Concord Hospital Concord Hospital
The Concord Research Office

How to Apply to the TGA

 

Once the medical practitioner has HREC approval, the following must be submitted to TGA:

·         The letter of endorsement from the HREC, signed by the HREC Chair

        Applications need to address criteria relating to the class of recipients, the product and the prescriber. Applicants can also provide any other information they consider important. In considering whether to grant approval, the TGA delegate will generally consider the quality and extent of the information provided and balances the position in relation to each of the criteria for the recipients, the product and the 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

For unapproved biologicals – name of biological, sponsor

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. Details of qualifications, specialty, training and experience. Site at which the goods will be used.

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

 

Contact details for enquiries about Authorised Prescribers:

Email: Authorised.Prescribers@health.gov.au

Phone: 1800 020 653

Fax: 02 6203 1105

Contact the Special Access Section via email at SAS@health.gov.au if you require support.