Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989

TABLE OF PROVISIONS

            

CHAPTER 1--Preliminary
            

   1.      Short title [see Note 1]  
   2.      Commencement [see Note 1]  
   3.      Interpretation  
   3A.     Declaration--member of European Community  
   3B.     Declaration--country covered by non-EC/EFTA MRA  
   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  
   7A.     Authorised persons  
   7B.     Kits  
   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  
   9B.     When registrations or listings of medical devices are taken to be cancelled  
   9C.     Inspection of entries in Register  
   9D.     Variation of entries in Register  
   9E.     Publication of list of goods on Register  
            

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

   PART 3-1--STANDARDS

   10.     Determination of standards  
   10A.    Application of standards to medical devices  
   11.     Date of effect of standards  
   12.     Standards to be disallowable  
   13.     Special provisions relating to 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  

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

           Division 1--Preliminary

   15A.    Application of this Part to medical devices  
   16.     Therapeutic goods and gazetted groups  
   18.     Exempt goods  
   18A.    Exemption because of emergency  
   19.     Exemptions for special and experimental uses  
   19A.    Exemptions 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 2--Registration and listing

   23.     Applications generally  
   24.     Applications for registration  
   24A.    When evaluation fee due for payment  
   24B.    Payment of evaluation fee by instalments  
   24C.    Recovery of evaluation fee  
   24D.    Reduction of evaluation fee where evaluation not completed within prescribed period  
   24E.    Deemed refusal of application  
   25.     Evaluation and registration of therapeutic goods  
   25A.    When the Secretary must not use protected information  
   25B.    Registration of therapeutic device to which EC/EFTA attestation of conformity applies  
   26.     Listing of therapeutic goods  
   26AA.   Listing of therapeutic device to which EC/EFTA attestation of conformity applies  
   26A.    Listing of certain medicines  
   26B.    Certificates required in relation to patents  
   26BA.   Approved form for notices  
   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  
   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  
   30.     Cancellation of registration or listing  
   30C.    Consultation with Gene Technology Regulator  
   30D.    Secretary may seek advice about classes of GM products  
   30E.    Secretary to take advice into account  

           Division 2A--Public notification and recovery of therapeutic goods

   30EA.   Public notification and recovery of therapeutic goods  
   30EB.   Publication of requirements  
   30EC.   Criminal offences for non-compliance with requirements  
   30ECA.  Civil penalty for non-compliance with requirements  
   30ED.   Power of cancellation unaffected  

           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  
   31AAA.  Civil penalty for providing false or misleading information in relation to medicines listed under section 26A  
   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  
   31C.    Criminal offence for failing to give information or documents sought under section 31A, 31AA or 31B  
   31D.    False or misleading information  
   31E.    False or misleading documents  
   31F.    Self-incrimination  

   PART 3-3--MANUFACTURING OF THERAPEUTIC GOODS

   33A.    Application of this Part to medical devices  
   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  
   39.     Term of licence  
   40.     Conditions of licences  
   41.     Revocation and suspension 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  
   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  

           Division 3--Application provisions

   41BJ.   Application of this Chapter to medical devices covered by Part 3-2  
   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  

   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  
   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 4-5--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  
   41FB.   How this Division works  

              Subdivision A--Applications

   41FC.   Applications  
   41FD.   Matters to be certified  
   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  
   41FJ.   Procedure following audits  
   41FK.   Lapsing of applications  

              Subdivision D--Miscellaneous

   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 under Part 4-4

   41GF.   Suspension of kinds of medical devices from the Register  
   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  
   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 4-7--EXEMPTING MEDICAL DEVICES FROM INCLUSION IN THE REGISTER

   41H.    What this Part is about  
   41HA.   Devices exempted from inclusion in the Register  
   41HB.   Exemptions for special and experimental uses  
   41HC.   Exemptions for medical practitioners  

   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  
   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

   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 authorities under section 41HC  
   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 RECOVERY OF MEDICAL DEVICES

   41K.    What this Part is about  
   41KA.   Public notification and recovery 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  

   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  
   41MM.   Claims about arranging supplies of medical devices not included in the Register  
   41MN.   Criminal offences relating to breaches of conditions  
   41MNA.  Civil penalties for breaching conditions  

           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  

           Division 2--Therapeutic goods advertisements for which an approval is required

   42BA.   Application of Division  
   42C.    Offences relating to publication of advertisements  

           Division 3--General provisions about advertising therapeutic goods

   42DA.   Application of Division  
   42DB.   Definitions  
   42DC.   Certain representations not to be published or broadcast  
   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.   Use of restricted or prohibited representations  
   42DL.   Advertising offences  
   42DM.   Compliance with Code  

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

   42DN.   Application of Division  
   42DO.   Compliance with the Code  
   42DP.   Offences--publication of generic information  

   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.    Recovery of therapeutic goods because of actual or potential tampering  
   42VA.   Civil penalty relating to the recovery of therapeutic goods because of actual or potential tampering  
   42VB.   Relief from liability for contraventions relating to the recovery of therapeutic goods because of actual or potential tampering  
   42W.    Supply etc. of therapeutic goods that are subject to recovery 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?  
   42YB.   Meaning of penalty unit  
   42YC.   Persons involved in contravening civil penalty provision  
   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.   Infringement notices in respect of offences  
   42YK.   Infringement notices in respect of civil penalty provisions  

   PART 5A-3--ENFORCEABLE UNDERTAKINGS

   42YL.   Enforcement of undertakings  
            

CHAPTER 6--Administration
            

   PART 6-1--PAYMENT OF CHARGES

   43.     By whom charges payable  
   44.     Time for payment of charges  
   45.     Therapeutic Goods Administration Account  

   PART 6-2--ENTRY, SEARCHES AND WARRANTS

   45A.    Definitions  
   46.     Searches to monitor compliance with Act  
   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.  
   48B.    Announcement before entry  
   48C.    Use of electronic equipment at premises  
   48D.    Compensation for damage to electronic equipment  
   48E.    Copies of seized things to be provided  
   48F.    Occupier entitled to be present during search  
   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.    Searches at request of manufacturer  
   51B.    Offences relating to warrants  
   52.     Identity cards  

   PART 6-3--NATIONAL DRUGS AND POISONS SCHEDULE COMMITTEE

   52A.    Definitions  
   52B.    Establishment and constitution of Committee  
   52C.    Functions of Committee  
   52D.    Poisons Standard  
   52E.    Matters to be taken into account in exercising powers  
   52EA.   Poisons Standard--validation etc.  
   52EB.   Compensation for acquisition of property  

   PART 6-4--COMPLEMENTARY MEDICINES

   52F.    Definitions  
   52G.    Establishment and constitution of Committee  
            

CHAPTER 7--Miscellaneous
            

   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.    Application of this Act to an executive officer of a body corporate  
   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, servants 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  
   62.     Consequential amendments  
   63.     Regulations  
            

CHAPTER 8--Repeal and transitional provisions
            

   64.     Interpretation  
   65.     Repeal  
   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  
           SCHEDULE Consequential Amendments