This guidance is to assist health practitioners understand their requirements when prescribing ‘unapproved’ therapeutic goods for an individual patient using the Special Access Scheme (SAS).
If you are a medical practitioner wanting to prescribe an ‘unapproved’ therapeutic good to multiple patients (a class of patients) on an ongoing basis you should consider becoming an Authorised Prescriber.
The guidance replaces all previous guidance about the 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
- Who can be the prescribing health practitioner
- Who can submit the SAS notification or application
- Which pathway to use
- What products can be supplied
- Before prescribing an ‘unapproved’ therapeutic good
- Consider ARTG treatments
- Consider risks of treatment
- Check the unapproved good is available
- Determine the appropriate SAS pathway
- Adhere to good medical practice and other codes of conduct
- Obtain informed consent
- Check state and territory requirements
- Submitting the SAS notification or application
- Notification and application forms
- Information needed for the notification or application
- What to expect once the form is submitted
- Obtaining unapproved therapeutic goods
- Products from Australian sponsors
- Products imported from overseas
- Cost to patients
- Reporting and record keeping
- Report adverse events and defects
- Record keeping and retention of documents
- TGA requests for patient information
- Privacy of information held by the TGA
- TGA release of information to other agencies
- Freedom of information
- Making a complaint
Supporting documents
Topics