- A Clinical Trial
- The Authorised Prescriber Scheme
- The Special Access Scheme (SAS)
Approvals required before a cannabis medicine can be legally prescribed
Doctors require an approval from the TGA before they can prescribe an unregistered Schedule 8 (S8) cannabis medicine. In assessing an application for a prescriber to import or supply an unregistered cannabis medicine, the TGA considers the prescriber’s expertise, the suitability of the medicine to treat the patient’s condition and the quality of the medicine.
An application to NSW Health must also be made where it is for:
- prescribing or supply to a drug dependent person, including a person treated under the Opioid Treatment Program, or
- prescribing or supply of an unregistered medicine for a clinical trial, or
- prescribing or supply to treat a child (aged under 16 years). Medical practitioners must seek an exemption under the Children and Young Persons (Care and Protection) Act 1998. Exemption is sought by making an application to NSW Health.
A NSW Health authority is not needed to prescribe a Schedule 4 cannabis medicine. Apply directly to the TGA.
Rules differ in other states and territories.
Further information on applying can be found on the NSW Health website.
The below fact sheet details the pathways to legal access of 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.