How to apply

As a medical practitioner, there are 2 pathways you can use to apply to become an authorised prescriber.

This will allow you to give patients with a particular medical condition, a specific or a class of unapproved therapeutic goods.

The application pathway will depend on the product you want to prescribe.

Established history of use pathway

If the product is included in the list of medicines with an established history of use, you don’t need approval from the Children’s Health Queensland Human Research Ethics Committee.

You’ll still need to apply to the TGA.

Find out how to submit your application on the Australian Government Therapeutic Goods Administration website.

Standard pathway

If the product you want to prescribe isn’t on the list of medicines with an established history of use, you’ll need one of the following:

• endorsement from the Children’s Health Queensland Human Research Ethics Committee (HREC)
• endorsement from a specialist college.

You must have one of these before you can submit an application to the TGA.

Get HREC endorsement

To get HREC endorsement, you’ll need to:

1. fill in the Request for Endorsement of Individual’s Application for TGA Authorised Prescriber of Unapproved Drugs and Devices Form.
2. submit your application by email to CHQETHICS@health.qld.gov.au.

Apply to TGA

Find out how to submit your application on the Australian Government Therapeutic Goods Administration website.

Contact the ethics committee

If you’d like more information or have any questions, you can contact the Children’s Health Queensland Human Research Ethics Committee.

Human Research Ethics Committee Coordinator
Phone: 07 3069 7002
Email: CHQEthics@health.qld.gov.au.

Chair, Human Research Ethics Committee
Phone: 07 3069 7002
Email: CHQEthics@health.qld.gov.au