- Getting Started
- Research Support Unit
- Funding Opportunities
- Research, Ethics, Governance & Integrity Unit
- Meet REGI
- ERM Guidance
- How to Prepare an Application
- Human Research Ethics Committee (HREC)
- Research Management Committee (RMC)
- Audits, QA & Negligible Risk Applications
- Prior Approval Applications
- Low Risk Applications
- Greater Than Low Risk Applications
- Multi-site Applications
- Consent, Waivers & PICFS
- Clinical Trials
- Research Governance
- Contracts & Agreements
- Safety Monitoring & Adverse Events
- Progress/Final Reports & Audits
- Guidelines & Advice
- Case Studies
- Authorised Prescriber Applications
- Special Access Scheme
- Radiation in Research
- Biostatistics Support Service
- Research Data Management Service
- Library Service
Authorised Prescriber Applications
- Authorised Prescriber Application Guide
- Renewal of Authorised Prescriber Application Guide
- Six Monthly Report Template
- TGA's Agreement to Treatment form
- TGA's Authorisation of Supply under Sections 19(5) or 41HC
TGA Update on Authorised Prescribers
On 24 July 2020, the TGA implemented a change to the Authorised Prescriber scheme to streamline the application process for medicines considered to have an established history of use in Australia. The application form and process have been updated for medical practitioners to apply under the new arrangements.
This change removes the requirement for Human Research Ethics Committee (HREC) approval or specialist college endorsement to be submitted to the TGA in circumstances where the medical practitioner is applying to become an Authorised Prescriber of medicines specified in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990. HREC or institutional approval may still be required to use certain ‘unapproved’ therapeutic goods within an institution, such as a hospital. Medical practitioners will need to confirm with the REGI Unit to confirm the requirements.
A medical practitioner will also still need to obtain prior HREC approval or specialist college endorsement for products that are not included in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990. Further details on applying for approval/endorsement are available in the TGA’s guidance document Authorised Prescriber Scheme - Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors.
There are circumstances where patients may require access to medicines 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.
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.
The following key points should be noted by the applicant:
- The applicant must be a fully registered medical practitioner, and must have the training and expertise appropriate for the condition being treated and the proposed use of the product
- The applicant must be an employee of, and practicing at, Barwon Health, and should not use the product in a private setting
- The applicant must be able to best determine the needs of the patient and must be able to monitor the outcome of the therapy
- The intended unapproved product should not be intended for use in a clinical trial
- There should be no conflicts of interest.
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.
Please refer to the Authorised Prescriber Application Guide for new applications to become an Authorised Prescriber.
As per Authorised Prescriber conditions, approval is granted for specific durations which may vary between one year and two years depending on the product - please refer to the Renewal of Authorised Prescriber Application Guide at the top of this page for Authorised Prescriber applications which require renewing.
Last Modified: Tuesday, 02 March 2021