Therapeutic Goods
No. 29 of 1966
An Act to make provision for and in relation to Standards for Goods for Therapeutic Use, and for other purposes.
[Assented to 24 May, 1966]
BE it enacted by the Queen’s Most Excellent Majesty, the Senate, and the House of Representatives of the Commonwealth of Australia, as follows:—
Part I.—Preliminary.
Short title.
1. This Act may be cited as the Therapeutic Goods Act 1966.
Commencement.
2. This Act shall come into operation on a date to be fixed by Proclamation.
Parts.
3. This Act is divided into Parts, as follows:—
Part I.—Preliminary (Sections 1-10).
Part II.—Determination of Standards (Sections 11-18).
Part III.—Goods to Conform to Standards (Sections 19-23).
Part IV.—Miscellaneous (Sections 24-30).
Repeal.
4. The Therapeutic Substances Act 1953 and the Therapeutic Substances Act 1959 are repealed.
Interpretation.
5.—(1.) In this Act, unless the contrary intention appears—
“general standard”, in relation to goods for therapeutic use, means a standard specified in an order made under section 13 of this Act that applies to a substance or article of which the goods consist, or are represented to consist, and—
(a) if the goods are for human use—has effect in relation to goods for human use; or
(b) if the goods are for veterinary use—has effect in relation to goods for veterinary use;
“goods for therapeutic use” means goods that—
(a) are (whether by writing or otherwise) represented to be, or are (whether by reason of the way in which the goods are put up or for any other reason) likely to be taken to be—
(i) for therapeutic use;
(ii) for use as an ingredient or component in the preparation or manufacture of a substance or article for therapeutic use; or
(iii) for use as a container, or as part of a container, of a substance or article for therapeutic use or use of a kind referred to in the last preceding sub-paragraph; or
(b) are included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or use of a kind referred to in sub-paragraph (ii) or (iii) of the last preceding paragraph,
but does not include—
(c) goods in respect of which a certificate has been issued under section 8 of this Act; or
(d) goods consisting of a vaccine prepared from microscopic organisms from the body of a person or animal for use only in the treatment of that person or animal;
“labelling and packaging requirements”, in relation to goods for therapeutic use, means requirements specified in an order made under section 15 of this Act that applies
to a substance or article of which the goods consist, or are represented to consist, and—
(a) if the goods are for human use—has effect in relation to goods for human use; or
(b
Overview
The Therapeutic Goods Act 1966 was enacted to establish a comprehensive regulatory framework for therapeutic goods, including medicines, medical devices, and other related products, in Australia. The Act was introduced to address the need for a unified and effective system to ensure the safety, quality, and efficacy of therapeutic goods available in the market. This legislation was enacted by the Parliament of Australia. The policy objective of the Act is to protect public health by regulating the importation, manufacture, supply, and advertising of therapeutic goods in a manner that ensures they are safe, of high quality, and effective for their intended use. The Act aims to prevent the distribution of harmful or substandard therapeutic goods while facilitating access to beneficial products through a balanced and efficient regulatory approach.
Scope and Application
The Therapeutic Goods Act 1966 applies to goods intended for therapeutic use, whether for human or veterinary purposes, across Australia. These goods include substances or articles represented for therapeutic use, or likely to be taken for such use, but exclude those for which a certificate has been issued under the Act stating they are not for therapeutic use, and vaccines prepared from microscopic organisms for treatment of the individual person or animal. The Act also applies to the labelling, packaging, and containers of such goods. The Minister has broad powers to determine specific and general standards for these goods, as well as requirements for their labelling, packing, and containers, through written orders which take effect upon notification in the Gazette. The importation, interstate trade, supply of goods for pharmaceutical benefits, and supply to the Commonwealth of therapeutic goods are all subject to compliance with these standards and requirements, and require consent from the Minister, which can be granted with or without conditions. The Act extends its application through subordinate instruments and regulations, which can include provisions for the examination and testing of goods, among other matters. Offences against the Act are subject to penalties including fines and imprisonment, with the forfeiture of goods also possible at the court's discretion. The Act's provisions do not exclude or limit the operation of other laws.
Key Provisions
- The Therapeutic Goods Act 1966 (the Act) establishes regulatory standards for goods intended for therapeutic use in Australia, focusing on their safety, efficacy, and quality. Under Section 11, the Minister is empowered to determine specific standards for certain substances or articles, including those listed in the British Pharmacopoeia, the British Pharmaceutical Codex, or the British Veterinary Codex. These standards may pertain to aspects such as composition, strength, potency, stability, sterility, quantity, quality, or method of preparation. Section 13 allows the Minister to set general standards for substances or articles, which can apply broadly or to specific classes, addressing matters such as composition, strength, potency, and more. Section 15 grants the Minister authority to specify requirements for labelling, packing, and containers of therapeutic goods, ensuring they meet particular criteria to maintain safety and compliance.
- The Act imposes several obligations on entities and individuals involved with therapeutic goods. Importers, traders, and suppliers must ensure that their goods conform to applicable standards and comply with labelling and packaging requirements (Sections 19-23). They must obtain necessary consents from the Minister for importing, interstate trade, supplying as a pharmaceutical benefit, or supplying to the Commonwealth (Section 23). Failure to adhere to these standards and requirements can result in significant penalties. Section 25 outlines that contraventions of the Act are offences, with penalties including fines up to $200 or imprisonment for up to six months for summary offences, and up to $1,000 or imprisonment for up to one year for indictable offences. Additionally, courts may order the forfeiture of goods involved in an offence.
- Under Section 29, the Governor-General has the authority to prohibit the importation of substances deemed dangerous and to mandate quarantine measures if a substance is likely to cause a serious disease outbreak or endanger public health. The Minister can exempt certain imports under specified conditions, but non-compliance with these conditions constitutes an offence. The Act also provides for the examination and testing of therapeutic goods through regulations (Section 24), ensuring that these goods meet the required standards before entering the market. Courts are directed to take judicial notice of the British Pharmacopoeia, the British Pharmaceutical Codex, and the British Veterinary Codex in proceedings under the Act (Section 26).
- Area of Law
- Medical Law
- Regulatory Standards
- Instrument
- Act
- Concepts
- Definitions & Interpretation
- Reporting & Disclosure Obligations
- Regulatory Standards
