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)
Approvals required before a cannabis medicine can be legally prescribed
Doctors require 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.
NSW Health approval is also required when seeking to prescribe or supply a S8 cannabis medicine:
- to a drug dependent person, including a person treated under the Opioid Treatment Program, or
- for a clinical trial of an unregistered medicine, or
- 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 (NSW). Exemption is sought by making an application to NSW Health.
A NSW Health authority is not needed to prescribe a Schedule 4 cannabis medicine. A medical practitioner only needs to obtain TGA approval to prescribe these medicines when unregistered.
Rules differ in other states and territories.
Further information on applying can be found on the NSW Health website.
The legal pathways for accessing cannabis medicines in NSW are outlined in the factsheet below.
Special Access Scheme (SAS) online system
In recent years, the NSW Government has worked with the TGA to streamline the application process for seeking authority to prescribe an unregistered cannabis medicine. Any medical practitioner in NSW can submit SAS applications and notifications electronically through the TGA’s online system.
- Clinical trials
- Talking to your patient
- Prescribing pathways
- Information and support for prescribers
- Clinical guidelines
- Children and vulnerable people
Residential aged cared facilities
- Education resources