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About the Special Access Scheme and Authorised Prescriber Scheme
The SAS refers to arrangements that provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case-by-case basis. Three pathways exist under the scheme, that can be utilised by health practitioners. The two most common pathways are as follows:
Category A is a notification pathway that can only be accessed by medical practitioners for patients 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 is an application pathway that can be accessed by health practitioners for patients who do not fit the Category A definition and where the unapproved good is not deemed to have an established history of use and cannot therefore be accessed through Category C. An approval letter from the TGA is required before the good may be accessed. Approvals for medicines accessed through this pathway are typically only issued to medical and dental practitioners.
The Authorised Prescriber Scheme allows authorised medical practitioners to prescribe a particular unapproved therapeutic good to a class of patients with a particular medical condition. An Authorised Prescriber is allowed to prescribe the product directly to specified patients under their immediate care without requiring separate approval for individual patients.
States & Territory Information: