Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 is an Act of the Commonwealth of Australia which regulates therapeutic goods. The Act is administered by the Therapeutic Goods Administration (TGA), which is part of the Commonwealth Department of Health.^[1] 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 (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) 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 a 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]

References

1. Administration, Australian Government Department of Health Therapeutic Goods. "Legislation & legislative instruments". Therapeutic Goods Administration (TGA). Retrieved 3 July 2022.
2. Administration, Australian Government Department of Health Therapeutic Goods. "About the Australian therapeutic goods legislation". Therapeutic Goods Administration (TGA). Retrieved 3 July 2022.
3. Administration, Australian Government Department of Health Therapeutic Goods (21 December 2020). "Notice of final decision to amend the current Poisons Standard - nicotine". Therapeutic Goods Administration (TGA). Retrieved 3 July 2022.
4. Administration, Australian Government Department of Health Therapeutic Goods (27 June 2022). "Nicotine vaping products: Information for prescribers". Therapeutic Goods Administration (TGA). Retrieved 3 July 2022.