Sub menu

 

 

Unapproved therapeutic goods

Therapeutic goods that are not included on the Australian Register of Therapeutic Goods (ARTG) may be accessed under certain pathways.

About unapproved therapeutic goods

Unapproved therapeutic goods are products that are not included in the Australian Register of Therapeutic Goods (ARTG). This means they haven’t been assessed by us for safety, quality, or effectiveness.

Certain registered health practitioners may access unapproved therapeutic goods under defined pathways if all other clinically appropriate treatment options on the ARTG have been considered. These pathways support access for individual patients or groups under specific conditions and include the:

Specific information exists for:

  • medicinal cannabis,
  • MDMA and psilocybine
  • therapeutic vaping goods.

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all products.

An overview of unapproved therapeutic goods

Regulation of unapproved therapeutic goods

Know your obligations at each point along your product’s regulatory journey.

Types of unapproved therapeutic goods

Explore different product types which have additional rules and requirements. Understand how to meet your obligations.

  • MDMA and psilocybine

    MDMA and psilocybine are controlled substances used in limited medical and research settings.

  • Medicinal cannabis

    Medicinal cannabis products are medicines made derived from cannabis plants.

  • Therapeutic vaping goods

    All vaping products intended for therapeutic use for smoking cessation or nicotine dependence, including those that do not contain nicotine, are regulated as therapeutic goods in Australia

  • Bacteriophages

    Bacteriophages are viruses that kill bacteria. In Australia, bacteriophage therapy, when used in humans, is regulated as a medicine.

  • Compounded medicines

    Find out how compounded medicines are regulated in Australia, and the responsibilities that apply to people who manufacture, supply or advertise them.

  • Nicotine pouches

    How nicotine pouches are regulated in Australia. From 24 July 2026, there is no longer a lawful pathway for consumers to buy or import nicotine pouches in Australia.

Related information

Latest alerts

  • ITCHA SSS capsules

    Safety alerts
    We are advising consumers that ITCHA SSS capsules, marketed for weight management, have been found to contain oxedrine, an undisclosed prescription-only medicine.
All alerts

Articles

  • TGA leads crackdown of illegal nicotine products across Darwin

    Media releases
    The TGA, in partnership with NT Health, Northern Territory Police Force and the Northern Territory Department of Trade, Business and Asian Relations, conducted a targeted multi-agency enforcement operation across three premises in Darwin.

  • TGA acts on melatonin imports

    Media releases
    We have issued 5 infringement notices totalling $99,000 to Acacia Pharmacy Pty Ltd for the alleged unlawful importation of unapproved melatonin products, in contravention of the Therapeutic Goods Act 1989.
All articles

Latest publications

All publications