- Therapeutic Goods Act 1989
- Contents
- Chapter 1—Preliminary
- Chapter 2—Australian Register of Therapeutic Goods
- Chapter 3—Medicines and other therapeutic goods that are notmedical devices
- Chapter 4—Medical devices
- Part 4-1—Introduction
- Part 4-2—Essential principles and medical device standards
- Part 4-3—Conformity assessment procedures
- Part 4-4—Conformity assessment certificates
- Part 4-5—Including medical devices in the Register
- Part 4-6—Suspension and cancellation from the Register
- Part 4-6A—Exempting medical devices to deal with
- Part 4-7—Other exemptions from including medical devices inthe Register
- Part 4-8—Obtaining information
- Part 4-9—Public notification and recovery of medical devices
- Part 4-10—Assessment fees
- Part 4-11—Offences and civil penalty provisions relating tomedical devices
- Part 4-11—Offences and civil penalty provisions relating to medical devices
- Chapter 5—Advertising, counterfeit therapeutic goods andproduct tampering
- Chapter 5A—Enforcement
- Chapter 6—Administration
- Chapter 7—Miscellaneous
- Chapter 8—Repeal and transitional provisions
- Schedule—Consequential Amendments
- Notes
- Chapter 1—Preliminary
- 1 Short title
- 2 Commencement
- 3 Interpretation
- 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 geographicaljurisdiction
- 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 poweron 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
- 7C Secretary may arrange for use of computer programs to makedecisions
- 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 ofTherapeutic Goods
- Chapter 3—Medicines and other therapeuticgoods that are not medical devices
- Part 3-1—Standards
- 10 Determination of standards
- 10A Application of standards to medical devices
- 13 Special provisions relating to standards
- 14 Criminal offences for importing, supplying or exporting goodsthat do not comply with standards
- 14A Civil penalties for importing, supplying or exporting goods thatdo 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 therapeuticgoods
- 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. ofimported, exported, manufactured and suppliedtherapeutic goods
- 19C Notice required to adduce evidence in support of exceptionunder 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 toimporting goods exempt under section 18A
- 20A Civil penalty relating to the importation, exportation,manufacture or supply of sponsored goods withoutproper 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 forregistration
- 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 completedwithin prescribed period
- 24E Deemed refusal of application
- 25 Evaluation and registration of therapeutic goods
- 25AA Approved product information for medicine
- 25A When the Secretary must not use protected information
- 25B Registration of therapeutic device to which EC/EFTAattestation of conformity applies
- 26 Listing of therapeutic goods
- 26AA Listing of therapeutic device to which EC/EFTA attestation ofconformity applies
- 26A Listing of certain medicines
- 26B Certificates required in relation to patents
- 26BA Approved form for notices
- 26BB Permissible ingredients
- 26BC Variation of determination under section 26BB —Minister’sinitiative
- 26BD Variation of determination under section 26BB —applicationby person
- 26C Certificates required in relation to patent infringementproceedings
- 26D Requirements for interlocutory injunction
- 27 Registration or listing number
- 28 Conditions of registration or listing
- 28A Certification of manufacturing steps outside Australia followingapplication for listing
- 29 Duration of registration or listing
- 29A Criminal offence for failing to notify adverse effects etc. ofgoods
- 29AA Civil penalty for failing to notify adverse effects etc. of goods
- 29B Notification of adverse effects etc. where application withdrawnor lapses
- 29C Civil penalties for failing to notify adverse effects etc. whereapplication 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 uponrequest
- 30C Consultation with Gene Technology Regulator
- 30D Secretary may seek advice about classes of GM products orgenetically modified organisms
- 30D Secretary may seek advice about classes of GM products orgenetically modified organisms
- 30E Secretary to take advice into account
- Division 2A—Public notification and recovery oftherapeutic goods
- Division 3—General
- 30F Criminal offences for goods exempt under section 18A notconforming to standards etc.
