This guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme (SAS).
If you have any feedback or want more information, please contact the SAS team.
- About this guidance
- Overview of the SAS
- When the SAS can be used
- When the SAS is not appropriate
- SAS pathways
- What products can be supplied
- SAS Category A pathway
- SAS Category B pathway
- SAS Category C pathway
- Sponsor requirements
- Ensure legal supply
- Importing and holding stock prior to supply
- Advertising ‘unapproved’ therapeutic goods
- Submit six-monthly supply reports
- Report adverse events and defects
- Timeframes for reporting
- Other adverse event reports
- Comply with other legislative requirements
- Additional import restrictions
- State and territory requirements
- Include the product in the ARTG for long term supply
- Ensure legal supply
- Quality standards
- Australian manufacturing requirements
- Manufacture of a good that is not included in the ARTG
- Requirement to hold a manufacturing licence
- Medicines and biologicals
- Medical devices
- Overseas manufacture
- Labelling and packaging
Supporting documents
Special Access Scheme (SAS): Guidance for Sponsors
[PDF, 472.15 KB]
Special Access Scheme (SAS): Guidance for Sponsors
[Word, 125.76 KB]