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Authorised prescribers

The Agreement to Treatment Directions form has been amended to include a privacy statement to be compliant with Australian Privacy Principle 5 (notification of the collection and disclosure of privacy information) as part of the Privacy Amendment (Enhancing Privacy Protection) Act 2012. Please also see TGA's general Privacy information.

Other changes to the form include formatting changes and a request for additional contact details for the applicant. The March 2014 form is now the current version and must be used for any new applications.

Once the application is completed, please email the application to eps@tga.gov.au (preferred method) or faxed to 02 6232 8112. Note: Only PDF and Microsoft Word documents are acceptable as email attachments.

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.

About authorised prescribers

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.

To be an Authorised Prescriber the medical practitioner must have:

  • the training and expertise appropriate for the condition being treated and the proposed use of the product;
  • the Authorised Prescriber must be able to best determine the needs of the patient; and
  • to monitor the outcome of therapy.

An Authorised Prescriber is allowed to supply the product directly to specified patients under their immediate care and not to other practitioners who prescribe/administer the product. Use of the product under an authorisation must be at all times in line with the conditions specified in the authorisation.

Once a medical practitioner becomes an 'Authorised Prescriber' they do not need to notify the TGA when they are prescribing the unapproved product, however they must report to the TGA the number of patients treated on a six monthly basis.

Authorised prescriber forms

How to access a pdf or Word document

These forms are available in both pdf and Microsoft Word formats. The pdf forms can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.

Send applications to:

Contact details for enquiries about Authorised Prescribers

If your enquiry is not about authorised prescribers, see: Contact the TGA

Email eps@tga.gov.au
Phone
  • Medicines: +61 2 6232 8101
  • Medical devices: +61 2 6232 8679
Fax +61 2 6232 8112
Postal address The Medical Officer
Experimental Products Section
Office of Scientific Evaluation
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia
Street address
(for deliveries)
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia

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Web page last updated: Wednesday, 26 March 2014

URL: http://www.tga.gov.au/hp/access-authorised-prescriber.htm