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.
The Government accepted the Expert Review of Medicines and Medical Devices Regulation recommendation to make changes to the Authorised Prescriber Scheme that will streamline the application process and improve access to required unapproved therapeutic goods.
From 3 July 2017, medical practitioners will not be required to submit their clinical justification to the TGA for evaluation as this will have already been approved by a human research ethics committee (HREC) or endorsed by a relevant specialist college.
Applications to become an Authorised Prescriber of therapeutic goods which are deemed to have an established history of use will be eligible for a longer duration of authorisation, at the discretion of the Delegate. The maximum duration of approval will increase from one year to two years for medical devices and from two years to five years for medicines and biologicals.
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
- 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:
- 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 therapeuitc goods, we have developed a SAS/AP Decision Tool.
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: firstname.lastname@example.org (preferred)
- Fax: 02 6232 8112
Contact details for enquiries about Authorised Prescribers
If your enquiry is not about authorised prescribers, see: Contact the TGA
|Phone||+61 2 6232 8911|
|Fax||+61 2 6232 8112|
|Postal address||The Medical Officer
Experimental Products Section
Pharmacovigilance and Special Access Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
|Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609