Unapproved products for multiple patients (Authorised Prescriber)

Check if the product you want to prescribe is on the lists of medicines with an established history of use.

The product you choose must match the dosage form and indication you want to prescribe for.

Check the list of products with an established history of use
 

How to apply (established history of use)

If the medicine you want to prescribe is on the lists, you can apply to become an Authorised Prescriber through the established history of use pathway.

You don’t need endorsement or approval from a human research ethics committee (HREC) or specialist college.

To apply, submit the form in the online system.

SAS and AP Online System

If the product you want to prescribe is not on the list of medicines with an established history of use, you will need either:

• human research ethics committee (HREC) approval
• endorsement by a specialist college.

HREC approval or specialist college endorsement

You must apply in writing to a HREC or specialist college for endorsement.

You will need to provide evidence to justify use of the unapproved product.

Where to find a HREC or specialist college

The National Health and Medical Research Council maintains a list of HRECs.

To find a HREC, download and check the list of HREC registered with NHMRC.

If you can’t access a HREC, you can seek endorsement from a specialist college.

The college must have expertise relevant to the condition you want to treat.

The list of specialist medical colleges you can use is recorded in the Health Insurance Regulations – Schedule 1.

Get HREC approval or specialist college endorsement

Your application in writing to a HREC or specialist college must include:

• details about your training and experience
• a description of the unapproved product you want to prescribe
• clinical justification for use of the unapproved product.

To find out more read pages 11 to 15 of the Authorised Prescriber Scheme guidance.

How to apply (standard pathway)

When you have approval or endorsement from a HREC or specialist college, you can apply to become an Authorised Prescriber through the standard pathway.

You must have HREC or specialist college approval before you apply.

To apply, submit the form in the online system.

SAS and AP Online System

If your application is approved, we will send you an approval letter. The letter will state:

• the class of patients you can prescribe to including specific indications
• what you can prescribe including dosage form
• conditions applied to the approval
• how long your approval lasts
• requirements for reporting.

Once approved to be an Authorised Prescriber of an unapproved product, you may prescribe it to patients in your care.

You must meet the conditions to retain your approval. This includes reporting requirements.

Your HREC or endorsing specialist college may apply their own conditions.

When your approval expires, you will need to renew your application.

How long approval takes

Applications are generally approved in 10 business days.

Renew your application

You will need a new HREC approval or specialist college endorsement letter.

Your six-monthly reports must be up to date before you apply to renew your approval.

To renew your application, use the online system.

SAS and AP Online System

Appeal a decision

To find out more about making a formal appeal read the guidance for requesting reconsideration of an initial decision.

Obtain unapproved products

As the prescriber, it is your responsibility to source the product.

You can do this in conjunction with the dispensing pharmacy.

If you can't source a product, contact someone experienced with importing unapproved products. For example:

• a hospital pharmacy

• wholesalers

• sponsors.

We give health practitioners approval to access unapproved products.

We don't arrange the supply of therapeutic goods.

As an Authorised Prescriber, you must report the total number of patients you have treated.

You must report this every 6 months for each unapproved product you are authorised to prescribe.

You are responsible for reporting adverse events or defects from the use of unapproved products you’ve prescribed.

Report patient numbers every 6 months

Your report must include the number of:

• patients that have started treatment in the reporting period
• total patients treated in the reporting period.

When to report

You must report for the periods:

• 1 January to 30 June
• 1 July to 31 December.

You must do this within one month of the reporting period ending.

This report is separate to any imposed by your HREC or specialist college.

How to report

1. Go to the SAS and AP online system.
2. Select Authorised Prescriber Reports.
3. Select Draft for the reporting period.

SAS and AP Online System

Report adverse events and product defects

You must report any suspected adverse events or defects within 15 days of learning of them.
 

Report a problem or side effect

Your Authorised Prescriber status can be revoked if:

• you don't report patient numbers every 6 months
• 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.

Can a nurse practitioner become an Authorised Prescriber?

Only registered medical practitioners can 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.

I am having issues with logging into my online system account, how do I get help?

For the Special Access Section to assist with all portal enquiries, please send an email with the below information to sas@health.gov.au:

• full first and last name
• AHPRA number
• username
• email address linked to the account
• screenshot of the issue.

The team will review the issue you are having and respond within 3 business days.

Does a medical practitioner need to become an Authorised Prescriber to access unapproved goods?

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:

• Special Access Scheme (SAS)
• Personal Importation Scheme
• clinical trials.

How will medical practitioners be informed of the outcome of their application?

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.

What reporting requirements will a medical practitioner have as an Authorised Prescriber?

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 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:

• new patients commenced on treatment or number of devices supplied
• total patients treated during this period.

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

The preferred method of reporting is through the SAS and AP online system. Alternatively, there is a 'paper' form available on the Authorised Prescriber webpage for use in exceptional circumstances. Information on using the online portal system to submit six monthly reports is found in the Authorised Prescriber Scheme Online system guidance.

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.

Human Research Ethics Committees and Specialist Colleges

What is the role of Human Research Ethics Committees and Specialist Colleges in the Authorised Prescriber Scheme?

Human Research Ethics Committees and Specialist colleges review and grant approvals or endorses application(s) submitted by the medical practitioner, who wish to become an Authorised Prescriber of the therapeutic goods() not specified in sub-regulation 12B(1B) or 12B(1C) of the Therapeutic Goods Regulations 1990.

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 would be provided with a letter advising that they have been approved or endorsed to submit an application to the TGA for authorisation to be an Authorised Prescriber.

What are specialist colleges?

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.

What is an appropriate HREC or Specialist College for a medical practitioner seeking endorsement to become an Authorised Prescriber?

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 committee to determine the appropriateness of the endorsement.

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

When should a medical practitioner seek approval from a human research ethics committee or endorsement from a specialist college?

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.

What information should be included in a letter of approval or endorsement?

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.

You can apply or report patient numbers using a downloadable PDF form in exceptional circumstances.

For example, if you are unable to access the online system.

To find out more email authorised.prescribers@health.gov.au