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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 are 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.

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    Understanding the difference between an approved and unapproved therapeutic good can help you make informed decisions and have meaningful conversations with your healthcare practitioner, especially when considering treatments like medicinal cannabis.

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    Medicinal cannabis prescribing in Australia has increased significantly in recent years. However, many patients are unaware that most medicinal cannabis products are unapproved goods. As a prescriber, you play a critical role in ensuring patients are informed, protected and supported when these products are being considered for their clinical situation.

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