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Medicinal cannabis: Role of the TGA
Patient access via the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathway
The TGA administers the Therapeutic Goods Act 1989 (the Act), which establishes the regulatory framework for all medicines in Australia.
The TGA has a responsibility to encourage the use of medicines that are included in the Australian Register of Therapeutic Goods (ARTG), as these products have been evaluated to ensure they meet strict standards of safety, quality and effectiveness.
The Act provides a number of mechanisms, including the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathway, to enable access to 'unapproved' therapeutic goods, such as medicinal cannabis.
It is expected that registered health practitioners (prescribers) will have considered clinically appropriate treatment options that are included in the ARTG before applying to access an unapproved medicinal cannabis product under the SAS or AP pathway.
It is important to note that the TGA does not vouch for the quality, safety and effectiveness of unapproved products accessed through the SAS and the prescriber and patient (via informed consent) accept responsibility for any adverse consequences of the treatment.
It is the responsibility of the prescriber making the application to specify for which indication they are intending to use the unapproved medicinal cannabis product. SAS Category B and AP applications are individually considered by the TGA based on the information provided with the application.
Special Access Scheme (SAS)
- The SAS allows prescribers (including nurse practitioners) to prescribe medicinal cannabis products for a single patient on a case-by-case basis.
- SAS Category A (SAS A) is a notification pathway that allows a registered medical practitioner to access and prescribe an unapproved medicinal cannabis product for a patient who is seriously ill. Under the SAS Category A pathway, prescribers must import medicinal cannabis products on a patient-by-patient basis via application to the Office of Drug Control
- Special Access Scheme Category B (SAS B) is an application pathway through which a registered health practitioner may apply to the TGA for approval to prescribe an unapproved medicinal cannabis product for a patient under their care. The applicant must provide a suitable clinical justification for the use of the therapeutic good, including reasons why products included in the ARTG are not suitable for treatment of the patient.
Authorised Prescriber Scheme (AP)
- Any Australian registered medical practitioner can become an AP.
- The TGA is able to grant a medical practitioner authority to prescribe a specified unapproved medicinal cannabis product for particular indications to a class of patients in their immediate care.
- To become an AP, a medical practitioner must obtain approval from a Human Research Ethics Committee (HREC) or endorsement from an appropriate specialist college to prescribe the product.
- Prescribers do not need HREC approval or specialist college endorsement if the selected medicine's active ingredient category, dosage form and indication is included in the TGA's List of medicinal cannabis medicines with established history of use.
- APs do not need to notify the TGA each time they prescribe medicinal cannabis products during the approval period (up to 5 years).
- APs must report the number of patients they treat every 6 months, even if the number is zero.
Medicinal Cannabis Access Data Dashboard
To improve transparency and data accessibility, the TGA publishes de-identified data on the number of unapproved medicinal cannabis products accessed through the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme. The Medicinal Cannabis Access Data Dashboard is a web-based platform that allows the public to access and filter this data through interactive graphs:
- Medicinal Cannabis Special Access Scheme Category A Data
- Medicinal Cannabis Special Access Scheme Category B Data
- Medicinal Cannabis Authorised Prescriber Scheme Data - available prior to the end of August 2022.
- The Dashboard is updated monthly, with figures correct at the time of publishing. These may change to reflect updates from subsequent application cancellations, withdrawals and amendments.
- The Dashboard includes access data since 1992 when TGA received the first known medicinal cannabis SAS application. However, the majority of approvals have occurred since 2016.
- Sativex (nabiximols) and Epidyolex (cannabidiol) are approved medicinal cannabis products included in the ARTG. Data on the use of these products is not included in the Dashboard.
- Approval and notification numbers do not equal the actual number of patients receiving these medicines under the SAS. This is because one patient can be associated with repeat applications for a single product as well as with approvals for multiple products. SAS applications contain de-identified patient information, so it is not possible for the TGA to report on individual patient numbers. Under AP, approvals allow a medical practitioner to prescribe a product to multiple patients.
- SAS and AP approvals or notifications does not mean the patient has accessed or continues to access treatment. Following approval, the actual supply of medicinal cannabis is a matter for the medical practitioner and their patient.
If you have a disability and are unable to use the Dashboard, please contact: email@example.com to access the data in an alternative format.
SAS & AP online system
In order to reduce the administrative burden of making SAS and AP applications, the TGA has created the SAS/AP Online System, which provides a single application point for Commonwealth and state/territory authorisations for medicinal cannabis products. Applications are reviewed by both the TGA and state/territory within 2 business days of submission.
Further information on the SAS online system and details on the submission of medicinal cannabis applications can be found at: Special Access Scheme and Authorised Prescriber online system.
Quality standard measures
The TGA is responsible for governing regulatory standards for medicinal cannabis products in Australia. Quality controls are implemented through standards such as the Therapeutic Goods -(Standard for Medicinal Cannabis) (TGO 93) Order 2017. TGO 93 provides appropriate regulatory controls to ensure that the quality of the medicinal cannabis and ingredients used in the manufacture is of an acceptable standard and safe for its consumer. For more information, please review the Conforming with the TGO93 web page.
Scheduling of medicines
The TGA also plays a vital role in the scheduling of medicines in Australia. The Schedules are published in the Poisons Standard and may be adopted by state and territory jurisdictions to take legal effect.
Scheduling of medicinal cannabis products
Cannabis and tetrahydrocannabinol
Under certain circumstances, cannabis (including seeds, extracts, resins and the plant or any part of the plant) and tetrahydrocannabinol (when extracted from cannabis) when prepared or packed for human therapeutic use, are 'Controlled Drugs' under Schedule 8 (S8) of the Poisons Standard.
Access will need to be confirmed with the relevant State/Territory noting that laws differ between jurisdictions. For State and Territory contact information please see: Applications and reporting.
Cannabidiol (CBD) is one of the cannabinoids which may be extracted as a therapeutic good from cannabis. From 1 June 2015, cannabidiol has been included under Schedule 4 (S4) Prescription Only Medicine of the Poisons Standard when the cannabinoids component in the preparation for therapeutic use contains at least 98% cannabidiol and 2% or less of other cannabinoids found in cannabis.
From 1 February 2021, certain preparations of cannabidiol were available as Schedule 3 Pharmacist Only medicines. However, at present, there are no products on the Australian Register of Therapeutic Goods that meet the requirements for this classification.
Nabiximols, nabilone and dronabinol are listed as Controlled Drugs in S8 of the Poisons Standard. S8 substances require a prescription from an Australian-registered medical practitioner to obtain and possess within Australia.