Australian Government

  Special Access Scheme (SAS) Applications - Quick Reference Guide (tga.gov.au)

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 - external site , 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 .

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  Special Access Scheme  approvals and notifications and  Authorised Prescriber  approvals specific to 'unapproved' medicinal cannabis. 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 November 2022. As of 30 September 2022 there are 1475 currently approved Authorised Prescribers for medicinal cannabis products. Please note: 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 si...

  Australian Register of Therapeutic Goods (ARTG) The ARTG is the public database of therapeutic goods that can be legally supplied in Australia. You can search the ARTG to find details of therapeutic goods approved for supply. Information held in the ARTG includes: product name and formulation details sponsor (company) and manufacturer details. For more details and how to use the ARTG search function go to  Searching the Australian Register of Therapeutic Goods (ARTG) - external site - external site .  Search results from the ARTG include  Consumer Medicines Information (CMI) ,  Product Information (PI)  and Public Summary documents. Not all CMI and PI documents are available on this website. Access to therapeutic goods not on the ARTG As with many aspects of the regulatory framework, there are situations where special policies have been developed in response to the needs of particular people or circumstances. Information on these policies and the relevant...

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