Commonwealth: Therapeutic Goods Act 1989 (Cth)

Therapeutic Goods Act 1989 No. 21, 1990 Compilation No. 87 Compilation date: 14 October 2024 Includes amendments: Act No. 39, 2024 This compilation is in 2 volumes Volume 1: sections 1–41A Volume 2: sections 41B–69 Endnotes Each volume has its own contents About this compilation This compilation This is a compilation of the Therapeutic Goods Act 1989 that shows the text of the law as amended and in force on 14 October 2024 (the compilation date). The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Editorial changes For more information about any editorial changes made in this compilation, see the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents Chapter 1—Preliminary 1 Short title 2 Commencement 3 Interpretation 3AA Homoeopathic preparations and homoeopathic standards 3AB Anthroposophic preparations and anthroposophic standards 3A Declaration—member of European Community 3B Declaration—country covered by non‑EC/EFTA MRA 3C Exempting monographs in pharmacopoeias 4 Objects of Act 5 Act to bind Crown 5A Application of the Criminal Code—extended geographical jurisdiction 6 Operation of Act 6AAA Commonwealth consent to conferral of functions etc. on its officers and authorities by corresponding State laws 6AAB When duty imposed 6AAC Imposing duty under State law 6AAD Conferral of jurisdiction on federal courts 6AAE Consequences of State law conferring duty, function or power on Commonwealth officer or Commonwealth authority 6B Review of certain decisions under State laws 6C Fees payable to Commonwealth under State laws 7 Declaration that goods are/are not therapeutic goods 7AAA Minister may determine that goods are therapeutic goods 7AA Excluded goods 7A Authorised persons 7B Kits 7C Secretary may arrange for use of computer programs to make decisions 7D Form for product information for medicine 8 Power to obtain information with respect to therapeutic goods 9 Arrangements with States etc. Chapter 2—Australian Register of Therapeutic Goods 9A Australian Register of Therapeutic Goods 9C Inspection of entries in Register 9D Variation of entries in Register 9E Publication of list of goods on Register 9F Removal of entries from Register 9G Criminal offences for false statements in requests for variation of entries in Register 9H Civil penalty for false statements in requests for variation of entries in Register Chapter 2A—Prohibition on import, export, manufacture or supply of therapeutic goods—international agreements 9J Simplified outline of this Chapter 9K Prohibition on import, export, manufacture or supply of therapeutic goods—international agreements 9L Offence and civil penalty 9M Application of Customs Act 1901 9N Constitutional basis Chapter 3—Medicines and other therapeutic goods that are not medical devices Part 3‑1—Standards 10 Determination of standards 13 Special provisions relating to Ministerial standards and default standards 13A Special provisions relating to homoeopathic standards and anthroposophic standards 14 Criminal offences for importing, supplying or exporting goods that do not comply with standards 14A Civil penalties for importing, supplying or exporting goods that do not comply with standards 14B Application of Customs Act 1901 15 Criminal offences relating to breaching a condition of a consent 15AA Civil penalty relating to breaching a condition of a consent 15AB Conditions relating to exceptional release of biologicals Part 3‑2—Registration and listing of therapeutic goods Division 1—Preliminary 15A Part does not apply to a medical device 15B Application of this Part to a biological 16 Therapeutic goods and gazetted groups 18 Exempt goods 18A Exemption because of emergency 19 Approvals or authorities for certain uses 19A Approvals where unavailability etc. of therapeutic goods 19B Criminal offences relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods 19C Notice required to adduce evidence in support of exception under subsection 19B(6) 19D Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods 20 Criminal offences relating to notifying the Secretary and to importing goods exempt under section 18A 20A Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification 21 Offence relating to wholesale supply 21A General criminal offences relating to this Part 21B General civil penalties relating to this Part 22 General offences relating to this Part 22AA Civil penalty for breaching conditions 22A Criminal offences for false statements in applications for registration 22B Civil penalty for false statements in applications for registration Division 1A—Provisional determinations for medicine 22C Applications for provisional determination 22D Provisional determinations 22E Period during which provisional determination is in force 22F Revocation of provisional determination Division 1B—Scientific advice about aspects of quality, safety or efficacy of medicine 22G Scientific advice about aspects of quality, safety or efficacy of medicine Division 2—Registration and listing 23 Applications generally 23AA Applications for provisional registration of medicine 23A Classes of therapeutic goods 23B Requirements relating to applications for registration of therapeutic goods and listing of medicines under section 26AE 23C Requirements relating to applications for listing of therapeutic goods under section 26 or 26A 24 Applications for registration 24A When evaluation fee due for payment 24B Payment of evaluation fee by instalments 24C Recovery of evaluation fee 24D Refund of evaluation fee where evaluation not completed within prescribed period 24E Deemed refusal of application 25 Evaluation of therapeutic goods 25AAA Therapeutic goods (priority applicant) determinations 25AA Approved product information for medicine 25AB Registration of therapeutic goods etc. 25AC Notice of decision not to register therapeutic goods 25A When the Secretary must not use protected information 26 Listing of therapeutic goods 26A Listing of certain medicines 26AB Application for listing of certain medicines following efficacy evaluation 26AC Evaluation fees for listing of medicine under section 26AE 26AD Lapsing and deemed refusal of applications for listing of medicine under section 26AE 26AE Evaluation and listing of certain medicines 26AF When the Secretary must not use restricted information in evaluating medicine for listing under section 26AE 26B Certificates required in relation to patents 26BA Approved form for notices 26BB Permissible ingredients 26BC Variation of determination under section 26BB—Minister's initiative 26BD Requirements relating to an application for variation of a section 26BB determination 26BDA Lapsing of application for variation of a section 26BB determination 26BE Evaluation of whether to make recommendation for variation of a section 26BB determination 26BF Permissible indications 26BG Limitations on determination under section 26BF 26BH Variation of determination under section 26BF—Minister's initiative 26BJ Variation of determination under section 26BF—application by person 26C Certificates required in relation to patent infringement proceedings 26D Requirements for