TGA Special Access Scheme Category B — Medical Practitioner Application

Issuing authority

Therapeutic Goods Administration (TGA)

Official source

How to apply

1. Confirm the patient does not qualify for Category A (not immediately life-threatening) and the product is not available under Category C (no established history of use in Australia).
2. Register for an account at the TGA SAS and Authorised Prescriber (AP) Online System at sas.tga.gov.au — provide your AHPRA registration number and professional details.
3. Log in to the SAS dashboard and select 'New SAS submission', then choose 'Category B application'.
4. Complete the application: enter patient details (de-identified if preferred), the unapproved therapeutic good (name, sponsor, intended indication), clinical justification, and your prescriber details.
5. Attach any supporting clinical evidence or literature the TGA delegate may need to assess the application.
6. Submit the application online — TGA will acknowledge receipt and assign a submission ID.
7. Await TGA delegate review (typically 2–5 business days; may be longer if additional information is requested).
8. On approval, receive a written approval letter from the TGA — you must not supply the good until this letter is received.
9. Retain the approval letter on the patient's clinical record and comply with any conditions of supply stated in the letter.

Related topics

Related forms

• TGA Personal Importation Scheme — Import Prescription Medicine
• Special Access Scheme (SAS) — Patient Access to Unapproved MedicineSAS Category B Application
• ABF Customs Declaration — Importing MedicinesIncoming Passenger Card / Online Declaration
• Medical Cannabis Prescription — How to Access Legally in Australia
• Medical Cannabis — Renewal and Ongoing Management