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This page provides prescribers with information on how to access an unapproved medicinal cannabis product using the SAS or Authorised Prescriber pathways; as well as the reporting requirements.
Submission by a health practitioner
SAS applications and notifications must be submitted by certain registered health practitioners.
Health practitioners who are considering treating a patient with an 'unapproved' therapeutic good must acknowledge that it has not been evaluated for quality, safety or efficacy and it has not been approved by the TGA. The TGA cannot guarantee the quality, safety or efficacy of an 'unapproved' product.
The prescribing health practitioner must consider the available evidence to support the use of the unapproved product and any potential risks for the individual patient.
The responsibilities of the prescribing health practitioner include adhering to relevant standards of good medical practice and obtaining informed consent. The prescribing health practitioner also accepts responsibility for the use of an 'unapproved' therapeutic good and any associated adverse reactions.
Read more about responsibilities and how to access an unapproved therapeutic good.
How to apply - SAS & Authorised Prescriber Online System
To access unapproved medicinal cannabis products, make your submission through the SAS and AP Online System.
Prescribers can submit applications to both the TGA and their State or Territory Health Department simultaneously. We will send a single correspondence containing both the TGA and relevant state or territory decision letter, after respective evaluations have been completed, within 2 to 5 business days of having received all the information required to make a decision.
- Register an account in the SAS & Authorised Prescriber Online System
- Access the SAS & Authorised Prescriber Online System.
Authorised Prescribers can also submit their patient six monthly reports using the System.
Note that applications for medicinal cannabis to the TGA are specific to ‘generic’ categories based on cannabinoid content. For further information see: Medicinal cannabis product categories.
Read more about the SAS and AP Online System.
Obtaining medicinal cannabis products
The TGA does not supply therapeutic goods. Before notifying or applying to TGA under the SAS and AP schemes, applicants should check with the intended sponsor (or supplier) to ensure that they are prepared to supply the product.
If the product is available from an Australian supplier, the prescribing health practitioner or someone acting on their behalf (e.g. pharmacist) should contact the sponsor to organise supply. Within an institution such as a hospital, supply may be arranged through the pharmacy department.
We recognise that prescribing by active ingredient for medicinal cannabis products can be difficult for prescribers and pharmacists due to the complexity of available product preparations.
To support health care professionals in prescribing and supplying medicinal cannabis products, we have published a list of available medicinal cannabis products (by trade name) according to the active ingredient categories included in TGA approval letters. Sponsor details are also included to facilitate patient access.
For more information on a particular product, please contact the product sponsor.
View medicinal cannabis products by SAS and AP category.
Extemporaneous compounding of medicinal cannabis products
Pharmacists can extemporaneously compound a medicinal cannabis product for a particular person on prescription. From 28th April 2022, extemporaneous compounding of medicinal cannabis products can only occur with a prescription based on approvals under either the Special Access Scheme (SAS) or Authorised Prescriber (AP) pathway.
Information for prescribers and pharmacists
- SAS and AP submissions are required be made on the basis of the active ingredient category of cannabinoid content and the dosage form of the final product.
- Details regarding the preparation of an extemporaneously compounded product should be provided on the prescription.
- Pharmacists involved in the compounding of medicines should consider applicable State and Territory requirements, including requirements under the Health Practitioner Regulations Law.
- Pharmacists should also consider the Pharmacy Board of Australia Guidelines on compounding of medicines. These guidelines include detailed guidance on when it is appropriate for a medicine to be compounded and the requirements to be complied with when compounding medicines.
- Prescribers and pharmacists should consider individual legal and professional responsibilities when a compounded medicine is prescribed and subsequently compounded and dispensed.
Quality standards
Medicinal cannabis products are required to comply with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017, which provides for minimum quality requirements for medicinal cannabis products. Further information can be obtained in the guidance document, Conforming with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017.
For each product they compound and dispense, pharmacists must:
- ensure that the product conforms to all of the requirements of TGO 93, and
- maintain records demonstrating that the product conforms to all of the requirements of TGO 93.
Advertising
Medicinal cannabis products are Prescription Only medicines, hence its advertising is prohibited under the Act. For more guidance in relation to the advertising of medicinal cannabis products (including extemporaneously compounded products) see the Advertising guidance for businesses involved with medicinal cannabis products.
Apply for a licence and permission to import, if necessary
Cannabis, cannabis resin, extracts, oils and tinctures of cannabis, and cannabinoids (including cannabidiol and tetrahydrocannabinols) are captured under the Customs (Prohibited Imports) Regulations 1956. A licence and permission to import is required prior to importing any product containing these substances.
The Office of Drug Control (ODC) hosts a list of manufacturers and suppliers of medicinal cannabis products on its website. Some suppliers may have stock available in Australia removing the need for the medical practitioner, or pharmacist acting on behalf of the medical practitioner to arrange for import. Please see the ODC website for more information.
If a medicinal cannabis product has not already been imported by the sponsor, a medical practitioner, or pharmacist acting on behalf of the medical practitioner, can apply for a licence and permission to import.
Please contact the ODC for further information regarding the application process.
State and territory requirements
Approval or permission from state or territories may be required to prescribe medicinal cannabis products.
It is the responsibility of the prescribing practitioner to know the legislative requirements of the state or territory in which they are practising.
Contact the relevant state or territory health department for further information. Contact details for each Australian state & territory are available below: