You are here

Authorised Prescriber Scheme

Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors

16 November 2020

Book pagination

How to become an Authorised Prescriber

There are 2 pathways medical practitioners may use to apply to become an Authorised Prescriber, depending on the product to be prescribed:

  1. Established history of use pathway
  2. Standard pathway

Established history of use pathway

If the medicine, concentration (if any), dosage from, route of administration and indication match an entry in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990, then HREC approval or specialist college endorsement is not required by the TGA. See a printable version on our website at list of medicines with an established history of use.

HREC or institutional approval may still be required to use certain 'unapproved' therapeutic goods within an institution such as a hospital. Medical practitioners need to liaise with the relevant institution to confirm the institutions requirements.

To become an Authorised Prescriber using the 'Established history of use 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 (if not, refer to Standard pathway below)
  2. complete an application to the TGA only using the SAS & Authorised Prescriber Online System (preferred) or paper form. Only the following details are required:
    1. Medical practitioners name and contact details
    2. Product details and indication or item code
    3. Signature (paper form only)
  3. If using paper applications submit to us by:

    OR

    1. email (preferred) to Authorised.Prescribers@health.gov.au
    2. fax to 02 6203 1105

Standard pathway

To become an Authorised Prescriber of products that are not included in subregulation 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 (preferred) 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 paper applications submit to us by:

    OR

    1. email (preferred) to Authorised.Prescribers@health.gov.au
    2. fax to 02 6203 1105

The TGA will assess the application and make a decision.

To renew an application, an Authorised Prescriber will need to follow the steps above and ensure that all six monthly reports for the previous authorisation period have been provided.

Where to find an HREC or specialist college

HRECs

In the therapeutic goods legislation, an ethics committee means a committee:

AND

  1. constituted and operating as an ethics committee in accordance with guidelines issued by the CEO of the National Health and Medical Research Council (NHMRC) as in force from time to time
  2. which has notified its existence to the Australian Health Ethics Committee (AHEC) established under the National Health and Medical Research Council Act 1992

A list of registered ethics committees is available on the NHMRC website.

Specialist colleges

For 'unapproved' medicines or biologicals - if the medical practitioner is engaged in clinical practice outside a hospital and does not have access to an ethics committee, then the medical practitioner may obtain endorsement from a specialist college that has expertise relevant to the treatment of the medical condition for which authority is sought.

For 'unapproved' medical devices - if the medical practitioner does not have access to an ethics committee that:

OR

  • has the expertise relating to the use of the 'unapproved' good
  • conducts its activities in the geographical area where the approval is sought,

then the medical practitioner may seek endorsement from a specialist college that has expertise relevant to the treatment of the medical condition for which the authority is sought.

The therapeutic goods legislation defines 'specialist' as having the same meaning as in the Health Insurance Act 1973. This includes that the medical practitioner is a fellow of a 'relevant organisation' in relation to the specialty.

A list of these 'relevant organisations' are provided 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. Medical practitioners may only obtain specialist college endorsement from one of the 'relevant organisations'.

Endorsment from a specialist society or other expert body cannot be accepted by the TGA. However, specialist colleges may choose seek advice from an expert body or specialist society when providing endorsement.

Applying for HREC approval or specialist college endorsement

The TGA does not provide a set template for HREC or specialist college applications. The medical practitioner's application for HREC approval or specialist college endorsement (if required) must be made in writing and provide sufficient evidence to justify the use of the 'unapproved' product. An application for HREC or specialist college approval or endorsement must contain details of the:

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

Medical practitioner details

The medical practitioner's details to include are:

  • name
  • contact details (postal address, phone number, fax number and email)
  • details of their qualifications, specialty, training and experience
    • generally, applications from medical practitioners with non-practising, limited, student, provisional registration (requiring supervised practice), or conditions placed on their registration will not be considered for the Authorised Prescriber scheme
  • have the training and expertise appropriate for the condition being treated and/or the proposed use of the product
  • 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

'Unapproved' therapeutic good description and evidence

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

The application should 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 by an overseas regulatory body

For 'unapproved' biologicals:

  • name of biological
  • sponsor
  • whether the good is approved for the indication by an overseas regulatory body

For 'unapproved' medical devices:

  • name of the medical device
  • sponsor
  • whether the good is approved for this indication by an overseas regulatory body
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 1: 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 2 is provided as a guide only.

Figure 2: 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

The TGA encourages the use of approved therapeutic goods as these have been assessed for safety, quality and efficacy. The clinical justification for use of an '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
  • seriousness of the condition
  • 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 or used?
  • 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 the TGA has not 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
  • provide a copy of your informed consent form template to the HREC or specialist college
  • keep the signed informed consent form on the patient's file

Informed consent forms should not be submitted to the TGA.

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 class of patients for a particular indication
  • requirements for reporting
  • any conditions applied to the approval
  • the duration of approval
  • approved sites of practice (where relevant)

All approvals are subject to general conditions. The 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 (if applicable) 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.

Book pagination