• Specific Year
    Any

THERAPEUTIC GOODS ACT 1989

Table of Provisions

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 theextended 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  
  • 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  
  • 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  
  • 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 a condition of an exemption  
  • 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  
  • 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
  • 32C What this Division is about  
  • 32CA Exempt biologicals  
  • 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.  
  • 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  
  • 32CO Approvals where substitutes for biologicals are unavailable etc.  
  • DIVISION 4--Including biologicals in the Register
  • 32D Simplified outline of this Division  
  • 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  
  • 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  
  • 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  
  • 32DN Transitional provisions for existing biologicals  
  • 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  
  • 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
  • 32J What this Division is about  
  • 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  
  • 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  
  • 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  
  • 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  

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

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  
  • 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  
  • 41FF Obligation to include kinds of medical devices in the Register  
  • 41FG Notification of unsuccessful 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  
  • 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
  • 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  
  • 41GF Suspension where conformity assessment certificate suspended  
  • 41GFA Suspension where other certificates or documents are suspended  
  • 41GG Duration of suspension  
  • 41GH Revocation 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 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  
  • 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 5-2--COUNTERFEIT THERAPEUTIC GOODS

PART 5-3--PRODUCT TAMPERING

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?  
  • 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  
  •  

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 Magistrate 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  
  • 52 Identity cards  

PART 6-3--SCHEDULING OF SUBSTANCES

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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