There are circumstances where patients may require access to medicines or medical devices that have not been approved for supply by the TGA.
In these circumstances a medical practitioner may be granted authority to become an authorised prescriber of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients (or classes of recipients) with a particular medical condition.
Authorised prescriber applications require formal endorsement from a HREC before submission to the TGA.
The Children’s Health Queensland Human Research Ethics Committee is able to review applications and provide endorsement to support submissions to the TGA.
For additional information about the submission process and to download the application documentation, please review the CHQ HREC Approval of Authorised Prescribers Procedure, or visit the TGA authorised prescriber website.