Authorised prescribers at a glance

Access to unapproved therapeutic goods

TGA is able to grant medical practitioners authority to prescribe a specified unapproved therapeutic good or class of unapproved therapeutic goods to specified recipients or classes of recipients (identified by their medical condition). The medical practitioner becomes an 'Authorised Prescriber' and can prescribe that product for that condition (also known as the 'indication') to individual patients in their immediate care without further TGA approval.
The authorisation extends only so far as to allow the Authorised Prescriber to supply the product directly to specified patients and not to other practitioners who prescribe/administer the product to patients.
Medical practitioners seeking to become Authorised Prescribers require endorsement from an ethics committee as follows:
- for a medical practitioner engaged in clinical practice in a hospital - endorsement from the ethics committee of that hospital;
- for a medical practitioner treating patients outside a hospital setting - endorsement from an appropriate ethics committee.
A special exemption exists for medical practitioners who can demonstrate that they do not have access to an ethics committee to get endorsement from an appropriate specialist college.
The following information is required by the TGA as part of an application to become an Authorised 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 data sufficient 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

Send applications to:

For unapproved medicines

Phone	02 6232 8111
Fax	02 6232 8112
Postal	The Medical Officer, SAS Drug Safety and Evaluation Branch Therapeutic Goods Administration PO Box 100 Woden ACT 2606

For unapproved medical devices

Phone	02 6232 8615
Fax	02 6232 8785
Postal	Chief Clinical Advisor Office of Devices, Blood and Tissues Therapeutic Goods Administration PO Box 100 Woden ACT 2606

Therapeutic Goods Administration