part is about...................................................................243 41KA Public notification and recovery of medical devices .....................243 41KB Publication of requirements...........................................................246 41KC Criminal offences for failing to comply with requirements
relating to a kind of medical device...............................................246 41KCA Civil penalty for failing to comply with requirements relating to a kind of medical device............................................................247
41KD Powers of suspension and cancellationunaffected........................247
Part 4-10—Assessment fees 248 41L What this Part is about...................................................................248 41LA Assessment fees.............................................................................248 41LB When assessment fee due for payment..........................................249 41LC Payment of assessment fee by instalments ....................................249 41LD Recovery of assessment fee...........................................................249 41LE Reduction of conformity assessment fee where decision not
made within prescribed period.......................................................249
Part 4-11—Offences and civil penalty provisions relating to medical devices 251 41M What this Part is about...................................................................251
Division 1—Non-compliance with essential principles 252 41MA Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles......252 41MAA Civil penalties for importing, supplying or exporting a
medical device that does not comply with essential principles......256
41MB Exceptions.....................................................................................257
41MC Criminal offences relating to breaching a condition of a
consent...........................................................................................257
41MCA Civil penalty relating to breaching a condition of a consent..........258
41MD Treating medical devices as prohibited imports or exports............259
Division 2—Failure to apply conformity assessment procedures 260 41ME Criminal offences for failing to apply conformity assessment procedures—manufacturers...........................................................260 41MEA Civil penalties for failing to apply conformity assessment procedures—manufacturers...........................................................262 41MF Criminal offences for failing to apply conformity assessment
procedures—sponsors....................................................................263 41MG Exceptions.....................................................................................265 41MH Criminal offence for making false statements in declarations.......265 41MHA Civil penalty for making false statements in declarations..............266
Division 3—Medical devices not included in the Register and related matters 267 41MI Criminal offences for importing, exporting, supplying or manufacturing a medical device not included in the Register........267 41MIA Notice required to adduce evidence in support of exception under subsection 41MI(7)..............................................................269 41MIB Civil penalty for importing, exporting, supplying or
manufacturing a medical device not included in the Register........271
41MJ Treating medical devices as prohibited imports or exports............272
41MK Wholesale supply of medical devices not included in the
Register..........................................................................................272
41ML False advertising about medical devices........................................273
41MLA Civil penalty for making misrepresentations about medical devices...........................................................................................273
41MM Claims about arranging supplies of medical devices not
included in the Register.................................................................274
41MN Criminal offences relating to breaches of conditions.....................274
41MNA Civil penalties for breachingconditions........................................276
under Part 4-6A 278 41MNB Criminal offences for breaching a condition of an exemption.......278 41MNC Civil penalty for breaching a condition of an exemption...............279 41MND Civil penalty for making misrepresentations about medical
devices...........................................................................................279
Division 4—Other offences and civil penalty provisions 280 41MO Criminal offences for misusing medical devices exempted
for special or experimental uses ....................................................280 41MP Criminal offence for failing to notify adverse events etc...............282 41MPA Civil penalty for failing to notify adverse events etc.....................284 41MPB Relief from liability for contraventions for failing to notify
adverse events etc..........................................................................285
41MQ Notification of adverse events etc. where application withdrawn or lapses.......................................................................286
41MR Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses ....................................................286
Chapter 5—Advertising, counterfeit therapeutic goods and product tampering 288
Division 1—Preliminary 288 42AA This Part not to apply to advertisements directed at health professionals etc............................................................................288 42AB This Part not to apply to advertisements for goods not for
human use......................................................................................289 42AC This Part not to apply to advertisements for exported goods.........289 42B Definitions.....................................................................................289 42BAA Therapeutic Goods Advertising Code............................................291
approval is required 292
42BA Application of Division.................................................................292
42C Offences relating to publication of advertisements........................292
goods 295 42DA Simplified outline..........................................................................295 42DB Definitions.....................................................................................295 42DD Restricted representations..............................................................295 42DE Applications for approval of use of restricted representation ........296 42DF Approval of use of restricted representation..................................296 42DG Noticeof approval or refusal.........................................................296 42DH Variation of conditions of approval...............................................297 42DI Withdrawal of approval.................................................................297 42DJ Prohibited and required representations.........................................298 42DK Use of restricted or prohibited representations..............................298
approval is not required 299 42DKA Application of Division.................................................................299 42DKB Certain representations not to be published or broadcast...............299 42DL Advertising offences......................................................................299 42DM Compliancewith Code..................................................................301
components of therapeutic goods 302 42DN Application of Division.................................................................302 42DO Compliance with the Code ............................................................302 42DP Offences—publication ofgeneric information..............................302
Part 5-2—Counterfeit therapeutic goods 303 42E Offence of dealing with counterfeit therapeutic goods..................303 42EA Civil penalty relating to dealing with counterfeit therapeutic
goods .............................................................................................304
42EB Relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods....................................304
42F Customs treatment of counterfeit therapeutic goods......................305
Part 5-3—Product tampering 306 42T Notifying of actual or potential tampering.....................................306 42U Meaning of actual or potential tampering etc. ..............................307 42V Recovery of therapeutic goods because of actual or potential tampering.......................................................................................307 42VA Civil penalty relating to the recovery of therapeutic goods because of actual or potential tampering .......................................309 42VB Relief from liability for contraventions relating to the recovery of therapeutic goods because of actual or potential tampering.......................................................................................310 42W Supply etc. of therapeutic goods that are subject to recovery requirements..................................................................................310
42X Saving of other laws......................................................................311
Chapter 5A—Enforcement 312
Division 1—Obtaining an order for a civil penalty 312 42Y Federal Court may order person to pay pecuniary penalty for contravening civil penalty provision..............................................312 42YA What is a civil penalty provision?..................................................313 42YB Meaning of penalty unit.................................................................313 42YC Persons involved in contravening civil penalty provision .............313 42YD Recovery of a pecuniary penalty ...................................................313 42YE Gathering information for application for pecuniary penalty ........314
Division 2—Civil penalty proceedings and criminal proceedings 315 42YF Civil proceedings after criminal proceedings ................................315 42YG Criminal proceedingsduring civil proceedings.............................315 42YH Criminal proceedings after civil proceedings ................................315 42YI Evidence given in proceedings for civil penalty not admissible in criminal proceedings................................................315
Part 5A-2—Infringement notices 317 42YJ Infringement notices in respect ofoffences...................................317 42YK Infringement notices in respect of civil penalty provisions ...........317
Part 5A-3—Enforceable undertakings 318 42YL Enforcement of undertakings.........................................................318
Part 6-1—Payment of charges 319 43 By whom charges payable.............................................................319 44 Time for payment of charges.........................................................319 44A Exemptions from liability topay charges......................................320 44B Recovery of unpaid charges ..........................................................321 45 Therapeutic Goods Administration Account.................................322
Part 6-2—Entry, searches and warrants 324 45A Definitions.....................................................................................324 46 Searchesto monitor compliance with Act.....................................325 46A Searches of certain premises to monitor compliance with Act......325 46B Searches and seizures on publichealth grounds............................327 47 Searches and seizures related to offences and civil penalty provisions ......................................................................................327 48 General powers of authorised persons in relation to premises.......328 48A Details of warrant to be given to occupier etc. ..............................329 48B Announcement before entry ..........................................................330
48C Use of electronic equipment atpremises.......................................330 48D Compensation for damage to electronic equipment.......................332 48E Copies of seized things to beprovided..........................................332 48F Occupier entitled to be present during search................................333 48G Receipts for things seized under warrant.......................................333 48H Retention of seized things..............................................................333 48J Magistrate may permit a thing to be retained ................................334 49 Monitoring warrants......................................................................334 50 Offence and civil penalty provision related warrants ....................335 51 Offence and civil penalty provision related warrants by telephone .......................................................................................336 51A Searchesatrequest of manufacturer..............................................338 51B Offences relating to warrants.........................................................338 52 Identity cards.................................................................................339
Part 6-3—Scheduling of substances 340 52AA Overview.......................................................................................340 52A Definitions.....................................................................................340 52B Advisory Committee on Medicines Scheduling ............................341 52C Advisory Committee onChemicals Scheduling............................342 52CA Joint meetings................................................................................342 52D Poisons Standard ...........................................................................343 52E Secretary to take certain matters into account in exercising powers ...........................................................................................343 52EAA Application for amendment of the Poisons Standard.....................344 52EA Poisons Standard—validation etc..................................................345 52EB Compensation for acquisition of property .....................................346 52EC Review of scheduling regime........................................................347
Chapter 7—Miscellaneous 349 53 Retention of material on withdrawal of application.......................349 53A Alternative verdicts for various offences.......................................349 54 Offences and forfeiture..................................................................350 54AA Offences for contravening conditions or requirements imposed under the regulations.......................................................351 54AB Criminal offence for damaging etc. documents.............................352 54AC Civil penalty for damaging etc. documents ...................................352 54A Time for bringing prosecutions .....................................................352 54B Application of this Act to an executive officer of a body corporate........................................................................................352 54C Establishing whether an executive officer took reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision .....................................353 55 Conduct by directors, servants and agents.....................................354 56 Judicial notice................................................................................355
56A Certificates to provide evidence of certain matters........................356 57 Delegation .....................................................................................358 58 Export certifications ......................................................................360 59 Fees ...............................................................................................360 60 Review of decisions.......................................................................360 60A New information on review—discretion to remit..........................363 61 Release of information ..................................................................366 61A Immunity fromcivil actions..........................................................371 62 Consequential amendments...........................................................372 63 Regulations....................................................................................372
Chapter 8—Repeal and transitional provisions 375 64 Interpretation.................................................................................375 65 Repeal............................................................................................375 66 Transitional arrangements for goods required to be registered
or listed..........................................................................................375 67 Transitional provision for therapeutic goods for export only.........377 68 Transitionalarrangements for Part 3-3..........................................377 69 Continuation of standards and requirements..................................378
Schedule—Consequential Amendments 379
An Act relating to therapeutic goods
1 Short title [see Note 1]
This Act may be cited as the Therapeutic Goods Act 1989.
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:
has not occurred; between the approval of one House and the approval of the other House.
(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.
Chapter 1 Preliminary
Section 3
application audit assessment fee means a fee payable under subsection 41LA(3).
batch means a quantity of a product that is:
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.
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.
Preliminary Chapter 1
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:
Chapter 1 Preliminary
Section 3
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.
default standard means any of the following:
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:
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.
Preliminary Chapter 1
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:
EC Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community, as in force from time to time.
EFTA Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Free Trade Association, as in force from time to time.
essential principles has the meaning given by section 41CA.
ethics committee means a committee:
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.
Chapter 1 Preliminary
Section 3
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:
Federal Court means the Federal Court of Australia.
financial corporation means a financial corporation within the meaning of paragraph 51(xx) of the Constitution.
first Poisons Standard has the meaning given by section 52A.
foreign corporation means a foreign corporation within the meaning of paragraph 51(xx) of the Constitution.
gazetted kits group means a group of kits identified in an order in force under subsection 16(3A).
gazetted therapeutic devices group has the meaning given by subsection 16(3).
gazetted therapeutic goods group has the meaning given by subsection 16(2).
Gene Technology Regulator has the same meaning as in the Gene Technology Act 2000.
genetically modified organism has the same meaning as in the Gene Technology Act 2000.
GM product has the same meaning as in the Gene Technology Act 2000.
Preliminary Chapter 1
grouped therapeutic goods means therapeutic goods included in:
included in the Register, in relation to a medical device to which Chapter 4 applies, means included in the Register under Chapter 4.
Note: For medical devices to which Chapter 4 applies, see section 41BJ.
indications, in relation to therapeutic goods, means the specific therapeutic uses of the goods.
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:
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:
listed goods means therapeutic goods that are included in the Part of the Register for goods known as listed goods.
Chapter 1 Preliminary
Section 3
listing number, in relation to listed goods, means any combination of numbers, symbols and letters assigned to the goods under section 27.
major interest holder of a body corporate means a person who:
manufacture, in relation to therapeutic goods that are not medical devices, means:
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 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.
Preliminary Chapter 1
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.
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.
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.
means:
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.
Chapter 1 Preliminary
Section 3
non-EC/EFTA MRA means an international instrument that Australia is bound by, or is a party to, if:
regulations made for the purposes of this paragraph; but does not include:
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:
presentation, in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.
primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers.
product information, in relation to therapeutic goods, means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods.
protected information, in relation to therapeutic goods, has the meaning given by section 25A.
Preliminary Chapter 1
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.
scheduling has the meaning given by section 52A.
Secretary means the Secretary to the Department.
sponsor, in relation to therapeutic goods, means:
but does not include a person who:
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.
Chapter 1 Preliminary
Section 3
standard, in relation to therapeutic goods, means any of the following:
Note: See also section 13.
State includes the Australian Capital Territory and the Northern Territory.
State law means a law of a State, of the Australian Capital Territory or of the Northern Territory.
supply includes:
Preliminary Chapter 1
system or procedure pack has the meaning given by section 41BF.
tamper: therapeutic goods are tampered with if:
therapeutic device means therapeutic goods 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.
and includes 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
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Section 3
Therapeutic Goods Advertising Code means the code in force under section 42BAA.
therapeutic use means use in or in connection with:
trading corporation means a trading corporation within the meaning of paragraph 51(xx) of the Constitution.
United States Pharmacopeia-National Formulary means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the United States Pharmacopeial Convention or any replacement body.
Preliminary Chapter 1
working day, for a person, means any day except:
(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).
(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
Chapter 1 Preliminary
Section 3A
(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.
(7A) For the purposes of this Act, a corresponding State law imposes a duty on a Commonwealth officer or Commonwealth authority if:
Preliminary Chapter 1
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).
(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
Chapter 1 Preliminary
Section 5
(ii) exported from Australia;
(b) to provide a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia.
(1A) The reference in paragraph (1)(a) to the efficacy of therapeutic goods is a reference, if the goods are medical devices, to the performance of the devices as the manufacturer intended.
(2) This Act is therefore not intended to apply to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory to the extent that the law is capable of operating concurrently with this Act.
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.
Preliminary Chapter 1
(iii) in relation to the Commonwealth or in relation to an authority of the Commonwealth.
Chapter 1 Preliminary
Section 6AAB
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:
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
Preliminary Chapter 1
Chapter 1 Preliminary
Section 6AAD
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.
If:
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.
(1) If a corresponding State law confers on a Commonwealth officer or Commonwealth authority:
the officer or authority may include the goods in the Register in accordance with the corresponding State law.
Preliminary Chapter 1
necessary to identify entries that relate to goods included in the Register under subsection (1).
Chapter 1 Preliminary
Section 7
(1) Where the Secretary is satisfied that particular goods or classes of goods:
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 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:
way, are therapeutic goods; the Secretary must disregard paragraphs (e) and (f) of the definition of therapeutic goods in subsection 3(1).
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.
The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of this Act:
Preliminary Chapter 1
(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.
(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.
Chapter 1 Preliminary
Section 7D
(1) The Secretary may, by notice in writing given to a person who has imported into Australia or has supplied in Australia:
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:
Preliminary Chapter 1
Note: The defendant bears an evidential burden in relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal Code.
(4) An offence under subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
Chapter 2 Australian Register of Therapeutic Goods
Section 9A
9A Australian Register of Therapeutic Goods
Australian Register of Therapeutic Goods Chapter 2
Time of cancellation of registration or listing Circumstances Time
1 That kind of medical device is When that kind of medical device is included included in the Register under in the Register under Chapter 4 Chapter 4 before 4 October 2007 because of an application finally determined before that day
2 An effective application for a The end of 30 days after the application is conformity assessment finally determined or, if the application certificate relating to that kind of lapses, the later of the following times (or medical device is made, but not either of them if they are the same):
finally determined, before (a) the time the application lapses;
4 October 2007 (b) the start of 4 October 2007
Chapter 2 Australian Register of Therapeutic Goods
Section 9B
Time of cancellation of registration or listing Circumstances Time
3 An effective application to Whichever one of the following times include that kind of medical applies, or the earlier of them: device in the Register under (a) the time that kind of medical device is Chapter 4 is made, but not included in the Register under Chapter 4 finally determined, before (even if that time is before 4 October
4 October 2007, and item 2 does 2007);
not apply
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:
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.
Australian Register of Therapeutic Goods Chapter 2
(1) The Secretary may:
vary the entry in the Register in relation to the goods if the entry contains information that is incomplete or incorrect.
(2) If:
the Secretary must vary the entry in accordance with the request.
Chapter 2 Australian Register of Therapeutic Goods
Section 9D
(2A) Subsection (2), to the extent to which it relates to subparagraph (2)(b)(i), applies despite subsection 16(1).
(3) If:
the Secretary may vary the entry in accordance with the request.
(3C) If:
the Secretary must vary the entry in accordance with the request.
(3D) If:
the Secretary may vary the entry in accordance with the request.
(4) If:
Australian Register of Therapeutic Goods Chapter 2
kind of medical device; the Secretary must move the entry relating to the goods from the part of the Register for medical devices to the part for goods to be known as registered goods or to the part for goods to be known as listed goods (whichever 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).
Approved forms for requests
Fees
(8) A request under this section must be accompanied by any prescribed application fee or prescribed evaluation fee or both.
The Secretary must, at least once every 12 months, publish a list of the therapeutic goods included in the Register.
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-1 Standards
Section 10
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.