interlocutory injunction 27 Registration or listing number 28 Conditions of registration or listing 28A Certification of manufacturing steps outside Australia following application for listing 29 Duration of registration or listing 29A Criminal offence for failing to notify adverse effects etc. of goods 29AA Civil penalty for failing to notify adverse effects etc. of goods 29B Notification of adverse effects etc. where application withdrawn or lapses 29C Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses 29D Suspension of registration or listing 29E When suspension takes effect etc. 29F Revocation of suspension 29G Effect of suspension 30 Cancellation of registration or listing 30A Revocation of cancellation of registration or listing upon request 30AA Revocation of cancellation of registration or listing—payment of annual registration or listing charge 30B Publication of cancellation of registration or listing 30C Consultation with Gene Technology Regulator 30D Secretary may seek advice about classes of GM products or genetically modified organisms 30E Secretary to take advice into account Division 2A—Public notification, and recall, of therapeutic goods 30EA Public notification, and recall, of therapeutic goods 30EB Publication of requirements 30EC Criminal offences for non‑compliance with requirements 30ECA Civil penalty for non‑compliance with requirements 30ED Powers of suspension and cancellation unaffected 30EE Saving of other laws Division 2B—Reporting medicine shortages and discontinuation of supply of medicine 30EF Reporting medicine shortages 30EFA Reporting changes to the period of a medicine shortage and resolution of a medicine shortage 30EG Reporting discontinuation of supply of medicine 30EH What is a reportable medicine? 30EI When is there a medicine shortage? 30EIA What is the period of a medicine shortage? 30EJ Medicines Watch List Division 2C—Substitution of prescription medicine by pharmacists 30EK Minister may declare a serious scarcity of medicine 30EL Substitution of prescription medicine by pharmacists Division 3—General 30F Criminal offences for goods exempt under section 18A not conforming to standards etc. 30FA Civil penalty for goods exempt under section 18A not conforming to standards etc. 30G Disposal of unused goods exempt under section 18A 30H Record for goods exempt under section 18A 31 Secretary may require information or documents 31AAA Civil penalty for providing false or misleading information or documents in relation to therapeutic goods 31A Secretary may require information etc. about goods exempt under section 18 31AA Secretary may require information etc. about goods exempt under section 18A 31B Secretary may require information relating to approvals and authorities under section 19 31BA Secretary may require information about therapeutic goods approved under section 19A 31C Criminal offences for failing to give information or documents sought under section 31A, 31AA, 31B or 31BA 31D False or misleading information 31E False or misleading documents 31F Self‑incrimination Part 3‑2A—Biologicals Division 1—Preliminary 32 What this Part is about 32A Meaning of biological 32AA Biological classes 32AB When biologicals are separate and distinct from other biologicals Division 2—Main criminal offences and civil penalties 32B What this Division is about 32BA Criminal offences for importing a biological 32BB Criminal offences for exporting a biological 32BBA Treating biologicals as prohibited imports or exports 32BC Criminal offences for manufacturing a biological 32BD Criminal offences for supplying a biological 32BE Notice required to adduce evidence in support of exception to offences 32BF Civil penalties for importing, exporting, manufacturing or supplying a biological 32BG Criminal offences and civil penalty relating to a failure to notify the Secretary about manufacturing 32BH Criminal offence relating to wholesale supply 32BI Criminal offence for using a biological not included in the Register 32BJ General criminal offences relating to this Part 32BK Civil penalty for making misrepresentations about biologicals 32BL Civil penalty for advertising biological for an indication Division 3—Exemptions Subdivision A—Preliminary 32C What this Division is about Subdivision B—Exempting biologicals under the regulations 32CA Exempt biologicals Subdivision C—Exempting biologicals to deal with emergencies 32CB Minister may make exemptions 32CC Conditions of exemptions 32CD Variation or revocation of exemption 32CE Informing persons of exemption etc. 32CF Notification and tabling 32CG Disposal of unused biologicals 32CH Criminal offences for breaching a condition of an exemption 32CI Civil penalty for breaching a condition of an exemption 32CJ Criminal offences and civil penalty for biologicals not conforming to standards etc. Subdivision D—Exempting biologicals for certain uses 32CK Approvals for importing, exporting or supplying a biological for special and experimental uses 32CL Conditions of use of biological for experimental purposes in humans 32CM Authorities for health practitioners 32CN Criminal offences relating to the giving of an authority to a health practitioner Subdivision E—Exempting biologicals where substitutes are unavailable etc. 32CO Approvals where substitutes for biologicals are unavailable etc. Division 4—Including biologicals in the Register Subdivision A—Preliminary 32D Simplified outline of this Division Subdivision B—Class 1 biologicals 32DA Application for inclusion in the Register 32DB Inclusion of Class 1 biological in the Register 32DC Refusal to include Class 1 biological in the Register Subdivision BA—Export only biologicals 32DCA Application for inclusion in the Register 32DCB Inclusion of export only biological in the Register 32DCC Refusal to include export only biological in the Register Subdivision C—Biologicals other than Class 1 biologicals or export only biologicals 32DD Application for inclusion in the Register 32DDA Preliminary assessment of applications 32DE Evaluation of biologicals 32DEA Biologicals (priority applicant) determinations 32DF Inclusion of biological in the Register 32DG Refusal to include biological in the Register 32DH Lapsing of application 32DI Evaluation fee 32DJ When evaluation fee due for payment 32DK Payment of evaluation fee by instalments 32DL Recovery of evaluation fee 32DM Reduction of evaluation fee where evaluation not completed within prescribed period Subdivision D—Transitional provisions for existing biologicals 32DN Transitional provisions for existing biologicals Subdivision E—Criminal offences and civil penalties 32DO Criminal offences for false statements in applications for including biologicals in the Register 32DP Civil penalty for false statements in applications for including biologicals in the Register 32DQ Criminal offence and civil penalty for failing to notify adverse effects etc. of biological while it is included in the Register 32DR Criminal offences and civil penalties for failing to notify adverse effects etc. of biological where application withdrawn or lapses Subdivision F—Advice from Gene Technology Regulator 32DS Consultation with