Special Access Scheme & Authorised Prescriber Scheme

Most therapeutic goods are required to undergo an evaluation for quality, safety and efficacy and be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. In recognition that there are circumstances where patients need access to therapeutic goods that are not included in the ARTG, the Therapeutic Goods Administration (TGA) manages the Special Access Scheme (SAS) and Authorised Prescriber Scheme (AP).

It is important to note that the prescribing health practitioner accepts responsibility for the use of an "unapproved" therapeutic good and any associated adverse reactions.

Medicinal Cannabis Submissions

On 13 April 2018, the Council of Australian Governments Health Ministers agreed to work together to streamline access to medicinal cannabis for Australian health practitioners. The announcement made, stated that prescribers of medicinal cannabis could provide the relevant information, through a single application process to fulfil both Commonwealth and jurisdictional requirements to enable access. The TGA will send a single correspondence containing both the TGA and relevant state or territory decision letter after respective evaluations have been completed within 48 hours (2 business days) of having received all the information required to make a decision.

Typically, prescribers of unapproved medicinal cannabis products were required to separately apply to the TGA and relevant State or Territory Health Department for authorisation.

Remember the following when using the SAS online system for medicinal cannabis applications:

You must be the prescribing health practitioner to submit an application for a medicinal cannabis product via the online system.

By using the SAS online system, prescribers will now be able to submit applications to the TGA and State or Territory Health Department simultaneously.

Currently most states and territories (except for Tasmania) can be applied to simultaneously via this online system.

If your state or territory is not available via the online system, you will need to apply separately to the TGA and the relevant State or Territory Health Department. Submitting your application via the online system will only satisfy TGA requirements.

Useful Resources