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.
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 List of medicines with established history of use
Authorised Prescriber - Standard pathway
Medical practitioners can apply to become Authorised Prescribers of medicinal cannabis products not included in the List of medicines with established history of use 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. Contact details are available from Import and export of controlled substances.
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.
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 |