Research Ethics and Governance Office

How to Apply to the TGA

How to become an Authorised Prescriber
Applications should be made in writing and addressed to:

For medicines:
The Medical Advisor
Experimental Drugs Section
Drug Safety and Evaluation Branch
Therapeutic Goods Administration
PO Box 100
Phone (02) 6232 8104      
For medical devices:
Chief Clinical Advisor
Office of Devices, Blood and Tissues
Therapeutic Goods Administration
PO Box 100
Phone (02) 6232 8679                 

 Applications need to address criteria relating to the class of recipients, the product and the prescriber. Applicants can also provide any other information they consider important. In considering whether to grant approval, the TGA delegate will generally consider the quality and extent of the information provided and balances the position in relation to each of the criteria for the recipients, the product and the prescriber.

The recipients

Indication Disease to be treated
Clinical justification  An outline of the seriousness of the condition, and, if other approved treatments are available, justification for the use of the unapproved product in preference to those treatments.

The product

Product details For unapproved medicines - active ingredient, trade name, dose form, supplier.
For unapproved medical devices - name of device, supplier
Administration and monitoring regime Dosage, route of administration, duration of treatment, details of and proposed monitoring.
Efficacy/safety data  Efficacy and safety datasufficient to support the proposed use of the product. A copy of the reference articles from which the data have been obtained should be included.

The prescriber

Details  Name, postal address, phone number, fax number
Ethics committee endorsement Evidence of endorsement from an ethics committee must be submitted
Agreement to Treatment Directions  A completed and signed Agreement to Treatment Directions form must accompany the application

Please refer to page 16-20 of the TGA Guideline for detailed information.

Who to contact for more information:

Fiona Guan: Fiona.guan@sswahs.nsw.gov.au
Ph: 9515 7035

Sharon Falleiro: Sharon.falleiro@sswahs.nsw.gov.au
Ph: 9515 6766