Gene Technology Regulator 32DT Secretary may seek advice about classes of GM products or genetically modified organisms 32DU Secretary to take advice into account Division 5—Conditions 32E What this Division is about 32EA Conditions applying automatically 32EB Certification of manufacturing steps outside Australia 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 32EF Criminal offences for breach of condition 32EG Civil penalty for breach of condition Division 6—Suspension from the Register 32F What this Division is about 32FA Suspension of biological from the Register 32FB When suspension takes effect etc. 32FC Revocation of suspension 32FD Effect of suspension Division 7—Cancellation from the Register 32G What this Division is about 32GA Immediate cancellation of biological from the Register in various circumstances 32GB Immediate cancellation of biological from the Register after failure to comply with information gathering notice 32GC Cancellation of biological from the Register after notice of proposed cancellation 32GD Revocation of cancellation of biological upon request 32GDA Revocation of cancellation of biological upon request—payment of annual charge 32GE Publication of cancellation of entry from Register 32GF Date of effect of cancellation of entries from Register Division 8—Public notification, and recall, of biologicals 32H What this Division is about 32HA Public notification, and recall, of biologicals 32HB Publication of requirements 32HC Criminal offences for non‑compliance with requirements 32HD Civil penalty for non‑compliance with requirements 32HE Powers of suspension and cancellation unaffected 32HF Saving of other laws Division 9—Obtaining information or documents Subdivision A—Preliminary 32J What this Division is about Subdivision B—Obtaining information or documents for biologicals included or proposed to be included in the Register 32JA Secretary may require information or documents 32JB Criminal offences for failing to comply with a notice etc. 32JC Civil penalty for giving false or misleading information or document in compliance with a notice 32JD Self‑incrimination Subdivision C—Obtaining information or documents for biologicals covered by exemptions 32JE Secretary may require information etc. about biologicals exempt under the regulations 32JF Secretary may require information etc. about biologicals exempt to deal with emergencies 32JG Secretary may require information etc. about biologicals exempt for special and experimental uses 32JH Secretary may require information etc. about biologicals exempt where substitutes are unavailable etc. 32JI Criminal offences for failing to comply with a notice etc. 32JJ Civil penalty for giving false or misleading information or document in compliance with a notice 32JK Self‑incrimination Subdivision D—Inspecting, copying and retaining documents 32JL Secretary may inspect and copy documents 32JM Secretary may retain documents Part 3‑3—Manufacturing of therapeutic goods 33A Part does not apply to a medical device 33B Application of this Part to biologicals 34 Exempt goods and exempt persons 35 Criminal offences relating to manufacturing therapeutic goods 35A Civil penalties relating to manufacturing therapeutic goods 35B Criminal offences relating to breaching a condition of a licence 35C Civil penalty relating to breaching a condition of a licence 36 Manufacturing principles 37 Application for licence 38 Grant of licence 38A Guidelines for multi‑site licences 38B Splitting multi‑site licences 39 Term of licence 40 Conditions of licences 40A Variation of manufacturing site authorisations—Secretary's own initiative 40B Variation of licences—application by licence holder 41 Revocation and suspension of licences 41AAAA Withdrawal of revocation of licence upon request 41AA Spent convictions scheme 41AB Secretary may require information or documents 41AC Criminal offence for contravening a requirement in a notice under section 41AB 41AD False or misleading information—offence 41AE False or misleading documents—offence 41AF False or misleading information or documents—civil penalty 41AG Self‑incrimination 41AAA Transfer of licences 41A Publication of list of manufacturers etc. An Act relating to therapeutic goods Chapter 1—Preliminary 1 Short title This Act may be cited as the Therapeutic Goods Act 1989. 2 Commencement This Act commences on the day after the day on which a House of the Parliament approves regulations made under this Act in the same form as approved by the other House, provided that: (a) not more than 90 days have elapsed; and (b) the places of Senators have not become vacant under section 13 of the Constitution; and (c) a dissolution or expiration of the House of Representatives has not occurred; between the approval of one House and the approval of the other House. 3 Interpretation (1) In this Act, unless the contrary intention appears: accessory, in relation to a medical device covered by paragraph 41BD(1)(a), (aa) or (ab), means a thing that the manufacturer of the thing specifically intended to be used together with the device to enable or assist the device to be used as the manufacturer of the device intended. actual or potential tampering has the meaning given by section 42U. advertise, in relation to therapeutic goods or vaping goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design: (a) is on the label of the goods; or (b) is on the package in which the goods are contained; or (c) is on any material included with the package in which the goods are contained. anthroposophic pharmacopoeia means: (a) a publication specified under paragraph 3AB(3)(a), as that publication is in force from time to time; or (b) a part of a publication specified under paragraph 3AB(3)(b), as that part is in force from time to time. anthroposophic preparation has the meaning given by subsection 3AB(1). anthroposophic standard has the meaning given by subsection 3AB(2). application audit assessment fee means a fee payable under subsection 41LA(3). assessment fee means: (a) a conformity assessment fee; or (b) an application audit assessment fee; payable under Part 4‑10. Australian conformity assessment body means an Australian corporation that is the subject of a conformity assessment body determination made under the regulations. Australian conformity assessment body certificate means a certificate that is issued by an Australian conformity assessment body and that is of a kind mentioned in section 41FIA. Australian corporation means a corporation that is registered under Part 2A.2 of the Corporations Act 2001. Australia‑UK Mutual Recognition Agreement means the Agreement on Mutual Recognition in Relation to Conformity Assessment, Certificates And Markings between the Government of Australia and the Government of the United Kingdom of Great Britain and Northern Ireland, as in force from time to time. Note: The Agreement could in 2020 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au). authorised person means: (a) in relation to any provision of this Act or the regulations, a person authorised by the Secretary to exercise powers under that provision; or (b) in relation to a provision