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Special Access Scheme and Authorised Prescriber online system
On Monday 30 July 2018, an online system was introduced to enable the electronic submission of Special Access Scheme (SAS) applications and notifications to the TGA. On 1 December 2018, this system was updated to allow the submission of Authorised Prescriber (AP) applications to the TGA. Use of this online system will reduce administrative burden on health practitioners and provide users with additional system benefits to manage their SAS applications and notifications.
Please note that while lodgement of SAS application and notifications and AP applications to the TGA via the online system is not mandatory, it is the preferred method of submission. The TGA is aiming to move the submission of all SAS and AP online by 1 July 2019.
Further information can be found in the Special Access Scheme (SAS): Online system guidance and the Authorised Prescriber user guidance.
Submission of medicinal cannabis SAS applications and notifications
In April 2018, the Commonwealth and State and Territory Health Departments announced they would work collaboratively to streamline access to medicinal cannabis for Australian health practitioners. This announcement made reference to a 'single-in' application process through which medical practitioners could notify or apply to both the Commonwealth and the relevant State or Territory Health Department (where applicable) to prescribe and supply medicinal cannabis products via a single application. Historically, prescribers of unapproved medicinal cannabis products have been required to separately apply/notify the TGA and the State or Territory Health Department (where applicable) for approval/authorisation to supply these products.
Prior to the introduction of the SAS online system, prescribers of unapproved medicinal cannabis products were required to separately apply to the TGA and relevant state or territory health department for authorisation.
There are circumstances where the TGA's SAS online system should not be used for medicinal cannabis submissions. These circumstances include:
- Where the prescriber of the unapproved therapeutic good is not a medical practitioner.
- If you are submitting an application on behalf of the prescriber. The medical practitioner prescribing the medicinal cannabis product must make the submission via the system.
- Where the prescriber is in possession of a current TGA approval and the notification/application only relates to the state or territory. A notification or application in these circumstances should be made directly to the State or Territory Health Department.