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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 via another pathway please visit the 'Access to medicinal cannabis products' section of our website.
About Authorised Prescribers
Authorised Prescribers are medical practitioners who are approved to prescribe unapproved therapeutic goods for a particular condition or class of patients in their immediate care without further TGA approval.
To become 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 each time they prescribe the unapproved product during the period of approval, however they must report to the TGA the number of patients treated every six months.Use of the product must be reported twice yearly covering each period between 1 January to 30 June and 1 July to 31 December within one month of that period ending. Please use this template for six monthly reporting:
This template is available in both pdf and Microsoft Word formats. The pdf template 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 template on-screen and print it out but you will not be able to save the completed template.
- Authorised Prescriber six monthly report template (pdf,81kb)
- Authorised Prescriber six monthly report template (docx,129kb)
The following are links to useful information and resources relating to becoming an Authorised Prescriber:
- Obtaining approval from a HREC or endorsement from a specialist college
Medical practitioners seeking to become Authorised Prescribers need to have their application approved by a HREC or endorsed by a specialist college
- Authorised Prescriber Scheme - Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors
Provides guidance on the operation of the Authorised Prescriber scheme for medical practitioners, HRECs, specialist colleges and sponsors
- Frequently asked questions about Authorised Prescribers
Answers to questions about Authorised Prescribers
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 online system
On 1 December 2018 an online system was introduced to enable the electronic submission of Authorised Prescriber applications to the TGA. Use of this online system will reduce administrative burden on health practitioners and allow users to manage applications that they submit to the TGA.
Visit the Special Access Scheme and Authorised Prescriber online system page to find out more.
See the Guidance for the Authorised Prescriber online system for further instructions.
Authorised Prescriber forms
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
- Authorised Prescriber application form (pdf,120kb)
- Authorised Prescriber application form (docx,134kb)
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.
- Authorised prescriber - Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma (pdf,84kb)
- Authorised prescriber - Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma (Microsoft Word,118kb)
Send applications to:
- Email: email@example.com (preferred)
- Fax: 02 6232 8112