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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:
- Special Access Scheme (SAS),
- Authorised Prescriber (AP) Scheme
- Clinical Trials (CT) Schemes
- Personal Importation (PI) Scheme
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.
