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About the Special Access 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.
SAS Online System
On Monday 30 July 2018, an online system was introduced to enable the electronic submission of SAS applications and notifications 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.
States & Territory Information: