24 July 2020 Update from TGA - https://www.tga.gov.au/form/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. A printable version is available on our 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.
Under subsections 19(5-9) of the Act and Regulation 12B, the TGA is able to grant a medical practitioner authority to prescribe a specified unapproved therapeutic good or class of unapproved therapeutic goods to specified recipients or classes of recipients (identified by their medical condition). An Authorised prescriber can then prescribe that product for that condition (also known as ‘the indication’) and no approval from the TGA is required for each individual patient. The legislation requires:
When reviewing applications to become an Authorised Prescriber, the HREC needs to assess not only the safety of the product in relation to its proposed use, but also the suitability of the medical practitioner. The HREC considers:
The applicant must provide the following documentation to the HREC:
-Details of the named prescriber to support the application. This should include information about whether the practitioner is seeking to treat a condition in his/her area of specialty or training and expertise. In general, endorsement will only be given when the practitioner has training and expertise appropriate for the proposed use of the product. A CV will normally demonstrate this training and expertise but the prescriber may submit other information to support his/her request such as past experience in prescribing the drug (attach CV of intended prescriber)
-Information about the drug and its use for the indication for which it will be prescribed, including the route of administration, dosage form, a clinical justification for its use, an assessment of the efficacy and safety of the product in relation to its proposed use, information about its previous use in humans and associated adverse events (attach an investigator brochure or equivalent if available)
-A patient information and consent form
-Any other material to support your request.
If endorsed, the HREC provides a letter to the applicant in the format suggested by the TGA. The HREC may impose conditions on the endorsement, if required, such as:
Where the HREC is satisfied that the welfare and/or rights of patients are not or will not be protected, it will:
To review access to unapproved therapeutic goods via Authorised Prescribers, the HREC and SWSLHD will determine the best process for considering applications. This process may consist of:
Final responsibility for the use of an unapproved product within an institution always rests with that institution. Medical practitioners working in a NSW Public Health Organisation should discuss the use of the unapproved therapeutic product and identify the approval process with the institution before applying for authorisation.
Step by step instructions submit authorised prescriber to SWSLHD HREC:
1. Complete a cover letter addressed to the SWSLHD HREC outlining the details of the authorised prescriber request including: the unapproved product names, indications for use, sites to be covered and all relevant documentation attached.