Research

Authorised Prescriber Application

Authorised Prescriber Application

Medical practitioners can obtain approval as an 'Authorised Prescriber' for the purpose of supplying an unapproved therapeutic good (medicine, 'other therapeutic goods' or medical device) to specific patients (or classes of recipients) with a particular medical condition under Section 19(5) and Section 41HC of the Therapeutic Goods Act 1989

 

How to submit an Authorised Prescriber Application at Austin Health
  1. Visit the Therapeutic Goods Administration (TGA) website for the required documentation.
  2. Submit the application to the Austin Health Drug & Therapeutics Committee  (Drugs Only) for review.
  3. Submit the application electronically to the Austin Health Human Research Ethics Committee (HREC) at ethics@austin.org.au with the letter issued by the Drug & Therapeutics Committee. This will be reviewed at the next available HREC meeting and if successful the application will be endorsed.

 

Please note all supporting electronic documents must be labelled according to the following Naming Requirement for Electronic Files using the approved acronyms and document types