Most medicinal cannabis (medical marijuana) products are ‘unregistered products’ and hence are not listed on the Australian Register of Therapeutic Goods (ARTG). To prescribe an unregistered product, a doctor must therefore be granted approval by both the TGA Australia and the State or Territory in which the patient resides*.
The Special Access Scheme (SAS) Category B pathway is currently the quickest route to access medicinal cannabis products for an individual patient. Approval from the TGA is issued on a case by case basis and, provided all the required information has been submitted, can be granted within 24 – 48 h.
It is preferred that the SAS Category B is applied for by a specialist in the illness being treated, however, a GP can be granted approval if the application is supported by a specialist. The letter of endorsement from the specialist should clearly state that they support the use of (name the medicinal cannabis product) for the treatment of (state the primary indication eg. chemotherapy induced nausea and vomiting).
When filling out the SAS B application the doctor should be as clear as possible. Using a disease state such as “cancer” as an indication is generally too broad and the TGA will need clarification. Instead clearly state the reason why medicinal cannabis therapy is being sought for this patient (such as CINV, appetite, pain etc.). This is also important when demonstrating treatment resistance. Depending on the primary indication, the doctor will need to include information on past treatment failures.
To avoid time consuming clarification requests from the TGA please follow the checklist below before submitting your SAS Category B application.
Doctors wanting to learn more about available medicinal cannabis products and submit a SAS Category B application can now do so via the CannabisAccess site.
- I am an Australian registered medical practitioner (medical doctor).
- Patient is treatment resistant/responding poorly to the currently available standard of care medicines.
- I have looked at the clinical evidence available and a medicinal cannabis product is suitable for my patient.
- I am a Specialist in the primary indication OR I have a letter of endorsement from a Specialist supporting the use of medicinal cannabis in this patient.
- I have clearly stated which medicinal cannabis product I am applying for.
- I have clearly stated the specific indication the application is for.
- I have clearly provided the intended dose range.
- I have attached evidence to support my application.
The TGA also provides an online tool for assessing different access pathways.