Special Access Scheme – Australia
Special Access Scheme request / Category A notification or Category B applicationStatutory/Administrative
Description & Eligibility
Australia’s Special Access Scheme permits health practitioners to request access to an unapproved therapeutic good for a single patient on a case-by-case basis. Category A is generally used for seriously ill patients, while Category B requires TGA authorization before supply. [?]
Eligibility Criteria
Patients with serious conditions or clinical circumstances where an unapproved medicine is needed and a registered health practitioner submits the request.
Legal Reference / Source
Therapeutic Goods Act 1989 and TGA Special Access Scheme guidance
Special Access Scheme – Australia
| Approval Form | Special Access Scheme request / Category A notification or Category B application |
| Legal Status | Statutory/Administrative |
| Source Ref. | Therapeutic Goods Act 1989 and TGA Special Access Scheme guidance |
| Countries | 0 countries |
Compliance Check
Legal Review7/24/2026
Global ValidityVerified