THERAPEUTIC GOODS ACT 1989

Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989

TABLE OF PROVISIONS

Long Title

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.

CHAPTER 4--Medical devices

PART 4-1--INTRODUCTION

Division 1--Overview of this Chapter

41B. General
41BA. Requirements for medical devices (Parts 4 - 2 and 4 - 3)
41BB. Administrative processes (Parts 4 - 4 to 4 - 10)
41BC. Enforcement (Part 4 - 11)

Division 2--Interpretation

41BD. What is a medical device
41BE. Kinds of medical devices
41BEA. Excluded purposes
41BF. System or procedure packs
41BG. Manufacturers of medical devices
41BH. Meaning of compliance with essential principles
41BI. Meaning of non - application of conformity assessment procedures
41BIA. Meaning of non - application of overseas requirements comparable to conformity assessment procedures
41BIB. Overseas regulators

Division 3--Application provisions

41BJA. Application of this Chapter to a biological
41BK. Application of the Criminal Code

PART 4-2--ESSENTIAL PRINCIPLES AND MEDICAL DEVICE STANDARDS

41C. What this Part is about

Division 1--Essential principles

41CA. Essential principles

Division 2--Medical device standards

41CB. Medical device standards
41CC. Content of medical device standards
41CD. Inconsistencies between medical device standards

Division 3--Database of unique device identifiers of medical devices

41CE. Database of unique device identifiers of medical devices

PART 4-3--CONFORMITY ASSESSMENT PROCEDURES

41D. What this Part is about

Division 1--Conformity assessment procedures

41DA. Conformity assessment procedures
41DB. Medical device classifications

Division 2--Conformity assessment standards

41DC. Conformity assessment standards
41DD. Content of conformity assessment standards
41DE. Inconsistencies between conformity assessment standards

PART 4-4--CONFORMITY ASSESSMENT CERTIFICATES

41E. What this Part is about

Division 1--Issuing conformity assessment certificates

41EA. When conformity assessment certificates are required
41EB. Applications
41EC. Considering applications
41ECA. Conformity assessment (priority applicant) determinations
41ED. Time for making decisions on applications
41EE. Procedure following making a decision whether to issue certificate
41EF. Duration of certificate
41EG. Lapsing of applications
41EH. Treating applications as having been refused
41EI. Criminal offences for making a false statement
41EIA. Civil penalty for making a false statement

Division 2--Conditions

41EJ. Automatic conditions on conformity assessment certificates
41EK. Conditions imposed when conformity assessment certificates are issued
41EL. Conditions imposed after issuing a conformity assessment certificate

Division 3--Suspension of conformity assessment certificates

41EM. Suspension of conformity assessment certificates
41EN. Notice of proposed suspension
41EO. Duration of suspension
41EP. Revocation of suspension
41EQ. Powers of revocation of conformity assessment certificates unaffected

Division 4--Revocation of conformity assessment certificates

41ER. Automatic revocation of conformity assessment certificates
41ES. Immediate revocation of conformity assessment certificates
41ET. Revocation of conformity assessment certificates after notice of proposed revocation
41EU. Limiting revocation of conformity assessment certificates to some medical devices of a particular kind
41EV. Publication of revocation etc. of conformity assessment certificates
41EW. Date of effect of revocation etc. of conformity assessment certificates

PART 4-4A----AUSTRALIAN CONFORMITY ASSESSMENT BODIES

41EWA. Conformity assessment body determinations
41EWB. Content of Australian conformity assessment body certificates
41EWC. Duration of Australian conformity assessment body certificates
41EWD. Record - keeping

PART 4-5--INCLUDING MEDICAL DEVICES IN THE REGISTER

41F. What this Part is about

Division 1--Including medical devices in the Register

41FA. What this Division is about

Subdivision A--Applications

41FC. Making an application
41FD. Matters to be certified
41FDA. Basis of certification of conformity assessment procedures
41FDB. Preliminary assessment of applications
41FE. Criminal offences for making a false statement
41FEA. Civil penalty for making a false statement

Subdivision B--Including kinds of medical devices in the Register

41FF. Obligation to include kinds of medical devices in the Register
41FG. Notification of unsuccessful applications

