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

Superseded version

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View as made version

F2023C00511 (C112)

14 June 2023 - 20 June 2023

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
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 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
- 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 Identity cards
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
- 46A Delegation under the Act
- 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
- 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 14—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021
  - 78 Exempt goods
- 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
  - 80 Nicotine vaping products
  - 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
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 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

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Therapeutic Goods Regulations 1990