Authorised Prescriber Scheme

Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors

Book pagination

3 July 2017

Information for Medical Practitioners

How medical practitioners become Authorised Prescribers

To become an Authorised Prescriber, a medical practitioner:

  • submits an application to an HREC (or a specialist college, if appropriate) with
    • an appropriate clinical justification
    • informed consent form template
  • receives approval from an HREC or endorsement from a specialist college.

Once the medical practitioner has HREC approval or specialist college endorsement, they submit an application to the TGA with:

  • the letter of approval from the HREC or letter of endorsement from the specialist college, which contains a declaration that all necessary documentation has been properly evaluated
  • a completed Authorised Prescriber scheme application form

The TGA will assess the application and make a decision.

Figure 1: How medical practitioners become Authorised Prescribers

1. Obtain HREC approval or specialist college endorsement, 2. Submit an application to TGA, 3. Receive decision letter from TGA

Preparing a submission for an HREC or specialist college

If you are a medical practitioner wanting to apply to TGA for Authorised Prescriber status, your application will need to be approved by a Human Research Ethics Committee (HREC) or endorsed by a specialist college.

Applying for HREC or specialist college approval or endorsement

The medical practitioner's application for HREC approval or specialist college endorsement must provide sufficient evidence to justify the use of the unapproved product. The application will contain details of the:

  • medical practitioner applying for Authorised Prescriber status
  • unapproved good
  • clinical justification for the use of the good

The prescriber

The medical practitioner's application will provide:

  • their name
  • their contact details (postal address, phone number, fax number and email)
  • details of their qualifications, specialty, training and experience
  • a description of how they propose to use the goods
  • details of the site(s) at which the goods will be used

The application should also provide evidence that the medical practitioner has:

  • the qualifications and experience necessary to appropriately manage the medical condition and use the product
  • access to the facilities needed to appropriately administer and monitor treatment.

Generally, medical practitioners will have to demonstrate a higher level of experience and training to be approved as Authorised Prescribers of therapeutic goods that:

  • are indicated for highly specialised medical conditions
  • have significant safety risks
  • require specialised monitoring
  • require specialised administration or handling

The unapproved good

The application should contain evidence of the unapproved good's suitability for the intended indication that supports the clinical justification the medical practitioner has provided.

The application will include the following details of the unapproved good.

Description

For unapproved medicines:

  • trade name
  • active ingredient
  • strength/concentration
  • dosage form
  • sponsor
  • whether the good is approved for the indication in another jurisdiction

For unapproved biologicals:

  • name of biological
  • sponsor
  • whether the good is approved for the indication in another jurisdiction

For unapproved medical devices:

  • name of the medical device
  • sponsor
  • whether the good is approved for this indication in another jurisdiction
Use and monitoring

The application should detail:

  • the dosage range (where applicable)
  • the route of administration or type of sample for IVDs
  • the duration of treatment
  • how the medical practitioner will determine if the use is effective
  • how the medical practitioner will determine whether an adverse event has occurred
  • what monitoring is required, how it will be done, and the interval and duration of monitoring
Efficacy and safety

The application must contain information on:

  • the unapproved good's efficacy and expected benefits
  • any known/expected adverse effects, risks and safety issues
  • related toxicology
Evidence

The application should contain appropriate sources of evidence to support the use of the unapproved good. The sources of evidence for data, with the highest level of significance first, in decreasing order are:

  • product information documents (of equivalent) (if the good is approved by an overseas regulator)
  • randomised controlled trials
  • non-randomised controlled trials
  • individual case studies
  • consensus opinion of specialist colleges and societies

Less serious conditions require stronger evidence than more serious medical conditions:

Figure 2: Evidence requirements and the seriousness of the medical condition

Low evidence required for high clinical need; High evidence required for low clinical need
Global regulatory status

The global regulatory status of the unapproved good may affect the level of evidence required in the application.

This table describes differences in global regulatory status and the effect that status may have on the level of evidence required.