Subdivision C--Auditing of applications

41FH. Selecting applications for auditing
41FI. Auditing of applications
41FIA. Certificates issued by Australian conformity assessment bodies
41FJ. Procedure following audits
41FK. Lapsing of applications

Subdivision D--Miscellaneous

41FKA. Medical devices (priority applicant) determinations
41FL. Device number
41FM. Duration of inclusion in the Register

Division 2--Conditions

41FN. Conditions applying automatically
41FO. Conditions imposed when kinds of medical devices are included in the Register
41FP. Conditions imposed after kinds of medical devices are included in the Register

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
41GA. Suspension of kinds of medical devices from the Register
41GB. Notice of proposed suspension must be given in certain cases
41GC. Duration of suspension
41GD. Revocation of suspension
41GE. Treating applications for revocation as having been refused

Subdivision B--Suspension as a result of suspension of conformity assessment document

41GF. Suspension where conformity assessment certificate suspended
41GFA. Suspension where other certificates or documents are suspended
41GG. Duration of suspension
41GH. Revocation of suspension

Subdivision C--Effect of suspension

41GI. Effect of suspension
41GJ. Powers of cancellation from Register unaffected

Division 2--Cancellation of entries from the Register

41GK. Automatic cancellation of entries of kinds of medical devices from the Register
41GL. Immediate cancellation of entries of kinds of medical devices from the Register
41GLA. Revocation of cancellation of entries upon request
41GLB. Revocation of cancellation of entries--payment of annual charge
41GM. Cancellation of entries of kinds of medical devices from the Register after section 41JA notice
41GN. Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation
41GO. Limiting cancellation of entries from Register to some medical devices of a particular kind
41GP. Publication of cancellation of entry from Register
41GQ. Date of effect of cancellation of entries from Register

PART 4-6A----EXEMPTING MEDICAL DEVICES TO DEAL WITH EMERGENCIES

41GR. What this Part is about
41GS. Minister may make exemptions
41GT. Conditions of exemptions
41GU. Variation or revocation of exemption
41GV. Informing persons of exemption etc.
41GW. Notification and tabling
41GY. Disposal of unused medical devices

PART 4-7--OTHER EXEMPTIONS FROM INCLUDING MEDICAL DEVICES IN THE REGISTER

41H. What this Part is about
41HA. Devices exempted from inclusion in the Register
41HB. Approvals for special and experimental uses
41HC. Authorities for health practitioners
41HD. Approvals if substitutes for medical devices are unavailable or in short supply

PART 4-8--OBTAINING INFORMATION

41J. What this Part is about

Division 1--Information relating to compliance with requirements and other matters

41JA. Secretary may require information or documents
41JB. Complying with the Secretary's requirements
41JBA. Civil penalty for giving false or misleading information in purported compliance with a notice
41JC. Self - incrimination

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
41JE. Secretary may require information relating to approvals under section 41HB
41JF. Secretary may require information relating to health practitioner authorisations
41JFA. Secretary may require information relating to approvals under section 41HD
41JG. Criminal offences for failing to give information or documents sought under this Division
41JH. False or misleading information
41JI. False or misleading documents
41JJ. Self - incrimination

PART 4-9--PUBLIC NOTIFICATION, AND RECALL, OF MEDICAL DEVICES

41K. What this Part is about
41KA. Public notification, and recall, of medical devices
41KB. Publication of requirements
41KC. Criminal offences for failing to comply with requirements relating to a kind of medical device
41KCA. Civil penalty for failing to comply with requirements relating to a kind of medical device
41KD. Powers of suspension and cancellation unaffected
41KE. Saving of other laws

PART 4-10----ASSESSMENT FEES

41L. What this Part is about
41LA. Assessment fees
41LB. When assessment fee due for payment
41LC. Payment of assessment fee by instalments
41LD. Recovery of assessment fee
41LE. Reduction of conformity assessment fee where decision not made within prescribed period

