Research and Ethics Office

Authorised Prescriber


24 July 2020 Update from TGA -

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.

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


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:

• An Authorised Prescriber to be a medical practitioner;
• A medical practitioner to obtain endorsement from an appropriate HREC; or
• Where a medical practitioner does not have access to an HREC and this can be
demonstrated to TGA, the medical practitioner may obtain endorsement from a specialist college having an established expertise relevant to the use of the medicines concerned.

Regulation 12B(4) states that medical devices may only be approved for medical practitioners practising in hospitals. Approval must be obtained from the HREC at the institution at which the practitioner practices. Approval will not be given to medical practitioners to use medical devices outside the hospital setting.
Full details of Authorised Prescribers are available from the TGA at

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:

a) The indication for which the product will be prescribed;
b) Efficacy and safety of the product in relation to its proposed use;
c) For medicines, the route of administration and dosage form;
d) Clinical justification for use of the product;
e) Suitability of the medical practitioner; and
f) Patient information about the product and the informed consent form.

The applicant must provide the following documentation to the HREC:

-A cover letter explaining the request and including details of the condition to be treated, its seriousness and why this drug is being used to treat the condition.

-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:

a) Regular reports to the HREC comprising information such as the number of patients prescribed the unapproved product; and
b) Reporting of adverse events.

The HREC will review its endorsement of the Authorised Prescriber if it is aware of:
a) Inappropriate use of the product by the Authorised Prescriber;
b) Safety concerns about the product;
c) Failure of the Authorised Prescriber to comply with conditions imposed by the HREC; or
d) Failure of the Authorised Prescriber to comply with legislation.

Where the HREC is satisfied that the welfare and/or rights of patients are not or will not be protected, it will:
a) Advise the medical practitioner and the Chief Executive of its concerns;
b) Withdraw its approval of the Authorised Prescriber if it is satisfied that the welfare and/or rights of patients are not or will not be protected; and
c) Report to the TGA (Chief Executive and Chairperson to determine).

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:
a) Determination by the HREC Executive Committee; and/or
b) Consultation with the LHD drug committee or delegate.

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.
2. Attach the documentation to be submitted to the TGA – Application Agreement to treat directions authorisation of prescribers under section 19(5), 32CM or section 41HC of the Therapeutic Goods Act 1989
3. Any relevant supporting documentation
4. TGA correspondence
5. Participant Information Sheet and Consent Form

Once the above is completed please send to addressed to SWSLHD HREC with the subject line – Authorised Prescriber and the date.

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Last Updated: 15 October, 2020
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