The TGA has 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. A printable version is available on the TGA website at list of medicines with an established history of use. 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 liaise with the relevant institution 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 our guidance document Authorised Prescriber Scheme - Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors.

Information and access to the SAS & Authorised Prescriber Online System to submit applications is available on our Authorised Prescribers webpage.

Contact Authorised.Prescribers@health.gov.au or phone on (02) 6289 4632 for further information.