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 or the United States Pharmacopeia-National Formulary).
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:
(iii) procedures to be carried out in the manufacture of the goods; or
(vii) a standard published by the Standards Australia International Limited; or
(viii) such other matters as the Minister thinks fit; or
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Section 10A
(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:
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 standards
(1) For the purposes of this Act, if a statement (the main statement) in a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia-National Formulary refers to a statement in a monograph in another publication, the main statement is taken to include the other statement.
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Section 13
(2) If:
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:
the standard referred to in paragraph (a) does not apply in relation to the goods referred to in paragraph (b).
(4) If:
combination; the standard referred to in paragraph (b) does not apply in relation to the goods.
(5) If:
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.
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Section 14
(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:
then the default standards that the goods do not conform with are taken not to apply to the goods at that time.
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:
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:
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Section 14
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:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Exception
(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.
Offences relating to supplying goods for use in Australia
(6) A person commits an offence if:
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Section 14
(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: 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.
(7) A person commits an offence if:
Penalty: 2,000 penalty units.
(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:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Offences relating to exporting goods from Australia
(10) A person commits an offence if:
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Section 14
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 (13) instead: see section 53A.
(11) A person commits an offence if:
Penalty: 2,000 penalty units.
(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:
Medicines and other therapeutic goods that are not medical devices Chapter 3 Standards Part 3-1
Section 14A
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Decisions on whether to give consent
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:
Maximum civil penalty:
Civil penalty relating to supplying goods for use in Australia
(2) A person contravenes this subsection if:
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-1 Standards
Section 14B
(b) for a body corporate—50,000 penalty units.
Civil penalty relating to exporting goods from Australia
(3) A person contravenes this subsection if:
Maximum civil penalty:
Decisions on whether to give consent
14B Application of Customs Act 1901
Where:
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:
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Section 15
15 Criminal offences relating to breaching a condition of a consent
Penalty: 2,000 penalty units.
Note: 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.
(3) A person commits an offence if:
Penalty: 1,000 penalty units.
(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:
Penalty: 500 penalty units.
15AA Civil penalty relating to breaching a condition of a consent
A person contravenes this section if:
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-1 Standards
Section 15AA
Maximum civil penalty:
Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1
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:
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.
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary
Section 15A
Applications made within 2 years relating to certain medical devices
(5) This Part applies to a medical device if:
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:
New approvals under section 19
(8) This Part applies to a medical device if:
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However, this subsection does not apply after the end of 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:
(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:
prescribe; from the therapeutic goods.
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Section 18
(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:
18 Exempt goods
(1) The regulations may, subject to such conditions (if any) as are specified in the regulations, exempt:
from the operation of this Part (except section 31A and sections 31C to 31F).
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
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(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:
When the exemption has effect
goods from the exemption; whichever first occurs.
(6) If the Minister revokes the exemption as mentioned in paragraph (4)(b), or varies the exemption as mentioned in paragraph (5)(b), the revocation or variation takes effect:
(a) if the Minister states in the revocation or variation that the revocation or variation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the revocation or variation is made; or
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Section 18A
(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:
by whether or not there is a breach of a condition of an exemption under this section in relation to those goods.
Note 1: A person may commit an offence by breaching a condition of an exemption under this section, see subsections 20(2A) and (2C), 22(7AB) and (7AD), and 30H(1) and (3).
Note 2: A person may also contravene a civil penalty provision, see section 22AA.
(8) The Minister may revoke or vary the conditions (including by imposing new conditions) after the exemption is made. The revocation or variation must be made in writing.
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(9) A revocation or variation under subsection (8) takes effect:
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):
Notification
(10) The Secretary must cause a document setting out particulars of:
covered by paragraph (2)(b); to be published in the Gazette within 5 working days after the day on which the Minister makes the exemption, revocation or variation. However, an exemption, or a revocation or variation, is not invalid merely because of a failure to comply with this subsection.
Tabling
(11) The Minister must cause a document setting out particulars of:
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Section 19
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:
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:
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).
(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
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(b) in the case of an application for use of the kind referred to in paragraph (1)(b):
(iii) be accompanied by the prescribed evaluation fee.
(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:
(5) The Secretary may, in writing, authorise a specified medical practitioner to supply:
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(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.
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:
(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
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(ii) an application that complies with section 23 has been made under that section for registration of the goods; and
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19B Criminal offences relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods
Offences relating to importing, exporting, manufacturing or supplying goods for use in humans
(1) A person commits an offence if:
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(iii) the goods are exempt under section 18A;
(c) either:
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.
(2) A person commits an offence if:
(iii) the goods are exempt under section 18A;
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(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: 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.
(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:
(iii) the goods are exempt under section 18A;
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.
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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:
(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:
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:
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
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(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:
(2) A defendant must not, without leave of the court, adduce evidence in support of the exception under subsection 19B(6) unless:
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:
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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:
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(iii) the goods are exempt under section 18A;
Maximum civil penalty:
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:
Maximum civil penalty:
Civil penalty relating to the supply of registered or listed goods
(4) A person contravenes this subsection if:
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Maximum civil penalty:
Application of Customs Act 1901
(5) Where:
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:
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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Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(1C) For the purposes of paragraph (1B)(c):
(2A) A person commits an offence if:
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:
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.
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20A Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification
(1) A person contravenes this section if:
Maximum civil penalty:
Meaning of properly notified
(2) For the purposes of paragraph (1)(c):
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21 Offence relating to wholesale supply
A person must not supply in Australia therapeutic goods for use in humans (other than listable devices), being goods of which the person is not a sponsor, to another person who is not the ultimate consumer of the goods unless:
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:
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:
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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:
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:
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:
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(d) the act or omission is 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:
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:
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(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:
(iii) the supply is not in accordance with regulations made for the purpose of subsection 19(7).
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:
(i) exempt goods; or
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(ii) listed goods; or
(iii) registered goods; or
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:
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(e) either:
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:
Civil penalty relating to breaching a condition of registration or listing of therapeutic goods
(2) A person contravenes this subsection if:
Maximum civil penalty:
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Civil penalty for falsely representing therapeutic goods
(3) A person contravenes this subsection if:
Maximum civil penalty:
22 General offences relating to this Part
Penalty: 60 penalty units.
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(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:
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.
(7AC) Strict liability applies to paragraph (7AB)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
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(7AD) A person commits an offence if:
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:
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:
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:
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
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(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:
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:
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:
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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:
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23 Applications generally
(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:
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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24A When evaluation fee due for payment
Subject to sections 24B and 24D, 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
(a) that or any other evaluation fee under section 24 payable by the person; or
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(b) any assessment fee under section 41LA payable by the
person; was unpaid immediately after the time when it became due for payment.
(3) Subsection (2) does not limit the generality of subsection (1).
24C Recovery of evaluation fee
An evaluation fee under section 24 may be recovered by the Commonwealth as a debt due to the Commonwealth.
24D Reduction of evaluation fee where evaluation not completed within prescribed period
evaluation is completed; that part becomes due and payable on the completion of the evaluation.
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the evaluation is taken for the purposes of subsections (2), (3) and
(4) to be completed immediately before the time of withdrawal.
24E Deemed refusal of application
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:
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(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:
the product information given by the applicant in relation to the medicine; and
(ja) whether all of the manufacturers of the goods are nominated as manufacturers of the goods in the application; and
(k) such other matters (if any) as the Secretary considers relevant.
Note: The Secretary must not use protected information when evaluating therapeutic goods for registration: see section 25A.
(2) In making a decision for the purposes of paragraph (1)(g), the matters that may be taken into account include:
(a) whether the applicant has provided:
(i) if the goods are not therapeutic devices and a step in the manufacture of the goods has been carried out in a
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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:
(2A) An evaluation under this section of goods in relation to which a period has been prescribed under paragraph 63(2)(da) must be completed within that period.
(2B) If therapeutic goods are exempt from the operation of Part 3-3 or a person is exempt from the operation of that Part in relation to the manufacture of the goods, subsection (1) has effect, in relation to the goods, as if paragraph (h) were omitted.
(2C) If a person is exempt from the operation of Part 3-3 in relation to a step in the manufacture of therapeutic goods, subsection (1) has effect, in relation to the goods, as if the reference in paragraph (h) to Part 3-3 were a reference to that Part to the extent that it applies to that person in relation to the manufacture of the goods.
(2D) If:
(a) therapeutic goods were made outside Australia; and
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(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:
(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:
completed; the Secretary must:
(4) If:
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,
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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.
25AA Approved product information for medicine
(1) If:
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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:
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:
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.
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Variations
(4) If:
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
(i) no other therapeutic goods consisting of, or containing, that active component were included in the Register; and
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(ii) no such therapeutic goods had been included in the Register at any time before then; and
(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:
the Secretary must register the device unless the Secretary considers that the device may compromise the health or safety of users.
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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:
(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:
(i) the goods have been refused registration or listing for supply in Australia; or
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(ii) the Secretary requires such a confirmation for a reason other than because the goods have been refused registration or listing; or
(1AA) If:
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:
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:
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(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:
(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.
(2C) If:
exempt from the operation of Part 3-3; subsection (1) has effect, in relation to the goods, as if paragraph (g) were omitted.
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(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:
(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.
26AA Listing of therapeutic device to which EC/EFTA attestation of conformity applies
(1) If:
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
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Secretary decides not to list the device, the notice must contain the reasons for that decision.
26A Listing of certain medicines
(1) If:
registration or listing cancelled; the Secretary must list the medicine in relation to the person.
(1A) To avoid doubt, if:
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
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medicine—none of the requirements have been contravened; 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:
(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
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(2A) The applicant must also certify any other matters prescribed by the regulations for the purposes of this subsection.
(a) whether the applicant has provided:
(i) if a step in the manufacture of the medicine has been carried out in a country that is a member of the European Community or a member of EFTA—an EC/EFTA attestation of conformity in relation to the medicine; or
(ia) if a step in the manufacture of the medicine has been carried out in a country declared by the Minister under section 3B to be covered by a non-EC/EFTA MRA—a non-EC/EFTA attestation of conformity, for the non-EC/EFTA MRA, in relation to the medicine; or
(ii) in any other case—an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the medicine is of an acceptable standard; and
(b) whether the applicant has agreed to provide, if the Secretary considers inspection of the manufacturing procedures used in the manufacture of the medicine to be necessary:
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(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.
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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(1) The certificate required under this subsection is either:
(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:
Penalty: 1,000 penalty units.
patent has the same meaning as in the Patents Act 1990.
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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:
26BB Permissible ingredients
(1) The Minister may, by legislative instrument, make a determination specifying either or both of the following:
Note: A person seeking the listing of a medicine under section 26A must certify that:
Requirements
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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(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
(3A) In deciding whether to vary the determination, the Minister must have regard to the quality and safety of the ingredients concerned. This subsection does not limit the matters to which the Minister may have regard to in deciding whether to vary the determination.
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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:
26C Certificates required in relation to patent infringement proceedings
The certificate must be signed by, or on behalf of, the second person and must be in a form approved by the Secretary.
(4) For the purpose of paragraph (3)(b), proceedings have reasonable prospects of success if:
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(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:
(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:
by reason of the second person exploiting the patent during the proceedings.
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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
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(4) If an interlocutory injunction is granted pursuant to an application made as described in subsection (1) and:
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:
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(6) In this section:
prescribed court has the same meaning as in the Patents Act 1990.
27 Registration or listing number
28 Conditions of registration or listing
(2A) Without limiting subsection (2), different conditions may be specified for:
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(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.
(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:
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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
(5A) In addition to any conditions imposed under subsection (1), (2B),
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(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:
(5C) Subsection (5B) does not apply if the medicine is exempt from the operation of Part 3-3.
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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).
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
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29AA Civil penalty for failing to notify adverse effects etc. of goods
(1) A person contravenes this section if:
Maximum civil penalty:
(2) The information with which subsection (1) is concerned is information of the following kinds:
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29B Notification of adverse effects etc. where application withdrawn or lapses
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
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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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:
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:
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:
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(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.
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.
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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
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:
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.
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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:
(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) 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
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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:
(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:
(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:
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(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
(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:
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30A Revocation of cancellation of registration or listing upon request
(1) If:
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
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(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
30E Secretary to take advice into account
If the Secretary receives advice from the Gene Technology Regulator:
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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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30EA Public notification and recovery of therapeutic goods
(1) The Secretary may, in writing, impose requirements, relating to therapeutic goods, on a person if:
Circumstances in which requirements may be imposed
Item Circumstance relating to therapeutic goods Person subject to requirements
section 19A; but they do not conform with a standard applicable to the goods
The person supplying the goods
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Circumstances in which requirements may be imposed
Item | Circumstance relating to therapeutic goods | Person subject to requirements |
---|---|---|
4. | The goods are supplied while: (a) they are exempt goods; or | The person supplying the goods |
(b) they are exempt under section 18A; or | ||
(c) they are the subject of an approval or authority under section 19; or | ||
(d) they are the subject of an approval under section 19A; | ||
but the 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 | The person in relation to | ||
---|---|---|---|---|
registered goods or listed goods, but it appears | whom the goods are | |||
to the Secretary that the quality, safety or | included in the Register | |||
efficacy of the goods is unacceptable or that the | ||||
presentation of the goods is unacceptable | ||||
6. | The goods are supplied while they are | The person in relation to | ||
registered goods or listed goods, but one or | whom the goods are | |||
more steps in the manufacture of the goods has | included in the Register | |||
been carried out by a manufacturer while the | ||||
manufacturer did not hold a licence that was in | ||||
force | ||||
6A. | The registration or listing of the goods has been | The person in relation to | ||
suspended under this Part | whom the goods were | |||
included in the Register | ||||
7. | The registration or listing of the goods has been | The person in relation to | ||
cancelled under this Part | whom the goods were | |||
included in the Register | ||||
(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 | ||||
120 | Therapeutic Goods Act 1989 |
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paragraph (1)(a) have occurred in relation to therapeutic
goods;
(c) to publish, in the specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or distribution of therapeutic goods.
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:
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:
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Penalty: 2,000 penalty units.
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:
Maximum civil penalty:
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.
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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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 (5) instead: see section 53A.
(4C) A person commits an offence if:
Penalty: 2,000 penalty units.
(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:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
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(6) For the purposes of an offence against subsection (5), strict liability applies to the following physical elements of circumstances:
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:
Maximum civil penalty:
30G Disposal of unused goods exempt under section 18A
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Section 30H
30H Record for goods exempt under section 18A
(1) A person commits an offence if:
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:
Penalty: 60 penalty units.
(4) An offence under subsection (3) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
31 Secretary may require information
(1) The Secretary may, by notice in writing given to a person:
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(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:
(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:
(iii) exported from Australia;
(1A) If a notice is given under subsection (1) to a person covered by paragraph (1)(ac), then paragraphs (1)(a) to (k) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the therapeutic goods were registered.
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(1B) If:
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:
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 the notice, information or documents relating to one or more of the following:
(a) the formulation of the goods;
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(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:
(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.
(a) either:
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(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:
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 (6) instead: see section 53A.
(5B) A person commits an offence if:
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(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.
(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:
Maximum civil penalty:
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;
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Section 31A
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:
Compliance period
(3) A notice under subsection (1) or (2) must specify a reasonable period within which the person to whom the notice is given must comply with it. The period must be at least 14 days starting on the day on which the notice is given.
Information may need to be given in accordance with specified software requirements
(4) A notice under subsection (1) or (2) may require information to be given in accordance with specified software requirements:
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31AA Secretary may require information etc. about goods exempt under section 18A
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:
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:
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Section 31B
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:
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:
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:
Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 General Division 3
31C Criminal offence for failing to give information or documents sought under section 31A, 31AA or 31B
A person commits an offence if:
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:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(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).
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 3 General
Section 31E
31E False or misleading documents
(1) A person is guilty of an offence if:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(2) Subsection (1) does not apply if the document is not false or misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in subsection (2).
(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:
Note: A defendant bears an evidential burden in relation to the matter in subsection (3).
31F Self-incrimination
Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 General Division 3
(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:
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-3 Manufacturing of therapeutic goods
Section 33A
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.
34 Exempt goods and exempt persons
35 Criminal offences relating to manufacturing therapeutic goods
(1) A person commits an offence if:
(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
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Section 35
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:
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:
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Section 35
(c) none of the following applies:
(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:
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 (9) instead: see section 53A.
(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:
Medicines and other therapeutic goods that are not medical devices Chapter 3 Manufacturing of therapeutic goods Part 3-3
Section 35A
Penalty: 2,000 penalty units.
(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:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(10) Strict liability applies to paragraph (9)(c).
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:
(i) the goods are exempt goods;
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-3 Manufacturing of therapeutic goods
Section 35B
(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:
(2) A person contravenes this subsection if:
Maximum civil penalty:
35B Criminal offences relating to breaching a condition of a licence
(1) A person commits an offence if:
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:
Medicines and other therapeutic goods that are not medical devices Chapter 3 Manufacturing of therapeutic goods Part 3-3
Section 35C
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:
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:
Maximum civil penalty:
36 Manufacturing principles
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-3 Manufacturing of therapeutic goods
Section 37
and may include codes of good manufacturing practice.
