If you determine that an 'unapproved' medicinal cannabis product is clinically suitable for your patient, there are four pathways through which your patient can access the product with your prescription.
You will need to notify or apply to the TGA for approval to supply the medicinal cannabis product through the SAS or Authorised Prescriber scheme (medical practitioners only) before you provide a prescription.
Submissions to access medicinal cannabis must be made via the SAS and AP Online System.
Read more about the SAS and AP Online System.
Access pathways available for medicinal cannabis
There are four pathways for accessing 'unapproved' medicinal cannabis products:
Authorised Prescriber - Established History of Use pathway
Medical practitioners can apply to become Authorised Prescribers of specified medicinal cannabis products without the need for approval from a Human Research Ethics Committee or endorsement from a specialist college.
Medicinal cannabis products and indications deemed by the TGA to have established history of use are specified in the established history of use lists.
Authorised Prescriber - Standard pathway
Medical practitioners can apply to become Authorised Prescribers of medicinal cannabis products not included in the established history of use lists via the standard pathway. This pathway requires approval from a Human Research Ethics Committee or endorsement from a specialist college before applying to the TGA.
SAS Category A notification pathway
Medicinal cannabis products supplied via the SAS Category A pathway must be imported on a patient-by-patient basis with permission from the Office of Drug Control (ODC). Licence and permit application forms and guidance are available on the ODC website. Please contact the ODC for further information regarding the application process.
SAS Category B application pathway
The SAS Category B pathway is an application pathway available to prescribing healthcare practitioners including Medical Practitioners and Nurse Practitioners. When applying to access an unapproved medicinal cannabis product on behalf of a patient under the SAS Category B pathway, prescribers must provide a clinical justification. The justification should include the seriousness of the patient's condition, consideration for the use of medicines that are included in the ARTG and the potential risks and benefits of using the proposed unapproved medicine.
The clinical justification may be succinct and should summarise:
- an outline of the patient's symptoms and/or diagnosis
- details of relevant past treatments and procedures trialled or considered, including reasons why therapeutic goods currently included in the ARTG may not be the most appropriate treatment for the individual patient in the particular circumstance
- an appraisal of the expected clinical benefits versus the potential risks of the proposed treatment.
There are no restrictions on the medical conditions for which a prescriber may apply via the SAS to access an unapproved medicinal cannabis product for their patient, provided the prescriber has the appropriate knowledge on the condition being treated and on the medicinal cannabis product they wish to prescribe.
Supporting evidence may be requested by the TGA for some novel indications.
In some instances, evidence of specialist support from a practitioner with appropriate expertise may also be requested.
SAS Category B - patients under 18 years of age (paediatric patients)
Caution is generally advised when using unapproved medicinal cannabis products containing THC in paediatric patients. Research has indicated that exposure to THC containing medicinal cannabis products carries potential risks for the developing brain.
SAS B applications received for paediatric patients for unapproved medicinal cannabis products must meet the below criteria.
- Medical practitioners submitting a SAS Category B application for an unapproved medicinal cannabis category 2, 3, 4 and 5 product for a patient under 18 years of age, are required to provide the TGA evidence of support from a paediatric specialist or relevant medical specialist supporting the use of the product for the patient’s medical condition.
- Nurse practitioners may apply to access lower risk category 1 medicinal cannabis products for paediatric patients with a letter of support from a medical practitioner or proof their scope of practice encompasses child and adolescent health.
The existing policy for SAS and guidance for health practitioners is highlighted in the TGA document titled Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods.
Key features of SAS and AP pathways
| Pathway | Authorised Prescriber – Established history of use | Authorised Prescriber – standard | SAS Category A notification | SAS Category B application |
|---|---|---|---|---|
| Medical practitioners can apply | yes | yes | yes | yes |
| Other health practitioners can apply | no | no | no | yes |
| Specified list of medicines | yes | no | no | no |
| Requires approval from a HREC | no | yes | no | no |
| Requires submission to TGA for every patient | no | no | yes | yes |
| Requires six monthly patient reports | yes | yes | no | no |