Concord Hospital Concord Hospital
The Concord Research Office

Authorised Prescriber Guidelines

 GUIDELINES TO APPLY TO BECOME AN AUTHORISED PRESCRIBER OF AN UNREGISTERED DRUG AT CONCORD HOSPITAL

The Therapeutic Goods Act indicates that the TGA can authorise individual medical practitioners to prescribe unapproved products to specific patients with a particular medical condition. The medical practitioner becomes an Authorised Prescriber of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to a specific class of recipients.

1. Refer to the detailed Authorised Prescriber Information from TGA to assist with your application.

https://www.tga.gov.au/book-page/information-medical-practitioners#hrec-clinical

2. Write to both Concord Hospital Drug Committee and Concord Hospital Human Research Ethics Committee (HREC) requesting endorsement to become an authorised prescriber of an unregistered drug.

The following documentation should be attached:

• Supporting literature.
• Copy of the consent form to be used – a template of the consent form can be found here 
• Clinical justification – the following details should be included in the clinical justification

 

  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 biologicals – name of biological, sponsor
For unapproved medical devices - name of device, supplier
Administration and monitoring regime
Dosage, route of administration, duration of treatment, details of access to facilities needed to appropriately administer and monitor treatment, adverse event 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, email.
Details of qualifications, specialty, training and experience.
Site at which the goods will be used.
 

Note: The global regulatory status of the unapproved good may affect the level of evidence required in the application.

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

• The letter of approval from the HREC which contains a declaration that all necessary documentation has been properly evaluated.
• A completed Authorised Prescriber scheme application form
https://www.tga.gov.au/form/authorised-prescribers#forms

Send applications to:

• Email: eps@health.gov.au (preferred)
• Fax: 02 6232 8112

Contact details for enquiries about Authorised Prescribers:

Email: eps@health.gov.au
Phone: 02 6232 8101
Fax: 02 6232 8112
Postal Address: The Medical Officer
Experimental Products Section
Pharmacovigilance and Special Access Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
AUSTRALIA

4. Once approval has been granted by the Therapeutic Goods Administration, a copy of the approval letter should be sent to the Concord Hospital Research Office and to the Concord Hospital Department of Pharmacy (the latter in the case of medicines only).


Prepared by Lucy Nigro, Clinical Trials Pharmacist, Concord Repatriation General Hospital.
3 August 2017