Therapeutic Goods Regulations 1990

In force

Administered by

Department of Health, Disability and Ageing

This item is authorised by the following title:

Therapeutic Goods Act 1989

Latest version

View as made version

F2025C00387 (C125)

25 March 2025

This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003

Table of contents

Part 1—Preliminary
- 1 Name of Regulations
- 2 Interpretation
- 2A Authorised officers
- 3 Corresponding State law
- 3AA Unacceptable presentation of therapeutic goods—prescribed class of medicine
- 3A Unacceptable presentations
- 3B Definitions relating to goods comprising etc. human cells and tissues
- 3C Classes of biologicals
Part 2—Advertisements
- Division 1—Application of Part
  - 4 Application of Part 2
  - 4A Interpretation
- Division 3—General provisions about advertising therapeutic goods
- 6AA Prescribed committees
- 6B Prohibited and required representations
- 7 Prescribed goods for advertising offence and civil penalty
- 7A Publisher exception for civil penalty provisions
- Division 4—Generic information about ingredients or components of therapeutic goods
- 8 Compliance with the Code
Part 2A—Patient information
- 9A Information about certain therapeutic goods to be supplied
- 9B Information about therapeutic goods manufactured using human embryos
Part 2C—Australian Register of Therapeutic Goods
- Division 2C.1—Registered and listed therapeutic goods
- Division 2C.2—Medical devices included in the Register under Chapter 4
- Division 2C.3—Biologicals included in the Register
Part 2CA—Prohibition on import, export or manufacture of certain therapeutic goods—international agreements
- Division 1—Prescribed international agreements
  - 10JA Prescribed international agreements
- Division 2—Prohibition on importation of mercury
  - 10JB Importation of a therapeutic good that is mercury from a non party to the Minamata Convention is prohibited unless approved by the Secretary before importation
- Division 3—Prohibition on export of mercury
  - 10JC Export of a therapeutic good that is mercury is prohibited unless approved by the Secretary before exportation
- Division 4—Applications to import or export mercury
- Division 5—Mercury added products
  - 10JG Import, export and manufacture of therapeutic goods that are mercury added products
  - 10JH Manufacture of therapeutic goods containing mercury added products
Part 2D—Provisional determinations for medicine
- 10K Applications for provisional determinations
- 10L Provisional determinations
Part 2E—Scientific advice about aspects of quality, safety or efficacy of medicine
- 10M Scientific advice about aspects of quality, safety or efficacy of medicine
Part 2F—Vaping goods
- 10N Commercial quantity of vaping goods
- 10P Unit of vaping goods
- 10Q Permitted quantity
Part 3—Registration, inclusion, listing and exemption of therapeutic goods
- 11 Characteristics that separate and distinguish certain medicines from other therapeutic goods
- 11A Characteristics that separate and distinguish certain biologicals from other biologicals
- 12 Exempt goods
- 12A Unapproved medicines and biological—exemption in life threatening cases
- 12AAB Disposal of unused emergency goods and unused emergency biologicals
- 12AA Applications for special and experimental uses
- 12AB Goods imported etc for experimental uses
- 12AC Powers of authorised officers in relation to goods imported etc for experimental uses
- 12AD Use of goods for experimental purposes—specified conditions
- 12B Exemptions for certain uses—medicines
- 12BA Authorities for certain uses—therapeutic vaping substances that are not medicines
- 12C Exemptions for health practitioners—biologicals
- 15 Application of registration or listing number to goods
- 15AA Clinical trial registries
- 15A Conditions of registration and listing of medicines
- 16AA Information or documents that Secretary may require
- 16AB Specified periods
Part 3A—Applications for evaluation
- Division 1—Preliminary
  - 16A Interpretation—working day
- Division 1A—Goods mentioned in Part 1 of Schedule 10
- Division 2—Applications for evaluation of substances
  - 16GA Evaluation other than evaluation under subsection 9D(1), (2) or (3) or section 25 of the Act
- Division 3—Class 2, Class 3 and Class 4 biologicals
- Division 4—Complementary medicines and certain other listed medicines
Part 3B—Designated orphan drugs
- 16H Application to designate medicine as orphan drug
- 16J Designation of medicine as orphan drug
- 16K Period during which designation is in force
- 16L Extension of designation
- 16M Revocation of designation
Part 3C—Therapeutic goods (priority applicant) determinations
- 16P Application of Part
- 16Q Application for therapeutic goods (priority applicant) determination
- 16R Making of therapeutic goods (priority applicant) determination
- 16S Period during which therapeutic goods (priority applicant) determination is in force
- 16T Revocation of therapeutic goods (priority applicant) determination
Part 3D—Biologicals (priority applicant) determinations
- 16U Application of Part
- 16V Application for biologicals (priority applicant) determination
- 16W Making of biologicals (priority applicant) determination
- 16X Period during which biologicals (priority applicant) determination is in force
- 16Y Revocation of biologicals (priority applicant) determination
Part 4—Licensing of manufacturers
- 17 Exempt goods for the purposes of subsection 34(1) of the Act
- 18 Exempt Persons
- 19 Requirements for licence holders
- 20 Conditions of licences
- 21 Persons having control of production etc to be named