- 30FA Civil penalty for goods exempt under section 18A notconforming 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 informationin relation to medicines listed under section 26A
- 31A Secretary may require information etc. about goods exemptunder section 18
- 31AA Secretary may require information etc. about goods exemptunder section 18A
- 31B Secretary may require information relating to approvals andauthorities under section 19
- 31B Secretary may require information relating to approvals andauthorities under section 19
- 31C Criminal offence for failing to give information or documentssought 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
- 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’sown initiative
- 41 Revocation and suspension of licences
- 41AA Spent convictions scheme
- 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
- Division 2—Interpretation
- Division 3—Application provisions
- Part 4-2—Essential principles and medical devicestandards
- Division 1—Essential principles
- Division 2—Medical device standards
- Part 4-3—Conformity assessment procedures
- Division 1—Conformity assessment procedures
- Division 2—Conformity assessment standards
- Part 4-4—Conformity assessment certificates
- 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 issuecertificate
- 41EF Duration of 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
- Division 3—Suspension of conformity assessmentcertificates
- Division 4—Revocation of conformity assessmentcertificates
- 41ER Automatic revocation of conformity assessment certificates
- 41ES Immediate revocation of conformity assessment certificates
- 41ET Revocation of conformity assessment certificates after noticeof proposed revocation
- 41EU Limiting revocation of conformity assessment certificates tosome medical devices of a particular kind
- 41EV Publication of revocation etc. of conformity assessmentcertificates
- 41EW Date of effect of revocation etc. of conformity assessmentcertificates
- Part 4-5—Including medical devices in the Register
- Division 1—Including medical devices in the Register
- Division 2—Conditions
- Part 4-6—Suspension and cancellation from theRegister
- Part 4-6A—Exempting medical devices to deal withemergencies
- Part 4-7—Other exemptions from includingmedical devices in the Register
- Part 4-8—Obtaining information
- Division 1—Information relating to compliance withrequirements and other matters
- Division 2—Information relating to medical devicescovered by exemptions
- 41JCA Secretary may require information etc. about medicaldevices exempt under Part 4-6A
- 41JD Secretary may require information etc. about devicesexempted under section 41HA from inclusion in theRegister
- 41JE Secretary may require information relating to approvalsunder section 41HB
- 41JF Secretary may require information relating to authoritiesunder section 41HC
- 41JFA Secretary may require information relating to approvalsunder section 41HD
- 41JG Criminal offences for failing to give information or documentssought under this Division
- 41JH False or misleading information
- 41JI False or misleading documents
- 41JJ Self-incrimination
- Part 4-9—Public notification and recovery ofmedical devices
- Part 4-10—Assessment fees
- Part 4-11—Offences and civil penalty provisionsrelating to medical devices
- Division 1—Non-compliance with essential principles
- 41MA Criminal offences for importing, supplying or exporting amedical device that does not comply with essentialprinciples
- 41MAA Civil penalties for importing, supplying or exporting amedical device that does not comply with essentialprinciples
- 41MB Exceptions
- 41MC Criminal offences relating to breaching a condition of aconsent
- 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 assessmentprocedures
- 41ME Criminal offences for failing to apply conformity assessmentprocedures—manufacturers
- 41MEA Civil penalties for failing to apply conformity assessmentprocedures—manufacturers
- 41MF Criminal offences for failing to apply conformity assessmentprocedures—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 ormanufacturing a medical device not included in theRegister
- 41MJ Treating medical devices as prohibited imports or exports
- 41ML False advertising about medical devices
- 41MLA Civil penalty for making misrepresentations about medicaldevices
- 41MM Claims about arranging supplies of medical devices notincluded in the Register
- 41MN Criminal offences relating to breaches of conditions
- 41MNA Civil penalties for breaching conditions
- Division 3A—Offences and civil penalties related toexemptions under Part 4-6A
- Division 4—Other offences and civil penalty provisions
- 41MO Criminal offences for misusing medical devices exempted forspecial 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 notifyadverse events etc.
- 41MQ Notification of adverse events etc. where applicationwithdrawn or lapses
- 41MR Civil penalties for failing to notify adverse effects etc. whereapplication withdrawn or lapses
- Division 1—Non-compliance with essential principles
- Chapter 5—Advertising, counterfeittherapeutic goods and producttampering
- Part 5-1—Advertising and generic information
- Division 1—Preliminary
- Division 2—Therapeutic goods advertisements for whichan approval is required
- Division 3—General provisions about advertisingtherapeutic goods
- 42DA Simplified outline
- 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 Use of restricted or prohibited representations
- Division 3A—Therapeutic goods advertisements for whichan approval is not required
- Division 4—Generic information about ingredients orcomponents of therapeutic goods
- Part 5-2—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 potentialtampering
- 42VA Civil penalty relating to the recovery of therapeutic goodsbecause of actual or potential tampering
- 42VB Relief from liability for contraventions relating to therecovery of therapeutic goods because of actual orpotential tampering
- 42W Supply etc. of therapeutic goods that are subject to recoveryrequirements
- 42X Saving of other laws
- Chapter 5A—Enforcement
- Chapter 6—Administration
- 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 requirementsimposed 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 bodycorporate
- 54C Establishing whether an executive officer took reasonable stepsto prevent the commission of an offence or thecontravention 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
- 61A Immunity from civil actions
- 62 Consequential amendments
- 63 Regulations
- Chapter 8—Repeal and transitionalprovisions
- Schedule—Consequential Amendments
- Notes to the Therapeutic Goods Act 1989
- Note 1
- Table of Acts
- Act Notes
- Table of Amendments
- Note 2
Therapeutic Goods Act 1989
Act No. 21 of 1990 as amended
This compilation was prepared on 12 January 2011 taking into account amendments up to Act No. 141 of 2010
The text of any of those amendments not in force on that date is appended in the Notes section
The operation of amendments that have been incorporated may be affected by application provisions that are set out in the Notes section
Prepared by the Office of Legislative Drafting and Publishing, Attorney-General’s Department, Canberra
Contents
Chapter 1—Preliminary
1 Short title [see Note 1].......................................................................1
2 Commencement [see Note 1].............................................................1
3 Interpretation.....................................................................................1
3A Declaration—member of European Community.............................16
3B Declaration—country covered by non-EC/EFTA MRA..................17
