Special Access Scheme & Authorised Prescriber Scheme Online System
The TGA has a responsibility to encourage the use of therapeutic goods that are included in the Australian Register of Therapeutic Goods (ARTG), as these products have been evaluated to ensure they meet strict standards of safety, quality and effectiveness.
The Special Access Scheme (SAS) and the Authorised Prescriber (AP) scheme allow certain registered health practitioners to access 'unapproved' therapeutic goods for patients under their care.
Prescriber responsibilities and conditions
- Use in exceptional circumstances where the prescribing health practitioner has first considered other appropriate treatment options included in the ARTG.
- Adhere to relevant standards of good medical practice and obtain informed patient consent.
- Report adverse events or defects associated with the use of the ‘unapproved’ therapeutic goods to the TGA.
|Scheme||Submission overview||Resources for technical support|
|Special Access Scheme||
Contact the Special Access Section via email at SAS@health.gov.au if you require support.