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Frequently asked questions about Authorised Prescribers

3 July 2017
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General

The Authorised Prescriber scheme allows authorised medical practitioners to supply specific unapproved therapeutic goods to a specific class of patients, without seeking approval or notification on an individual patient, as is the case with the Special Access Scheme.

Only registered medical practitioners are able to become Authorised Prescribers. Other health practitioners may be able to access unapproved therapeutic goods through Category B and Category C of the Special Access Scheme.

Medical practitioners

To become an Authorised Prescriber, a medical practitioner must first obtain approval from a human research ethics committee (HREC) or endorsement from a specialist college. They will then need to submit an application to us for evaluation. This submission should include:

  • a completed Authorised Prescriber Scheme application form
  • evidence of either approval from a HREC or endorsement from a specialist college.

For more information on how to become an Authorised Prescriber, refer to the guidance document Authorised Prescriber Scheme - Guidance for Medical Practitioners, Human Research Ethics Committees and Specialist Colleges.

The Government accepted the Expert Review of Medicines and Medical Devices Regulation recommendation to make changes to the Authorised Prescriber Scheme that will streamline the application process and improve access to required unapproved therapeutic goods.

From 3 July 2017, medical practitioners will not be required to submit their clinical justification to the TGA for evaluation as this will have already been approved by a human research ethics committee (HREC) or endorsed by a relevant specialist college.

Applications to become an Authorised Prescriber of therapeutic goods which are deemed to have an established history of use will be eligible for a longer duration of authorisation, at the discretion of the Delegate. The maximum duration of approval will increase from one year to two years for medical devices and from three years to five years for medicines and biologicals.

After obtaining approval from a human research ethics committee (HREC) or endorsement from a specialist college for the use of the unapproved therapeutic good, they will be provided with a letter which states that approval or endorsement has been provided and that all necessary documentation has been reviewed.

With the changes to the scheme, medical practitioners are no longer required to submit the clinical justification for authorisation as an Authorised Prescriber to us for evaluation. They must provide both a:

  • copy of your letter of approval from a HREC or endorsement from a specialist college
  • completed Authorised Prescriber scheme application form.

The medical practitioner will be notified by the delegate of the duration of authorisation if the application is successful.

These goods and their indications listed on in the following legislative instruments are deemed to have an established history of use:

  • Medicines: Therapeutic Goods (Authorised Supply of Specified Medicines) Rules 2017
  • Medical Devices: Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules 2017
  • Biologicals: Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules 2017

Goods other than those listed in the instruments above or the same goods used for different indications/uses will be considered on an individual basis at the discretion of the Delegate.

Yes. The Authorised Prescriber Scheme - Guidance for Medical Practitioners, Human Research Ethics Committees and Specialist Colleges has been updated to reflect the changes to the scheme and is available on the TGA website. This guideline has also been updated to provide more user-focussed guidance to our stakeholders.

We will contact the medical practitioner by email to inform them of whether their application was successful.

We can only send the decision letter to emails that have been provided on the application form that was submitted. If medical practitioners require the decision letter be sent to more than one email address, this information must be provided on the application form before submission.

It is a condition of authorisation that Authorised Prescribers must report all adverse events that occur with the use of the unapproved good and to provide supply reports on the number of patients treated with a specified unapproved therapeutic good at 6 monthly intervals.

The number of patients treated should reflect the two periods, January to July and August to December. These reports must be received by us with one month of the reporting period. If no patients have been treated in the relevant period, this must also be reported.

We may apply other conditions to your authorisation that are related to reporting that must also be followed.

Failure to comply with conditions of authorisation may result in the revocation of the Authorised Prescriber's status.

Human Research Ethics Committees and Specialist Colleges

Before submitting an application to us to become an Authorised Prescriber, medical practitioners must obtain approval from a Human Research Ethics Committee (HREC) or endorsement from a specialist college.

To gain approval or endorsement, a medical practitioner must submit a clinical justification for the use of the unapproved goods for evaluation by a HREC or specialist college. If this justification is appropriate, the medical practitioner will be provided with a letter advising that they have been approved or endorsed to submit an application to us for authorisation to be an Authorised Prescriber.

It is expected that a medical practitioner will first attempt to gain approval from a human research ethics committee (HREC). Endorsement from a specialist college should only be sought if you do not have access to an appropriate HREC.

The letter of endorsement or approval should include the following details, which must match the information provided on the application form:

  • a clear statement that approval or endorsement is being given for the purpose of the medical practitioner becoming an authorised prescriber
  • the name of the medical practitioner who has gained approval or endorsement
  • the unapproved therapeutic goods for which approval or endorsement has been given
  • the sites at which use is covered by the approval or endorsement
  • any conditions that have been applied to the approval or endorsement
  • a declaration that all necessary documentation has been reviewed.

The declaration that all necessary documentation has been reviewed may be either included in the letter or approval or endorsement, or as a separate document.

This letter should be signed by the chair of the approving ethics committee or an appropriate representative of the endorsing specialist college.