This information in Figure 3 is provided as a guide only.

Figure 3: Effect of global regulatory status
Regulatory status Possible effect on the level of extra evidence required to be submitted to a HREC or specialist college
Goods which are not approved in Australia, but are approved for the indication and the conditions of use in countries with a regulatory standard comparable to Australia Decreased
Goods previously approved by the TGA which have been withdrawn for non-safety reasons Decreased
Goods which are not approved in Australia, but are approved in countries with regulatory standards that are not comparable to Australia Increased
Goods that have not been approved anywhere for the indication and are still undergoing clinical trials Increased
Goods previously approved by the TGA which have been withdrawn for safety reasons Increased
Goods that have not been granted registration in Australian for safety reasons Increased

When an HREC or specialist college assesses your application, they should consider the following factors to determine what level of evidence is required:

  • whether other treatments registered on the ARTG are available and suitable for the intended class of patients
  • the seriousness of the medical condition
  • the global regulatory status of the therapeutic good
  • the relevant experience and qualifications of the applicant

You may wish to contact the HREC or specialist college before you submit your application to ensure you submit the necessary evidence.

Clinical justification for the use of the goods

TGA encourages the use of approved therapeutic goods as these have been assessed for safety, quality and efficacy. The clinical justification for use of the unapproved good should provide sufficient evidence to demonstrate that this use is appropriate, considering the availability of any approved goods that may be suitable alternatives.

The clinical justification should contain information on:

  • the indication for which the good will be used
  • the seriousness of the condition
  • the expected benefits of the proposed treatment versus its potential risks

It should also address the circumstances where there are approved treatments for the same indication, specifically:

  • have they been attempted?
  • will they be attempted prior to supplying the unapproved good?
  • why are they inappropriate?
  • why is the proposed unapproved good a more appropriate option than any approved available alternative
  • how the risk associated with the use of an unapproved good will be managed
    • the monitoring that will be undertaken
    • the process of investigating and reporting adverse events

The following are not acceptable justifications for the use of an unapproved good:

  • that the unapproved good is less expensive than any suitable approved treatment
  • personal preference for an unapproved good

Informed consent

The use of unapproved goods is considered experimental. The Authorised Prescriber must obtain the informed consent of each patient for whom they prescribe the unapproved good.

The Authorised Prescriber must advise patients:

  • that TGA has not have evaluated the unapproved good's safety, quality and efficacy
  • of the possible benefits and risks of its use
  • of the possibility that there may be unknown side effects
  • of any alternative approved goods

It is best practice to obtain informed consent in writing using a standard form. The medical practitioner will provide the template of the informed consent form they intend to use with their application to the HREC or specialist college. This should not be submitted to the TGA, but should be kept on the patients file. If the unapproved good is, however, derived from biological tissues including blood or plasma, the medical practitioner must obtain informed consent using the form available on the TGA website.

Applying to TGA

Once you have the approval of an HREC or endorsement by a specialist college, you can apply to TGA to become an Authorised Prescriber. Your application must include:

  • the HREC letter of approval or a letter of endorsement from a specialist college, including a declaration that all necessary documentation has been reviewed
  • a completed application form. Ensure the indication listed on this form is the indication approved by the HREC or specialist college

Submit your application to us by:

  • email (preferred) to EPS@health.gov.au
  • fax to 02 6232 8112
  • post to:
    • Medicines Shortages Section
      Pharmacovigilance and Special Access Branch
      Therapeutic Goods Administration
      PO Box 100
      Woden ACT 2606
      Australia

TGA decision

Applications that we authorise

If we approve your application, we will send you an approval letter. The letter will state the:

  • approved goods and dosage form
  • approved indication
  • approved class of patients
  • requirements for reporting
  • any conditions applied to the approval
  • approved sites of practice

It will also state the period for which the approval will be valid.

All approvals are subject to general conditions. TGA may also apply specific conditions on a case-by-case basis. You must meet these conditions to retain your approval. The approving HREC or endorsing specialist college may also apply conditions to your approval.

