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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.
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.
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 Scheme - Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors
Guidance for medical practitioners, HRECs, specialist colleges and sponsors explaining their requirements in relation to the Authorised Prescriber scheme
- Frequently asked questions about Authorised Prescribers
Questions and answers about Authorised Prescribers
- Guidance for the Authorised Prescriber Online System
Users of the online system should refer to this guidance for information on the system's features and functionality
- Authorised Prescriber Online System quick reference guide: Medicinal cannabis
A quick guide for submitting Authorised Prescriber applications for medicinal cannabis products using the online system
- Guidance tool for access to unapproved therapeutic goods
This tool assists health practitioners to determine the most appropriate pathway (if any) to access unapproved therapeutic goods
- Access to medicinal cannabis products
Information relevant to accessing unapproved medicinal cannabis products
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 application form (pdf,202kb)
- Authorised Prescriber application form (docx,154kb)
Authorised Prescriber six monthly reporting form
- Six monthly report - supply of unapproved therapeutic goods by an authorised prescriber (pdf,83kb)
- Six monthly report - supply of unapproved therapeutic goods by an authorised prescriber (docx,120kb)
Sponsor six monthly reporting form
- Six monthly report - supply of unapproved therapeutic goods by a sponsor (pdf,94kb)
- Six monthly report - supply of unapproved therapeutic goods by a sponsor (docx,179kb)
Sponsors (importers/manufacturers) are reminded that they must report to the TGA every six months in relation to unapproved therapeutic goods supplied under the SAS and Authorised Prescriber (AP) schemes.
Regulation 47B of the Therapeutic Goods Regulations 1990 outlines the requirement for the sponsor (importer) to submit six-monthly supply reports to the TGA listing the product (brand name) details and quantities supplied in Australia in the relevant period. Reporting periods are 1 January - 30 June (inclusive) and 1 July - 31 December (inclusive). Reports must be submitted within 1 month of the end of the relevant reporting period.