- 22 Transfer of licences
Part 5—Examination, testing and analysis of goods
- 23 Interpretation
- 24 Authorised officer—powers and duties
- 25 Appointment of analysts and official analysts and powers of official analysts
- 26 Taking of samples for testing
- 26A Receiving samples for testing
- 27 Examination and testing of sample
- 28 Tests for determining conformity with a standard or compliance with essential principles
- 29 Certificate of responsible analyst
- 30 Review of results of examination and analysis
- 31 Payment for samples
- 32 Offences relating to analysis etc
- 33 Production of identity card
Part 5A—Exceptional release
- 33A Prescribed circumstances under which biologicals may be imported, exported or supplied
- 33B Conditions for supply of biologicals
- 33C Report on release of nonconforming biological
Part 6—Committees
- Division 1A—Advisory Committee on Medicines
- Division 1D—Advisory Committee on Medical Devices
- Division 1E—Advisory Committee on Complementary Medicines
- Division 1EA—Advisory Committee on Biologicals
- Division 1EB—Advisory Committee on Vaccines
- Division 1F—General
- Division 3A—Advisory Committee on Medicines Scheduling
- Division 3B—Advisory Committee on Chemicals Scheduling
- Subdivision 3B.1—Preliminary
  - 42ZCQ Definitions for Division 3B
- Subdivision 3B.2—Constitution of Committee
- Subdivision 3B.3—Committee meetings
- Division 3C—Joint meetings
- 42ZCZG Joint meetings
- 42ZCZH Procedure for joint meetings
- Division 3D—Procedure for amending the current Poisons Standard
- Subdivision 3D.1—Preliminary
  - 42ZCZI Definitions for Division 3D
- Subdivision 3D.2—Procedure if proposed amendment referred to expert advisory committee
- Subdivision 3D.3—Procedure if proposed amendments not referred to expert advisory committee
Part 7—Charges for registration, listing and inclusion, licences, exemptions, costs and fees
- Division 1—Charges for registration, listing and inclusion of therapeutic goods, exemptions and licences
- Division 2—Fees and costs
Part 8—Miscellaneous
- 46AA Identity cards for authorised officers
- 46A Delegation under the Act
- 46B Protected persons
- 46 Release of information
- 47 Delegation—powers and functions under these Regulations
- 47A Delegation—powers under paragraphs 19(1)(a), 32CK(1)(d) and 41HB(1)(d) of the Act
- 47B Provision of information concerning medicines, biologicals and medical devices
- 47C Enforceable directions
- 48 Review of decisions
Part 9—Transitional
- Division 1—Transitional provisions relating to the Therapeutic Goods Amendment Regulations 2010 (No. 1)
  - 48A Definitions
  - 48B Application of 2010 Amendment Regulations
- Division 2—Transitional provisions relating to the Therapeutic Goods Amendment Regulation 2012 (No. 3)
  - 49 Transitional
- Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015
  - 50 Application
- Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
  - 51 Application
- Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017
  - 52 Definitions
  - 53 Transitional—continuing application of evaluation fees for variations of permissible ingredients determinations
  - 54 Transitional—existing orphan drug designations
  - 55 Transitional—pending orphan drug designation applications
  - 56 Transitional—fee waivers in relation to certain designations
- Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017
  - 57 Definitions
  - 58 Application—statements in relation to unapproved medicines and biologicals
  - 59 Transitional—approval of form for statements
- Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018
  - 60 Application provisions
  - 61 Operation of Schedule 2—complementary medicines
  - 62 Saving provision
- Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018
  - 63 Application of amendments
- Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018
  - 64 Definitions
  - 65 Transitional provisions—exemptions from Parts 3 2 and 3 2A of the Act
  - 66 Transitional provisions—exemptions from Part 3 3 of the Act
- Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018
  - 67 Application
- Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019
  - 68 Application and transitional provisions
- Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019
  - Subdivision A—Definitions
    - 69 Definitions
  - Subdivision B—Faecal microbiota transplant products
    - 70 Faecal microbiota transplant products—Division 4 of Part 3 2A of the Act
    - 71 Faecal microbiota transplant products—Part 3 3 of the Act
  - Subdivision C—Consumer medicine information documents
    - 72 Consumer medicine information documents
  - Subdivision D—Handling and testing of samples
    - 73 Handling and testing of samples
  - Subdivision E—Fee waivers and refunds for certain requests relating to prescription opioids
    - 74 Fee waivers and refunds for certain requests relating to prescription opioids
  - Subdivision F—Clinical trials
    - 75 Clinical trials
- Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020
  - 76 Approving supply of therapeutic goods under authorised prescriber scheme
  - 77 Preliminary assessment of applications for variation of permissible ingredients determination
- Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021
  - 79 Application of amendments made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021
- Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021
  - 81 Access to medicines in emergency situations
  - 82 Consumer medicine information documents
  - 83 Approving supply of therapeutic goods under authorised prescriber scheme
- Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021