37 Application for licence
(1) An application for a licence must:
(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
Medicines and other therapeutic goods that are not medical devices Chapter 3 Manufacturing of therapeutic goods Part 3-3
Section 38
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:
Further information
(2) The Secretary may, by notice in writing given to an applicant for a licence, require the applicant:
Applications or information may be given electronically
(3) An approval of a form mentioned in paragraph (1)(a), or a notice mentioned in subsection (2), may require or permit an application or information to be given in accordance with specified software requirements:
38 Grant of licence
(1) Where:
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-3 Manufacturing of therapeutic goods
Section 38
(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:
(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:
(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
Medicines and other therapeutic goods that are not medical devices Chapter 3 Manufacturing of therapeutic goods Part 3-3
Section 38
(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:
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:
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 46(3) of the Acts Interpretation Act 1901.
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-3 Manufacturing of therapeutic goods
Section 38A
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:
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.
38B Splitting multi-site licences
The Secretary must give the holder written notice of the revocation and grant.
Medicines and other therapeutic goods that are not medical devices Chapter 3 Manufacturing of therapeutic goods Part 3-3
Section 38B
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:
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:
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-3 Manufacturing of therapeutic goods
Section 39
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.
Licence charges
(10) Subsection 4(2) of the Therapeutic Goods (Charges) Act 1989 does not apply in relation to a new licence for the financial year in which the new licence is granted.
No review of revocation of old licence
(11) The revocation of the old licence is taken not to be an initial decision for the purposes of section 60.
39 Term of licence
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).
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.
Medicines and other therapeutic goods that are not medical devices Chapter 3 Manufacturing of therapeutic goods Part 3-3
Section 40
(a) ensure that:
(aa) if:
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
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-3 Manufacturing of therapeutic goods
Section 40
(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
(5) The information with which paragraph (4)(ab) is concerned is information of the following kinds:
Medicines and other therapeutic goods that are not medical devices Chapter 3 Manufacturing of therapeutic goods Part 3-3
Section 40A
40A Variation of manufacturing site authorisations—Secretary’s own initiative
40B Variation of licences—application by licence holder
Addition of manufacturing sites
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-3 Manufacturing of therapeutic goods
Section 40B
Note 1: For specification by class, see subsection 46(3) 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
Medicines and other therapeutic goods that are not medical devices Chapter 3 Manufacturing of therapeutic goods Part 3-3
Section 41
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:
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:
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;
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-3 Manufacturing of therapeutic goods
Section 41
(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:
(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
(ea) the holder contravenes a manufacturing site authorisation in relation to the licence; or
Medicines and other therapeutic goods that are not medical devices Chapter 3 Manufacturing of therapeutic goods Part 3-3
Section 41
(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:
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:
Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-3 Manufacturing of therapeutic goods
Section 41AA
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
41A Publication of list of manufacturers etc.
The Secretary may, from time to time and in such manner as the Secretary determines, publish a list of the persons who are licensed under this Part, the classes of goods to which the licences relate, the steps of manufacture that the licences authorise and the addresses of the manufacturing sites to which the licences relate.
Medical devices Chapter 4 Introduction Part 4-1 Overview of this Chapter Division 1
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:
41BA Requirements for medical devices (Parts 4-2 and 4-3)
The requirements for medical devices are:
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:
Chapter 4 Medical devices Part 4-1 Introduction Division 1 Overview of this Chapter
Section 41BC
(ca) exempting medical devices from various provisions of this Chapter to deal with emergency situations; and
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:
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).
Medical devices Chapter 4 Introduction Part 4-1 Interpretation Division 2
Division 2—Interpretation
41BD What is a medical device
(1) A medical device is:
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:
Chapter 4 Medical devices Part 4-1 Introduction Division 2 Interpretation
Section 41BE
(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:
Medical devices Chapter 4 Introduction Part 4-1 Interpretation Division 2
Unique medical devices
(2) If a medical device is not of the same kind as any other medical 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
41BG Manufacturers of medical devices
Chapter 4 Medical devices Part 4-1 Introduction Division 2 Interpretation
Section 41BH
supplying the device under the person’s name, does one or more of the following using ready-made products:
(iii) any advertising material relating to the device;
(iv) technical documentation describing the mechanism of action of the device.
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.
Medical devices Chapter 4 Introduction Part 4-1 Interpretation Division 2
41BI Meaning of non-application of conformity assessment procedures
Chapter 4 Medical devices Part 4-1 Introduction Division 3 Application provisions
Section 41BJ
Division 3—Application provisions
41BJ Application of this Chapter to medical devices covered by Part 3-2
(1) This Chapter does not apply to a medical device if section 15A applies to the device, except for purposes connected with:
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:
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.
Medical devices Chapter 4 Essential principles and medical device standards Part 4-2
Section 41C
Part 4-2—Essential principles and medical device standards
41C What this Part is about
The essential principles set out the requirements relating to the safety and performance characteristics of medical devices. Compliance with applicable medical device standards is not required, but it is one way to establish compliance with essential principles.
Note: Dealing in medical devices that do not comply with the essential principles may be an offence or may contravene a civil penalty provision: see Division 1 of Part 4-11.
Chapter 4 Medical devices Part 4-2 Essential principles and medical device standards Division 1 Essential principles
Section 41CA
Division 1—Essential principles 41CA Essential principles
Medical devices Chapter 4 Essential principles and medical device standards Part 4-2 Medical device standards Division 2
Division 2—Medical device standards
41CB Medical device standards
(1) The Minister may, by legislative instrument, make an order determining that:
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
Chapter 4 Medical devices Part 4-2 Essential principles and medical device standards Division 2 Medical device standards
Section 41CD
41CD Inconsistencies between medical device standards
(1) A 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.
Medical devices Chapter 4 Conformity assessment procedures Part 4-3
Section 41D
Part 4-3—Conformity assessment procedures
41D What this Part is about
The conformity assessment procedures set out the requirements relating to the application of quality management systems for medical devices, and other requirements imposed on manufacturers.
Compliance with applicable conformity assessment standards is not required, but it is one way to establish that one or more parts of the conformity assessment procedures have been applied to medical devices.
Note 1: | Dealing in medical devices that have not had the conformity assessment procedures applied may be an offence or may contravene a civil penalty provision: see Division 2 of Part 4-11. |
Note 2: | See section 41BI on applying the conformity assessment procedures. |
Chapter 4 Medical devices Part 4-3 Conformity assessment procedures Division 1 Conformity assessment procedures
Section 41DA
Division 1—Conformity assessment procedures
41DA Conformity assessment procedures
Medical devices Chapter 4 Conformity assessment procedures Part 4-3 Conformity assessment procedures Division 1
(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:
Chapter 4 Medical devices Part 4-3 Conformity assessment procedures Division 2 Conformity assessment standards
Section 41DC
Division 2—Conformity assessment standards
41DC Conformity assessment standards
(1) The Minister may, by legislative instrument, make an order determining that:
Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
41DD Content of conformity assessment standards
Medical devices Chapter 4 Conformity assessment procedures Part 4-3 Conformity assessment standards Division 2
Section 41DE
41DE Inconsistencies between conformity assessment standards
A conformity assessment standard that:
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).
Chapter 4 Medical devices Part 4-4 Conformity assessment certificates
Section 41E
Part 4-4—Conformity assessment certificates
41E What this Part is about
The Secretary can issue a conformity assessment certificate (which may be limited to some medical devices) in respect of a manufacturer of medical devices, signifying one or more of these:
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).
Medical devices Chapter 4 Conformity assessment certificates Part 4-4 Issuing conformity assessment certificates Division 1
Division 1—Issuing conformity assessment certificates
41EA When conformity assessment certificates are required
The regulations may prescribe:
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:
Note: A conformity assessment fee is payable under section 41LA for consideration of the application.
(2) An application is not effective if:
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
Chapter 4 Medical devices Part 4-4 Conformity assessment certificates Division 1 Issuing conformity assessment certificates
Section 41EC
(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:
41EC Considering applications
(a) whether at least one of the following persons:
(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
Medical devices Chapter 4 Conformity assessment certificates Part 4-4 Issuing conformity assessment certificates Division 1
(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
(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:
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.
Chapter 4 Medical devices Part 4-4 Conformity assessment certificates Division 1 Issuing conformity assessment certificates
Section 41EE
41EE Procedure following making a decision whether to issue certificate
41EF Duration of certificate
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
Medical devices Chapter 4 Conformity assessment certificates Part 4-4 Issuing conformity assessment certificates Division 1
41EH Treating applications as having been refused
Chapter 4 Medical devices Part 4-4 Conformity assessment certificates Division 1 Issuing conformity assessment certificates
Section 41EI
41EI Criminal offences for making a false statement
(1) A person commits an offence if:
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:
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:
Medical devices Chapter 4 Conformity assessment certificates Part 4-4 Issuing conformity assessment certificates Division 1
(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:
Maximum civil penalty:
Chapter 4 Medical devices Part 4-4 Conformity assessment certificates Division 2 Conditions
Section 41EJ
Division 2—Conditions
Note: Breaching conditions of the conformity assessment certificate may lead to suspension or revocation of the certificate (see Divisions 3 and 4), may be an offence (see subsections 41MN(5), (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:
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
Medical devices Chapter 4 Conformity assessment certificates Part 4-4 Conditions Division 2
to the following matters have been applied to the kinds of medical devices covered by the certificate:
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:
Fees
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.
Chapter 4 Medical devices Part 4-4 Conformity assessment certificates Division 2 Conditions
Section 41EK
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:
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:
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:
Medical devices Chapter 4 Conformity assessment certificates Part 4-4 Suspension of conformity assessment certificates Division 3
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
Note: The period of the suspension may be extended under section 41EO.
41EN Notice of proposed suspension
Chapter 4 Medical devices Part 4-4 Conformity assessment certificates Division 3 Suspension of conformity assessment certificates
Section 41EO
41EO Duration of suspension
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
(a) if:
(i) the manufacturer in relation to whom the conformity assessment certificate was issued; or
Medical devices Chapter 4 Conformity assessment certificates Part 4-4 Suspension of conformity assessment certificates Division 3
(ii) the person who applied for the certificate (if the
applicant was not the manufacturer); applies in writing to the Secretary; or
(b) on the Secretary’s own initiative.
41EQ Powers of revocation of conformity assessment certificates unaffected
Chapter 4 Medical devices Part 4-4 Conformity assessment certificates Division 4 Revocation of conformity assessment certificates
Section 41ER
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:
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:
Medical devices Chapter 4 Conformity assessment certificates Part 4-4 Revocation of conformity assessment certificates Division 4
within a further 10 working days from the day specified in that notice; or
(iii) if the holder is a body corporate—a major interest
holder of the body corporate; has:
(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
(f) any other circumstances prescribed by the regulations for the purposes of this paragraph exist.
Chapter 4 Medical devices Part 4-4 Conformity assessment certificates Division 4 Revocation of conformity assessment certificates
Section 41EU
(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:
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).
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:
applies; the Secretary must limit the revocation to the medical devices to which that ground or any other ground for revocation applies.
Medical devices Chapter 4 Conformity assessment certificates Part 4-4 Revocation of conformity assessment certificates Division 4
(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:
Chapter 4 Medical devices Part 4-5 Including medical devices in the Register
Section 41F
Part 4-5—Including medical devices in the Register
41F What this Part is about
Kinds of medical devices can be included in the Register if they comply with the essential principles, and conformity assessment procedures have been applied to the kinds of devices (and certain other requirements are complied with).
Inclusions in the Register are subject to certain automatic conditions and the Secretary may impose further conditions.
Medical devices Chapter 4 Including medical devices in the Register Part 4-5 Including medical devices in the Register Division 1
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. |
Chapter 4 Medical devices Part 4-5 Including medical devices in the Register Division 1 Including medical devices in the Register
Section 41FB
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—Applications
41FC Applications
(a) the application is not made in accordance with subsection (1); or
Medical devices Chapter 4 Including medical devices in the Register Part 4-5 Including medical devices in the Register Division 1
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:
41FD Matters to be certified
The applicant must certify that:
Chapter 4 Medical devices Part 4-5 Including medical devices in the Register Division 1 Including medical devices in the Register
Section 41FE
(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:
Medical devices Chapter 4 Including medical devices in the Register Part 4-5 Including medical devices in the Register Division 1
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:
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:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Chapter 4 Medical devices Part 4-5 Including medical devices in the Register Division 1 Including medical devices in the Register
Section 41FEA
41FEA Civil penalty for making a false statement
A person contravenes this section if:
Maximum civil penalty:
Subdivision B—Including kinds of medical devices in the Register
41FF Obligation to include kinds of medical devices in the Register
(1) If:
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.
Medical devices Chapter 4 Including medical devices in the Register Part 4-5 Including medical devices in the Register Division 1
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:
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:
41FI Auditing of applications
Chapter 4 Medical devices Part 4-5 Including medical devices in the Register Division 1 Including medical devices in the Register
Section 41FJ
(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:
41FK Lapsing of applications
An application that has been selected for auditing lapses if:
Medical devices Chapter 4 Including medical devices in the Register Part 4-5 Including medical devices in the Register Division 1
(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
Chapter 4 Medical devices Part 4-5 Including medical devices in the Register Division 2 Conditions
Section 41FN
Division 2—Conditions
Note: Breaching conditions of the inclusion of a kind of medical device may lead to suspension or cancellation of the entry of the kind of device from the Register (see Part 4-6), may be an offence (see subsections 41MN(1), (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:
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
Medical devices Chapter 4 Including medical devices in the Register Part 4-5 Conditions Division 2
(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:
Chapter 4 Medical devices Part 4-5 Including medical devices in the Register Division 2 Conditions
Section 41FO
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:
(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
Medical devices Chapter 4 Including medical devices in the Register Part 4-5 Conditions Division 2
(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:
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:
Chapter 4 Medical devices Part 4-6 Suspension and cancellation from the Register Division 1 Suspension from the Register
Section 41G
Part 4-6—Suspension and cancellation from the Register
Division 1—Suspension from the Register
Subdivision A—General power of suspension
41G What this Part is about
Inclusions in the Register may be suspended in certain circumstances, such as when a conformity assessment 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
Medical devices Chapter 4 Suspension and cancellation from the Register Part 4-6 Suspension from the Register Division 1
(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
41GC Duration of suspension
(i) the period specified in the notice under subsection 41GA(3); or
Chapter 4 Medical devices Part 4-6 Suspension and cancellation from the Register Division 1 Suspension from the Register
Section 41GD
(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.
41GD Revocation of suspension
Medical devices Chapter 4 Suspension and cancellation from the Register Part 4-6 Suspension from the Register Division 1
(4) If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must:
41GE Treating applications for revocation as having been refused
Subdivision B—Suspension as a result of suspension under Part 4-4
41GF Suspension of kinds of medical devices from the Register
Chapter 4 Medical devices Part 4-6 Suspension and cancellation from the Register Division 1 Suspension from the Register
Section 41GG
(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
41GH Revocation of suspension
(1) The Secretary must revoke the suspension if:
. (2) After revoking the suspension, the Secretary must:
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.
Medical devices Chapter 4 Suspension and cancellation from the Register Part 4-6 Suspension from the Register Division 1
41GJ Powers of cancellation from Register unaffected
Chapter 4 Medical devices Part 4-6 Suspension and cancellation from the Register Division 2 Cancellation of entries from the Register
Section 41GK
Division 2—Cancellation of entries from the Register
41GK Automatic cancellation of entries of kinds of medical devices from the Register
The Secretary must, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:
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:
section 41FD relating to the application; was false or misleading in a material particular; or
Medical devices Chapter 4 Suspension and cancellation from the Register Part 4-6 Cancellation of entries from the Register Division 2
41GM Cancellation of entries of kinds of medical devices from the Register after section 41JA notice
(a) the Secretary gives to the person a notice under section 41JA requiring the person to give to the Secretary information or
Chapter 4 Medical devices Part 4-6 Suspension and cancellation from the Register Division 2 Cancellation of entries from the Register
Section 41GN
documents relating to whether medical devices of that kind are being:
(iii) exported from Australia; and
(b) either:
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:
further 10 working days from the day specified in that notice; or
Medical devices Chapter 4 Suspension and cancellation from the Register Part 4-6 Cancellation of entries from the Register Division 2
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.
41GO Limiting cancellation of entries from Register to some medical devices of a particular kind
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.
Chapter 4 Medical devices Part 4-6 Suspension and cancellation from the Register Division 2 Cancellation of entries from the Register
Section 41GQ
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:
Medical devices Chapter 4 Exempting medical devices to deal with emergencies Part 4-6A
Section 41GR
Part 4-6A—Exempting medical devices to deal with emergencies
41GR What this Part is about
The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies.
Note 1: | There are offences and civil penalty provisions related to the making |
of exemptions under this Part: see Division 3A of Part 4-11. | |
Note 2: | Some of the other provisions of this Act about medical devices |
exempt under this Part are:
41GS Minister may make exemptions
(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
Chapter 4 Medical devices Part 4-6A Exempting medical devices to deal with emergencies
Section 41GT
(b) the devices can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.
Period of exemption
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:
Medical devices Chapter 4 Exempting medical devices to deal with emergencies Part 4-6A
Section 41GU
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:
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
Chapter 4 Medical devices Part 4-6A Exempting medical devices to deal with emergencies
Section 41GV
(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):
41GW Notification and tabling
Notification
(1) The Secretary must cause a notice setting out particulars of the following:
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:
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
Medical devices Chapter 4 Exempting medical devices to deal with emergencies Part 4-6A
Section 41GY
revocation is not invalid merely because of a failure to comply with this subsection.
