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
Authorised Prescriber
  • Medical practitioners only
  • AP applications and prescriber six-monthly reporting data
  • AP applications for ‘unapproved’ nicotine vaping products without the need for ethics committee approval
Special Access Scheme
  • Certain registered prescribing health practitioners
  • SAS Category A and C notifications and Category B applications
  • SAS applications for access to ‘unapproved’ medicinal cannabis products to the TGA and certain State or Territory Health Departments simultaneously

Contact the Special Access Section via email at SAS@health.gov.au if you require support.