PART 4-11----OFFENCES AND CIVIL PENALTY PROVISIONS RELATING TO MEDICAL DEVICES

41M. What this Part is about

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
41MAA. Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles
41MB. Exceptions
41MC. Criminal offences relating to breaching a condition of a consent
41MCA. Civil penalty relating to breaching a condition of a consent
41MD. Treating medical devices as prohibited imports or exports

Division 2--Failure to apply conformity assessment procedures

41ME. Criminal offences for failing to apply conformity assessment procedures--manufacturers
41MEA. Civil penalties for failing to apply conformity assessment procedures--manufacturers
41MF. Criminal offences for failing to apply conformity assessment procedures--sponsors
41MG. Exceptions
41MH. Criminal offence for making false statements in declarations
41MHA. Civil penalty for making false statements in declarations

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
41MIA. Notice required to adduce evidence in support of exception under subsection 41MI(7)
41MIB. Civil penalty for importing, exporting, supplying or manufacturing a medical device not included in the Register
41MJ. Treating medical devices as prohibited imports or exports
41MK. Wholesale supply of medical devices not included in the Register
41ML. False advertising about medical devices
41MLA. Civil penalty for making misrepresentations about medical devices
41MLB. Civil penalty for false advertising about medical devices
41MN. Criminal offences relating to breaches of conditions
41MNA. Civil penalties for breaching conditions

Division 3A--Offences and civil penalties related to exemptions under Part 4-6A

41MNB. Criminal offences for breaching a condition of an exemption
41MNC. Civil penalty for breaching a condition of an exemption
41MND. Civil penalty for making misrepresentations about medical devices

Division 4--Other offences and civil penalty provisions

41MO. Criminal offences for misusing medical devices exempted for special or experimental uses
41MP. Criminal offence for failing to notify adverse events etc.
41MPA. Civil penalty for failing to notify adverse events etc.
41MPB. Relief from liability for contraventions for failing to notify adverse events etc.
41MQ. Notification of adverse events etc. where application withdrawn or lapses
41MR. Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses

CHAPTER 4A--Vaping goods

PART 4A-1--INTRODUCTION

Division 1--Introduction

41N. Simplified outline of this Chapter
41NA. Relationship with other Chapters of this Act

Division 2--Interpretation

41P. Meaning of vaping goods and related terms

PART 4A-2--OFFENCES AND CIVIL PENALTY PROVISIONS RELATING TO VAPING GOODS

Division 1--General

41Q. Offences and civil penalty provision--importing vaping goods into Australia
41QA. Offences and civil penalty provision--manufacturing vaping goods in Australia
41QB. Offences and civil penalty provision--supplying vaping goods
41QC. Offences and civil penalty provision--possessing at least commercial quantity of vaping goods
41QD. Offences and civil penalty provision--possessing less than commercial quantity of vaping goods

Division 2--Miscellaneous

41QE. Exceptions etc. to civil penalty provisions--burden of proof

PART 4A-3--OTHER PROVISIONS

Division 1--Determinations by Minister

41R. Minister may determine that specified vaping goods may be supplied or possessed in Australia in specified circumstances etc.
41RA. Minister may determine other indications for which vaping goods may be used

Division 2--Consent of Secretary

41RB. Application to Secretary for consent to manufacture, supply or possess vaping goods
41RC. Secretary may give consent
41RD. Offences and civil penalty provision--breaching condition of a consent

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.
42AB. This Part not to apply to advertisements for goods not for human use
42AC. This Part not to apply to advertisements for exported goods
42AD. This Part not to apply to advertisements about vaping goods
42B. Definitions
42BAA. Therapeutic Goods Advertising Code

Division 3--General provisions about advertising therapeutic goods

42DA. Simplified outline of this Division
42DB. Definitions
42DD. Restricted representations
42DE. Applications for approval of use of restricted representation
42DF. Approval of use of restricted representation
42DG. Notice of approval or refusal
42DH. Variation of conditions of approval
42DI. Withdrawal of approval
42DJ. Prohibited and required representations
42DK. Permitted use of restricted or prohibited representations

