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.