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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 Special Access Scheme (SAS) or Authorised Prescriber (AP) 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
Use the searchable table to determine if you are eligible to access ‘unapproved’ medicinal cannabis products using the SAS or AP pathways.
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 for adult patients over 18 years 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. This pathway can also be used for non-general practitioner (non-GP) medical practitioner ‘specialists’ to supply medicinal cannabis for patients under 18 years old. See Patients under 18 years of age (paediatric patients).
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 and AP access for patients under 18 years of age (paediatric patients)
Category 2, 3, 4 and 5 medicinal cannabis products are classified as Schedule 8 (‘Controlled Drugs’) in the Poisons Standard. These are products where cannabidiol is less than 98% of the total cannabinoid content of the medicine, and other cannabinoids (including tetrahydrocannabinol (THC)), make up the remaining content.
Caution is advised when using unapproved medicinal cannabis products containing THC to treat paediatric patients. Research has indicated that exposure to THC-containing medicinal cannabis products carries potential risks for the developing brain. Additionally, products containing low amounts of THC and other cannabinoids, such as cannabigerol (CBG), remain as Schedule 8 medicines until the risks and benefits can be demonstrated through the Scheduling process.
To apply AP authorisation for Category 2, 3, 4 and/or 5 medicinal cannabis products to treat patients less than 18 years of age you must be a non-GP ‘specialist’ medical practitioner with a specialty relevant to the paediatric indication(s) (use(s)) you are requesting approval for AND provide a HREC approval specific to patients under 18 years.
SAS Category B for paediatric patients
Evidence of support from a medical practitioner with a paediatric or relevant specialty is required to access Category 2, 3, 4 and/or 5 medicinal cannabis products to treat patients less than 18 years of age.
Medical practitioners may access Category 1 products without paediatric specialist or relevant specialist support.
SAS B and AP applications received for paediatric patents for unapproved medicinal cannabis products must meet the below criteria.
| Prescriber type | PAEDIATRIC SAS-B requirements | PAEDIATRIC AP requirements |
|---|---|---|
| ‘Specialist’ (non-GP) medical practitioner | If prescribing:
If referring or endorsing another medical practitioner:
| Must have a specialty relevant to the indication (use) in the application and approval from a HREC specific to patients under 18 years |
| Other medical practitioners (such as GPs) | Must have evidence of support from a ‘specialist’ (non-GP) medical practitioner with a paediatric specialty relevant to the indication (use) in the application The letter must:
Renewal of a SAS B approval for the same patient requires a new application and a new letter of support. Letter of support is not required to prescribe lower risk Category 1 products | Not eligible |
| Nurse practitioners | Can only 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, neurology or psychiatry | Not eligible |
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.