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Legislation & legislative instruments | Therapeutic Goods Administration (TGA)
Legislation & legislative instruments
Legislation & legislative instruments
The Therapeutic Goods Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, including advertising, labelling, product appearance and appeal guidelines. Some provisions such as the scheduling of substances and the safe storage of therapeutic goods, are covered by the relevant State or Territory legislation.
Australian legislation in full text is available from the Attorney General's Federal Register of Legislation (link is external).
About the Australian therapeutic goods legislation | Therapeutic Goods Administration (TGA)
Therapeutic Goods Act 1989
Therapeutic Goods Act 1989
The Act (link is external) sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia.
It details the requirements for listing, registering or including medicines, medical devices and biological products on the Australian Register of Therapeutic Goods (ARTG), as well as many other aspects of the law including advertising, labelling, and product appearance.
The Act is supported by the Regulations, and various Orders and Determinations which provide further details of matters covered in the Act. The Act is a Commonwealth Act that provides a substantially uniform national system of controls over therapeutic goods, facilitating trade between the states and territories and benefiting both consumers and industry.
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