41GY Disposal of unused medical devices
Chapter 4 Medical devices Part 4-7 Other exemptions from including medical devices in the Register
Section 41H
Part 4-7—Other exemptions from including medical devices in the Register
41H What this Part is about
In addition to Part 4-6A, there are 4 other kinds of exemptions from the prohibitions in Division 3 of Part 4-11 on dealing in medical devices that are not included in the Register:
41HA Devices exempted from inclusion in the Register
(1) The regulations may exempt from the operation of Division 3 of Part 4-11:
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).
Medical devices Chapter 4 Other exemptions from including medical devices in the Register Part 4-7
Section 41HB
41HB Exemptions for special and experimental uses
(1) The Secretary may grant a written approval to a person for:
of a specified medical device or kind of medical device (other than medical devices included in the Register or exempt devices):
(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).
Chapter 4 Medical devices Part 4-7 Other exemptions from including medical devices in the Register
Section 41HC
Note: Breach of the conditions may be an offence: see subsection 41MN(9).
41HC Exemptions for medical practitioners
Medical devices Chapter 4 Other exemptions from including medical devices in the Register Part 4-7
Section 41HD
regulations for the purposes of this paragraph. However, the regulations may prescribe exceptional circumstances in which paragraph (b) does not apply.
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:
and the supply in Australia of that device; if the Secretary is satisfied that:
(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
Chapter 4 Medical devices Part 4-7 Other exemptions from including medical devices in the Register
Section 41HD
(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
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:
and the supply in Australia of that device; if the Secretary is satisfied that:
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:
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
Medical devices Chapter 4 Other exemptions from including medical devices in the Register Part 4-7
Section 41HD
(b) if the decision is not to grant the approval—the reasons for the decision.
Determinations
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
Chapter 4 Medical devices Part 4-7 Other exemptions from including medical devices in the Register
Section 41HD
that lapsing. The other approval may be expressed to take effect on the expiry of that period.
Approval not a legislative instrument
(12) An approval under subsection (1) or (2) is not a legislative instrument.
Medical devices Chapter 4 Obtaining information Part 4-8
Section 41J
Part 4-8—Obtaining information
41J What this Part is about
The Secretary may seek information or documents relating to:
Note: There are additional obligations relating to notifying defects in medical devices: see sections 41MP, 41MPA, 41MQ and 41MR.
Chapter 4 Medical devices Part 4-8 Obtaining information Division 1 Information relating to compliance with requirements and other matters
Section 41JA
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:
(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
(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:
(iii) exported from Australia;
Medical devices Chapter 4 Obtaining information Part 4-8 Information relating to compliance with requirements and other matters Division 1
(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.
Chapter 4 Medical devices Part 4-8 Obtaining information Division 1 Information relating to compliance with requirements and other matters
Section 41JB
spent convictions and require persons aware of such convictions to disregard them).
41JB Complying with the Secretary’s requirements
Offence for failing to comply with a notice
(3) A person commits an offence if:
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:
(i) the use of the kind of medical device has resulted in, or will result in, harm or injury to any person; or
Medical devices Chapter 4 Obtaining information Part 4-8 Information relating to compliance with requirements and other matters Division 1
(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: 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.
(5) A person commits an offence if:
Penalty: 2,000 penalty units.
(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:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
41JBA Civil penalty for giving false or misleading information in purported compliance with a notice
A person contravenes this section if:
Chapter 4 Medical devices Part 4-8 Obtaining information Division 1 Information relating to compliance with requirements and other matters
Section 41JC
Maximum civil penalty:
41JC Self-incrimination
indirect consequence of giving the information or document; is not admissible in evidence in:
Medical devices Chapter 4 Obtaining information Part 4-8 Information relating to medical devices covered by exemptions Division 2
Division 2—Information relating to medical devices covered by exemptions
41JCA Secretary may require information etc. about medical devices exempt under Part 4-6A
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;
Chapter 4 Medical devices Part 4-8 Obtaining information Division 2 Information relating to medical devices covered by exemptions
Section 41JE
41JE Secretary may require information relating to approvals under section 41HB
Approval under subsection 41HB(1)
(1) The Secretary may give to a person granted an approval under subsection 41HB(1) (special and experimental uses), in relation to specified kinds of medical devices, a written notice requiring the
Medical devices Chapter 4 Obtaining information Part 4-8 Information relating to medical devices covered by exemptions Division 2
person to give to the Secretary specified information or documents relating to one or more of the following:
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:
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:
Chapter 4 Medical devices Part 4-8 Obtaining information Division 2 Information relating to medical devices covered by exemptions
Section 41JF
41JF Secretary may require information relating to authorities under section 41HC
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:
Medical devices Chapter 4 Obtaining information Part 4-8 Information relating to medical devices covered by exemptions Division 2
41JG Criminal offences for failing to give information or documents sought under this Division
A person commits an offence if:
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:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
41JI False or misleading documents
(1) A person is guilty of an offence if:
(a) the person produces a document to the Secretary; and
Chapter 4 Medical devices Part 4-8 Obtaining information Division 2 Information relating to medical devices covered by exemptions
Section 41JJ
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(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:
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
indirect consequence of giving the information or document; is not admissible in evidence in:
Medical devices Chapter 4 Public notification and recovery of medical devices Part 4-9
Section 41K
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:
Circumstances in which requirements may be imposed
Item Circumstance relating to a kind of medical Person subject to device requirements
Chapter 4 Medical devices Part 4-9 Public notification and recovery of medical devices
Section 41KA
Circumstances in which requirements may be imposed
Item | Circumstance relating to a kind of medical | Person subject to |
device | requirements | |
3. | It is supplied while: | The person supplying the |
(a) medical devices of that kind are exempt | kind of medical device | |
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 medical devices of that kind do not | ||
comply with the essential principles | ||
4. | It is supplied while: | The person supplying the |
(a) medical devices of that kind are exempt | kind of medical device | |
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 |
Medical devices Chapter 4 Public notification and recovery of medical devices Part 4-9
Section 41KA
Circumstances in which requirements may be imposed
Item Circumstance relating to a kind of medical Person subject to device requirements
5. | It is supplied while: (a) it is not included in the Register; and The person supplying the kind of medical device |
(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. | |
5A. | It is supplied while it is covered by an exemption in force under section 41GS, and the Secretary is satisfied that it is not fit to be used for its intended purpose The person supplying the kind of medical device |
5B. | It is supplied while it is included in the Register, but it appears to the Secretary that the quality, safety or performance of medical devices of that kind is unacceptable The person in relation to whom the kind of medical device is included in the Register |
6. | It has been suspended from the Register The person in relation to whom it was included in the |
Register | |
7. | Its entry has been cancelled from the Register The person in relation to whom it was included in the |
Register | |
(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 |
Chapter 4 Medical devices Part 4-9 Public notification and recovery of medical devices
Section 41KB
paragraph (1)(a) have occurred in relation to medical devices
of that kind.
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.
41KC Criminal offences for failing to comply with requirements relating to a kind of medical device
(1) A person commits an offence if:
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:
Penalty: 2,000 penalty units.
(3) Subsection (2) is an offence of strict liability.
Medical devices Chapter 4 Public notification and recovery of medical devices Part 4-9
Section 41KCA
Note: For strict liability, see section 6.1 of the Criminal Code.
(4) A person commits an offence if:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
41KCA Civil penalty for failing to comply with requirements relating to a kind of medical device
A person contravenes this section if:
Maximum civil penalty:
41KD Powers of suspension and cancellation unaffected
Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:
Chapter 4 Medical devices Part 4-10 Assessment fees
Section 41L
Part 4-10—Assessment fees
41L What this Part is about
Conformity assessment fees must be paid for consideration of applications for conformity assessment certificates. Application audit assessment fees must be paid for auditing applications that are required to be selected for auditing under paragraph 41FH(1)(a).
41LA Assessment fees
Medical devices Chapter 4 Assessment fees Part 4-10
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
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:
Chapter 4 Medical devices Part 4-10 Assessment fees
Section 41LE
(c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application.
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.
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11
Section 41M
Part 4-11—Offences and civil penalty provisions relating to medical devices
41M What this Part is about
This Part contains offences and civil penalty provisions that are aimed at ensuring that:
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).
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
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:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
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:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Non-compliance with essential principles Division 1
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:
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:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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
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:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
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:
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:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Non-compliance with essential principles Division 1
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 (12) instead: see section 53A.
(10) A person commits an offence if:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
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.
(12) A person commits an offence if:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
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
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:
Maximum civil penalty:
Civil penalty relating to supplying a medical device
(2) A person contravenes this subsection if:
Maximum civil penalty:
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Non-compliance with essential principles Division 1
Civil penalty relating to exporting a medical device
(3) A person contravenes this subsection if:
Maximum civil penalty:
41MB Exceptions
(1) Sections 41MA and 41MAA do not apply if:
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).
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
Chapter 4 Medical devices Part 4-11 Offences and civil penalty provisions relating to medical devices Division 1 Non-compliance with essential principles
Section 41MCA
(b) in respect of particular medical devices or kinds of medical devices.
(2) A person commits an offence if:
Penalty: 2,000 penalty units.
Note: 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.
(3) A person commits an offence if:
Penalty: 1,000 penalty units.
(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:
Penalty: 500 penalty units.
41MCA Civil penalty relating to breaching a condition of a consent
A person contravenes this section if:
Maximum civil penalty:
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Non-compliance with essential principles Division 1
41MD Treating medical devices as prohibited imports or exports
If:
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:
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
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:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
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:
(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
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Failure to apply conformity assessment procedures Division 2
(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.
(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:
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:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
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.
Chapter 4 Medical devices Part 4-11 Offences and civil penalty provisions relating to medical devices Division 2 Failure to apply conformity assessment procedures
Section 41MEA
(6) A person commits an offence if:
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and
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:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
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:
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Failure to apply conformity assessment procedures Division 2
Maximum civil penalty:
Civil penalty relating to exporting a medical device
(2) A person contravenes this subsection if:
Maximum civil penalty:
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:
(ba) the device is not of a kind covered by an exemption in force under section 41GS; and
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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
Note: 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.
(2) A person commits an offence if:
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:
(ba) the device is not of a kind covered by an exemption in force under section 41GS; and
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.
(4) A person commits an offence if:
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Failure to apply conformity assessment procedures Division 2
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:
Note: Conformity assessment standards are determined under Division 2 of Part 4-3.
(2) For the purposes of this section, a conformity assessment standard relates to a part or parts of the conformity assessment procedures only if the standard specifies that part or parts.
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:
Chapter 4 Medical devices Part 4-11 Offences and civil penalty provisions relating to medical devices Division 2 Failure to apply conformity assessment procedures
Section 41MHA
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
41MHA Civil penalty for making false statements in declarations
A person contravenes this section if:
Maximum civil penalty:
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
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:
(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:
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:
(i) imports a medical device into Australia; or
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
(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.
(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:
(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.
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 41MIA
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:
(iii) the improper use of the medical device.
Note: A defendant bears an evidential burden in relation to the matters in subsection (7): see subsection 13.3(3) of the Criminal Code.
41MIA Notice required to adduce evidence in support of exception under subsection 41MI(7)
(1) If:
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
the committing magistrate or the court must:
(2) A defendant must not, without leave of the court, adduce evidence in support of the exception under subsection 41MI(7) unless:
hearing of the offence begins; he or she gives notice of particulars of the exception.
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 41MIB
proved, taken as having been given with the authority of the defendant.
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:
(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;
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 41MJ
(iv) the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person.
Maximum civil penalty:
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:
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:
41MK Wholesale supply of medical devices not included in the Register
A person is guilty of an offence if:
(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;
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 41ML
(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:
Penalty: 60 penalty units.
41MLA Civil penalty for making misrepresentations about medical devices
(1) A person contravenes this section if:
Maximum civil penalty:
(2) Subsection (1) applies to the following representations:
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 41MM
41MM Claims about arranging supplies of medical devices not included in the Register
A person is guilty of an offence if:
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:
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:
Penalty: 2,000 penalty units.
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 41MN
(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:
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:
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:
Penalty: 2,000 penalty units.
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 41MNA
(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:
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:
(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:
Maximum civil penalty:
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 41MNA
(2) A person contravenes this subsection if:
Maximum civil penalty:
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
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:
Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.
(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:
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:
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Offences and civil penalties related to exemptions under Part 4-6A Division 3A
(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:
Maximum civil penalty:
41MND Civil penalty for making misrepresentations about medical devices
A person contravenes this section if:
Maximum civil penalty:
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 41MO
Division 4—Other offences and civil penalty provisions
41MO Criminal offences for misusing medical devices exempted for special or experimental uses
(1) A person commits an offence if:
(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:
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Other offences and civil penalty provisions Division 4
(iii) otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5); and
(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:
(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:
(i) the use of the device has resulted in, or will result in, harm or injury to any person; or
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 41MP
(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:
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:
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
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Other offences and civil penalty provisions Division 4
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(2) The information with which subsection (1) is concerned is information of the following kinds:
(a) information relating to:
(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;
procedures to a particular device; has been restricted, suspended, revoked or is no longer in effect.
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 41MPA
41MPA Civil penalty for failing to notify adverse events etc.
(1) A person contravenes this section if:
Maximum civil penalty:
(2) The information with which subsection (1) is concerned is information of the following kinds:
(a) information relating to:
(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;
(i) compliance with the essential principles; or
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Other offences and civil penalty provisions Division 4
(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:
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.
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
41MQ Notification of adverse events etc. where application withdrawn or lapses
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
41MR Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses
Civil penalty for failing to comply with requirements of a notice
(1) A person contravenes this subsection if the person does not comply with the requirements of a notice under subsection 41MQ(1) within 20 working days after the day on which the notice is given to the person.
Maximum civil penalty:
Medical devices Chapter 4 Offences and civil penalty provisions relating to medical devices Part 4-11 Other offences and civil penalty provisions Division 4
Civil penalty for giving false or misleading information in purported compliance with requirements of a notice
(2) A person contravenes this subsection if:
Maximum civil penalty:
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering Part 5-1 Advertising and generic information Division 1 Preliminary
Section 42AA
Chapter 5—Advertising, counterfeit therapeutic goods and product tampering
Part 5-1—Advertising and generic information
Division 1—Preliminary
42AA This Part not to apply to advertisements directed at health professionals etc.
(1) This Part does not apply to advertisements directed exclusively to:
(1A) The Minister may, by legislative instrument, specify a class of persons for the purposes of paragraph (1)(d).
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Advertising and generic information Part 5-1 Preliminary Division 1
(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
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:
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:
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
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering Part 5-1 Advertising and generic information Division 1 Preliminary
Section 42B
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:
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:
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:
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Advertising and generic information Part 5-1 Preliminary Division 1
(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.
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 42BA
Division 2—Therapeutic goods advertisements for which an approval is required
42BA Application of Division
This Division applies only to advertisements to which Part 2 of the Therapeutic Goods Regulations applies.
42C Offences relating to publication of advertisements
(1) A person is guilty of an offence if:
(a) the person:
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:
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.
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Advertising and generic information Part 5-1 Therapeutic goods advertisements for which an approval is required Division 2
(3) It is a defence to a prosecution under subsection (2) if:
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:
paragraph (a), (c) or (d) of the definition of specified media; and
(b) the advertisement:
(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:
in the ordinary course of business.
Note: A defendant bears an evidential burden in relation to the matters in subsection (5) (see subsection 13.3 of the Criminal Code).
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
(6) A person is guilty of an offence if:
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.
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Advertising and generic information Part 5-1 General provisions about advertising therapeutic goods Division 3
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). |
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
42DE Applications for approval of use of restricted representation
An application for approval of the use of a restricted representation must be:
42DF Approval of use of restricted representation
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.
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Advertising and generic information Part 5-1 General provisions about advertising therapeutic goods Division 3
42DH Variation of conditions of approval
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:
(iii) there has been a breach of a condition of approval; or
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 42DJ
(b) both:
(2) The notice must:
42DJ Prohibited and required representations
42DK Use of restricted or prohibited representations
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Advertising and generic information Part 5-1 Therapeutic goods advertisements for which an approval is not required Division 3A
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
42DL Advertising offences
(1) A person must not publish or broadcast an advertisement about therapeutic goods:
(i) a reference to the Act other than in a statement of the registration number, listing number or device number of the goods; or
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering Part 5-1 Advertising and generic information Division 3A Therapeutic goods advertisements for which an approval is not required
Section 42DL
(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
Penalty: 60 penalty units.
(2) For the purposes of an offence against subsection (1), strict liability applies to the following physical elements:
(i) are exempt goods or exempt devices prescribed in the regulations made for the purposes of subparagraph (1)(h)(i); or
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Advertising and generic information Part 5-1 Therapeutic goods advertisements for which an approval is not required Division 3A
(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:
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:
Penalty: 60 penalty units.
(2) An offence against this section is an offence of strict liability.
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering Part 5-1 Advertising and generic information Division 4 Generic information about ingredients or components of therapeutic goods
Section 42DN
Division 4—Generic information about ingredients or components of therapeutic goods
42DN Application of Division
This Division applies to generic information about goods that:
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:
Penalty: 60 penalty units.
(2) An offence against this section is an offence of strict liability.
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Counterfeit therapeutic goods Part 5-2
Section 42E
Part 5-2—Counterfeit therapeutic goods
42E Offence of dealing with counterfeit therapeutic goods
(1) A person is guilty of an offence if:
Penalty: 7 years imprisonment or 2,000 penalty units, or both.
