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
- 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
- 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
- 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 ofetc.
- 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?
- 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
- 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