of Part 6‑2 or 6‑2A, a member of the Australian Federal Police, or a Customs officer exercising powers in a Customs place (within the meaning of section 183UA of the Customs Act 1901). batch means a quantity of a product that is: (a) uniform in composition, method of manufacture and probability of chemical or microbial contamination; and (b) made in one cycle of manufacture and, in the case of a product that is sterilised or freeze dried, sterilised or freeze dried in one cycle. bioburden, in relation to therapeutic goods, means the quantity and characteristics of microorganisms present in the goods or to which the goods may be exposed in a manufacturing environment. biological has the meaning given by section 32A. biological number of a biological means: (a) the number assigned to the biological under subsection 32DB(2), 32DCB(2), 32DF(2) or 32DN(5); or (b) if, in accordance with regulations made for the purposes of paragraph 9A(4)(ca), a different number is assigned to the biological—that different number. British Pharmacopoeia means the edition of the publication of that name, including any additions or amendments, that was in effect for the purposes of this Act immediately before the commencement of Schedule 4 to the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the British Pharmacopoeia Commission or any replacement body. certification‑related activities, when used in relation to an Australian conformity assessment body, means activities that consist of, or relate to, the issue of certificates as mentioned in section 41FIA. civil penalty provision has the meaning given by section 42YA. Class 1 biological means a biological, other than an export only biological, included in a class of biologicals that is: (a) a class prescribed by the regulations for the purposes of section 32AA; and (b) a class referred to in those regulations as Class 1 biologicals. commercial quantity of a kind of vaping goods means the quantity of that kind of vaping goods prescribed by the regulations. Commonwealth authority includes: (a) a body corporate, or an unincorporated body, established for a public purpose by or under an Act; and (b) a tribunal or authority established by or in accordance with an Act. Commonwealth officer includes: (a) a Minister; and (b) a person holding: (i) an office established by or under an Act; or (ii) an appointment made under an Act; or (iii) an appointment made by the Governor‑General or a Minister but not under an Act; and (c) a person who is a member or officer of a Commonwealth authority; and (d) a person who is in the service or employment of the Commonwealth, or of a Commonwealth authority, or is employed or engaged under an Act or regulations made under an Act. composite pack has the meaning given by subsection 7B(2). Comptroller‑General of Customs means the person who is the Comptroller‑General of Customs in accordance with subsection 11(3) or 14(2) of the Australian Border Force Act 2015. conformity assessment body determination has the meaning given by section 41EWA. conformity assessment certificate means a certificate issued under section 41EE. conformity assessment document means: (a) a conformity assessment certificate; or (b) an Australian conformity assessment body certificate; or (c) an overseas regulator conformity assessment document. conformity assessment fee means a fee payable under subsection 41LA(1). conformity assessment procedures has the meaning given by section 41DA. conformity assessment standard means a conformity assessment standard specified in an order under section 41DC. container, in relation to therapeutic goods, means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion. corporation means a body corporate that is: (a) a foreign corporation; or (b) a trading corporation formed within the limits of the Commonwealth or a financial corporation so formed. corresponding State law means a State law declared by the regulations to correspond to this Act or the regulations, including such a law as amended from time to time. counterfeit has the meaning given by section 42E. current Poisons Standard has the meaning given by section 52A. Customs officer means an officer of Customs within the meaning of the Customs Act 1901. data processing device means any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device. default standard means any of the following: (a) a standard referred to in paragraph (b) of the definition of standard in this subsection; (b) a standard referred to in paragraph (c) of that definition; (c) a standard referred to in paragraph (d) of that definition. device number, in relation to a medical device, means any combination of numbers, symbols and letters assigned to the device under section 41FL. directions for use, in relation to therapeutic goods, includes information on: (a) appropriate doses of the goods; and (b) the method of administration or use of the goods; and (c) the frequency and duration of treatment for each indication of the goods; and (d) the use of the goods by persons of particular ages or by persons having particular medical conditions. EC/EFTA attestation of conformity means an attestation of conformity (within the meaning of the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement) issued by an EC/EFTA conformity assessment body that is approved by the Secretary in writing. EC/EFTA conformity assessment body means a Conformity Assessment Body designated in one of the following Sectoral Annexes to the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement: (a) Sectoral Annex (Medical Devices); (b) Sectoral Annex (Medicinal Products GMP Inspection and Batch Certification). EC Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community, as in force from time to time. EFTA Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Free Trade Association, as in force from time to time. essential principles has the meaning given by section 41CA. ethics committee means a committee: (a) constituted and operating as an ethics committee in accordance with guidelines issued by the CEO of the National Health and Medical Research Council as in force from time to time; and (b) which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992. European Pharmacopoeia means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the Council of Europe or any replacement body. evidential burden, in relation to a matter, means the burden of adducing or pointing to evidence that suggests a reasonable possibility that the matter exists or does not exist. exempt device means a medical device that is of a kind that is exempted from Division 3 of Part 4‑11 by the regulations. exempt goods, in relation to a provision of Part 3‑2, means therapeutic goods that are exempted from the operation of that Part (except section 31A and sections 31C to 31F) by the regulations. exempt goods, in relation to a provision of Part 3‑3, means therapeutic goods that are exempted from the operation of that Part by the regulations. exempt person, in relation to therapeutic goods, means a person exempted from the operation of Part 3‑3 in relation to those goods by the regulations. export only biological means a biological that is: (a) manufactured in Australia for export only; or (b) imported into Australia for export only. export only medicine means a medicine that: (a) is manufactured in Australia for export only, or imported into Australia for export only; and (b) is listable goods only because it is so manufactured or imported (and not for any other reason). Federal Court means the Federal Court of Australia. 