Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 is a piece of legislation passed by the Australian Parliament which aims to regulate therapeutic goods. The Act is administered by the Therapeutic Goods Administration (TGA), which is part of the Commonwealth Department of Health.^[1] As of July 2025^[update], the statutory framework set out in the Act is mainly supplemented by the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods (Charges) Act 1990.

Therapeutic Goods Act 1989
Parliament of Australia
Long title An Act relating to therapeutic goods
Citation	Therapeutic Goods Act 1989 (Cth)
Territorial extent	Australia
Assented to by	Governor-General Bill Hayden
Assented to	17 January 1990
Administered by	Department of Health
Bill citation	Therapeutic Goods Bill 1989 (Cth)
Introduced	5 October 1989
Repeals
Therapeutic Goods Act 1966
Status: Current legislation

The central mechanism through which therapeutic goods (medicines, biologicals and medical devices) are regulated is the Australian Register of Therapeutic Goods (ARTG). Subject to the alternative supply and 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) in the ARTG to be lawfully supplied in Australia.^[2]

History

In 2020, the TGA re-classified nicotine as a Schedule 4 substance under the Poisons Standard, meaning that consumers require a prescription from a medical prescription to obtain a nicotine vaping product.^[3] 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.^[4]