Commonwealth Consolidated Acts Commonwealth Consolidated ActsThe Secretary may, from time to time and in such manner as the Secretary determines, publish a list of the persons who are licensed under this Part, the classes of goods to which the licences relate, the steps of manufacture that the licences authorise and the addresses of the manufacturing sites to which the licences relate.
No. 21, 1990
Compilation No. 87
Compilation date: 14 October 2024
Includes amendments: Act No. 39, 2024
This compilation is in 2 volumes
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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 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
Endnotes
Endnote 1--About the endnotes
Endnote 2--Abbreviation key
Endnote 3--Legislation history
Endnote 4--Amendment history