  - 84 Amendments made by Division 1 of Part 2 of Schedule 1
  - 85 Amendments made by Division 2 of Part 2 of Schedule 1
- Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022
  - 86 Extemporaneously compounded medicinal cannabis products
- Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022
  - 87 Reconsideration of decisions
- Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022
  - 88 Exempt goods
  - 89 Fee for requests to vary entries in Register
- Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023
  - 90 Clinical trials
- Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023
  - 91 Clinical trials
  - 92 Removal of exemptions for sunscreen preparations
- Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023
  - 93 Definitions
  - 94 Approving supply of therapeutic goods under authorised prescriber scheme
  - 95 Goods to be included in parts of the Register
  - 96 Exempt goods
  - 97 Transitional vaping manufacturers—exemption from Part 3 3 of the Act
- Division 24—Application provision relating to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024
  - 98 Exempt goods
- Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024
  - 99 Definitions
  - 100 Fee waivers in relation to the Medicines Repurposing Program
  - 101 Examination, testing and analysis of goods
  - 102 Identity cards
  - 103 Sunscreen preparations
- Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024
  - 104 Definitions
  - 105 Authorities for therapeutic vaping substances that are not medicines
  - 106 Therapeutic vaping packs
  - 107 Exempt goods
  - 108 Transitional vaping goods—exemption from Part 3 2 of the Act
- Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024
  - 109 Definitions
  - 110 Exempt therapeutic goods
  - 111 Notices, statements and determinations
Schedule 1—Part 2 does not apply to members of an Australian branch of one of these bodies
Schedule 2—Prohibited and required representations
- Part 1—Prohibited representations
- Part 2—Required representations
- Part 3—Vitamins referred to in Item 3 of Part 1 of this Schedule
Schedule 3—Therapeutic goods required to be included in the part of the Register for goods known as registered goods or as provisionally registered goods
- Part 1—Medicines
- Part 2—Therapeutic goods that are not medicines
- Part 3—Therapeutic goods attracting no fee under Division 1 or 2 of Part 3 2 of the Act
Schedule 4—Therapeutic goods required to be included in the part of the Register for listed goods
Schedule 5—Therapeutic goods exempt from the operation of Parts 3 2 and 3 2A of the Act
Schedule 5A—Therapeutic goods exempt from operation of Parts 3 2 and 3 2A of Act subject to conditions
Schedule 5B—Disposal of unused emergency goods and unused emergency biologicals
- 1 Early end of exemption—notice of goods held
- 1A Early cessation of exemption—notice of biologicals held
- 2 Expiration of period of exemption—notice of goods held
- 2A Expiration of period of exemption—notice of biologicals held
- 3 Storage and disposal of unused emergency goods and unused emergency biologicals
- 4 Direction for disposal of unused emergency goods and unused emergency biologicals
- 5 Relocation of unused emergency goods and unused emergency biologicals
- 6 Disposal of unused emergency goods and unused emergency biologicals—destruction
- 7 Disposal of unused emergency goods and unused emergency biologicals—export
- 8 Disposal of unused emergency goods and unused emergency biologicals—supply
- 9 Owner to be paid for goods or biologicals supplied
- 10 Records about unused emergency goods and unused emergency biologicals
- 11 Failure to comply with this Schedule
Schedule 7—Therapeutic goods exempt from the operation of Part 3 3 of the Act unless supplied as pharmaceutical benefits
Schedule 8—Persons exempt from the operation of Part 3 3 of the Act
Schedule 9—Fees—therapeutic goods other than biologicals
- Part 1—Interpretation
  - 1 Definitions
  - 2 Part 2 fees do not apply in relation to applications etc. covered by Part 3 or 4
- Part 2—Table of fees other than for applications etc. covered by Part 3 or 4
  - 3 Table of fees
- Part 3—Table of fees for applications etc. in relation to certain OTC medicines
  - 4 Table of fees
- Part 4—Table of fees for applications etc. in relation to certain complementary medicines and certain other listed medicines
  - 5 Table of fees
Schedule 9A—Fees—biologicals
- Part 1—Interpretation of table
  - 1 Definitions
- Part 2—Table of fees
Schedule 10—Therapeutic goods for evaluation
- Part 1—Evaluation of prescription and other medicines by the Prescription Medicines Authorisation Branch
- Part 2—Evaluation of complementary medicines by the Complementary and OTC Medicines Branch
- Part 3—Evaluation of non prescription and other medicines by the Complementary and OTC Medicines Branch
Schedule 12—Consumer medicine information documents
- 1 General requirements
- 2 Specific requirements—document enclosed within packaging etc.
- 3 Specific requirements—document not enclosed within packaging etc.
Schedule 13—Consumer medicine information documents
- 1 General requirements
- 2 Specific requirements—document enclosed within packaging etc.
- 3 Specific requirements—document not enclosed within packaging etc.
Schedule 14—Designated active ingredients
Schedule 16—Classes of biologicals
- 1A Class 1 biologicals
- 1 Class 4 biologicals
- Endnotes

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Therapeutic Goods Regulations 1990

New features, 29 May 2025 update

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Therapeutic Goods Regulations 1990