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 goods group has the meaning given by subsection 16(2). Gene Technology Regulator has the same meaning as in the Gene Technology Act 2000. genetically modified organism has the same meaning as in the Gene Technology Act 2000. GM product has the same meaning as in the Gene Technology Act 2000. grouped therapeutic goods means therapeutic goods included in: (a) a gazetted therapeutic goods group; or (c) a gazetted kits group. health practitioner means a person who, under a law of a State or internal Territory, is registered or licensed to practice in any of the following health professions: (a) Aboriginal and Torres Strait Islander health practice; (b) dental (not including the professions of dental therapist, dental hygienist, dental prosthetist or oral health therapist); (c) medical; (d) medical radiation practice; (e) nursing; (f) midwifery; (g) occupational therapy; (h) optometry; (i) pharmacy; (j) physiotherapy; (k) podiatry; (l) psychology. homoeopathic pharmacopoeia means: (a) a publication specified under paragraph 3AA(3)(a), as that publication is in force from time to time; or (b) a part of a publication specified under paragraph 3AA(3)(b), as that part is in force from time to time. homoeopathic preparation has the meaning given by subsection 3AA(1). homoeopathic standard has the meaning given by subsection 3AA(2). included in the Register: (a) in relation to a biological—means included in the Register under Part 3‑2A; and (b) in relation to a medical device to which Chapter 4 applies—means included in the Register under Chapter 4. indications, in relation to therapeutic goods, means the specific therapeutic uses of the goods. international instrument means: (a) any treaty, convention, protocol, agreement or other instrument that is binding in international law; and (b) a part of such a treaty, convention, protocol, agreement or other instrument. issuing officer means: (a) a magistrate; or (b) a registrar or other officer of a court of a State or Territory who is authorised under a law of the State or Territory to issue search warrants. kind, in relation to a medical device, has the meaning given by section 41BE. label, in relation to therapeutic goods, means a display of printed information: (a) on or attached to the goods; or (b) on or attached to a container or primary pack in which the goods are supplied; or (c) supplied with such a container or pack. licence means a licence under Part 3‑3. listable goods means therapeutic goods that are required under the regulations to be included in the part of the Register relating to listed goods. listed goods means therapeutic goods that are included in the Part of the Register for goods known as listed goods. listing number, in relation to listed goods, means any combination of numbers, symbols and letters assigned to the goods under section 27. major interest holder of a body corporate means a person who: (a) is in a position to cast, or control the casting of, more than one‑fifth of the maximum number of votes that might be cast at a general meeting of the body corporate; or (b) holds more than one‑fifth of the issued share capital of the body corporate (excluding any part of that issued share capital that carries no right to participate beyond a specified amount in a distribution of either profits or capital). manufacture, in relation to therapeutic goods, or vaping goods, that are not medical devices, means: (a) to produce the goods; or (b) to engage in any part of the process of producing the goods or of bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process. manufacturer, of a medical device, has the meaning given by section 41BG. manufacturing principles means the principles for the time being having effect under section 36. manufacturing site means premises: (a) that are for use in the manufacture of a particular kind of therapeutic goods; and (b) at which the same persons have control of the management of the production of the goods and the procedures for quality control. manufacturing site authorisation means an authorisation referred to in subsection 38(2B) or 40B(4). medical device has the meaning given by section 41BD. medical device classification means a classification specified in the regulations made for the purposes of section 41DB. medical device standard, in relation to a kind of medical device, means a medical device standard, specified in an order under section 41CB, that is applicable to that kind of medical device. medical practitioner means a person who is registered or licensed as a medical practitioner under a law of a State or an internal Territory that provides for the registration or licensing of medical practitioners. medicine means therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human. member of EFTA means a country declared by the Minister under section 3A to be a member of the European Free Trade Association. member of the European Community means a country declared by the Minister under section 3A to be a member of the European Community. mother substance means any of the following: (a) an animal; (b) a plant; (c) an alga; (d) a fungus; (e) a micro‑organism; (f) a mineral; (g) a mineral compound; (h) a chemical; (i) a product obtained from any of the things mentioned in paragraphs (a) to (h). Mutual Recognition Convention means the Convention for the Mutual Recognition of Inspections in respect of the Manufacture of Pharmaceutical Products done at Geneva on 8 October 1970. national emergency declaration has the same meaning as in the National Emergency Declaration Act 2020. non‑EC/EFTA attestation of conformity, for a non‑EC/EFTA MRA, means an attestation of conformity issued, after the non‑EC/EFTA MRA has come into force, by a conformity assessment body that is designated in the non‑EC/EFTA MRA and approved by the Secretary in writing for the non‑EC/EFTA MRA. non‑EC/EFTA MRA means an international instrument that Australia is bound by, or is a party to, if: (a) a purpose of the instrument is the recognition of attestations of conformity; and (b) the instrument satisfies the requirements (if any) set out in regulations made for the purposes of this paragraph; but does not include: (c) the EC Mutual Recognition Agreement; or (d) the EFTA Mutual Recognition Agreement. nurse practitioner means a person who is registered, or authorised (however described) to practise, as a nurse practitioner by or under a law of a State or an internal Territory that provides for the registration of nurse practitioners, or the authorisation of persons to practise as nurse practitioners. oath includes affirmation. overseas regulator has the meaning given by section 41BIB. overseas regulator conformity assessment document