Contents
- Part 1 Preliminary
- Part 2 Advertisements
- Part 2A Patient information
- Part 2C Australian Register of Therapeutic Goods
- Part 2CA Prohibition on import, export or manufacture of certain therapeutic goods—international agreements
- Part 2D Provisional determinations for medicine
- Part 2E Scientific advice about aspects of quality, safety or efficacy of medicine
- Part 2F Vaping goods
- Part 3 Registration, inclusion, listing and exemption of therapeutic goods
- Part 3A Applications for evaluation
- Part 3B Designated orphan drugs
- Part 3C Therapeutic goods (priority applicant) determinations
- Part 3D Biologicals (priority applicant) determinations
- Part 4 Licensing of manufacturers
- Part 5 Testing of goods
- Part 5A Exceptional release
- Part 6 Committees
- Part 7 Charges for registration, listing and inclusion, licences, exemptions, costs and fees
- Part 8 Miscellaneous
- Part 9 Transitional
- Schedule 1 Part 2 does not apply to members of an Australian branch of one of these bodies
- Schedule 2 Prohibited and required representations
- 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
- 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
- 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
- Schedule 9A Fees—biologicals
- Schedule 10 Therapeutic goods for evaluation
- Schedule 12 Consumer medicine information documents
- Schedule 13 Consumer medicine information documents
- Schedule 14 Designated active ingredients
- Schedule 16 Classes of biologicals
Contents
3,345 provisions, too many to show on one page. Open a part or section to read it with its history and connections, or search inside the text.
- Part 1 · Preliminary
- Part 2 · Advertisements
- Part 2A · Patient information
- Part 2C · Australian Register of Therapeutic Goods
- Part 2CA · Prohibition on import, export or manufacture of certain therapeutic goods—international agreements
- Part 2D · Provisional determinations for medicine
- Part 2E · Scientific advice about aspects of quality, safety or efficacy of medicine
- Part 2F · Vaping goods
- 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
- 12BB Circumstances in which approvals or authorities for certain uses must not be given
- 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
- Part 3B · Designated orphan drugs
- 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
- Part 4 · Licensing of manufacturers
- Part 5 · Testing of goods
- Part 5A · Exceptional release
- 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
- Division 3C Joint meetings
- Division 3D Procedure for amending the current Poisons Standard
- Part 7 · Charges for registration, listing and inclusion, licences, exemptions, costs and fees
- 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
- 47B Provision of information concerning medicines, biologicals and medical devices
- 47C Enforceable directions
- 48 Review of decisions
- 48AA Secretary may arrange for conduct of conferences etc.
- Part 9 · Transitional
- Division 1 Transitional provisions relating to the Therapeutic Goods Amendment Regulations 2010 (No. 1)
- Division 2 Transitional provisions relating to the Therapeutic Goods Amendment Regulation 2012 (No. 3)
- Division 3 Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015
- Division 4 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
- Division 5 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017
- Division 6 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017
- Division 7 Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018
- Division 8 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018
- Division 9 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018
- Division 10 Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018
- Division 11 Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019
- Division 12 Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019
- Division 13 Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020
- Division 15 Application provisions relating to 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
- Division 17 Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021
- Division 18 Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022
- Division 19 Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022
- Division 20 Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022
- Division 21 Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023
- Division 22 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023
- Division 23 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023
- Division 24 Application provision relating to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024
- Division 25 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024
- Division 26 Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024
- Division 27 Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024
- Division 28 Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025
- Division 29 Application provisions relating to the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026
- Division 30 Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2026
- Schedule 1 · Part 2 does not apply to members of an Australian branch of one of these bodies
- Schedule 2 · Prohibited and required representations
- 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
- 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
- (regulation 12AAB)
- 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
- (regulation 43)
- Part 1 Interpretation
- Part 2 Table of fees other than for applications etc. covered by Part 3 or 4
- Part 3 Table of fees for applications etc. in relation to certain OTC medicines
- Part 4 Table of fees for applications etc. in relation to certain complementary medicines and certain other listed medicines
- Schedule 9A · Fees—biologicals
- Schedule 10 · Therapeutic goods for evaluation
- Note: See regulations 16C, 16D, 16F, 16G and 45.
- 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
- Schedule 13 · Consumer medicine information documents
- Schedule 14 · Designated active ingredients
- Schedule 16 · Classes of biologicals
Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.