RPA RPA
Research Ethics and Governance Office

Authorised Prescriber & Special Access Scheme(SAS)

Authorised Prescriber

There are circumstances where patients may require access to medicines or medical devices which have not been approved for supply by the Therapeutic Goods Administration (TGA).  A medical practitioner may apply to become an Authorised Prescriber of a specified therapeutic good (or class of unapproved therapeutic goods) to specific patients (or class of recipients) with a particular medical condition.

Medical practitioners wishing to become Authorised Prescribers must have their application endorsed by an Ethics Committee.

See https://www.tga.gov.au/form/authorised-prescribers

Special Access Scheme (SAS)

The SAS scheme allows for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. Patients are grouped into 2 categories under the scheme:

Category A patients are “persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months or from which premature death is reasonably likely to occur in the absence of early treatment”.

Category B patients are all other patients

See https://www.tga.gov.au/form/special-access-scheme