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering Part 5-2 Counterfeit therapeutic goods
Section 42EA
(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:
Maximum civil penalty:
42EB Relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods
(1) If:
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.
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Counterfeit therapeutic goods Part 5-2
Section 42F
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.
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering Part 5-3 Product tampering
Section 42T
Part 5-3—Product tampering
42T Notifying of actual or potential tampering
(1) A person is guilty of an offence if:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(2) A person is guilty of an offence if:
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Product tampering Part 5-3
Section 42U
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.
(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:
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:
42U Meaning of actual or potential tampering etc.
Actual or potential tampering, in relation to therapeutic goods, means:
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:
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering Part 5-3 Product tampering
Section 42V
(i) the use of the goods has resulted in, or will result in, harm or injury to any person; or
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Product tampering Part 5-3
Section 42VA
(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: 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.
(6A) A person commits an offence if:
Penalty: 2,000 penalty units.
(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 30 or Division 1 or 2 of Part 4-6.
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
Chapter 5 Advertising, counterfeit therapeutic goods and product tampering Part 5-3 Product tampering
Section 42VB
(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:
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.
42W Supply etc. of therapeutic goods that are subject to recovery requirements
(1) A person is guilty of an offence if:
Advertising, counterfeit therapeutic goods and product tampering Chapter 5 Product tampering Part 5-3
Section 42X
(c) the Secretary has not consented in writing to the supply.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(2) A person is guilty of an offence if:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(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.
Chapter 5A Enforcement Part 5A-1 Civil penalties Division 1 Obtaining an order for a civil penalty
Section 42Y
Chapter 5A—Enforcement
Part 5A-1—Civil penalties
Division 1—Obtaining an order for a civil penalty
42Y Federal Court may order person to pay pecuniary penalty for contravening civil penalty provision
Application for order
(1) Within 6 years of a person (the wrongdoer) contravening a civil penalty provision, the Secretary may apply on behalf of the Commonwealth to the Federal Court for an order that the wrongdoer pay the Commonwealth a pecuniary penalty.
Court may order wrongdoer to pay pecuniary penalty
(2) If the Court is satisfied that the wrongdoer has contravened a civil penalty provision, the Court may order the wrongdoer to pay to the Commonwealth for each contravention the pecuniary penalty that the Court determines is appropriate (but not more than the maximum amount specified for the provision).
Determining amount of pecuniary penalty
(3) In determining the pecuniary penalty, the Court must have regard to all relevant matters, including:
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.
Enforcement Chapter 5A Civil penalties Part 5A-1 Obtaining an order for a civil penalty Division 1
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
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
Chapter 5A Enforcement Part 5A-1 Civil penalties Division 1 Obtaining an order for a civil penalty
Section 42YE
(b) the Commonwealth may enforce the order as if it were a judgment of the Court.
42YE Gathering information for application for pecuniary penalty
Penalty: 30 penalty units.
Enforcement Chapter 5A Civil penalties Part 5A-1 Civil penalty proceedings and criminal proceedings Division 2
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
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
Chapter 5A Enforcement Part 5A-1 Civil penalties Division 2 Civil penalty proceedings and criminal proceedings
Section 42YI
against the individual for a contravention of a civil penalty provision (whether or not the order was made); and
(b) the conduct alleged to constitute the offence is substantially the same as the conduct that was claimed to constitute the contravention.
However, this does not apply to a criminal proceeding in respect of the falsity of the evidence given by the individual in the proceedings for the pecuniary penalty order.
Enforcement Chapter 5A Infringement notices Part 5A-2
Section 42YJ
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).
42YK Infringement notices in respect of civil penalty provisions
Chapter 5A Enforcement Part 5A-3 Enforceable undertakings
Section 42YL
Part 5A-3—Enforceable undertakings
42YL Enforcement of undertakings
Administration Chapter 6 Payment of charges Part 6-1
Section 43
Chapter 6—Administration
Part 6-1—Payment of charges
43 By whom charges payable
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:
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:
(i) on 1 October in that year; or
Chapter 6 Administration Part 6-1 Payment of charges
Section 44A
(ii) if the regulations specify another day for the purposes of
this subparagraph—on that other day in that year. This subsection is subject to subsection (3).
Charge may become payable on a later day
(3) The Secretary may, by notice in writing given to a person, specify a later day on which a charge referred to in subsection (1) 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:
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
Administration Chapter 6 Payment of charges Part 6-1
Section 44B
(b) that specifies whether the person’s turnover of the therapeutic goods concerned for the financial year concerned is of low value.
Additional information
(4) The regulations may provide for the obtaining of additional information or documents from applicants for exemptions or persons granted exemptions.
Merits review
(5) The regulations may provide for review by the Administrative Appeals Tribunal of decisions of the Secretary to refuse applications for exemptions or to cancel exemptions.
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
Chapter 6 Administration Part 6-1 Payment of charges
Section 45
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.
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.
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
Administration Chapter 6 Payment of charges Part 6-1
Section 45
(b) to enable the Commonwealth to participate in the international harmonisation of regulatory controls on therapeutic goods and other related activities.
Chapter 6 Administration Part 6-2 Entry, searches and warrants
Section 45A
Part 6-2—Entry, searches and warrants
45A Definitions
In this Part, unless the contrary intention appears:
evidential material means:
(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.
Administration Chapter 6 Entry, searches and warrants Part 6-2
Section 46
46 Searches to monitor compliance with Act
46A Searches of certain premises to monitor compliance with Act
Chapter 6 Administration Part 6-2 Entry, searches and warrants
Section 46A
(a) premises of a person:
(ia) who is required to comply with a condition of an exemption of therapeutic goods under section 18A; 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
Administration Chapter 6 Entry, searches and warrants Part 6-2
Section 46B
46B Searches and seizures on public health grounds
(1) Subject to subsection (2), if an authorised person has reasonable grounds for suspecting that:
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:
(2) An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises if:
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:
Chapter 6 Administration Part 6-2 Entry, searches and warrants
Section 48
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:
Administration Chapter 6 Entry, searches and warrants Part 6-2
Section 48A
(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.
Chapter 6 Administration Part 6-2 Entry, searches and warrants
Section 48B
(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
48C Use of electronic equipment at premises
(i) is brought to the premises; or
Administration Chapter 6 Entry, searches and warrants Part 6-2
Section 48C
(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.
he or she may do whatever is necessary to secure the equipment, whether by locking it up, placing a guard or otherwise.
Chapter 6 Administration Part 6-2 Entry, searches and warrants
Section 48D
48D Compensation for damage to electronic equipment
(1) If:
the equipment; compensation for the damage is payable to the owner of the equipment.
48E Copies of seized things to be provided
(1) Subject to subsection (2), if an authorised person seizes, under a warrant relating to premises:
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:
Administration Chapter 6 Entry, searches and warrants Part 6-2
Section 48F
48F Occupier entitled to be present during search
48G Receipts for things seized under warrant
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:
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:
Chapter 6 Administration Part 6-2 Entry, searches and warrants
Section 48J
(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 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:
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:
49 Monitoring warrants
(1) An authorised person may apply to a magistrate for a warrant under this section in relation to premises.
Administration Chapter 6 Entry, searches and warrants Part 6-2
Section 50
50 Offence and civil penalty provision related warrants
Chapter 6 Administration Part 6-2 Entry, searches and warrants
Section 51
magistrate requires concerning the grounds on which the issue of the warrant is being sought.
(4) The warrant must:
51 Offence and civil penalty provision related warrants by telephone
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.
Administration Chapter 6 Entry, searches and warrants Part 6-2
Section 51
(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
Chapter 6 Administration Part 6-2 Entry, searches and warrants
Section 51A
(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
51B Offences relating to warrants
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Section 52
(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
Note: For strict liability, see section 6.1 of the Criminal Code.
Chapter 6 Administration Part 6-3 Scheduling of substances
Section 52AA
Part 6-3—Scheduling of substances
52AA Overview
This Part provides the basis for a uniform system in Australia of access controls for goods containing scheduled substances.
The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety. This is aimed at minimising the risks of poisoning from, and the misuse and abuse of, scheduled substances.
52A Definitions
(1) In this Part, unless the contrary intention appears:
current Poisons Standard means:
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:
Administration Chapter 6 Scheduling of substances Part 6-3
Section 52B
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
Chapter 6 Administration Part 6-3 Scheduling of substances
Section 52C
52C Advisory Committee on Chemicals Scheduling
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.
Administration Chapter 6 Scheduling of substances Part 6-3
Section 52D
52D Poisons Standard
(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:
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;
Chapter 6 Administration Part 6-3 Scheduling of substances
Section 52EAA
(2) In exercising a power under subsection 52D(2), the Secretary must comply with any guidelines of:
notified to the Secretary for the purposes of this section.
52EAA Application for amendment of the Poisons Standard
Administration Chapter 6 Scheduling of substances Part 6-3
Section 52EA
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:
52EA Poisons Standard—validation etc.
Scope
(1) This section applies to the following instruments:
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
Chapter 6 Administration Part 6-3 Scheduling of substances
Section 52EB
(4) If:
that Act has effect, and is taken always to have had effect, as if:
Definition
(5) In this section:
register has the same meaning as in the Legislative Instruments Act 2003.
52EB Compensation for acquisition of property
Administration Chapter 6 Scheduling of substances Part 6-3
Section 52EC
(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
and may make recommendations for further changes to the scheduling regime.
Chapter 6 Administration Part 6-3 Scheduling of substances
Section 52EC
(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:
the Department may retain the application and any material submitted in connection with the application.
53A Alternative verdicts for various offences
If a jury acquits a person of an offence against a provision listed in column 2 of an item in the following table, but is satisfied beyond reasonable doubt of facts that prove that the person is guilty of the offence listed in column 3 of that item, the jury may convict the person of the offence listed in column 3 of that item:
Alternative verdicts for various offences
Column 1 Column 2 Column 3
Item If a prosecution is for the jury may instead an offence against... convict the person of an offence against...
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) 10 subsection 22A(1) subsection 22A(4)
Chapter 7 Miscellaneous
Section 54
Alternative verdicts for various offences
Column 1 Column 2 Column 3
Item | If a prosecution is for | the jury may instead |
an offence against... | convict the person of an | |
offence against... | ||
11 | subsection 30EC(1) | subsection 30EC(4) |
12 | subsection 30F(4B) | subsection 30F(5) |
13 | subsection 31(5A) | subsection 31(6) |
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) |
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:
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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.
54AA Offences for contravening conditions or requirements imposed under the regulations
(1) If:
the licence or permission is subject under the regulations; 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:
(2) If:
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.
Chapter 7 Miscellaneous
Section 54AB
54AB Criminal offence for damaging etc. documents
(1) A person is guilty of an offence if:
Penalty: 7 years imprisonment or 2,000 penalty units, or both.
(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:
Maximum civil penalty:
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 Application of this Act to an executive officer of a body corporate
(1) An executive officer of a body corporate commits an offence if:
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Note: An offence against this Act includes an offence against the regulations: see subsection 3(7).
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.
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
Chapter 7 Miscellaneous
Section 55
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.
55 Conduct by directors, servants and agents
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subsections (3) and (4) had not been enacted; the person is not liable to be punished by imprisonment for that offence.
56 Judicial notice
All courts (except in proceedings under Chapter 4) are to take judicial notice of the British Pharmacopoeia, the European Pharmacopoeia and the United States Pharmacopeia-National Formulary.
Chapter 7 Miscellaneous
Section 56A
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 (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
(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
(eb) particular medical devices were suspended from the Register; or
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provisions); a certificate by the Secretary to the effect that:
exportation subject to conditions specified in the certificate; is prima facie evidence of the matters specified in the certificate.
Chapter 7 Miscellaneous
Section 57
(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:
(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
(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.
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Chapter 7 Miscellaneous
Section 58
58 Export certifications
59 Fees
60 Review of decisions
(1) In this section and section 60A:
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975.
initial decision means a decision of the Secretary or of a delegate of the Secretary:
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(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
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:
Chapter 7 Miscellaneous
Section 60
(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:
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:
(3A) Subject to subsection 60A(2), in reconsidering the initial decision:
(3B) Paragraph (3A)(a) does not limit the information the Minister may take into account in reconsidering the initial decision.
(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
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of the request, the Minister is taken to have confirmed under subsection (3) the initial decision.
60A New information on review—discretion to remit
Chapter 7 Miscellaneous
Section 60A
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.
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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.
(6A) If:
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.
authorised delegate means a delegate of the Secretary:
initial new information means information that:
such information (whether the opinions were formed before or after that decision was made).
Chapter 7 Miscellaneous
Section 61
later new information means information that:
such information (whether the opinions were formed before or after that decision was made).
61 Release of information
(a) release to the World Health Organisation therapeutic goods information relating to:
(iii) the content of reports to the Department concerning adverse effects of therapeutic goods; or
(iv) the issue of, imposition of conditions on, or revocation
of, conformity assessment certificates; for use in the development of policies relating to the regulation of therapeutic goods or for the provision of information to regulatory authorities of member countries of the World Health Organisation; or
(b) release, in confidence, therapeutic goods information to the World Health Organisation, being information concerning proceedings of committees established under the regulations.
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(3) The Secretary may release to an authority of the Commonwealth, a State or a Territory that has functions relating to therapeutic goods, therapeutic goods information relating to:
conformity assessment certificates; for use in the performance of those functions.
(3A) The Secretary may release information obtained in response to a notice under section 31A, 31AA, 31B, 41JCA, 41JD, 41JE or 41JF to:
(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:
Chapter 7 Miscellaneous
Section 61
(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
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:
(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:
(da) action taken by the Secretary under section 30EA (about notification and recovery of therapeutic goods);
with therapeutic goods; (fa) any cases, or possible cases, of counterfeit therapeutic goods;
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(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) 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:
(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).
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Section 61
(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:
(6A) Regulations made for the purposes of subsection (6) may:
(8A) Regulations prescribing fees in respect of applications for information under the regulations:
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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.
61A Immunity from civil actions
(1) No civil action, suit or proceeding lies against:
a protected person’s functions, duties or powers under this Act or the regulations.
protected person means any of the following:
Chapter 7 Miscellaneous
Section 62
62 Consequential amendments
The Acts specified in the Schedule are amended as set out in the Schedule.
63 Regulations
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(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
(db) provide for the periods within which decisions under section 41EP to revoke suspensions of conformity assessment certificates are to be made, in cases where applications for revocation have been made under paragraph 41EP(2)(a); and
(dc) provide for the periods within which decisions on applications for the issuing of conformity assessment certificates under Part 4-4 are to be made if considering the applications involves examining the design of medical devices; and
(dd) provide for the periods within which decisions under section 41GD to revoke suspensions of entries on the Register are to be made, in cases where applications for revocation have been made under paragraph 41GD(2)(a); and
(3) The regulations may:
Chapter 7 Miscellaneous
Section 63
(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:
Repeal and transitional provisions Chapter 8
Chapter 8—Repeal and transitional provisions
64 Interpretation
In this Part, former Act means the Therapeutic Goods Act 1966.
65 Repeal
The former Act is repealed.
66 Transitional arrangements for goods required to be registered or listed
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
Chapter 8 Repeal and transitional provisions
Section 66
(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:
(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:
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:
Repeal and transitional provisions Chapter 8
(4B) If, on an application under subsection (3), goods have been listed without consideration of the matters mentioned in paragraphs 26(1)(c) to (m), the Secretary may, if he or she thinks it appropriate, give the person in relation to whom the goods are listed written notice that the Secretary intends to determine whether the goods should continue to be listed.
(4C) If notice is given under subsection (4B), section 26 applies as if the person in relation to whom the goods are listed were an applicant for the listing of the goods.
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
(a) this section applies to a step in the manufacture of therapeutic goods in relation to a person in relation to premises; and
Chapter 8 Repeal and transitional provisions
Section 69
(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:
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 former Act, and any requirements that were in force at that time under section 15 of the former Act, continue in force as if they were standards made under Part 3-1 of this Act.
Consequential Amendments Schedule
Schedule—Consequential Amendments
Section 62
Note:
The amendments made by this Schedule are incorporated in the compilations on ComLaw.
Agricultural and Veterinary Chemicals Act 1988
[repealed by Act No. 36, 1964, s. 24] Commonwealth Serum Laboratories Act 1961 Sea Installations Act 1987
For access to the wording of the amendments made by this Schedule, see Act No. 21, 1990.
Notes to the Therapeutic Goods Act 1989
Notes to the Therapeutic Goods Act 1989 Note 1
The Therapeutic Goods Act 1989 as shown in this compilation comprises Act No. 21, 1990 amended as indicated in the Tables below.
All relevant information pertaining to application, saving or transitional provisions prior to 30 May 2000 is not included in this compilation. For subsequent information see Table A.