Once you have been authorised to be an Authorised Prescriber of an unapproved good, you may prescribe that good to patients in your care.

Applications that we do not authorise

If we do not authorise your application, we will send you a letter stating:

  • that an authorisation has not been granted
  • the reasons for the decision
  • the contact details of the delegate who made the decision, if you wish to discuss the decision
  • the process if you want to appeal the decision

You should inform the HREC or specialist college which approved or endorsed your application of our response and provide them with a copy of the decision letter.

If we do not authorise your application to become an Authorised Prescriber, you may submit a new application addressing the reasons for rejection.

Appeals mechanisms

Informal appeals

If you wish to appeal a TGA decision, and before you make a formal appeal, you should contact the delegate who evaluated your submission to discuss the matter informally.

Formal appeals

If you disagree with the outcome of an informal appeal, you can make a formal appeal:

You must have attempted to appeal a decision under section 60 of the Therapeutic Goods Act 1989 before lodging an appeal with the AAT.

Obtaining unapproved goods

As an Authorised Prescriber, you are responsible for obtaining the unapproved good. You can do this by contacting the sponsor of the good to arrange supply; however, the sponsor is not legally obligated to supply the good. You can also ask a pharmacy or supplier to arrange supply of the unapproved good.

You must give the sponsor a copy of your TGA approval letter. This authorises them to legally supply the good for use.

You must also consider whether the good is controlled under the Customs (Prohibited Import) Regulations 1956 and the Customs (Prohibited Export) Regulations 1958, and, if the good is controlled, obtain a permit to import it from the Office of Drug Control.

Access to medicinal cannabis may have additional requirements. For further information, refer to the TGA web page discussing Access to medicinal cannabis products: steps to using access scheme.

If you are supplying the goods in a hospital, you might need any hospital drugs and therapeutics committees to approve the use and funding of these goods within the institution.

Unapproved therapeutic goods are not subsidised under the Pharmaceutical Benefits Scheme (PBS), so you should consider the cost that will be incurred.

Prescribing and using the unapproved good

In prescribing the unapproved good for a patient, you are responsible for considering the benefits and risks that apply for the patient. As unapproved goods have not been evaluated by the TGA, you should remain informed of changes to the benefits and risks as they arise.

Prescribe the goods in accordance with the legislative requirements relevant to your State or Territory.

Periodic reporting

You will receive a periodic report template with the letter of approval. You must report to us every six months (for the periods ending 30 June and 31 December) how many patients you treated with the unapproved good during that six-month period. You must send this to us within one month after the reporting period. If you treated no patients during that time, you must also report this.

Reporting adverse events and product defects

Unapproved therapeutic goods generally have not been evaluated for safety, quality and efficacy and could pose unknown risks. When you become an Authorised Prescriber you must report any adverse event or product defect related to the unapproved good to us within 15 calendar days of learning of it.

The HREC, specialist college and/or the good's sponsor may also require you to provide them with adverse event reports.

There are various ways to report adverse events and product defects, which can be found on our website at Reporting adverse events.

Revoking authorisation

TGA can revoke your Authorised Prescriber status if:

  • the HREC or specialist college withdraws their approval or endorsement of your status
  • you do not meet the conditions we apply to your approval
  • a suitable alternative good becomes available and is entered on the ARTG
  • we become aware of any significant concerns about a good's safety

If a suitable alternative good becomes available on the ARTG, you should stop using the unapproved good. If there is a good reason to continue using the unapproved good you must reapply. You will need to submit a clinical justification to your evaluating HREC or specialist college on why you want to use the unapproved good instead of the now approved good. The HREC or specialist college will consider this and decide whether continued approval or endorsement is appropriate in light of any available approved good that has been thoroughly evaluated for safety, quality and efficacy. You must then resubmit this approval or endorsement to the TGA in a new application to become an Authorised prescriber.

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