3C Exempting monographs in pharmacopoeias....................................17
4 Objects of Act..................................................................................17
5 Act to bind Crown...........................................................................18
5A Application of the Criminal Code—extended geographical
jurisdiction.......................................................................................18
6 Operation of Act..............................................................................18
6AAA Commonwealth consent to conferral of functions etc. on its
officers and authorities by corresponding State laws.......................19
6AAB When duty imposed.........................................................................20
6AAC Imposing duty under State law........................................................21
6AAD Conferral of jurisdiction on federal courts.......................................22
6AAE Consequences of State law conferring duty, function or
power on Commonwealth officer or Commonwealth
authority ..........................................................................................22
6B Review of certain decisions under State laws..................................23
6C Fees payable to Commonwealth under State laws...........................23
7 Declaration that goods are/are not therapeutic goods ......................24
7A Authorised persons..........................................................................24
7B Kits..................................................................................................25
7C Secretary may arrange for use of computer programs to
make decisions ................................................................................25
7D Form for product information for medicine.....................................26
8 Power to obtain information with respect to therapeutic
goods ...............................................................................................26
9 Arrangements with States etc. .........................................................27
Chapter 2—Australian Register of Therapeutic Goods 28 9A Australian Register of Therapeutic Goods.......................................28 9B When registrations or listings of medical devices are taken to be cancelled.....................................................................................29 9C Inspectionof entries in Register......................................................31 9D Variation of entries in Register........................................................31 9E Publication of list of goods on Register...........................................33
Chapter 3—Medicines and other therapeutic goods that are not medical devices 34
Part 3-1—Standards 34 10 Determination of standards..............................................................34 10A Application of standards to medical devices....................................35 13 Special provisions relating to standards...........................................35 14 Criminal offences for importing, supplying or exporting
goods that do not comply with standards.........................................37 14A Civil penalties for importing, supplying or exporting goods
that do not comply with standards...................................................41
14B Application of Customs Act 1901 ....................................................42
15 Criminal offences relating to breaching a condition of a
consent.............................................................................................43 15AA Civil penalty relating to breaching a condition of a consent............43
Part 3-2—Registration and listing of therapeutic goods 45
Division 1—Preliminary 45 15A Application of this Part to medical devices .....................................45 16 Therapeutic goods and gazetted groups...........................................47 18 Exempt goods..................................................................................48 18A Exemption because of emergency ...................................................48 19 Exemptionsforspecialand experimental uses................................52 19A Exemptions where unavailability etc. of therapeutic goods.............54 19B Criminal offences relating to registration or listing etc. of
imported, exported, manufactured and supplied therapeutic goods ...............................................................................................56
19C Notice required to adduce evidence in support of exception under subsection 19B(6)..................................................................59
19D Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods ...............................................................................................61
20 Criminal offences relating to notifying the Secretary and to importing goods exemptunder section 18A....................................63
20A Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification ......................................................................................65
21 Offence relating to wholesale supply...............................................66 21A General criminal offences relating to this Part.................................66 21B General civil penalties relating to this Part......................................71 22 General offences relating to this Part...............................................72 22AA Civil penalty for breaching a condition of an exemption.................74 22A Criminal offences for false statements in applications for
registration.......................................................................................75
22B Civil penalty for false statements in applications for registration.......................................................................................76
Division 2—Registration and listing
23 Applications generally.....................................................................77
24 Applications for registration............................................................77
24A When evaluation fee due for payment.............................................78
24B Payment of evaluation fee by instalments .......................................78
24C Recovery of evaluation fee..............................................................79
24D Reduction of evaluation fee where evaluation not completed
within prescribed period..................................................................79
24E Deemed refusal of application.........................................................80
25 Evaluation and registration of therapeutic goods.............................80
25AA Approved product information for medicine...................................84
25A When the Secretary must not use protected information .................86
25B Registration of therapeutic device to which EC/EFTA
attestation of conformity applies .....................................................87
26 Listing of therapeutic goods............................................................88
26AA Listing of therapeutic device to which EC/EFTA attestation
of conformity applies.......................................................................9
Act No. 21 of 1990 as amended
This compilation was prepared on 12 January 2011 taking into account amendments up to Act No. 141 of 2010
The text of any of those amendments not in force on that date is appended in the Notes section
The operation of amendments that have been incorporated may be affected by application provisions that are set out in the Notes section
Prepared by the Office of Legislative Drafting and Publishing, Attorney-General’s Department, Canberra