Table of Acts
Act | Number | Date | Date of | Application, |
and year | of Assent | commencement | saving or | |
transitional | ||||
provisions | ||||
Therapeutic Goods Act | 21, 1990 | 17 Jan 1990 | 15 Feb 1991 | |
1989 | ||||
Community Services and | 141, 1990 | 28 Dec 1990 | Part 8 (ss. | — |
Health Legislation | 78–81): (a) | |||
Amendment Act (No. 2) | ||||
1990 | ||||
Community Services and | 84, 1991 | 26 June 1991 | S. 14: 1 Aug 1991 | Ss. 33–36 |
Health Legislation | (see s. 2(2) and | |||
Amendment Act 1991 | Gazette 1991, | |||
No. S207) | ||||
Remainder: Royal | ||||
Assent | ||||
Therapeutic Goods | 204, 1991 | 24 Dec 1991 | 24 Dec 1991 | Ss. 4(2), |
Amendment Act 1991 | 10(2) and | |||
13(2) | ||||
Health, Housing and | 88, 1992 | 30 June 1992 | Ss. 82–88: Royal | S. 83(2) |
Community Services | Assent (b) | |||
Legislation Amendment | ||||
Act 1992 | ||||
Health and Community | 76, 1993 | 25 Nov 1993 | Ss. 29(h) and | Ss. 33(2), |
Services Legislation | 30–32: 14 Feb | 36(2), 41(2), | ||
Amendment Act (No. 2) | 1994 (see Gazette | 49(2), 50(2) | ||
1993 | 1994, No. GN5) | and 51(2) | ||
Ss. 29(i), 37(b), | ||||
38(b), 47 and | ||||
50(1)(d): 2 May | ||||
1994 (see Gazette | ||||
1994, No. S149) | ||||
Remainder: Royal | ||||
Assent | ||||
Customs, Excise and | 85, 1995 | 1 July 1995 | S. 12 (items 5, 6): | S. 18 |
Bounty Legislation | 1 July 1995 (c) | |||
Amendment Act 1995 | S. 18: Royal | |||
Assent (c) |
Notes to the Therapeutic Goods Act 1989
Table of Acts
Act | Number | Date | Date of | Application, |
and year | of Assent | commencement | saving or | |
transitional | ||||
provisions | ||||
Therapeutic Goods | 6, 1996 | 11 June 1996 | 11 June 1996 | S. 84 |
Amendment Act 1996 | ||||
Therapeutic Goods | 116, 1997 | 7 July 1997 | Schedule 1 (Part 2 | — |
Amendment Act 1997 | [items | |||
2–14]): 1 Jan | ||||
1999 (see Gazette | ||||
1998, No. S609) | ||||
Remainder: Royal | ||||
Assent | ||||
as amended by | ||||
Therapeutic Goods Legislation Amendment | 3, 1999 | 29 Mar 1999 | (see 3, 1999 below) | — |
Act 1999 | ||||
Audit (Transitional and | 152, 1997 | 24 Oct 1997 | Schedule 2 | — |
Miscellaneous) | (item 1249): 1 Jan | |||
Amendment Act 1997 | 1998 (see Gazette | |||
1997, No. GN49) | ||||
(d) | ||||
Therapeutic Goods | 34, 1998 | 17 Apr 1998 | 17 Apr 1998 | — |
Legislation Amendment | ||||
Act 1998 | ||||
Therapeutic Goods | 3, 1999 | 29 Mar 1999 | Schedule 2: (e) | — |
Legislation Amendment | Remainder: 1 Apr | |||
Act 1999 | 1999 (see Gazette | |||
1999, No. S143) | ||||
Public Employment | 146, 1999 | 11 Nov 1999 | Schedule 1 (items | — |
(Consequential and | 936–938): 5 Dec | |||
Transitional) Amendment | 1999 (see Gazette | |||
Act 1999 | 1999, No. S584) | |||
(f) | ||||
Therapeutic Goods | 12, 2000 | 31 Mar 2000 | 31 Mar 2000 | — |
Amendment Act 2000 | ||||
Therapeutic Goods | 56, 2000 | 30 May 2000 | 30 May 2000 | Sch. 1 |
Amendment Act (No. 2) | (item 5) [see | |||
2000 | Table A] | |||
Therapeutic Goods | 120, 2000 | 12 Sept 2000 | Schedule 1: 10 | Sch. 1 |
Amendment Act (No. 3) | Oct 2000 | (items 4, 6, | ||
2000 | Remainder: Royal | 8, 10, 17) | ||
Assent | [see Table | |||
A] | ||||
Gene Technology | 170, 2000 | 21 Dec 2000 | 22 June 2001 | — |
(Consequential | (see s. 2) | |||
Amendments) Act 2000 | ||||
Therapeutic Goods | 14, 2001 | 22 Mar 2001 | 22 Sept 2001 | Sch. 1 |
Amendment Act 2001 | (item 36) | |||
[see Table | ||||
A] |
Notes to the Therapeutic Goods Act 1989
Act | Number | Date | Date of | Application, |
and year | of Assent | commencement | saving or | |
transitional | ||||
provisions | ||||
Australia New Zealand Food | 81, 2001 | 10 July 2001 | S. 2(6): Royal | S. 2(6) [see |
Authority Amendment Act | Assent (g) | Table A] | ||
2001 | Schedule 3 | |||
(item 8): 1 July | ||||
2002 (see Gazette | ||||
2002, No. GN30) | ||||
(g) | ||||
Health and Aged Care | 111, 2001 | 17 Sept 2001 | 17 Sept 2001 | S. 4 [see |
Legislation Amendment | Table A] | |||
(Application of Criminal | ||||
Code) Act 2001 | ||||
Therapeutic Goods | 23, 2002 | 4 Apr 2002 | 4 Apr 2002 | — |
Amendment Act (No. 1) | ||||
2002 | ||||
Therapeutic Goods | 24, 2002 | 4 Apr 2002 | Schedule 1: 4 Oct | Sch. 1 |
Amendment (Medical | 2002 | (items 38, | ||
Devices) Act 2002 | Schedule 2:(h) | 46, 55) [see | ||
Remainder: Royal | Table A] | |||
Assent | 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) | 39, 2006 | 3 May 2006 | Schedule 1 (item 158): (h) | — |
2006 | ||||
Therapeutic Goods Amendment Act 2007 | 140, 2007 | 14 Sept 2007 | Schedule 1 (items 7, 8): 3 Oct | — |
2007 | ||||
Therapeutic Goods and | 56, 2002 | 3 July 2002 | Schedule 1 (items | Sch. 3 |
Other Legislation | 6, 7), Schedule 3 | (items 20, | ||
Amendment Act 2002 | (items 4, 22) and | 21) [see | ||
Schedule 4 | Table A] | |||
(item 1): (i) | ||||
Remainder: Royal | ||||
Assent | ||||
Therapeutic Goods | 39, 2003 | 27 May 2003 | Schedule 1 (items | Sch. 1 |
Amendment Act (No. 1) | 1–19) and | (items 41, | ||
2003 | Schedule 2: | 55, 60) [see | ||
27 Nov 2003 | Table A] | |||
Schedule 1 | ||||
(item 79): (j) | ||||
Remainder: Royal | ||||
Assent | ||||
US Free Trade Agreement | 120, 2004 | 16 Aug 2004 | Schedule 7: 1 Jan | Sch. 7 |
Implementation Act 2004 | 2005 | (item 7) [see | ||
Table A] |
Notes to the Therapeutic Goods Act 1989
Table of Acts
Act | Number | Date | Date of | Application, |
and year | of Assent | commencement | saving or | |
transitional | ||||
provisions | ||||
Financial Framework | 8, 2005 | 22 Feb 2005 | S. 4 and | S. 4 and |
Legislation Amendment | Schedule 1 (items | Sch. 1 | ||
Act 2005 | 493, 496): Royal | (item 496) | ||
Assent | [see Table | |||
A] | ||||
Therapeutic Goods | 2, 2006 | 1 Mar 2006 | Schedule 1: 3 Apr | Sch. 1 |
Amendment Act (No. 2) | 2006 (see | (item 15) | ||
2006 | F2006L00889) | [see Table | ||
Remainder: Royal | A] | |||
Assent | ||||
Therapeutic Goods | 5, 2006 | 3 Mar 2006 | 3 Mar 2006 | S. 3 [see |
Amendment (Repeal of | Table A] | |||
Ministerial responsibility | ||||
for approval of RU486) | ||||
Act 2006 | ||||
Therapeutic Goods | 39, 2006 | 3 May 2006 | Schedule 1 (items | S. 2(1) |
Amendment Act (No. 1) | 1–117, 119–157): | (item 5) (rep. | ||
2006 | 31 May 2006 | by 140, | ||
Schedule 1 | 2007, Sch. 1 | |||
(item 118): 27 Nov | [item 4]) | |||
2003 | ||||
Remainder: Royal | ||||
Assent | ||||
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 | 50, 2006 | 9 June 2006 | Schedule 1: 1 July | — |
Research Council | 2006 | |||
Amendment Act 2006 | Remainder: Royal | |||
Assent | ||||
Therapeutic Goods | 96, 2006 | 5 Sept 2006 | 5 Sept 2006 | — |
Amendment Act (No. 3) | ||||
2006 | ||||
Therapeutic Goods | 140, 2007 | 14 Sept 2007 | 3 Oct 2007 | — |
Amendment Act 2007 | ||||
Therapeutic Goods | 9, 2008 | 20 Mar 2008 | 20 Mar 2008 | — |
Amendment (Poisons | ||||
Standard) Act 2008 | ||||
Statute Law Revision Act | 73, 2008 | 3 July 2008 | Schedule 1 | — |
2008 | (item 47): (k) | |||
Therapeutic Goods | 96, 2008 | 3 Oct 2008 | Schedule 1 (items | Sch. 1 |
Legislation Amendment | 1–3): 1 Jan 2009 | (item 3) [see | ||
(Annual Charges) Act | (see | Table A] | ||
2008 | F2008L04263) |
Notes to the Therapeutic Goods Act 1989
Act Number Date Date of Application, and year of Assent commencement saving or transitional provisions
Therapeutic Goods 38, 2009 17 June 2009 Schedules 1, 2 Amendment (Medical and 5–7: 18 June Devices and Other 2009 Measures) Act 2009 Schedule 3: 1 Dec 2009 (see F2009L03387) Schedule 4: 1 July 2009 Remainder: Royal Assent
Therapeutic Goods 76, 2009 27 Aug 2009 Schedules 1, 3, 6 Amendment (2009 and Schedule 7 Measures No. 1) Act 2009 (items 1–28): 28 Aug 2009 Schedule 2: 25 Feb 2010 (see F2009L03994) Schedule 4: [see Note 2] Schedule 5: 8 Feb 2010 (see F2009L03994) Schedule 7 (items 29–58): 25 Jan 2010 (see F2009L03994) Remainder: Royal Assent
Therapeutic Goods 96, 2009 29 Sept 2009 Schedule 1: 1 July Amendment (2009 2010 Measures No. 2) Act 2009 Schedule 2 and Schedule 3 (items 1–7): 30 Sept 2009 Schedule 3 (items 8–10): 29 Mar 2010 Remainder: Royal Assent
Statute Law Revision Act 8, 2010 1 Mar 2010 Schedule 5 (item 2010 124): Royal Assent Schedule 5 (item 137(a)): (l)
Sch. 2 (item 4), Sch. 3 (item 23), Sch. 4 (item 20), Sch. 5 (item 3) and Sch. 6 (item 12) [see Table A]
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 Table A]
Sch. 1 (item 13), Sch. 2 (item 4) and Sch. 3 (items 7, 10) [see Table A]
—
Notes to the Therapeutic Goods Act 1989
Table of Acts
Act Number Date Date of Application, and year of Assent commencement saving or transitional provisions
Therapeutic Goods 54, 2010 31 May 2010 Schedule 1: [see Amendment (2009 Note 3 and Table Measures No. 3) Act 2010 A]
Schedules 2–6: 1 June 2010 Remainder: Royal Assent
Therapeutic Goods 141, 2010 15 Dec 2010 Schedule 1 and Amendment (2010 Schedule 2 (items Measures No. 1) Act 2010 7A–21): 16 Dec
2010 Schedule 1A and Schedule 2 (items 1A–7): 12 Jan 2010 Schedule 2 (items 22, 23): [see (m) and Note 4] Remainder: Royal Assent
386 Therapeutic Goods Act 1989
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 Table A]
Sch. 1A (item 10) and Sch. 2 (items 7, 21) [see Table A]
Notes to the 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.
(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).
the Minister must cause to be published in the Gazette a notice specifying the day on which those provisions commenced.
Notes to the Therapeutic Goods Act 1989
Act Notes
(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, The later of: 4 October 2002 items 6 and 7 (b) immediately after Schedule 1 to the
Therapeutic Goods Amendment (Medical Devices) Act 2002 commences
4. Schedule 3, Immediately after item 22 of Schedule 3 4 October 2002 item 4 commences, subject to subsection (3)
item 1 Goods Amendment (Medical Devices) Act 2002 commences
Provision(s) | Commencement | Date/Details |
---|---|---|
4. Schedule 1, | Immediately after the commencement of the | 17 September |
item 79 | Health and Aged Care Legislation Amendment | 2001 |
(Application of Criminal Code) Act 2001 |
(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, Immediately after the commencement of item 79 of 17 September
item 47 Schedule 1 to the Therapeutic Goods Amendment 2001 Act (No. 1) 2003.
Notes to the Therapeutic Goods Act 1989
(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.
Provision(s) | Commencement | Date/Details |
---|---|---|
31. Schedule 5, | The day this Act receives the Royal Assent. | 1 March 2010 |
items 1 to 51 |
38. Schedule 5, Immediately after the provision(s) covered by table 1 March 2010 Parts 2 and 3 item 31.
(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, | The later of: | [see Note 4] |
Part 3 | (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. | (paragraph (b) applies) |
Notes to the Therapeutic Goods Act 1989
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
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
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
rep. No. 56, 2002
Ss. 6AAA–6AAD...................... ad. No. 56, 2002
S. 6AAE ................................... ad. No. 56, 2002 am. No. 56, 2002
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
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
Chapter 2
Chapt. 2 ................................... ad. No. 24, 2002
S. 9A ........................................ ad. No. 24, 2002 am. No. 56, 2002
Notes to the Therapeutic Goods Act 1989
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
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. No. 141, 2010
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
S. 10 ........................................ am. No. 24, 2002; Nos. 38 and 76, 2009 Note to s. 10(1) ........................ ad. No. 76, 2009
S. 10A ...................................... ad. No. 24, 2002 Ss. 11, 12................................. rep. No. 76, 2009
S. 13 ........................................ rs. No. 38, 2009
S. 14 ........................................ am. No. 85, 1995; No. 6, 1996; No. 39, 2003 rs. No. 39, 2006 am. No. 38, 2009
Ss. 14A, 14B............................ ad. No. 39, 2006
S. 15 ........................................ am. No. 6, 1996; No. 111, 2001 rs. No. 39, 2006 am. No. 38, 2009
S. 15AA.................................... ad. No. 39, 2006
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. 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
Notes to the Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
S. 19A ...................................... ad. No. 6, 1996 am. No. 76, 2009
S. 19B ...................................... ad. No. 39, 2006 am. No. 38, 2009 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
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
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
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
S. 24A ...................................... ad. No. 84, 1991 am. No. 204, 1991
S. 24B ...................................... ad. No. 84, 1991 am. No. 24, 2002
S. 24C...................................... ad. No. 84, 1991
S. 24D...................................... ad. No. 204, 1991 am. No. 56, 2002; No. 76, 2009
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
Notes to the Therapeutic Goods Act 1989
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
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 am. No. 56, 2002
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 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
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
S. 29C...................................... ad. No. 39, 2006
Notes to the Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
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
S. 30EC ................................... ad. No. 39, 2003 rs. No. 39, 2006 am. No. 38, 2009
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
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
S. 31AAA ................................. ad. No. 39, 2006 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
Notes to the Therapeutic Goods Act 1989
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
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
S. 31E ...................................... ad. No. 120, 2000 am. No. 39, 2006; No. 38, 2009
S. 31F ...................................... ad. No. 120, 2000 am. No. 39, 2006
S. 32 ........................................ am. Nos. 84 and 204, 1991; No. 76, 1993; No. 6, 1996 rep. No. 24, 2002
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. 35 ........................................ am. No. 6, 1996; No. 111, 2001; No. 23, 2002; No. 39, 2003 rs. No. 39, 2006 am. No. 38, 2009
S. 35A ...................................... ad. No. 39, 2006
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 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
Ss. 38A, 38B............................ ad. No. 76, 2009
S. 39 ........................................ am. No. 23, 2002
S. 40 ........................................ am. No. 76, 1993; No. 56, 2002; No. 39, 2003; Nos. 38 and 76, 2009
Ss. 40A, 40B............................ ad. No. 76, 2009
S. 41 ........................................ am. No. 34, 1998; No. 23, 2002; No. 39, 2003; No. 39, 2006; Nos. 38 and 76, 2009
S. 41AA.................................... ad. No. 38, 2009
S. 41AAA ................................. ad. No. 76, 2009
S. 42 ........................................ am. No. 76, 1993 Renumbered s. 41A............. No. 24, 2002
Notes to the Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
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
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
Ss. 41BJ, 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
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 am. No. 76, 2009
Notes to the Therapeutic Goods Act 1989
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
Note to s. 41DC(1)................... ad. No. 76, 2009 Ss. 41DD, 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
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
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
Notes to the Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
S. 41FE.................................... ad. No. 24, 2002 am. No. 39, 2003 rs. No. 39, 2006 am. No. 38, 2009
S. 41FEA ................................. ad. No. 39, 2006
Subdivision B
S. 41FF .................................... ad. No. 24, 2002 am. No. 96, 2009
S. 41FG ................................... ad. No. 24, 2002
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
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
Notes to the Therapeutic Goods Act 1989
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
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
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
Ss. 41JH–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
S. 41KCA ................................. ad. No. 39, 2006
Notes to the Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
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
S. 41MAA................................. ad. No. 39, 2006 am. No. 38, 2009
S. 41MB ................................... ad. No. 24, 2002 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
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
S. 41MEA................................. ad. No. 39, 2006 am. No. 38, 2009
S. 41MF ................................... ad. No. 24, 2002 am. No. 39, 2003 rs. No. 39, 2006 am. No. 38, 2009
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
S. 41MHA ................................ ad. No. 39, 2006
Notes to the Therapeutic Goods Act 1989
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
Division 3
S. 41MI ....................................
S. 41MIA ..................................
S. 41MIB ..................................
S. 41MJ....................................
S. 41MK ...................................
Heading to s. 41ML..................
