The Therapeutic Goods Act 1989 is an Act of the

Commonwealth of Australia Australia, officially the Commonwealth of Australia, is a sovereign country comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands. With an area of , Australia is the largest country by ...

which regulates therapeutic goods. The Act is administered by the

Therapeutic Goods Administration The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, p ...

(TGA), which is part of the Commonwealth

Department of Health A health department or health ministry is a part of government which focuses on issues related to the general health of the citizenry. Subnational entities, such as states, counties and cities, often also operate a health department of their ow ...

. The statutory framework set out in the Act is supplemented by the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. The central mechanism through which therapeutic goods (being medicines, biologicals and medical devices) are regulated is the

Australian Register of Therapeutic Goods Australian(s) may refer to: Australia * Australia, a country * Australians, citizens of the Commonwealth of Australia ** European Australians ** Anglo-Celtic Australians, Australians descended principally from British colonists ** Aboriginal Au ...

(ARTG). Subject to the alternative supply/export pathways set out in the Act, all therapeutic goods must be "registered" (for prescription medicines), "listed" (for complementary and over-the-counter medicines) or "included" (for biologicals and

medical devices A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...

) in the ARTG to be lawfully supplied in Australia.

History

In 2020, the TGA re-classified

nicotine Nicotine is a natural product, naturally produced alkaloid in the nightshade family of plants (most predominantly in tobacco and ''Duboisia hopwoodii'') and is widely used recreational drug use, recreationally as a stimulant and anxiolytic. As ...

as a Schedule 4 substance under the Poisons Standard, meaning that consumers require a prescription from a medical prescription to obtain a nicotine a vaping product. To date, there are no nicotine vaping products registered or included on the ARTG, so consumers must obtain these through the Authorised Prescriber (AP) Scheme, Special Access Scheme (SAS) B or Personal Importation Scheme pathways.

References

{{reflist 1989 in Australia Health law in Australia Health policy in Australia Law of Australia Medical regulation in Australia Pharmaceuticals policy Medical law