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Supply and distribution for medicinal cannabis

Information about manufacturing, supplying and importing or exporting an unapproved medicinal cannabis product.  

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.

Supply

Understand your obligations to manage the ongoing supply of products.

  • Supplying unapproved therapeutic goods as a sponsor

    Guidance
    This guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.

Import and export

Access requirements for import and export of therapeutic goods.

Product types