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THERAPEUTIC GOODS ACT 1989


TABLE OF PROVISIONS

           Long Title

            

CHAPTER 1--Preliminary
            

   1.      Short title  
   2.      Commencement  
   3.      Interpretation  
   3AA.    Homoeopathic preparations and homoeopathic standards  
   3AB.    Anthroposophic preparations and anthroposophic standards  
   3A.     Declaration--member of European Community  
   3B.     Declaration--country covered by non - EC/EFTA MRA  
   3C.     Exempting monographs in pharmacopoeias  
   4.      Objects of Act  
   5.      Act to bind Crown  
   5A.     Application of the Criminal Code-- extended geographical jurisdiction  
   6.      Operation of Act  
   6AAA.   Commonwealth consent to conferral of functions etc. on its officers and authorities by corresponding State laws  
   6AAB.   When duty imposed  
   6AAC.   Imposing duty under State law  
   6AAD.   Conferral of jurisdiction on federal courts  
   6AAE.   Consequences of State law conferring duty, function or power on Commonwealth officer or Commonwealth authority  
   6B.     Review of certain decisions under State laws  
   6C.     Fees payable to Commonwealth under State laws  
   7.      Declaration that goods are/are not therapeutic goods  
   7AA.    Excluded goods  
   7A.     Authorised persons  
   7B.     Kits  
   7C.     Secretary may arrange for use of computer programs to make decisions  
   7D.     Form for product information for medicine  
   8.      Power to obtain information with respect to therapeutic goods  
   9.      Arrangements with States etc.  
            

CHAPTER 2--Australian Register of Therapeutic Goods
            

   9A.     Australian Register of Therapeutic Goods  
   9C.     Inspection of entries in Register  
   9D.     Variation of entries in Register  
   9E.     Publication of list of goods on Register  
   9F.     Removal of entries from Register  
   9G.     Criminal offences for false statements in requests for variation of entries in Register  
   9H.     Civil penalty for false statements in requests for variation of entries in Register  
            

CHAPTER 2A--Prohibition on import, export, manufacture or supply of therapeutic goods--international agreements
            

   9J.     Simplified outline of this Chapter  
   9K.     Prohibition on import, export, manufacture or supply of therapeutic goods--international agreements  
   9L.     Offence and civil penalty  
   9M.     Application of Customs Act 1901  
   9N.     Constitutional basis  
            

CHAPTER 3--Medicines and other therapeutic goods that are not medical devices
            

   PART 3-1--STANDARDS

   10.     Determination of standards  
   13.     Special provisions relating to Ministerial standards and default standards  
   13A.    Special provisions relating to homoeopathic standards and anthroposophic standards  
   14.     Criminal offences for importing, supplying or exporting goods that do not comply with standards  
   14A.    Civil penalties for importing, supplying or exporting goods that do not comply with standards  
   14B.    Application of Customs Act 1901  
   15.     Criminal offences relating to breaching a condition of a consent  
   15AA.   Civil penalty relating to breaching a condition of a consent  
   15AB.   Conditions relating to exceptional release of biologicals  

   PART 3-2--REGISTRATION AND LISTING OF THERAPEUTIC GOODS

           Division 1--Preliminary

   15A.    Part does not apply to a medical device  
   15B.    Application of this Part to a biological  
   16.     Therapeutic goods and gazetted groups  
   18.     Exempt goods  
   18A.    Exemption because of emergency  
   19.     Approvals or authorities for certain uses  
   19A.    Approvals where unavailability etc. of therapeutic goods  
   19B.    Criminal offences relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods  
   19C.    Notice required to adduce evidence in support of exception under subsection 19B(6)  
   19D.    Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods  
   20.     Criminal offences relating to notifying the Secretary and to importing goods exempt under section 18A  
   20A.    Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification  
   21.     Offence relating to wholesale supply  
   21A.    General criminal offences relating to this Part  
   21B.    General civil penalties relating to this Part  
   22.     General offences relating to this Part  
   22AA.   Civil penalty for breaching 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 biological  
   32AA.   Biological classes  
   32AB.   When biologicals are separate and distinct from other biologicals  

           Division 2--Main criminal offences and civil penalties

   32B.    What this Division is about  
   32BA.   Criminal offences for importing a biological  
   32BB.   Criminal offences for exporting a biological  
   32BBA.  Treating biologicals as prohibited imports or exports  
   32BC.   Criminal offences for manufacturing a biological  
   32BD.   Criminal offences for supplying a biological  
   32BE.   Notice required to adduce evidence in support of exception to offences  
   32BF.   Civil penalties for importing, exporting, manufacturing or supplying a biological  
   32BG.   Criminal offences and civil penalty relating to a failure to notify the Secretary about manufacturing  
   32BH.   Criminal offence relating to wholesale supply  
   32BI.   Criminal offence for using a biological not included in the Register  
   32BJ.   General criminal offences relating to this Part  
   32BK.   Civil penalty for making misrepresentations about biologicals  
   32BL.   Civil penalty for advertising biological for an indication  

           Division 3--Exemptions

              Subdivision A--Preliminary

   32C.    What this Division is about  

              Subdivision B--Exempting biologicals under the regulations

   32CA.    Exempt biologicals  

              Subdivision C--Exempting biologicals to deal with emergencies

   32CB.   Minister may make exemptions  
   32CC.   Conditions of exemptions  
   32CD.   Variation or revocation of exemption  
   32CE.   Informing persons of exemption etc.  
   32CF.   Notification and tabling  
   32CG.   Disposal of unused biologicals  
   32CH.   Criminal offences for breaching a condition of an exemption  
   32CI.   Civil penalty for breaching a condition of an exemption  
   32CJ.   Criminal offences and civil penalty for biologicals not conforming to standards etc.  