means a certificate or other document that is issued by an overseas regulator after that regulator is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to a medical device by the manufacturer of the device. passed preliminary assessment: (a) when used in relation to a section 23 application for registration—has the meaning given by subsection 23B(3); and (b) when used in relation to a section 23 application for listing under section 26AE—has the meaning given by subsection 23B(3); and (ba) when used in relation to a section 26BD application—has the meaning given by subsection 26BD(4); and (c) when used in relation to a section 32DD application—has the meaning given by subsection 32DDA(3); and (d) when used in relation to a section 41FC application—has the meaning given by subsection 41FDB(3). period of a shortage of a medicine in Australia has the meaning given by section 30EIA. personal information has the same meaning as in the Privacy Act 1988. pharmacist means a person who is registered as a pharmacist under a law of a State or an internal Territory that provides for the registration of pharmacists. poison means an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury and includes any ingredient, compound, material or preparation referred to in a schedule to the current Poisons Standard. premises includes: (a) a structure, building, aircraft, vehicle or vessel; and (b) a place (whether enclosed or built upon or not); and (c) a part of a thing referred to in paragraph (a) or (b). presentation, in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods. primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers. product information, in relation to therapeutic goods, means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods. protected information, in relation to therapeutic goods, has the meaning given by section 25A. quality, in relation to therapeutic goods, includes the composition, strength, potency, stability, sterility, purity, bioburden, design, construction and performance characteristics of the goods. refurbishment has the meaning given by the regulations. Register means the Australian Register of Therapeutic Goods maintained under section 9A. registered goods means: (a) therapeutic goods included in the part of the Register for goods known as registered goods; or (b) therapeutic goods included in the part of the Register for goods known as provisionally registered goods. Note: Subsection (8) provides that a reference in this Act to therapeutic goods that are registered, or to the registration of therapeutic goods, includes a reference to a medicine that is provisionally registered under section 29. registration number, in relation to registered goods, means any combination of numbers, symbols and letters assigned to the goods under section 27. related body corporate has the same meaning as in the Corporations Act 2001. reportable medicine has the meaning given by section 30EH. restricted information has the meaning given by section 26AF. restricted medicine means: (a) a medicine specified in an instrument under subsection (2A); or (b) a medicine included in a class of medicine specified in an instrument under subsection (2B). scheduling has the meaning given by section 52A. Secretary means the Secretary of the Department. shortage of a medicine in Australia has the meaning given by section 30EI. sponsor, in relation to therapeutic goods, means: (a) a person who exports, or arranges the exportation of, the goods from Australia; or (b) a person who imports, or arranges the importation of, the goods into Australia; or (c) a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere); but does not include a person who: (d) exports, imports or manufactures the goods; or (e) arranges the exportation, importation or manufacture of the goods; on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia. standard, in relation to therapeutic goods, means any of the following: (a) a standard that is constituted by the matters specified in an order under section 10 that is applicable to the goods; (b) if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1) in relation to the goods) in the British Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) in those monographs, as interpreted in accordance with the General Notices section of the British Pharmacopoeia; (c) if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1) in relation to the goods) in the European Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) in those monographs, as interpreted in accordance with the General Notices section of the European Pharmacopoeia; (d) if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1) in relation to the goods) in the United States Pharmacopeia‑National Formulary—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) in those monographs, as interpreted in accordance with the General Notices section of the United States Pharmacopeia‑National Formulary; (e) a homoeopathic standard; (f) an anthroposophic standard. Note: See also section 13. State includes the Australian Capital Territory and the Northern Territory. State law means a law of a State, of the Australian Capital Territory or of the Northern Territory. supply includes: (a) supply by way of sale, exchange, gift, lease, loan, hire or hire‑purchase; and (b) supply, whether free of charge or otherwise, by way of sample or advertisement; and (c) supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods or vaping goods in persons; and (d) supply by way of administration to, or application in the treatment of, a person. system or procedure pack has the meaning given by section 41BF. tamper: therapeutic goods are tampered with if: (a) they are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and (b) the interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person. therapeutic goods means goods: (a) that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be: (i) for therapeutic use; or (ii) for use as an ingredient or component in the manufacture of therapeutic goods; or (iii) for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or (b) included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii); or (ba) determined to be therapeutic goods under subsection 7AAA(1); and includes biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include: (c) goods declared not to be therapeutic goods under an order in force under section 7; or (d) goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or (e) goods (other than goods declared to be therapeutic goods under an order in force under section 7 and goods determined to be therapeutic goods under subsection 7AAA(1)) for which there is a standard (within the meaning of subsection 4(1) of the Food Standards Australia New Zealand Act 1991); or (f) goods (other than goods declared to be therapeutic goods under an order in force under section 7 and goods determined to be therapeutic goods under subsection 7AAA(1)) which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented; or (g) goods covered by a determination under subsection 7AA(1) (excluded goods); or (h) goods covered by a determination under subsection 7AA(2) (excluded goods), if the goods are used, advertised, or presented for supply in the way specified in the determination. Therapeutic Goods Advertising Code means the code in force under section 42BAA. therapeutic use means use in or in connection with: (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or (b) influencing, inhibiting or modifying a physiological process in persons; or (c) testing the susceptibility of persons to a disease or ailment; or (d) influencing, controlling or preventing conception in persons; or (e) testing for pregnancy in persons; or (f) the replacement or modification of parts of the anatomy in persons. trading corporation means a trading corporation within the meaning of paragraph 51(xx) of the Constitution. unique device identifier of a medical device means any combination of numbers, symbols and letters given to the device to enable identification of the device (whether or not that combination also allows identification of information relating to the device). unit of vaping goods has the meaning prescribed by the regulations. 