Special access scheme rules
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The Special Access Scheme (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.
The Therapeutic Goods Amendment (2016 Measures No.1) Act 2017 (the Amendment Act) amended the Therapeutic Goods Act 1989 (the Act) to enable health practitioners to supply certain unapproved therapeutic goods - principally those with an established history of use in similar overseas countries or in Australia through the existing provisions to access unapproved therapeutic goods - to their patients by way of notification to the TGA, rather than (as previously) requiring pre-approval. This is known as SAS Category C.
The following subsections of the Act provides that the Minister may, by legislative instrument, make rules authorising any health practitioner who is included in a specified class of health practitioners to supply specific therapeutic goods:
- subsection 19(7A) - Medicines
- subsection 41HC(6) - Medical Devices
- subsection 32CM(7A) - Biologicals.
The Rules specify classes of health practitioners; therapeutic goods; classes of recipients; circumstances and conditions; and set out the relevant authorisations for the purposes of the relevant subsections.
The following Therapeutic Goods Rules apply to SAS Category C. There are separate lists for medicines, medical devices and biologicals, as follows:
- Medicines: Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017.
- Medical Devices: Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules September 2017.
- Biologicals: Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules September 2017.
Further information can be found on the Special Access Scheme webpage.