S. 41ML ...................................
S. 41MLA .................................
S. 41MM ..................................
S. 41MN...................................
S. 41MNA ................................
Division 3A
Div. 3A of Part 4-11 ................. Ss. 41MNB–41MND ................
Division 4
Heading to Div. 4 of ................. Part 4-11
S. 41MO...................................
Heading to s. 41MP .................
S. 41MP ...................................
Ss. 41MPA, 41MPB .................
S. 41MQ...................................
S. 41MR...................................
Chapter 5
Heading to Part 4A .................. Heading to Chapt. 5................. Part 4A.....................................
Part 5-1
Heading to Part 5-1..................
ad. No. 24, 2002 am. No. 39, 2003 rs. No. 39, 2006 am. No. 38, 2009; No. 141, 2010
ad. No. 39, 2006
ad. No. 39, 2006 am. No. 38, 2009; No. 141, 2010
ad. No. 24, 2002 am. No. 39, 2006
ad. No. 24, 2002 am. No. 38, 2009; No. 141, 2010
rs. No. 39, 2006; No. 96, 2009
ad. No. 24, 2002 am. No. 39, 2006; No. 38, 2009 rs. No. 96, 2009
ad. No. 39, 2006 am. No. 141, 2010
ad. No. 24, 2002 am. No. 38, 2009
ad. No. 24, 2002 rs. No. 39, 2006 am. No. 38, 2009; No. 141, 2010
ad. No. 39, 2006
ad. No. 38, 2009 ad. No. 38, 2009
rs. No. 39, 2006
ad. No. 24, 2002 rs. No. 39, 2006 am. No. 38, 2009
rs. No. 39, 2006
ad. No. 24, 2002 am. No. 39, 2006; No. 38, 2009 ad. No. 39, 2006 ad. No. 24, 2002
am. No. 39, 2006; No. 38, 2009 ad. No. 39, 2006
rep. No. 24, 2002 ad. No. 24, 2002 ad. No. 3, 1999
ad. No. 24, 2002
Notes to the Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
rs. No. 39, 2003
Division 1
Heading to Div. 1 of ................. ad. No. 39, 2003 Part 5-1
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 ................. ad. No. 39, 2003 Part 5-1
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............... ad. No. 38, 2009 Part 5-1
Ss. 42DKA, 42DKB.................. ad. No. 38, 2009
Notes to the Therapeutic Goods Act 1989
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
S. 42DL.................................... ad. No. 39, 2003 am. No. 38, 2009; No. 54, 2010
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
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
S. 42U...................................... ad. No. 120, 2000
S. 42V ...................................... ad. No. 120, 2000 am. No. 24, 2002; No. 39, 2006; No. 38, 2009
Ss. 42VA, 42VB ....................... ad. No. 39, 2006
S. 42W ..................................... ad. No. 120, 2000 am. No. 39, 2006; No. 38, 2009
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
Notes to the Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
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 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; No. 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
S. 51 ........................................ am. No. 6, 1996
S. 51A ...................................... ad. No. 76, 1993
Notes to the Therapeutic Goods Act 1989
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
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
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
S. 53A ...................................... ad. No. 39, 2006 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
S. 54AC ................................... ad. No. 39, 2006
S. 54A ...................................... ad. No. 6, 1996 Ss. 54B, 54C............................ ad. No. 39, 2006
Notes to the Therapeutic Goods Act 1989
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected How affected
S. 55 ........................................ am. No. 6, 1996; No. 39, 2006
S. 56 ........................................ am. No. 24, 2002; No. 38, 2009
S. 56A ...................................... ad. No. 6, 1996
am. No. 24, 2002; No. 39, 2006; Nos. 38 and 76, 2009; No. 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
S. 58 ........................................ am. No. 76, 1993; No. 76, 2009
S. 60 ........................................ am. No. 6, 1996; No. 24, 2002; No. 39, 2003; No. 39, 2006; No. 76, 2009; No. 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. 63 ........................................ am. No. 204, 1991; No. 76, 1993; No. 6, 1996; No. 34, 1998; No. 24, 2002
Chapter 8
Heading to Part 7..................... rep. No. 24, 2002 Heading to Chapt. 8................. ad. No. 24, 2002
S. 66 ........................................ am. No. 76, 1993 Heading to s. 68....................... am. No. 24, 2002
S. 69 ........................................ am. No. 24, 2002
Schedule
Schedule.................................. am. No. 141, 1990
Notes to the Therapeutic Goods Act 1989
Note 2
Note 2
Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009
(No. 76, 2009)
The following amendments commence on 1 July 2011:
Schedule 4 1 Subsection 3(1)
Insert: anthroposophic pharmacopoeia means:
2 Subsection 3(1)
Insert:
anthroposophic preparation has the meaning given by subsection 3AB(1).
3 Subsection 3(1)
Insert:
anthroposophic standard has the meaning given by subsection 3AB(2).
4 Subsection 3(1)
Insert: homoeopathic pharmacopoeia means:
Notes to the Therapeutic Goods Act 1989
5 Subsection 3(1)
Insert:
homoeopathic preparation has the meaning given by subsection 3AA(1).
6 Subsection 3(1)
Insert:
homoeopathic standard has the meaning given by subsection 3AA(2).
7 Subsection 3(1)
Insert:
mother substance means any of the following:
8 Subsection 3(1) (at the end of the definition of standard) (before the note)
Add: ; (e) a homoeopathic standard;
(f) an anthroposophic standard.
9 After section 3
Insert:
Notes to the Therapeutic Goods Act 1989
Note 2
3AA Homoeopathic preparations and homoeopathic standards
Homoeopathic preparation
(1) For the purposes of this Act, a homoeopathic preparation is a preparation:
Homoeopathic standard
(2) For the purposes of this Act, if:
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):
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.
Notes to the Therapeutic Goods Act 1989
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:
Anthroposophic standard
(2) For the purposes of this Act, if:
then there is an anthroposophic standard, in relation to the goods, that is constituted by the statements (other than statements exempt under subsection (5)) in those monographs, as interpreted in accordance with any interpretation sections of that anthroposophic pharmacopoeia.
Specifying publications
(3) The Minister may, by legislative instrument, specify either or both of the following for the purposes of the definition of anthroposophic pharmacopoeia in subsection 3(1):
Notes to the Therapeutic Goods Act 1989
Note 2
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).
10 Subsection 10(1)
Omit “or the United States Pharmacopeia-National Formulary”, substitute “, the United States Pharmacopeia-National Formulary, a homoeopathic pharmacopoeia or an anthroposophic pharmacopoeia”.
11 Subparagraph 10(2)(a)(iv)
Omit “or the United States Pharmacopeia-National Formulary”, substitute “, the United States Pharmacopeia-National Formulary, a homoeopathic pharmacopoeia or an anthroposophic pharmacopoeia”.
12 After section 13
Insert:
13A Special provisions relating to homoeopathic standards and anthroposophic standards
Notes to the Therapeutic Goods Act 1989
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.
Note: The heading to section 13 is altered by omitting “standards” and substituting “Ministerial standards and default standards”.
13 Section 56
Omit “and the United States Pharmacopeia-National Formulary”, substitute “, the United States Pharmacopeia-National Formulary, a homoeopathic pharmacopoeia and an anthroposophic pharmacopoeia”.
As at 12 January 2011 the amendments are not incorporated in this compilation.
Note 3
Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010
(No. 54, 2010)
The following amendments commence on 31 May 2011 unless proclaimed earlier:
Schedule 1
1 Subsection 3(1)
Insert:
biological has the meaning given by section 32A.
2 Subsection 3(1)
Insert:
biological number of a biological means:
3 Subsection 3(1)
Insert:
Notes to the Therapeutic Goods Act 1989
Note 3
Class 1 biological means a biological included in a class of
biologicals that is:
4 Subsection 3(1) (definition of included in the Register)
Repeal the definition, substitute:
included in the Register:
Note: Section 41BJ deals with the application of Chapter 4 to medical devices.
5 Subsection 3(1) (paragraph (a) of the definition of medicine)
After “goods”, insert “(other than biologicals)”.
6 Subsection 3(1) (definition of therapeutic device)
After “means therapeutic goods”, insert “(other than biologicals)”.
7 Subsection 3(1) (definition of therapeutic goods)
After “and includes”, insert “biologicals,”.
8 After paragraph 6AAE(6)(b)
Insert: (ba) in the part of the Register for biologicals included under Part 3-2A; or
9 Paragraph 7B(1)(b)
Omit “or are exempt goods in relation to Part 3-2”, substitute “, 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”.
10 After paragraph 9(1)(a)
Insert:
Notes to the Therapeutic Goods Act 1989
(aa) the evaluation of a biological, other than a Class 1 biological, for inclusion in the Register under Part 3-2A; or
11 Subsection 9A(3)
Omit “3 parts”, substitute “4 parts”.
12 After paragraph 9A(3)(b)
Insert: (ba) a part for biologicals included in the Register under Part 3-2A; and
13 Paragraph 9A(4)(b)
Repeal the paragraph, substitute:
(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
14 After paragraph 9A(4)(c)
Insert: (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
15 After subsection 9D(3)
Insert:
(3A) If:
the Secretary may vary the entry in accordance with the request.
(3B) If:
Notes to the Therapeutic Goods Act 1989
Note 3
the part of the Register for biologicals to whichever other part of the Register is applicable.
16 Subsection 9D(4)
Omit “the part for goods to be known as registered goods or to the part for goods to be known as listed goods (whichever is applicable)”, substitute “whichever other part of the Register is applicable”.
17 After subsection 14(5)
Insert:
(5A) Subsection (1), (2) or (4) does not apply if:
Note: A defendant bears an evidential burden in relation to the matter in subsection (5A): see subsection 13.3(3) of the Criminal Code.
Note: The heading to subsection 14(5) is replaced by the heading “Exceptions”.
18 After subsection 14(9)
Insert:
Exception
(9A) Subsection (6), (7) or (9) does not apply if:
Note: A defendant bears an evidential burden in relation to the matter in subsection (9A): see subsection 13.3(3) of the Criminal Code.
19 After subsection 14(13)
Insert:
Notes to the Therapeutic Goods Act 1989
Exception
(13A) Subsection (10), (11) or (13) does not apply if:
Note: A defendant bears an evidential burden in relation to the matter in subsection (13A): see subsection 13.3(3) of the Criminal Code.
20 After subsection 14A(1)
Insert:
Exception
(1A) Subsection (1) does not apply if:
21 After subsection 14A(2)
Insert:
Exception
(2A) Subsection (2) does not apply if:
22 After subsection 14A(3)
Insert:
Exception
(3A) Subsection (3) does not apply if:
(a) the therapeutic goods are a biological; and
Notes to the Therapeutic Goods Act 1989
Note 3
(b) the person exports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.
23 At the end of Part 3-1
Add:
15AB Conditions relating to exceptional release of biologicals
Penalty for contravention of this subsection:60 penalty units.
24 After section 15A
Insert:
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.
Notes to the Therapeutic Goods Act 1989
Pending applications
(3) If:
commencement; this Part continues to apply to the biological on and after that commencement until the earliest of the following:
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
25 After Part 3-2
Insert:
Notes to the Therapeutic Goods Act 1989
Note 3
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:
32A Meaning of biological
Notes to the Therapeutic Goods Act 1989
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
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).
Notes to the Therapeutic Goods Act 1989
Note 3
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:
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:
Notes to the Therapeutic Goods Act 1989
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:
(iii) the biological is exempt under section 32CB;
Notes to the Therapeutic Goods Act 1989
Note 3
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:
(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:
(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
Notes to the Therapeutic Goods Act 1989
approval covering the exportation from Australia of the biological; and
(c) either:
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:
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:
(i) the biological is included in the Register in relation to the person;
Notes to the Therapeutic Goods Act 1989
Note 3
(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:
(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.
32BC Criminal offences for manufacturing a biological
(1) A person commits an offence if:
Notes to the Therapeutic Goods Act 1989
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:
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:
(i) the biological is included in the Register in relation to the person;
Notes to the Therapeutic Goods Act 1989
Note 3
(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:
(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.
32BD Criminal offences for supplying a biological
(1) A person commits an offence if:
Notes to the Therapeutic Goods Act 1989
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:
(iii) the biological is exempt under section 32CB;
Notes to the Therapeutic Goods Act 1989
Note 3
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.
(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:
(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 supply.
Note: A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.
Notes to the Therapeutic Goods Act 1989
(6) Subsection (1) does not apply if:
(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:
the committing magistrate or the court must:
(a) the notice under subsection (2) includes the name and address of the person or, if the name and address is not
Notes to the Therapeutic Goods Act 1989
Note 3
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
Notes to the Therapeutic Goods Act 1989
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:
(iii) the biological is exempt under section 32CB;
Maximum civil penalty:
Exporting a biological for use in humans
(2) A person contravenes this subsection if:
Notes to the Therapeutic Goods Act 1989
Note 3
(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:
Manufacturing a biological for use in humans
(3) A person contravenes this subsection if:
(iii) the biological is exempt under section 32CB.
Maximum civil penalty:
Supplying a biological for use in humans
(4) A person contravenes this subsection if:
(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
Notes to the Therapeutic Goods Act 1989
approval covering the supply in Australia of the biological;
Maximum civil penalty:
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:
Maximum civil penalty:
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:
Notes to the Therapeutic Goods Act 1989
Note 3
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Civil penalty
(2) A person contravenes this subsection if:
Notes to the Therapeutic Goods Act 1989
Maximum civil penalty:
Definition
(3) For the purposes of this section:
32BH Criminal offence relating to wholesale supply
A person commits an offence if:
(iii) the biological is exempt under section 32CB;
Notes to the Therapeutic Goods Act 1989
Note 3
(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:
Notes to the Therapeutic Goods Act 1989
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:
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
Notes to the Therapeutic Goods Act 1989
Note 3
(iii) the biological is exempt under section 32CB;
(vii) the person uses the biological in accordance with an authority under subsection 32CM(1).
Penalty for contravention of this subsection:500 penalty units.
32BJ General criminal offences relating to this Part
Including incorrect biological number on containers etc.
(1) A person commits an offence if:
Penalty: 60 penalty units.
(2) For the purposes of subsection (1), number includes any combination of one or more of the following:
Notes to the Therapeutic Goods Act 1989
Advertising biological for an indication
(3) A person commits an offence if:
Penalty: 60 penalty units.
Arranging supply of biological not included in Register
(4) A person commits an offence if:
(iii) the biological is exempt under section 32CB;
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
Notes to the Therapeutic Goods Act 1989
Note 3
(b) the representation is false or misleading.
Maximum civil penalty:
(2) Subsection (1) applies to the following representations:
Division 3—Exemptions
Subdivision A—Preliminary
32C What this Division is about
There are 4 kinds of exemptions in relation to biologicals:
Notes to the Therapeutic Goods Act 1989
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.
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 46(3) 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.
Notes to the Therapeutic Goods Act 1989
Note 3
(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:
Period of exemption
Note: Section 32CD deals with variation and revocation of the exemption.
Effect of inclusion of biological in the Register
(5) An exemption under subsection (1) ceases to have effect in relation to a particular biological when that biological becomes included in the Register under Division 4.
Exemption not a legislative instrument
(6) An exemption under subsection (1) is not a legislative instrument.
32CC Conditions of exemptions
An exemption under section 32CB is subject to conditions specified in the exemption about any of the following:
Notes to the Therapeutic Goods Act 1989
the circumstances under which a stockpile of biologicals may be supplied for use);
affected by whether or not there is a breach of a condition under this section in relation to those biologicals.
Note 1: There are criminal offences and civil penalties related to the breach of a condition of an exemption: see sections 32CH and 32CI.
Note 2: Section 32CD deals with variation and revocation of the conditions.
32CD Variation or revocation of exemption
Variation of exemption
(1) The Minister may, by writing, vary an exemption made under section 32CB by removing specified biologicals from the exemption.
Note: For specification by class, see subsection 46(3) 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
When variation or revocation takes effect
Notes to the Therapeutic Goods Act 1989
Note 3
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):
32CF Notification and tabling
Notification
(1) The Secretary must cause a notice setting out particulars of the following:
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:
Notes to the Therapeutic Goods Act 1989
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
32CH Criminal offences for breaching a condition of an exemption
(1) A person commits an offence if:
Notes to the Therapeutic Goods Act 1989
Note 3
Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
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:
Maximum civil penalty:
Notes to the Therapeutic Goods Act 1989
32CJ Criminal offences and civil penalty for biologicals not conforming to standards etc.