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. vaping accessory has the meaning given by section 41P. vaping device has the meaning given by section 41P. vaping goods has the meaning given by section 41P. vaping substance has the meaning given by section 41P. working day, for a person, means any day except: (a) Saturday or Sunday; or (b) a day that is a public holiday in the State or Territory in which the person is located. (2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals. (2A) The Minister may, by legislative instrument, specify medicines for the purposes of paragraph (a) of the definition of restricted medicine in subsection (1). (2B) The Minister may, by legislative instrument, specify classes of medicine for the purposes of paragraph (b) of the definition of restricted medicine in subsection (1). (3) The Secretary must, at least once in each year, cause to be published in the Gazette or on the Department's website a list of the names of all persons, other than members of the Australian Federal Police, who are, at the time of publication, authorised persons. (4) The provisions of this Act are in addition to, and not in substitution for, the provisions of any other Act that relate to therapeutic goods. (5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and, without limiting the previous words in this subsection, the presentation of therapeutic goods is unacceptable: (a) if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or (b) if a name applied to the goods is the same as the name applied to other therapeutic goods that are supplied in Australia where those other goods contain additional or different therapeutically active ingredients; or (c) if the label of the goods does not declare the presence of a therapeutically active ingredient; or (ca) if the therapeutic goods are medicine included in a class of medicine prescribed by the regulations for the purposes of this paragraph—if the medicine's label does not contain the advisory statements specified under subsection (5A) in relation to the medicine; or (d) if a form of presentation of the goods may lead to unsafe use of the goods or suggests a purpose that is not in accordance with conditions applicable to the supply of the goods in Australia; or (e) in prescribed cases. (5A) The Minister may, by legislative instrument, specify advisory statements in relation to medicine for the purposes of paragraph (5)(ca). (5B) For the purposes of subsection (5A), the Minister may specify different advisory statements for different medicines or different classes of medicine. (6) A reference in this Act to an annual registration charge, an annual listing charge, an annual charge for inclusion in the Register, an annual licensing charge or an annual conformity assessment body determination charge is a reference to such a charge imposed under the Therapeutic Goods (Charges) Act 1989. (7) A reference to an offence against this Act includes a reference to: (a) an offence against the regulations; and (b) an offence against section 6 of the Crimes Act 1914, or section 11.1, 11.4 or 11.5 of the Criminal Code, in relation to an offence against this Act or the regulations; and (c) an offence against section 136.1, 137.1 or 137.2 of the Criminal Code in relation to this Act or the regulations. (7A) For the purposes of this Act, a corresponding State law imposes a duty on a Commonwealth officer or Commonwealth authority if: (a) the corresponding State law confers a function or power on the officer or authority; and (b) the circumstances in which the function or power is conferred give rise to an obligation on the officer or authority to perform the function or to exercise the power. (8) To avoid doubt: (a) a reference in this Act to therapeutic goods that are registered includes a reference to a medicine that is provisionally registered; and (b) a reference in this Act to the registration of therapeutic goods includes a reference to the provisional registration of a medicine. Note: Subsection 29(2) deals with the provisional registration of a medicine. 3AA Homoeopathic preparations and homoeopathic standards Homoeopathic preparation (1) For the purposes of this Act, a homoeopathic preparation is a preparation: (a) manufactured from a mother substance; and (b) manufactured in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia. Homoeopathic standard (2) For the purposes of this Act, if: (a) there are therapeutic goods that are a homoeopathic preparation; and (b) the goods are the subject of one or more monographs (other than a monograph exempt under subsection (4)) in the homoeopathic pharmacopoeia describing the manufacturing procedure that the preparation was manufactured in accordance with; then there is a homoeopathic standard, in relation to the goods, that is constituted by the statements (other than statements exempt under subsection (5)) in those monographs, as interpreted in accordance with any interpretation sections of that homoeopathic pharmacopoeia. Specifying publications (3) The Minister may, by legislative instrument, specify either or both of the following for the purposes of the definition of homoeopathic pharmacopoeia in subsection 3(1): (a) publications; (b) parts of publications. Exempting entire monographs (4) The Minister may, by legislative instrument, determine that specified monographs in a specified homoeopathic pharmacopoeia are exempt for the purposes of paragraph (2)(b). Note: For specification by class, see subsection 13(3) of the Legislation Act 2003. Exempting parts of monographs (5) The Minister may, by legislative instrument, determine that specified statements in specified monographs in a specified homoeopathic pharmacopoeia are exempt for the purposes of subsection (2). 