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Pharma Knowledge Base

TGA Special Access Scheme – Category B (SAS-B)

TGA SAS-B Notification/Approval FormTherapeutic Goods Act 1989 Section 1928 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

TGA SAS Category B allows supply of unapproved therapeutic goods to individual patients on a case-by-case basis, with TGA approval required before supply.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

TGA SAS Guidelines

Countries Using This Pathway (1)

AU
Australia
AU
TGA Special Access Scheme – Category B (SAS-B)
Approval FormTGA SAS-B Notification/Approval Form
Timeline28 days
Legal StatusTherapeutic Goods Act 1989 Section 19
Source Ref.TGA SAS Guidelines
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified