Prescribing pathways

The Australian Government’s Therapeutic Goods Administration (TGA) may approve the supply of unregistered cannabis medicines under the following pathways:

  • A Clinical Trial
  • The Authorised Prescriber Scheme
  • The Special Access Scheme (SAS)

NSW applications – Schedule 8 and Schedule 4 medicines

The Special Access Scheme (SAS) Category A notification (SASA) form and SAS Category B (SASB) online application form include both TGA's requirements under the SAS and the requirements for NSW's Health's Application for Authority Application form to Prescribe and Supply a Cannabis Product for Human Therapeutic Use, for Schedule 8 medicines.

These forms should only be submitted via the online portal on the TGA website (see below). The TGA will forward the form to NSW Health. Once submitted, the TGA and NSW Health will simultaneously review the information provided for Schedule 8 medicines.

For unregistered Schedule 4 cannabis medicines, an application is only required to the TGA. Decision letter/s will then be emailed to the contact details provided on the form.

Apply directly to NSW Health for authority to prescribe:

  • unregistered Schedule 8 medicines under the Authority Prescriber Scheme, and
  • registered product nabiximols (Sativex).

Rules differ in other states and territories.

The below fact sheet details the pathways to legal access of unregistered cannabis medicines in NSW.

Special Access Scheme (SAS) online system

The TGA has been working in collaboration with the state and territory Health Departments to streamline the application processes for the prescription of and subsequent access to unregistered medicinal cannabis products in Australia. Medical practitioners in NSW can submit SAS applications and notifications electronically for cannabis medicine through the TGA’s online system.