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Authorised Prescribers

8 October 2020

The Authorised Prescriber Scheme allows authorised medical practitioners to supply therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) to a class of patients with a particular medical condition.

An Authorised Prescriber is allowed to supply the product directly to specified patients under their immediate care without requiring separate approval for individual patients.

Authorised Prescribers must report the number of patients treated every 6 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. See template at Authorised Prescriber forms.

To access an unapproved therapeutic good for a single patient, go to the Special Access Scheme web page.

To access medicinal cannabis, go to the Access to medicinal cannabis web page.

Applying through the online system

To reduce processing times you can submit your Authorised Prescriber application through the Special Access Scheme (SAS) and Authorised Prescriber Online System.

SAS & Authorised Prescriber Online System

For instructions, refer to the Authorised Prescriber user guidance: Special Access Scheme & Authorised Prescriber Scheme Online System

Authorised Prescriber pathways

There are 2 pathways to apply to become an Authorised Prescriber, depending on the product to be prescribed.

Established history of use pathway

The 'Established history of use pathway' requires one application to be submitted to the TGA for medicines deemed to have an established history of use.

Human Research Ethics Committee (HREC) approval or specialist college endorsement is not required before applying to the TGA. Prescribers will still need to check institutional requirements.

Medicines deemed to have an established history of use are specified in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990.

Standard pathway

The 'Standard pathway' requires a 2-step application process for products that are not included in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990.

Approval from a human research ethics committee (HREC) or endorsement by specialist college must be obtained before applying to the TGA.

Guidance and FAQs

Authorised Prescriber forms

The SAS & Authorised Prescriber Online System is the preferred submission method to reduce processing times for applicants. However, paper forms are still available for use in exceptional circumstances, such as where the health practitioner is unable to access the online system.

Authorised Prescriber application form

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.

Six monthly report template

Send forms to:

Contact details for enquiring about the Authorised Prescriber Scheme

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

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

If your enquiry is not about Authorised Prescribers, Contact the TGA