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Most medicinal cannabis products are unapproved therapeutic goods, meaning they are not included in the Australian Register of Therapeutic Goods (ARTG) and have not been assessed by us for safety, quality or effectiveness.
Unapproved medicinal cannabis products can be manufactured, exported, imported, or supplied in Australia under strict regulatory conditions.
Unapproved medicinal cannabis products can only be supplied under specific access pathways, such as the:
- Special Access Scheme (SAS)
- Authorised Prescriber (AP) Scheme
- Clinical Trial (CT) Schemes
You are responsible for ensuring that an exemption, approval, or authority is obtained prior to supplying unapproved medicinal cannabis products.
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.