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Special access scheme rules
If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
The following Therapeutic Goods Rules apply to the Special Access Scheme (SAS) Category C. There are separate lists for medicines, medical devices and biologicals, as follows:
- Medicines: Therapeutic Goods (Medicines-Authorised Supply) Rules 2020
- Medical Devices: Therapeutic Goods (Medical Devices - Authorised Supply) Rules 2020
- Biologicals: Therapeutic Goods (Biologicals - Authorised Supply) Rules 2020
Why do the Rules exist?
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.
Further information can be found on the Special Access Scheme webpage.