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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 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.

Documents required for submission of an Authorised Prescriber application.

  1. Explanatory cover letter to the HREC
    Please submit a cover letter which includes the following information:
    • the reason for the Authorised Prescriber application
    • the name of each registered medical practitioner seeking endorsement to become an Authorised Prescriber.
  2. Complete and submit the Authorised Prescriber Application form available on the TGA website for each medical practitioner.
  3. Submit curriculum vitae (CV) for each registered medical practitioner.
  4. Provide product information or an investigator brochure including toxicology and safety information (If available).

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