You are here

Authorised Prescribers

27 July 2022

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 can 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. Reporting through the SAS & Authorised Prescriber Online System is preferred.

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

For medicinal cannabis information, go to the Access to medicinal cannabis web page.

Applying through the online system

To reduce processing times, please 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 by the TGA.

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) and 12B(1C) 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) and 12B(1C) 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.

Detailed information on the application process is found in Authorised Prescriber Scheme - Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors and Guidance for the Authorised Prescriber Online System.

Guidance and FAQs

Authorised Prescriber forms

The SAS & Authorised Prescriber Online System is the preferred submission method to reduce processing times and provide medical practitioners with additional reporting and functions to assist in the management of their applications, including prescriber 6 monthly reporting. Paper forms are available for use in exceptional circumstances, such as where the health practitioner is unable to access the online system.

Authorised Prescriber application form

Authorised Prescriber six monthly reporting form

Send forms to:

Contact details for enquiring about the Authorised Prescriber Scheme

Post: Special Access Section, International Regulatory Branch, Therapeutic Goods Administration, PO Box 100, Canberra ACT 2601, 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 lists of Authorised Prescribers.

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