Authorised Prescribers
As a certified Human Research Ethics Committee, the SCHN HREC is able to support SCHN medical practitioners in becoming an Authorised Prescriber.
To apply for endorsement from the SCHN HREC, please see pages 11-15 of the Authorised Prescriber Scheme Guidance document found on the TGA website. See more on submitting endorsement requests or renewals.
Health practitioners can prescribe unapproved products in certain circumstances. See more information on how to prescribe unapproved therapeutic goods on the Therapeutic Goods Administration (TGA) website.
To prescribe an unapproved product to multiple patients, health practitioners can become an Authorised Prescriber. 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) and 12B(1C) of the Therapeutic Goods Regulations 1990 that are considered to have an established history of use. This arrangement only applies where the medicine to be prescribed, concentration (if any), dosage form, route of administration and indication match an entry in subregulation 12B(1B) or 12B(1C). Subregulation 12B(1C) includes the addition of certain medicinal cannabis medicines to the ‘Established history of use’ pathway, by reference to active ingredient categories, dosage forms and indications.
To prescribe a product on this list, applications are made through the TGA website. This is called the established history of use pathway.
For all other unapproved products, health practitioners 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 TGA. The SCHN HREC has the jurisdiction to review Authorised Prescriber applications only for SCHN medical practitioners. This is called the standard pathway.
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.
New applications and renewals
Please submit new or renewal applications to the SCHN Research Ethics Office via email with all the necessary information outlined by the TGA (see pages 11-15 of the Authorised Prescriber Scheme Guidance). These requirements include:
- TGA Authorised Prescriber scheme application form
- Cover letter
- An information sheet and consent form
- Details of the unapproved good and its suitability for the intended indication
See below for more information on what information is contained in each of the above requirements.
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.
Cover letter
Cover letter outlining the following:
- Clinical justification for the use of the good (see page 15).
- 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.
- 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 dosage form, route of administration, indication and class of patient.
An information sheet and consent form
An information sheet and consent form which contains the following:
- The product is not approved (i.e. registered or listed) in Australia. Please note that if the unapproved good is derived from biological tissues including human blood or plasma, informed consent must be obtained using the TGA consent template (see template on the TGA website)
- 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.
Details of the unapproved good and its suitability for the intended indication
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. Please note sources of evidence for data may include but are not limited to product information documents, randomised controlled trials, non-randomised controlled trials, individual case studies and consensus opinion of specialist colleges and societies (see pages 12-15).
Approval duration
As per the Authorised Prescriber Scheme (see page 6) via ‘the standard pathway’ it is at the discretion of the approving HREC to determine the HREC endorsement period. The endorsement period for medicines may be authorised for supply for up to a 5 year period (from a 2 year period), medical devices for up to a 2 year period (from a 1 year period) and biologicals for up to a 5 year period (from a 2 year period).
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.