Division 3A--Advertising offences and civil penalties

42DKB. Certain representations not to be advertised
42DL. Advertising offences--general
42DLA. Advertising offences--contravening section 42DKB notice
42DLB. Civil penalty relating to advertisements--general
42DLC. Civil penalty relating to advertisements--contravening section 42DKB notice
42DM. Offences--non - compliance with the Therapeutic Goods Advertising Code
42DMA. Civil penalty--non - compliance with the Therapeutic Goods Advertising Code

Division 4--Generic information about ingredients or components of therapeutic goods

42DN. Application of Division
42DO. Compliance with the Code
42DP. Offences--dissemination of generic information
42DQ. Civil penalty for dissemination of generic information

Division 5--Secretary may require information or documents

42DR. Secretary may require information or documents
42DS. Criminal offences for failing to comply with a notice etc.
42DT. Civil penalty for giving false or misleading information or document in compliance with a notice
42DU. Self - incrimination

Division 6--Directions about advertisements or generic information

42DV. Directions about advertisements or generic information
42DW. Offences--contravening direction under section 42DV
42DX. Civil penalty for contravening direction under section 42DV

Division 7--Public warning notices

42DY. Secretary may issue a public warning notice

PART 5-1A----VAPING GOODS

Division 1--Preliminary

42DZA. This Part not to apply to certain advertisements for exported goods
42DZB. Definitions

Division 2--General provisions about advertising vaping goods

42DZC. Authorised advertisements etc.

Division 3--Offences and civil penalty provisions

42DZD. Offences--no authorisation or conditions of authorisation not complied with
42DZE. Civil penalty--no authorisation or conditions of authorisation not complied with

Division 4--Secretary may require information or documents

42DZF. Secretary may require information or documents
42DZG. Offences--failing to comply with a notice etc.
42DZH. Civil penalty--giving false or misleading information or document in compliance with a notice
42DZJ. Self - incrimination

Division 5--Directions about advertisements or generic information

42DZK. Directions about advertisements or generic information
42DZL. Offences--contravening direction under section 42DZK
42DZM. Civil penalty--contravening direction under section 42DZK

Division 6--Public warning notices

42DZN. Secretary may issue a public warning notice

PART 5-2--COUNTERFEIT THERAPEUTIC GOODS

42E. Offence of dealing with counterfeit therapeutic goods
42EA. Civil penalty relating to dealing with counterfeit therapeutic goods
42EB. Relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods
42F. Customs treatment of counterfeit therapeutic goods

PART 5-3--PRODUCT TAMPERING

42T. Notifying of actual or potential tampering
42U. Meaning of actual or potential tampering etc.
42V. Recall of therapeutic goods because of actual or potential tampering
42VA. Civil penalty relating to the recall of therapeutic goods because of actual or potential tampering
42VB. Relief from liability for contraventions relating to the recall of therapeutic goods because of actual or potential tampering
42W. Supply etc. of therapeutic goods that are subject to recall requirements
42X. Saving of other laws

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
42YA. What is a civil penalty provision ?
42YC. Persons involved in contravening civil penalty provision
42YCA. Continuing contraventions of civil penalty provisions
42YD. Recovery of a pecuniary penalty
42YE. Gathering information for application for pecuniary penalty

Division 2--Civil penalty proceedings and criminal proceedings

42YF. Civil proceedings after criminal proceedings
42YG. Criminal proceedings during civil proceedings
42YH. Criminal proceedings after civil proceedings
42YI. Evidence given in proceedings for civil penalty not admissible in criminal proceedings

PART 5A-2--INFRINGEMENT NOTICES

42YJ. Simplified outline of this Part
42YK. When an infringement notice may be given
42YKA. Matters to be included in an infringement notice
42YKB. Extension of time to pay amount--application by person
42YKBA. Extension of time to pay amount--extension by Secretary on own initiative
42YKC. Withdrawal of an infringement notice
42YKD. Effect of payment of amount
42YKE. Effect of this Part

PART 5A-3--ENFORCEABLE UNDERTAKINGS

42YL. Enforcement of undertakings

PART 5A-4--INJUNCTIONS

42YM. Simplified outline of this Part
42YN. Grant of injunctions
42YO. Interim injunctions
42YP. Discharging or varying injunctions
42YQ. Certain limits on granting injunctions not to apply
42YR. Other powers of court unaffected

