Authorised prescribers

30 July 2018

There are circumstances where patients may require access to medicines, biologicals 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.

If you are seeking approval to access medicinal cannabis product please visit the 'Access to medicinal cannabis products' section of our website.

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
  • be able to best determine the needs of the patient
  • be able 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.

The following are links to useful information and resources relating to becoming an Authorised Prescriber:

The TGA administers other schemes such as the Special Access Scheme (SAS) that may also be used, when appropriate, to access unapproved therapeutic goods. To assist health practitioners determine the most appropriate pathway (if any) to access unapproved therapeutic goods, we have developed a SAS/AP Decision Tool.

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.

Authorised Prescriber application form

Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma

Note: Do not send the 'Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma' to the TGA. This should be kept on the patient's file.

Send applications to:

Contact details for enquiries about Authorised Prescribers

If your enquiry is about medicinal cannabis please see the 'Access to medicinal cannabis products' section of our website. Please note that the TGA does not release a list of Authorised Prescribers of medicinal cannabis products.

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

Email: eps@health.gov.au

Phone:

  • +61 2 6232 8911 (general application enquiries)
  • +61 2 6232 8866 (medicinal cannabis application enquiries)

Fax: +61 2 6232 8112

Post: The Medical Officer, Experimental Products Section, Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606, Australia

Street address (for deliveries): Therapeutic Goods Administration, 136 Narrabundah Lane, Symonston ACT 2609, Australia