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Pharma Knowledge Base

TGA Authorised Prescriber Scheme – Australia

TGA Authorised Prescriber ApplicationTherapeutic Goods Act 1989 Section 1960 days

Contents

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

Description & Eligibility

Allows medical practitioners to supply unapproved therapeutic goods to a class of patients with a particular medical condition without requiring individual TGA approvals for each patient.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

TGA Authorised Prescriber Guidance

Countries Using This Pathway (1)

AU
Australia
AU
TGA Authorised Prescriber Scheme – Australia
Approval FormTGA Authorised Prescriber Application
Timeline60 days
Legal StatusTherapeutic Goods Act 1989 Section 19
Source Ref.TGA Authorised Prescriber Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified