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Source: Australian Department of Health

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.

The therapeutic goods legislation defines a medical practitioner as a person who is registered in a state or internal territory, as a medical practitioner. The medical practitioner must also have the ‘qualifications and experience necessary to appropriately manage the medical condition and use the product’.

Generally, only applications from medical practitioners with specialist registration or general registration with the Medical Board of Australia are considered appropriate for the Authorised Prescriber scheme.

Applications from medical practitioners with non-practising, limited, student, or provisional registration (requiring supervised practice), or with conditions on their registration, will generally not be considered.

For privacy reasons, the TGA cannot provide a list of doctors who have been approved or authorised to supply unapproved products.

In addition, health practitioners in Australia are not allowed to advertise to the public that they are able to prescribe a particular medicine. Therefore, we encourage patients to discuss the use of any ‘unapproved’ treatments with their doctor.

It is also important to note that a health practitioner has the right to refuse to prescribe a product if they believe there is either insufficient clinical justification or evidence to support the use of the therapeutic good.

On 24 July 2020, the Therapeutic Goods Administration (TGA) implemented a change to the Authorised Prescriber scheme to streamline the application process for medicines considered to have an established history of use.

This change removes the requirement to submit Human Research Ethics Committee (HREC) approval or specialist college endorsement to the TGA in circumstances where the medical practitioner is applying to become an Authorised Prescriber of medicines specified in sub-regulation 12B(1B) of the Therapeutic Goods Regulations 1990, that are considered to have an established history of use. The new arrangement will only apply where the medicine to be prescribed, concentration (if any), dosage form, route of administration and indication match an entry in subregulation 12B(1B).

There are 2 pathways to apply to become an Authorised Prescriber, depending on the product to be prescribed.

To renew an application, an Authorised Prescriber will also need to follow one of the 2 pathways outlined below and ensure that all six monthly reports for the previous authorisation period have been provided.

Established history of use pathway

If the medicine, concentration (if any), dosage from, route of administration and indication matches an entry in sub-regulation 12B(1B) of the Therapeutic Goods Regulations 1990, then HREC approval or specialist college endorsement is not required to be submitted to the TGA.

To become an Authorised Prescriber using the ‘Established history of use medicines pathway’, a medical practitioner should follow these steps:

  1. check if the product is included in the list of medicines with an established history of use available on our website
    • if the product does not match an entry in this list, refer to the ‘Standard pathway’ below
  2. complete an application to the TGA using the SAS & Authorised Prescriber Online System or paper form. The following details are required:
    1. Medical practitioner’s name and contact details
    2. Product details and indication or item code
    3. Signature (paper form only)
  3. If using a paper application, submit this to us by:

The TGA will assess the application and make a decision.

Standard pathway

To become an Authorised Prescriber of products that are not included in sub-regulation 12B(1B) of the Therapeutic Goods Regulations 1990, a medical practitioner should follow the ‘Standard pathway’ steps:

  1. submit an application to an HREC or a specialist college as outlined in ‘Applying for HREC approval or specialist college endorsement’ and receive approval
  2. complete an application to the TGA using the SAS & Authorised Prescriber Online System or paper form
  3. attach the HREC letter of approval or a letter of endorsement from a specialist college (where required), including a declaration that all necessary documentation has been reviewed
  4. If using a paper application, submit this to us by:

The TGA will assess the application and make a decision.

The medical practitioner’s application for HREC approval or specialist college endorsement must be in writing and provide sufficient evidence to justify the use of the ‘unapproved’ product.

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

Submitting application using the SAS & Authorised Prescriber Online System is preferred to reduce processing times.

A paper form is still available for use in exceptional circumstances, such as where the medical practitioner is unable to access the online system.

Paper applications can be submitted to us by:

No. Generally, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be imported into, supplied in, and exported from Australia.

The TGA encourages the use of therapeutic goods that are included in the ARTG. However, there are various provisions that allow access to ‘unapproved’ therapeutic goods outside of the Authorised Prescriber pathway. These provisions include the Special Access Scheme (SAS), Personal Importation and Clinical Trials.

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 an email address that has been provided on the application form. If medical practitioners require the decision letter to be sent to more than one email address, this information must be provided in the application form.

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

You will receive a six monthly report template with the letter of approval. You must report to us every 6 months (for the periods ending 30 June and 31 December). You must send your six monthly report to us within one month after the reporting period. There are 2 categories to report:

  • patients who have newly commenced use of the unapproved product in the six month period for reporting
    AND
  • patients who have continued on the treatment (those who have received supply of the product in a previous reporting period and required further supply in the current reporting period)

If you treated no patients during that time, you must also report this.

We may apply other conditions to your authorisation that are related to reporting. Failure to comply with conditions of authorisation may result in the revocation of the Authorised Prescriber status.

If the medicine, strength and concentration, dosage form, route of administration and indication match an entry in sub-regulation 12B(1B) of the Therapeutic Goods Regulations 1990, then HREC approval or specialist college endorsement is not required to be submitted to the TGA with an Authorised Prescriber application.

Before submitting an application to become an Authorised Prescriber of an ‘unapproved’ good that is not specified in sub-regulation 12B(1B) of the Therapeutic Goods Regulations 1990, medical practitioners must obtain approval for certain therapeutic goods 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’ good for evaluation by the HREC or specialist college. If this justification is appropriate, the medical practitioner should 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.

The therapeutic goods legislation defines ‘specialist’ as having the same meaning as in the Health Insurance Act 1973, which includes that the medical practitioner is a fellow of a ‘relevant organisation’ in relation to the specialty. A list of relevant organisations are listed in Schedule 1 of the The Health Insurance Regulations 2018. Therefore, the list of ‘relevant organisations’ are taken to be the ‘specialist colleges’ referred to for the purposes of the Authorised Prescriber scheme.

For a medical practitioner engaged in clinical practice in a hospital, the ethics committee of that hospital should provide the approval.

For medical practitioners engaged in clinical practice outside of a hospital, an appropriate HREC will be one which has relevant expertise in the use of the ‘unapproved’ good and conducts its activities in the geographical area where the medical practitioner intends to use the ‘unapproved’ good.

If the medical practitioner does not have access to an appropriate HREC, then they may seek endorsement from a specialist college that has expertise relevant to the use of the ‘unapproved’ product. For example, a medical practitioner in private practice may obtain approval from a HREC at a hospital where they have admitting rights or the Area Health Service in which they practice. Alternatively, a medical practitioner could be endorsed by a specialist college having expertise relevant to the treatment of the condition for which use of the product is being sought.

The TGA may consult with an independent expert advisory committees to determine the appropriateness of the endorsement.

A list of registered ethics committees is available on the National Health and Medical Research Council (NHMRC) website. This list may assist medical practitioners to find a suitable ethics committee.

We expect that a medical practitioner will attempt to gain approval from a human research ethics committee (HREC) in the first instance. 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 of approval or endorsement, or as a separate document.

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

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