Chapter 1—Preliminary
1 Short title [see Note 1].......................................................................1
2 Commencement [see Note 1].............................................................1
3 Interpretation.....................................................................................1
3A Declaration—member of European Community.............................16
3B Declaration—country covered by non-EC/EFTA MRA..................17
3C Exempting monographs in pharmacopoeias....................................17
4 Objects of Act..................................................................................17
5 Act to bind Crown...........................................................................18
5A Application of the Criminal Code—extended geographical
jurisdiction.......................................................................................18
6 Operation of Act..............................................................................18
6AAA Commonwealth consent to conferral of functions etc. on its
officers and authorities by corresponding State laws.......................19
6AAB When duty imposed.........................................................................20
6AAC Imposing duty under State law........................................................21
6AAD Conferral of jurisdiction on federal courts.......................................22
6AAE Consequences of State law conferring duty, function or
power on Commonwealth officer or Commonwealth
authority ..........................................................................................22
6B Review of certain decisions under State laws..................................23
6C Fees payable to Commonwealth under State laws...........................23
7 Declaration that goods are/are not therapeutic goods ......................24
7A Authorised persons..........................................................................24
7B Kits..................................................................................................25
7C Secretary may arrange for use of computer programs to
make decisions ................................................................................25
7D Form for product information for medicine.....................................26
8 Power to obtain information with respect to therapeutic
goods ...............................................................................................26
9 Arrangements with States etc. .........................................................27
Chapter 2—Australian Register of Therapeutic Goods 28 9A Australian Register of Therapeutic Goods.......................................28 9B When registrations or listings of medical devices are taken to be cancelled.....................................................................................29 9C Inspectionof entries in Register......................................................31 9D Variation of entries in Register........................................................31 9E Publication of list of goods on Register...........................................33
Part 3-1—Standards 34 10 Determination of standards..............................................................34 10A Application of standards to medical devices....................................35 13 Special provisions relating to standards...........................................35 14 Criminal offences for importing, supplying or exporting
goods that do not comply with standards.........................................37 14A Civil penalties for importing, supplying or exporting goods
that do not comply with standards...................................................41
14B Application of Customs Act 1901 ....................................................42
15 Criminal offences relating to breaching a condition of a
consent.............................................................................................43 15AA Civil penalty relating to breaching a condition of a consent............43
Division 1—Preliminary 45 15A Application of this Part to medical devices .....................................45 16 Therapeutic goods and gazetted groups...........................................47 18 Exempt goods..................................................................................48 18A Exemption because of emergency ...................................................48 19 Exemptionsforspecialand experimental uses................................52 19A Exemptions where unavailability etc. of therapeutic goods.............54 19B Criminal offences relating to registration or listing etc. of
imported, exported, manufactured and supplied therapeutic goods ...............................................................................................56
19C Notice required to adduce evidence in support of exception under subsection 19B(6)..................................................................59
19D Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods ...............................................................................................61
20 Criminal offences relating to notifying the Secretary and to importing goods exemptunder section 18A....................................63
20A Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification ......................................................................................65
21 Offence relating to wholesale supply...............................................66 21A General criminal offences relating to this Part.................................66 21B General civil penalties relating to this Part......................................71 22 General offences relating to this Part...............................................72 22AA Civil penalty for breaching a condition of an exemption.................74 22A Criminal offences for false statements in applications for
registration.......................................................................................75
22B Civil penalty for false statements in applications for registration.......................................................................................76
Division 2—Registration and listing
23 Applications generally.....................................................................77
24 Applications for registration............................................................77
24A When evaluation fee due for payment.............................................78
24B Payment of evaluation fee by instalments .......................................78
24C Recovery of evaluation fee..............................................................79
24D Reduction of evaluation fee where evaluation not completed
within prescribed period..................................................................79
24E Deemed refusal of application.........................................................80
25 Evaluation and registration of therapeutic goods.............................80
25AA Approved product information for medicine...................................84
25A When the Secretary must not use protected information .................86
25B Registration of therapeutic device to which EC/EFTA
attestation of conformity applies .....................................................87
26 Listing of therapeutic goods............................................................88
26AA Listing of therapeutic device to which EC/EFTA attestation
of conformity applies.......................................................................9 Contents
Chapter 3—Medicines and other therapeutic goods that are not medical devices 34
Part 3-2—Registration and listing of therapeutic goods 45