PART 5A-5--ENFORCEABLE DIRECTIONS

42YS. Simplified outline of this Part
42YT. Secretary may give directions if this Act or an instrument is not being complied with

CHAPTER 6--Administration

PART 6-1--PAYMENT OF CHARGES

43. By whom charges payable
44. Time for payment of charges
44A. Exemptions from liability to pay charges
44B. Recovery of unpaid charges
45. Therapeutic Goods Administration Account

PART 6-1A----INFORMATION GATHERING POWERS

Division 1--Preliminary

45AA. Simplified outline of this Part

Division 2--Obtaining information or documents

45AB. Secretary may require information or documents
45AC. Offences for failing to comply with notice
45AD. Offences and civil penalty for giving false or misleading information or documents
45AE. Self - incrimination

Division 3--Inspecting, copying and retaining documents

45AF. Secretary may inspect and copy documents
45AG. Secretary may retain documents

PART 6-2--ENTRY, SEARCHES AND WARRANTS

45A. Definitions
46. Searches to monitor compliance with Act or regulations
46A. Searches of certain premises to monitor compliance with Act
46B. Searches and seizures on public health grounds
47. Searches and seizures related to offences and civil penalty provisions
48. General powers of authorised persons in relation to premises
48A. Details of warrant to be given to occupier etc.
48AA. Completing execution of warrant under section 50 after temporary cessation
48B. Announcement before entry
48BA. Use of electronic equipment at premises for monitoring compliance with Act or regulations
48C. Use of electronic equipment at premises relating to offences and civil penalty provisions
48D. Compensation for damage to electronic equipment
48E. Copies of seized things to be provided
48F. Occupier entitled to be present during search
48FA. Responsibility to provide facilities and assistance
48G. Receipts for things seized under warrant
48H. Retention of seized things
48J. Issuing officer may permit a thing to be retained
49. Monitoring warrants
50. Offence and civil penalty provision related warrants
51. Offence and civil penalty provision related warrants by telephone
51A. Inspections for purposes of Mutual Recognition Convention
51B. Offences relating to warrants
51C. Issuing officers--personal capacity
52. Identity cards

PART 6-2A----FORFEITURE OF THINGS SEIZED

52AAA. Forfeiture of things seized under search warrant in certain circumstances
52AAB. Return or retention of thing declared not to be forfeited to the Commonwealth

PART 6-3--SCHEDULING OF SUBSTANCES

52AA. Overview
52A. Definitions
52B. Advisory Committee on Medicines Scheduling
52C. Advisory Committee on Chemicals Scheduling
52CA. Joint meetings
52D. Poisons Standard
52E. Secretary to take certain matters into account in exercising powers
52EAA. Application for amendment of the Poisons Standard
52F. Incorporation of current Poisons Standard

CHAPTER 7--Miscellaneous

52G. Exemptions, approvals and authorities to be consistent with prohibitions under Chapter 2A
53. Retention of material on withdrawal of application
53A. Alternative verdicts for various offences
54. Offences and forfeiture
54AA. Offences for contravening conditions or requirements imposed under the regulations
54AB. Criminal offence for damaging etc. documents
54AC. Civil penalty for damaging etc. documents
54A. Time for bringing prosecutions
54B. Personal liability of an executive officer of a body corporate--general
54BA. Personal liability of an executive officer of a body corporate--offences covered
54C. Establishing whether an executive officer took reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision
55. Conduct by directors, employees and agents
56. Judicial notice
56A. Certificates to provide evidence of certain matters
57. Delegation
58. Export certifications
59. Fees
60. Review of decisions
60A. New information on review--discretion to remit
61. Release of information
61A. Immunity from civil actions
62. Protection from criminal responsibility
63. Regulations

CHAPTER 8--Repeal and transitional provisions

66. Transitional arrangements for goods required to be registered or listed
67. Transitional provision for therapeutic goods for export only
68. Transitional arrangements for Part 3 - 3
69. Continuation of standards and requirements

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