Therapeutic Goods Act 1989
No. 21, 1990
Compilation No. 89
Compilation date: 5 September 2025
Includes amendments: Act No. 38, 2025
This compilation is in 2 volumes
Volume 1: sections 1‑41A
Volume 2: sections 41B‑69
Endnotes
Each volume has its own contents
About this compilation
This compilation
This is a compilation of the Therapeutic Goods Act 1989 that shows the text of the law as amended and in force on 5 September 2025 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au).
Application, saving and transitional provisions
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see the endnotes.
Presentational changes
The Legislation Act 2003 provides for First Parliamentary Counsel to make presentational changes to a compilation. Presentational changes are applied to give a more consistent look and feel to legislation published on the Register, and enable the user to more easily navigate those documents.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. Any modifications affecting the law are accessible on the Register.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
Chapter 1—Preliminary
1 Short title
2 Commencement
3 Interpretation
3AA Homoeopathic preparations and homoeopathic standards
3AB Anthroposophic preparations and anthroposophic standards
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 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
7AAA Minister may determine that goods are therapeutic goods
7AA Excluded goods
7A Authorised persons
7B Kits
7C Secretary may arrange for use of computer programs to make decisions
Overview
The Therapeutic Goods Act 1989, enacted by the Australian Parliament, addresses the need for a national system to regulate the quality, safety, and efficacy of therapeutic goods used in Australia. The primary objective of this Act is to establish and maintain a national system of controls over therapeutic goods, including medicines, medical devices, and other health-related products, ensuring they meet safety and quality standards before they are made available to the public. The Act also aims to provide a framework for the regulation of these goods, including their import, export, manufacture, and supply, to protect public health. By binding the Crown and extending the geographical jurisdiction of the Criminal Code, the Act ensures comprehensive oversight and enforcement capabilities across the country.
Scope and Application
The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods, including medicines, vaccines, blood, tissues, and medical devices, within Australia. The Act applies to corporations and natural persons who engage in activities such as the importation, exportation, manufacture, and supply of therapeutic goods. The Act also applies to the Commonwealth, states, territories, and any authorities or officers exercising functions or powers under corresponding state laws, subject to certain constitutional constraints and the provisions of this Act. The Act does not apply to medical devices, which are regulated under Chapter 4. Therapeutic goods that are exempt under section 18A and those that are subject to certain international agreements are excluded from the scope of the Act. The Act extends its application through subordinate instruments such as regulations and legislative instruments, which may specify classes of goods, set standards, and outline procedures for registration, evaluation, and licensing. The Act includes criminal offences and civil penalties for non-compliance, breach of conditions, and misrepresentation, among other violations. It also provides for the establishment of the Australian Register of Therapeutic Goods, which maintains information on registered and listed goods, and enables the Secretary to impose conditions on the registration or listing of goods, as well as to suspend or revoke entries in the Register.
Key Provisions
- The Therapeutic Goods Act 1989 (the Act) is designed to regulate therapeutic goods and vaping goods within Australia, ensuring their quality, safety, and efficacy. Section 7 of the Act provides the authority to declare certain goods as therapeutic goods, establishing a framework for their regulation. Section 7A allows the Secretary to authorise specific individuals to exercise powers under the Act, facilitating the enforcement of its provisions. Section 7B requires the Secretary to approve a form for product information in relation to medicine, ensuring consistency and clarity in the information provided to consumers. Additionally, Section 8 mandates that the Secretary must publish a list of therapeutic goods included in the Australian Register of Therapeutic Goods at least once every 12 months, enhancing transparency and accessibility of information about registered therapeutic goods.
- The Act imposes several obligations on parties and entities it governs. For instance, Section 7D requires the Secretary to approve a form for product information in relation to medicine, ensuring that all product information is provided in a consistent and clear manner. Section 31 mandates that the Secretary may require information or documents from applicants for the registration of therapeutic goods, enabling the Secretary to verify the legitimacy and safety of the goods before registration. Furthermore, Section 31A and 31AA allow the Secretary to require information from persons in relation to goods that have been registered or listed, facilitating ongoing oversight and compliance checks.
- There are various offences and penalties outlined in the Act for breaches. Section 9G imposes criminal penalties for false statements in requests for variation of entries in the Australian Register of Therapeutic Goods, with imprisonment of up to 5 years or fines of up to 4,000 penalty units, or both. Section 19C establishes criminal offences for failing to comply with the requirements of the Act, with penalties including imprisonment of up to 5 years and fines of up to 4,000 penalty units. Section 22A sets out criminal offences for making false or misleading statements in applications for registration, with maximum penalties of imprisonment for 5 years or fines of up to 4,000 penalty units for individuals, and up to 50,000 penalty units for body corporates. Section 29A imposes a civil penalty of up to 5,000 penalty units for individuals and up to 50,000 penalty units for body corporates for failing to notify the Secretary of adverse effects of therapeutic goods. Furthermore, Section 30A outlines criminal offences for contravening conditions of registration or listing, with penalties of imprisonment for 12 months or fines of up to 1,000 penalty units for individuals, and up to 50,000 penalty units for body corporates. These provisions ensure that any breaches of the Act are met with appropriate legal consequences, thereby maintaining the integrity of the therapeutic goods market in Australia.
- Area of Law
- Medical Law
- Regulatory Law
- Consumer Law
- Instrument
- Act
- Concepts
- Definitions & Interpretation
- Commencement Provisions
- Licensing & Registration
- Penalty Provisions
- Enforcement Powers
- Compliance Obligations
- Prohibited Conduct
- Review & Appeal
