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.
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.
For all other unapproved products, a medical practitioner wishing to become an Authorised Prescriber, must submit an application to a HREC for approval prior to the submission of a separate application to the Therapeutic Goods Administration (TGA). The SCHN HREC has the jurisdiction to review Authorised Prescriber applications for SCHN medical practitioners only.
The following instructions outline how to apply to the SCHN HREC to become an Authorised Prescriber. These instructions have been sourced from the Authorised Prescriber Scheme: Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors, V3.0, July 2017, Therapeutic Goods Administration, used with permission of the Australian Government: <https://www.tga.gov.au/authorised-prescriber-scheme>
Application to Become an Authorised Prescriber
1. TGA Authorised Prescriber scheme application form (please refer to the following link to access the application form: https://www.tga.gov.au/form/authorised-prescribers
2. A cover letter outlining the following:
- Clinical justification for the use of the good.
- The clinical justification should provide sufficient evidence to demonstrate that this use is appropriate, considering the availability of any approved goods that may be suitable alternatives.
- Please refer to pages 12-13 of the Authorised Prescriber Scheme Guidance document cited in the introductory paragraph above for detailed guidance regarding the information required in the clinical justification.
- Details of the medical practitioner’s qualifications, speciality, training and experience
- A description of how the goods will be used.
- Details of the site(s) at which the goods will be used
For Medicinal cannabis products, please also provide the following information in the cover letter:
- The dosage form
- Route of administration
- Indication and class of patient
3. An Information sheet and consent form which contains the following details:
- The product is not approved (i.e. registered or listed) in Australia;
- Any risks and side effects that are known;
- The possibility of unknown risks and late side effects;
- Any alternative treatments using approved products which are available.
Please note that if the unapproved good is derived from biological tissues including human blood or plasma, the medial practitioner must obtain informed consent using the TGA consent template (please refer to the following link to access the consent form: https://www.tga.gov.au/form/authorised-prescribers)
4. Details of the unapproved good and its suitability for the intended indication including:
- Product Description
- Use and Monitoring
- Efficacy and Safety
- Appropriate sources of evidence to support the use of the unapproved good. The sources of evidence for data may include but are not limited to the following, which are listed with the highest level of significance first and decrease in order:
- Product information documents
- Randomised controlled trials
- Non-randomised controlled trials
- Individual case studies
- Consensus opinion of specialist colleges and societies.
(Please refer to pages 10-12 of the Authorised Prescriber Scheme Guidance document cited in the introductory paragraph above for detailed instructions regarding how to provide sufficient information regarding the product details and suitability for the intended indication).
Once approval has been received from the HREC, the TGA requires the submission of the approval letter issued by the HREC with a completed Authorised Prescriber scheme application form. Please refer to the Authorised Prescriber Scheme Guidance document cited in the introductory paragraph above for detailed information regarding the TGA Authorised Prescriber application process.
Authorised Prescriber – Approval Duration
In 2017, the TGA implemented changes which have enabled HRECs to extend the approval duration at its discretion for therapeutic goods which are deemed to have an established history of use. Please refer to page 4 of the Authorised Prescriber Scheme Guidance document cited in the introductory paragraph above for further information regarding the unapproved goods which may be eligible for this extension.
Authorised Prescriber – Conditions of Approval
The following conditions are required to be fulfilled by all Authorised Prescribers endorsed by the SCHN HREC. Please note that there may be additional conditions required on a case by case basis. Please review your HREC approval letter for any additional conditions relevant to your application.
- Submission of a copy of the TGA 6 monthly supply report for the periods ending 30 June and 31 December to the HREC.
- Submission of any adverse events, adverse drug reactions and adverse device events (ADE) to the HREC.