Notice is not a legislative instrument
Offences
(6) A person commits an offence if:
Notes to the Therapeutic Goods Act 1989
Note 3
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(7) A person commits an offence if:
Penalty: 2,000 penalty units.
(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:
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.
Notes to the Therapeutic Goods Act 1989
Civil penalty
(11) A person contravenes this subsection if:
Maximum civil penalty:
Subdivision D—Exempting biologicals for special and experimental uses
32CK Approvals for importing, exporting or supplying a biological for special and experimental uses
Application for approval
(3) An application for an approval for use of the kind referred to in paragraph (1)(d) must:
Notes to the Therapeutic Goods Act 1989
Note 3
(4) An application for an approval for use of the kind referred to in paragraph (1)(e) must:
Secretary’s decision
(5) If an application for an approval is made, the Secretary must:
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
Penalty: 60 penalty units.
Notes to the Therapeutic Goods Act 1989
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:
is subject to the conditions (if any) specified in the regulations relating to one or more of the following:
(2) A person commits an offence if:
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.
Notes to the Therapeutic Goods Act 1989
Note 3
committee to supply the specified biological. Paragraph (b) does not apply in the exceptional circumstances (if any) prescribed by the regulations for the purposes of this subsection.
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:
Notes to the Therapeutic Goods Act 1989
(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:
(iii) the supply is not in accordance with regulations made for the purpose of subsection 32CM(6).
Penalty: 2,000 penalty units.
Notes to the Therapeutic Goods Act 1989
Note 3
(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:
(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:
the supply in Australia of that biological; if the Secretary is satisfied that:
Notes to the Therapeutic Goods Act 1989
(2) The Secretary may, by notice in writing, grant an approval to a person for:
the supply in Australia of that biological; if the Secretary is satisfied that:
Application for approval
(3) An application for an approval must:
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
Notes to the Therapeutic Goods Act 1989
Note 3
Conditions
Penalty: 60 penalty units.
Period of approval
(9) The Secretary may grant an approval for such period as is specified in the notice of approval.
When approval lapses
Approval not a legislative instrument
(13) An approval under subsection (1) or (2) is not a legislative instrument.
Notes to the Therapeutic Goods Act 1989
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
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Note 3
(4) An approval of a form may require or permit an application to be given in accordance with specified software requirements:
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
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.
Notes to the Therapeutic Goods Act 1989
32DC Refusal to include Class 1 biological in the Register
If:
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
Note: An evaluation fee is also payable: see sections 32DI to 32DM.
Notes to the Therapeutic Goods Act 1989
Note 3
32DE Evaluation of biologicals
32DF Inclusion of biological in the Register
(1) If:
Notes to the Therapeutic Goods Act 1989
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
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:
Notes to the Therapeutic Goods Act 1989
Note 3
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
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
Notes to the Therapeutic Goods Act 1989
32DJ When evaluation fee due for payment
32DK Payment of evaluation fee by instalments
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
465
Notes to the Therapeutic Goods Act 1989
Note 3
evaluation if a period is prescribed under paragraph 63(2)(daa) for completing the evaluation.
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:
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:
Notes to the Therapeutic Goods Act 1989
Register under Chapter 4; then, as soon as practicable after the commencement of this section, the Secretary must:
Pending applications
(2) If:
(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:
Notes to the Therapeutic Goods Act 1989
Note 3
(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
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.
Notes to the Therapeutic Goods Act 1989
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:
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:
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:
Notes to the Therapeutic Goods Act 1989
Note 3
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:
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:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Civil penalty
(2) A person contravenes this subsection if:
Notes to the Therapeutic Goods Act 1989
Maximum civil penalty:
Relevant information
(3) This subsection applies to information of the following kinds:
32DR Criminal offences and civil penalties for failing to notify adverse effects etc. of biological where application withdrawn or lapses
(1) If an application for inclusion of a biological in the Register is withdrawn or lapses, the Secretary may, within 14 days after the application is withdrawn or lapses, give the applicant written notice requiring the applicant:
(a) to inform the Secretary in writing whether the applicant is aware of any information of a kind to which subsection (2) applies; and
Notes to the Therapeutic Goods Act 1989
Note 3
(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:
Offences
(3) A person commits an offence if:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(4) A person commits an offence if:
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Civil penalties
(5) A person contravenes this subsection if:
Notes to the Therapeutic Goods Act 1989
Maximum civil penalty:
(6) A person contravenes this subsection if:
Maximum civil penalty:
Subdivision F—Advice from Gene Technology Regulator
32DS Consultation with Gene Technology Regulator
Notes to the Therapeutic Goods Act 1989
Note 3
32DT Secretary may seek advice about classes of GM products or genetically modified organisms
32DU Secretary to take advice into account
If the Secretary receives advice from the Gene Technology Regulator:
Notes to the 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
Notes to the Therapeutic Goods Act 1989
Note 3
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:
Manufacturing
Notes to the Therapeutic Goods Act 1989
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
Notes to the Therapeutic Goods Act 1989
Note 3
32EC Imposition of conditions by legislative instrument
32ED Imposition of conditions at time biological included in the Register
32EE Imposition or variation or removal of conditions after biological included in the Register
Notes to the Therapeutic Goods Act 1989
32EF Criminal offences for breach of condition
(1) A person commits an offence if:
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:
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:
Notes to the Therapeutic Goods Act 1989
Note 3
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:
Maximum civil penalty:
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:
Notes to the Therapeutic Goods Act 1989
Notice of proposed suspension in some cases
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.
Notes to the Therapeutic Goods Act 1989
Note 3
Notice not a legislative instrument
(6) A notice under subsection (1) is not a legislative instrument.
32FB When suspension takes effect etc.
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
Notice 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
Notes to the Therapeutic Goods Act 1989
biological is included in the Register, if the Secretary is satisfied that:
(2) The Secretary’s power to revoke the suspension may be exercised:
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:
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.
Notes to the Therapeutic Goods Act 1989
Note 3
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:
(i) under the regulations, an authority constituted by or under the regulations gives a direction to, or makes a
Notes to the Therapeutic Goods Act 1989
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
Notes to the Therapeutic Goods Act 1989
Note 3
(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:
Note: Section 32AB deals with when a biological is separate and distinct from other biologicals.
further 14 days after the end of the period specified in that notice; or
Notes to the Therapeutic Goods Act 1989
32GD Revocation of cancellation of biological upon request
(1) If:
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.
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
Notes to the Therapeutic Goods Act 1989
Note 3
cancellation is given to the person in relation to whom the biological was included in the Register.
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:
Circumstances in which requirements may be imposed
Item Circumstance relating to biological Person subject to requirements
It is supplied while it is included in the The person in relation to Register, but it does not conform with a whom it is included in the standard applicable to it Register
It is a biological, other than a Class 1 The person in relation to biological, and it is supplied while it is included whom it is included in the in the Register, but the manufacturing Register principles have not been observed in its manufacture
Notes to the Therapeutic Goods Act 1989
Circumstances in which requirements may be imposed
Item | Circumstance relating to biological | Person subject to |
requirements | ||
3 | It is supplied while: | The person supplying it |
(a) the person is exempt under subsection | ||
32CA(1) in relation to the biological or the | ||
biological is exempt under subsection | ||
32CA(2); or | ||
(b) it is exempt under section 32CB; or | ||
(c) it is the subject of an approval under | ||
subsection 32CK(1); or | ||
(d) it is the subject of an authority under | ||
subsection 32CM(1); or | ||
(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 | The person supplying it |
biological, and it is supplied while: | ||
(a) the person is exempt under subsection | ||
32CA(1) in relation to the biological or the | ||
biological is exempt under subsection | ||
32CA(2); or | ||
(b) it is exempt under section 32CB; or | ||
(c) it is the subject of an approval under | ||
subsection 32CK(1); or | ||
(d) it is the subject of an authority under | ||
subsection 32CM(1); or | ||
(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 |
Notes to the Therapeutic Goods Act 1989
Note 3
Circumstances in which requirements may be imposed
Item Circumstance relating to biological Person subject to requirements
5 It is supplied while: The person supplying it
6 It is supplied while it is exempt under The person supplying it section 32CB, and the Secretary is satisfied that it is not fit to be used for its intended purpose
7 It is supplied in contravention of subsection The person supplying it 42E(1) or section 42EA
8 It is a biological, other than a Class 1 The person in relation to biological, and it is supplied while it is included whom it is included in the in the Register, but there is a breach of the Register condition set out in subsection 32EA(5)
9 It appears to the Secretary that the quality, The person in relation to safety or efficacy of the biological is whom the biological is unacceptable or that the presentation of the included in the Register biological is unacceptable
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
Notes to the Therapeutic Goods Act 1989
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:
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:
Notes to the Therapeutic Goods Act 1989
Note 3
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:
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:
Maximum civil penalty:
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.
Notes to the 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:
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:
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:
Notes to the Therapeutic Goods Act 1989
Note 3
(2) The person must give the information, or produce the documents, to the Secretary:
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.
Notes to the Therapeutic Goods Act 1989
32JB Criminal offences for failing to comply with a notice etc.
(1) A person commits an offence if:
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:
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 (5) instead: see section 53A.
(3) A person commits an offence if:
Notes to the Therapeutic Goods Act 1989
Note 3
(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.
(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:
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:
Maximum civil penalty:
32JD Self-incrimination
Notes to the Therapeutic Goods Act 1989
are not admissible in evidence against the individual:
Subdivision C—Obtaining information or documents for biologicals covered by exemptions
32JE Secretary may require information etc. about biologicals exempt under the regulations
Notes to the Therapeutic Goods Act 1989
Note 3
Compliance
(3) A person given a notice under subsection (1) or (2) must give the information, or produce the documents, to the Secretary:
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:
32JF Secretary may require information etc. about biologicals exempt to deal with emergencies
Notes to the Therapeutic Goods Act 1989
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:
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:
Approval under subsection 32CK(1)—use by another person
(2) The Secretary may give to a person (the experimenter) using a biological that is the subject of an approval:
a 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;
Notes to the Therapeutic Goods Act 1989
Note 3
(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:
Compliance
(4) A person given a notice under subsection (1), (2) or (3) must give the information, or produce the documents, to the Secretary:
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:
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
Notes to the Therapeutic Goods Act 1989
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:
Compliance
(2) A person given a notice under subsection (1) must give the information, or produce the documents, to the Secretary:
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:
32JI Criminal offences for failing to comply with a notice etc.
(1) A person commits an offence if:
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
Notes to the Therapeutic Goods Act 1989
Note 3
Penalty for contravention of this subsection:Imprisonment for 12 months or 1,000 penalty units, or both.
32JJ Civil penalty for giving false or misleading information or document in compliance with a notice
A person contravenes this section if:
Maximum civil penalty:
32JK Self-incrimination
are not admissible in evidence against the individual:
Notes to the Therapeutic Goods Act 1989
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
26 After section 33A
Insert:
33B Application of this Part to biologicals
This Part does not apply to a Class 1 biological.
27 Paragraphs 35(1)(a), (2)(a) and (4)(a)
After “section 18A”, insert “or 32CB”.
28 Paragraphs 35(5)(c), (7)(c) and (9)(c)
After “section 18A”, insert “or 32CB”.
29 Paragraphs 35A(1)(c) and (2)(c)
After “section 18A”, insert “or 32CB”.
Notes to the Therapeutic Goods Act 1989
Note 3
30 At the end of section 39
Add:
(3) If:
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).
31 Paragraph 40(4)(a)
Repeal the paragraph, substitute:
(a) ensure that:
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
32 After paragraph 41(1)(g)
Insert: (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
33 After section 41BJ
Insert:
Notes to the Therapeutic Goods Act 1989
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.
Pending applications
(3) If:
commencement; this Chapter continues to apply to the biological on and after that commencement until the earliest of the following:
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.
Notes to the Therapeutic Goods Act 1989
Note 3
Transitional
34 After paragraph 42DL(1)(f)
Insert: (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
35 Subsection 42V(7)
Omit “section 30”, substitute “section 29D or 30, Division 6 or 7 of Part 3-2A”.
36 After subparagraph 46A(4)(a)(ii)
Insert: (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
37 After paragraph 53(b)
Insert: (ba) inclusion of a biological in the Register; or
38 Section 53A (after table item 13)
Insert:
Notes to the Therapeutic Goods Act 1989
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)
39 After paragraph 56A(1)(a)
Insert: (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
40 After paragraph 56A(1)(b)
Insert: (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
41 After paragraph 56A(1)(c)
Insert: (ca) there was no approval under subsection 32CO(1) or (2) granted to a particular person in relation to a particular biological; or
42 After paragraph 56A(1)(e)
Insert: (eaa) a particular biological was or was not included in the Register; or
Notes to the Therapeutic Goods Act 1989
Note 3
43 Subsections 57(2) and (3)
After “paragraph 19(1)(a)”, insert “, 32CK(1)(d)”.
44 Paragraph 57(5)(b)
After “paragraph 19(1)(a)”, insert “, 32CK(1)(d)”.
45 Subsections 57(6) and (7)
After “subsection 19(5)”, insert “, 32CM(1)”.
46 Subsection 57(8)
After “section 19A”, insert “or 32CO”.
47 After subsection 57(10)
Insert:
(10A) The power of the Minister under subsection 32CB(1) may be delegated only to the Secretary.
48 Subsection 59(3)
Repeal the subsection.
49 Subsection 60(1) (after paragraph (c) of the definition of initial decision)
Insert: (ca) under Part 3-2A (Biologicals); or
50 Subsection 60A(1)
After “section 25”, insert “, 32DF, 32DG”.
51 After subsection 60A(6)
Insert:
(6AA) If:
Notes to the Therapeutic Goods Act 1989
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.
52 Subsection 60A(7)
After “Part 3-2”, insert “, 3-2A”.
53 Subsection 60A(8) (after paragraph (a) of the definition of authorised delegate)
Insert: (aa) exercising a power to decide whether to include a biological in the Register; or
54 Subsection 61(3A)
After “31B,”, insert “32JE, 32JF, 32JG, 32JH,”.
55 After paragraph 61(4)(b)
Insert: (baa) decisions on the inclusion of biologicals in the Register, or the suspension or cancellation of the inclusion of biologicals in the Register; or
56 Subsection 61(10)
After “subsection 25(2E)”, insert “(including as that subsection applies because of subsection 32DE(2) or 32EB(3))”.
57 After paragraph 63(2)(da)
Insert: (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
As at 12 January 2011 the amendments are not incorporated in this compilation.
Notes to the Therapeutic Goods Act 1989
Note 4
Note 4
Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010
(No. 141, 2010)
The following amendments commence immediately after the commencement of Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010:
Schedule 2
22 Before subsection 9D(3A)
Insert:
(3AA) If:
the Secretary must vary the entry in accordance with the request.
23 After paragraph 9D(3A)(a)
Insert: (aa) subsection (3AA) does not apply to the request; and
As at 12 January 2011 the amendments are not incorporated in this compilation.
Notes to the Therapeutic Goods Act 1989
Table A
Application, saving or transitional provisions
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
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).
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).
Notes to the Therapeutic Goods Act 1989
Table A
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
Therapeutic Goods Amendment Act 2001 (No. 14, 2001)
Schedule 1
36 Application of amendments
Notes to the 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
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.
Notes to the Therapeutic Goods Act 1989
Table A
46 Saving of existing registrations and listings
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:
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:
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.
Therapeutic Goods and Other Legislation Amendment Act 2002 (No. 56, 2002)
Schedule 3
20 Application
Notes to the Therapeutic Goods Act 1989
21 Transitional
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
Notes to the Therapeutic Goods Act 1989
Table A
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:
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
Financial Framework Legislation Amendment Act 2005 (No. 8, 2005)
4 Saving of matters in Part 2 of Schedule 1
(1) If:
Notes to the Therapeutic Goods Act 1989
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.
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.
Notes to the Therapeutic Goods Act 1989
Table A
Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008
(No. 96, 2008)
Schedule 1
3 Application
Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 (No. 38, 2009)
Schedule 2
4 Application
Schedule 3
23 Application and transitional
Notes to the Therapeutic Goods Act 1989
Schedule 4
20 Application and transitional
(1) If:
Notes to the Therapeutic Goods Act 1989
Table A
then that standard is taken not to apply to the goods at that time.
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).
Schedule 6
12 Saving and transitional
Notes to the Therapeutic Goods Act 1989
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
26 Transitional—existing licences
(1) This item applies to a licence that:
Notes to the Therapeutic Goods Act 1989
Table A
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.
Schedule 3
16 Application
Notes to the Therapeutic Goods Act 1989
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
Medical device standards
Conformity assessment standards
Notes to the Therapeutic Goods Act 1989
Table A
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
Notes to the Therapeutic Goods Act 1989
57 Application and transitional—registration or listing conditions
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.
Notes to the Therapeutic Goods Act 1989
Table A
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.
Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009
(No. 96, 2009)
Schedule 1
13 Saving and transitional
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:
Notes to the Therapeutic Goods Act 1989
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.
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
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.
Notes to the Therapeutic Goods Act 1989
Table A
Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010
(No. 54, 2010)
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
Notes to the Therapeutic Goods Act 1989
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.
Schedule 6
20 Application
The following provisions commence on 31 May 2011 unless proclaimed earlier:
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
Notes to the Therapeutic Goods Act 1989
Table A
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:
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.
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
Notes to the Therapeutic Goods Act 1989
which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect.
Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
Schedule 2
7 Application
21 Application
Notes to the Therapeutic Goods Act 1989
Table A