3AB Anthroposophic preparations and anthroposophic standards Anthroposophic preparation (1) For the purposes of this Act, an anthroposophic preparation is a preparation: (a) manufactured from a mother substance; and (b) manufactured in accordance with a manufacturing procedure described in an anthroposophic pharmacopoeia. Anthroposophic standard (2) For the purposes of this Act, if: (a) there are therapeutic goods that are an anthroposophic preparation; and (b) the goods are the subject of one or more monographs (other than a monograph exempt under subsection (4)) in the anthroposophic pharmacopoeia describing the manufacturing procedure that the preparation was manufactured in accordance with; then there is an anthroposophic standard, in relation to the goods, that is constituted by the statements (other than statements exempt under subsection (5)) in those monographs, as interpreted in accordance with any interpretation sections of that anthroposophic pharmacopoeia. Specifying publications (3) The Minister may, by legislative instrument, specify either or both of the following for the purposes of the definition of anthroposophic pharmacopoeia in subsection 3(1): (a) publications; (b) parts of publications. Exempting entire monographs (4) The Minister may, by legislative instrument, determine that specified monographs in a specified anthroposophic pharmacopoeia are exempt for the purposes of paragraph (2)(b). Note: For specification by class, see subsection 13(3) of the Legislation Act 2003. Exempting parts of monographs (5) The Minister may, by legislative instrument, determine that specified statements in specified monographs in a specified anthroposophic pharmacopoeia are exempt for the purposes of subsection (2). 3A Declaration—member of European Community (1) The Minister may declare, in writing, that a country specified in the declaration is a member of: (a) the European Community; or (b) the European Free Trade Association. (2) A declaration under subsection (1) must be published in the Gazette or on the Department's website. 3B Declaration—country covered by non‑EC/EFTA MRA (1) The Minister may declare, in writing, that a country specified in the declaration is covered by the non‑EC/EFTA MRA specified in the declaration. (2) A declaration under subsection (1) must be published in the Gazette or on the Department's website. 3C Exempting monographs in pharmacopoeias Exempting entire monographs (1) The Minister may, by legislative instrument, determine that specified monographs in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary are exempt in relation to specified therapeutic goods for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1). The determination applies to those monographs as in force from time to time. Note: For specification by class, see subsection 13(3) of the Legislation Act 2003. Exempting parts of monographs (2) The Minister may, by legislative instrument, determine that specified statements in specified monographs in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary are exempt in relation to specified therapeutic goods for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1). The determination applies to those statements and monographs as in force from time to time. Incorporation of other instruments (3) Despite subsection 14(2) of the Legislation Act 2003, a determination under subsection (1) or (2) of this section may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time. 4 Objects of Act (1) The objects of this Act are to do the following, so far as the Constitution permits: (a) provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are: (i) used in Australia, whether produced in Australia or elsewhere; or (ii) exported from Australia; (b) to provide a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia; (c) provide for a scheme allowing pharmacists to substitute certain medicine for other medicine if the Minister has declared there is a serious scarcity of the other medicine; (d) provide for the establishment and maintenance of a national system of controls relating to the regulation of vaping goods that are: (i) imported into Australia; or (ii) manufactured in Australia; or (iii) supplied in Australia, whether manufactured in Australia or elsewhere; or (iv) exported from Australia. (1A) The reference in paragraph (1)(a) to the efficacy of therapeutic goods is a reference, if the goods are medical devices, to the performance of the devices as the manufacturer intended. (2) This Act is therefore not intended to apply to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory to the extent that the law is capable of operating concurrently with this Act. 5 Act to bind Crown This Act binds the Crown in right of the Commonwealth, of each of the States, of the Australian Capital Territory and of the Northern Territory, but nothing in this Act renders the Crown liable to be prosecuted for an offence or to be subject to civil proceedings for a contravention of a civil penalty provision. 5A Application of the Criminal Code—extended geographical jurisdiction Section 15.2 of the Criminal Code (extended geographical jurisdiction—category B) applies to offences against subsections 21A(1), (4) and (4A), sections 22A, 32DO and 41FE, subsections 42DZD(1) and (2) and sections 42DZG, 42DZL, 42E and 42T. 6 Operation of Act (1) This Act (other than Part 6‑1A) applies to: (a) things done by corporations; and (b) things done by natural persons or corporations in so far as those things are done: (i) in the course of, or in preparation for, trade or commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories; or (ii) under a law of the Commonwealth relating to the provision of pharmaceutical or repatriation benefits; or (iii) in relation to the Commonwealth or in relation to an authority of the Commonwealth. (2) Without limiting the effect of this Act apart from this subsection, this Act also has the effect it would have if the reference in paragraph (1)(a) to things done by corporations were confined to things done by trading corporations for the purposes of their trading activities. 6AAA Commonwealth consent to conferral of functions etc. on its officers and authorities by corresponding State laws (1) A corresponding State law may confer functions or powers, or impose duties, on: (a) a Commonwealth officer; or (b) a Commonwealth authority. (2) Subsection (1) does not authorise the conferral of a function or power, or the imposition of a duty, by a corresponding State law to the extent to which: (a) the conferral or imposition, or the authorisation, would contravene any constitutional doctrines restricting the duties that may be imposed on Commonwealth officers or Commonwealth authorities; or (b) the authorisation would otherwise exceed the legislative power of the Commonwealth. (3) Subsection (1) does not extend to a function, power or duty of a kind specified in regulations made for the purposes of this subsection. (4) This Act is not intended to exclude or limit the operation of a corresponding State law that confers any functions or powers, or imposes any duties, on a Commonwealth officer or Commonwealth authority to the extent to which that law: (a) is consistent with subsections (1) to (3); and (b) is capable of operating concurrently with this Act. 6AAB When duty imposed Application (1) This section applies if a corresponding State law purports to impose a duty on a Commonwealth officer or Commonwealth authority. State legislative power sufficient to support duty (2)