              Subdivision D--Exempting biologicals for certain uses

   32CK.   Approvals for importing, exporting or supplying a biological for special and experimental uses  
   32CL.   Conditions of use of biological for experimental purposes in humans  
   32CM.   Authorities for health practitioners  
   32CN.   Criminal offences relating to the giving of an authority to a health practitioner  

              Subdivision E--Exempting biologicals where substitutes are unavailable etc.

   32CO.   Approvals where substitutes for biologicals are unavailable etc.  

           Division 4--Including biologicals in the Register

              Subdivision A--Preliminary

   32D.    Simplified outline of this Division  

              Subdivision B--Class 1 biologicals

   32DA.   Application for inclusion in the Register  
   32DB.   Inclusion of Class 1 biological in the Register  
   32DC.   Refusal to include Class 1 biological in the Register  

              Subdivision BA--Export only biologicals

   32DCA.  Application for inclusion in the Register  
   32DCB.  Inclusion of export only biological in the Register  
   32DCC.  Refusal to include export only biological in the Register  

              Subdivision C--Biologicals other than Class 1 biologicals or export only biologicals

   32DD.   Application for inclusion in the Register  
   32DDA.  Preliminary assessment of applications  
   32DE.   Evaluation of biologicals  
   32DEA.  Biologicals (priority applicant) determinations  
   32DF.   Inclusion of biological in the Register  
   32DG.   Refusal to include biological in the Register  
   32DH.   Lapsing of application  
   32DI.   Evaluation fee  
   32DJ.   When evaluation fee due for payment  
   32DK.   Payment of evaluation fee by instalments  
   32DL.   Recovery of evaluation fee  
   32DM.   Reduction of evaluation fee where evaluation not completed within prescribed period  

              Subdivision D--Transitional provisions for existing biologicals

   32DN.   Transitional provisions for existing biologicals  

              Subdivision E--Criminal offences and civil penalties

   32DO.   Criminal offences for false statements in applications for including biologicals in the Register  
   32DP.   Civil penalty for false statements in applications for including biologicals in the Register  
   32DQ.   Criminal offence and civil penalty for failing to notify adverse effects etc. of biological while it is included in the Register  
   32DR.   Criminal offences and civil penalties for failing to notify adverse effects etc. of biological where application withdrawn or lapses  

              Subdivision F--Advice from Gene Technology Regulator

   32DS.   Consultation with Gene Technology Regulator  
   32DT.   Secretary may seek advice about classes of GM products or genetically modified organisms  
   32DU.   Secretary to take advice into account  

           Division 5--Conditions

   32E.    What this Division is about  
   32EA.   Conditions applying automatically  
   32EB.   Certification of manufacturing steps outside Australia  
   32EC.   Imposition of conditions by legislative instrument  
   32ED.   Imposition of conditions at time biological included in the Register  
   32EE.   Imposition or variation or removal of conditions after biological included in the Register  
   32EF.   Criminal offences for breach of condition  
   32EG.   Civil penalty for breach of condition  

           Division 6--Suspension from the Register

   32F.    What this Division is about  
   32FA.   Suspension of biological from the Register  
   32FB.   When suspension takes effect etc.  
   32FC.   Revocation of suspension  
   32FD.   Effect of suspension  

           Division 7--Cancellation from the Register

   32G.    What this Division is about  
   32GA.   Immediate cancellation of biological from the Register in various circumstances  
   32GB.   Immediate cancellation of biological from the Register after failure to comply with information gathering notice  
   32GC.   Cancellation of biological from the Register after notice of proposed cancellation  
   32GD.   Revocation of cancellation of biological upon request  
   32GDA.  Revocation of cancellation of biological upon request--payment of annual charge  
   32GE.   Publication of cancellation of entry from Register  
   32GF.   Date of effect of cancellation of entries from Register  

           Division 8--Public notification, and recall, of biologicals

   32H.    What this Division is about  
   32HA.   Public notification, and recall, of biologicals  
   32HB.   Publication of requirements  
   32HC.   Criminal offences for non - compliance with requirements  
   32HD.   Civil penalty for non - compliance with requirements  
   32HE.   Powers of suspension and cancellation unaffected  
   32HF.   Saving of other laws  

           Division 9--Obtaining information or documents

              Subdivision A--Preliminary

   32J.    What this Division is about  

              Subdivision B--Obtaining information or documents for biologicals included or proposed to be included in the Register

