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Patient access via the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathway
We administer the Therapeutic Goods Act 1989 (the Act), which establishes the regulatory framework for all medicines in Australia.
We have 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 we do 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 us based on the information provided with the application.
Special Access Scheme (SAS)
- The SAS allows a prescriber (including nurse practitioners) to prescribe a medicinal cannabis product 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 us 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 apply to us to become an AP.
- Medical practitioners must apply for AP approval for a specified unapproved medicinal cannabis product for a particular indication (usage) for a class of patients in their immediate care.
- Medical practitioners can apply for multiple AP approvals for different medicinal cannabis product types and indications (usages).
- 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 our List of medicinal cannabis medicines with established history of use.
- APs do not need to notify us each time they prescribe medicinal cannabis products during the approval period (up to 5 years). However, APs must provide 6 monthly reports of patients treated under each AP approval they hold.
Medicinal cannabis access data dashboard
To improve transparency and data accessibility, we publish de-identified data on Special Access Scheme approvals and notifications and Authorised Prescriber approvals specific to 'unapproved' medicinal cannabis.
Please note:
- The dashboards are 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 we received the first known medicinal cannabis SAS application. However, the majority of approvals have occurred since 2016.
- On 22 November 2021 we changed from approving trade name based medicinal cannabis products to Category Based products.
- 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.
Patient data
We are not able to provide accurate figures on the number of patients accessing medicinal cannabis. SAS applications contain only de-identified patient information, and AP six monthly reports contain no patient details.
Approval and notification numbers do not equal the actual number of patients receiving these medicines under the SAS and AP schemes. One patient can potentially be associated with:
- multiple AP approvals for different products under the same prescriber
- multiple SAS approvals for different products
- repeat SAS approvals for a single product, and
- approvals for the same product under each scheme.
SAS and AP approvals and notifications do 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. Further, we do not hold prescription data.
The dashboard is best viewed on a desktop.
Filters can be applied to the data by clicking on the graphs to refine results and capture the desired data. Any filter applied that produces a result less than10 will display ‘<10’ instead of the exact number, to ensure anonymity of individuals. Filters can be removed by clicking the ‘Clear Selections’ button. Filtered data can be exported into an excel spreadsheet by clicking the ‘Bulk Export’ button.
If you have a disability and are unable to use the dashboard, please contact: medicinal.cannabis@health.gov.au 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, we have created the SAS/AP Online System, which provides a single application point for Commonwealth and state/territory authorisations for medicinal cannabis products. Where applicable, applications are reviewed by both us and state/territory within 2 business days of submission of the required information.
Read more about the SAS and AP Online System.
Quality standard measures
We are 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
We also play 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
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.
Other substances
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.