The TGA Special Access Scheme
How the TGA Special Access Scheme allows access to unapproved peptides in defined circumstances.
Last updated: 8 April 2026
What is the Special Access Scheme?
The Special Access Scheme (SAS) is an Australian regulatory pathway that allows doctors to access unapproved therapeutic goods for patients with serious or life-threatening conditions when approved alternatives are unavailable or unsuitable.
It is not a blanket approval. It requires a qualified doctor to make a clinical judgment for a specific patient.
When SAS is available
The patient must have a serious condition or life-threatening illness. Approved treatments must be unavailable or unsuitable. A registered medical practitioner must apply, providing clinical justification.
Not all unapproved peptides are eligible — the scheme is for therapeutically relevant compounds, not cosmetic or enhancement compounds.
The SAS process
A doctor submits an application to the TGA with patient details, diagnosis, clinical justification, and details of the unapproved medicine. The TGA assesses the application — some are approved immediately, others require more information.
Approval is patient-specific. A doctor cannot use SAS approval for multiple patients — each requires assessment.
Limitations and considerations
SAS does not mean unlimited supply. It does not mean the drug is safe or effective — it is an access pathway for serious conditions. Patients using SAS compounds are typically monitored carefully.
SAS is not appropriate for enhancement or 'optimisation' — it is for medical necessity.