Special Access Scheme – Australia (TGA)

TGA Special Access Scheme Application Form (Category A or B)Statutory2 days

Description & Eligibility

The Therapeutic Goods Administration's Special Access Scheme (SAS) provides access to unapproved therapeutic goods for individual patients. Category A covers seriously ill patients, while Category B covers other cases where approved alternatives are unavailable or unsuitable.

Eligibility Criteria

Patients requiring unapproved medicines where no suitable approved alternative exists, authorized by medical practitioner

Legal Reference / Source

Therapeutic Goods Act 1989, Section 19

Special Access Scheme – Australia (TGA)
Approval FormTGA Special Access Scheme Application Form (Category A or B)
Timeline2 days
Legal StatusStatutory
Source Ref.Therapeutic Goods Act 1989, Section 19
Countries0 countries
Compliance Check
Legal Review3/21/2026
Global ValidityVerified
Special Access Scheme – Australia (TGA) — Regulatory Pathway | OrphanDrug