   32JA.   Secretary may require information or documents  
   32JB.   Criminal offences for failing to comply with a notice etc.  
   32JC.   Civil penalty for giving false or misleading information or document in compliance with a notice  
   32JD.   Self - incrimination  

              Subdivision C--Obtaining information or documents for biologicals covered by exemptions

   32JE.   Secretary may require information etc. about biologicals exempt under the regulations  
   32JF.    Secretary may require information etc. about biologicals exempt to deal with emergencies  
   32JG.   Secretary may require information etc. about biologicals exempt for special and experimental uses  
   32JH.   Secretary may require information etc. about biologicals exempt where substitutes are unavailable etc.  
   32JI.   Criminal offences for failing to comply with a notice etc.  
   32JJ.   Civil penalty for giving false or misleading information or document in compliance with a notice  
   32JK.   Self - incrimination  

              Subdivision D--Inspecting, copying and retaining documents

   32JL.   Secretary may inspect and copy documents  
   32JM.   Secretary may retain documents  

   PART 3-3--MANUFACTURING OF THERAPEUTIC GOODS

   33A.    Part does not apply to a medical device  
   33B.    Application of this Part to biologicals  
   34.     Exempt goods and exempt persons  
   35.     Criminal offences relating to manufacturing therapeutic goods  
   35A.    Civil penalties relating to manufacturing therapeutic goods  
   35B.    Criminal offences relating to breaching a condition of a licence  
   35C.    Civil penalty relating to breaching a condition of a licence  
   36.     Manufacturing principles  
   37.     Application for licence  
   38.     Grant of licence  
   38A.    Guidelines for multi - site licences  
   38B.    Splitting multi - site licences  
   39.     Term of licence  
   40.     Conditions of licences  
   40A.    Variation of manufacturing site authorisations--Secretary's own initiative  
   40B.    Variation of licences--application by licence holder  
   41.     Revocation and suspension of licences  
   41AAAA. Withdrawal of revocation of licence upon request  
   41AA.   Spent convictions scheme  
   41AB.   Secretary may require information or documents  
   41AC.   Criminal offence for contravening a requirement in a notice under section 41AB  
   41AD.   False or misleading information--offence  
   41AE.   False or misleading documents--offence  
   41AF.   False or misleading information or documents--civil penalty  
   41AG.   Self - incrimination  
   41AAA.  Transfer of licences  
   41A.    Publication of list of manufacturers etc.  
            

CHAPTER 4--Medical devices
            

   PART 4-1--INTRODUCTION

           Division 1--Overview of this Chapter

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

           Division 2--Interpretation

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

           Division 3--Application provisions

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

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

   41C.    What this Part is about  

           Division 1--Essential principles

   41CA.   Essential principles  

           Division 2--Medical device standards

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

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

   41CE.   Database of unique device identifiers of medical devices  

   PART 4-3--CONFORMITY ASSESSMENT PROCEDURES

   41D.    What this Part is about  

           Division 1--Conformity assessment procedures

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

           Division 2--Conformity assessment standards

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

   PART 4-4--CONFORMITY ASSESSMENT CERTIFICATES

   41E.    What this Part is about  

           Division 1--Issuing conformity assessment certificates

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

           Division 2--Conditions

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

           Division 3--Suspension of conformity assessment certificates

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

           Division 4--Revocation of conformity assessment certificates

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

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

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

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

   41F.    What this Part is about  

           Division 1--Including medical devices in the Register

   41FA.   What this Division is about  

              Subdivision A--Applications

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

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

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

              Subdivision C--Auditing of applications

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

              Subdivision D--Miscellaneous

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

           Division 2--Conditions

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

   PART 4-6--SUSPENSION AND CANCELLATION FROM THE REGISTER

           Division 1--Suspension from the Register

              Subdivision A--General power of suspension

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

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

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

              Subdivision C--Effect of suspension

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

           Division 2--Cancellation of entries from the Register

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

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

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

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

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

   PART 4-8--OBTAINING INFORMATION

   41J.    What this Part is about  

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

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

           Division 2--Information relating to medical devices covered by exemptions

   41JCA.  Secretary may require information etc. about medical devices exempt under Part 4 - 6A  
   41JD.   Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register  
   41JE.   Secretary may require information relating to approvals under section 41HB  
   41JF.   Secretary may require information relating to health practitioner authorisations  
   41JFA.  Secretary may require information relating to approvals under section 41HD  
   41JG.   Criminal offences for failing to give information or documents sought under this Division  
   41JH.   False or misleading information  
   41JI.   False or misleading documents  
   41JJ.   Self - incrimination  

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

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

   PART 4-10----ASSESSMENT FEES

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

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

   41M.    What this Part is about  

           Division 1--Non-compliance with essential principles

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

           Division 2--Failure to apply conformity assessment procedures

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

           Division 3--Medical devices not included in the Register and related matters

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

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

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

           Division 4--Other offences and civil penalty provisions

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

CHAPTER 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 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  
            

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  
            

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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