Access to unapproved therapeutic goods for multiple patients (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'.

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

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

If conditions are imposed on a medical practitioner’s registration, this may affect their ability to become an authorised prescriber.

Please send an email with the below information to SAS.Support@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.

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

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 your Authorised Prescriber (AP) authority to report the number of patients treated using your specific AP authority in the 6-month period. If you fail to meet your reporting requirements, the TGA may move to revoke your AP authority.

There are two reporting periods which you are required to submit reports for. These are:

• 1 January – 30 June (inclusive)
  • Reporting opens beginning of July and must be submitted before the 31st of July.
• 1 July – 31 December (inclusive)
  • Reporting opens beginning of January and must be submitted before the 31st of January.

You will receive an email to remind you when your reports are due. All reports must be submitted via the SAS and AP Online System.

You are still required to report even if you have not treated any patients in the 6-monthly reporting period. You must enter 0 (zero) in the online reporting form for each product you hold authority for. You will be unable to submit your report if any fields are incomplete. If you are no longer using your authority, see question What if I want to withdraw my Authorised Prescriber authority as I no longer need it?

You must report on 2 types of patient categories.

These categories are the number of new patients, and the total number of patients treated with the specific product within the reporting period.

• The ‘new patient’ figure is the number of patients that commenced treatment of a specific product with you as the prescriber during the reporting period.
• The ‘total patient’ figure is the number of new patients plus the patients that you treated during a previous reporting period with the specific product and the patient has returned for continued treatment during the reporting period.

For medicine and biological AP authorities, you must report the number of patients treated, not the number of prescriptions provided.

If your AP authority is for a medicine or biological, you must report on the ‘number of new patients commenced on treatment’ and the ‘number of total patients treated during this period’. If your AP authority is for a device, you must report on the ‘number of devices supplied’ and the ‘number of total patients treated during this period’.

To identify what product type you have approval for, the TGA authority will have the below reference number:

• All medicine authorities start with ‘M’ (e.g. MAP24-0000000).
• All biological authorities start with ‘B’ (e.g. BAP24-0000000).
• All device authorities start with ‘D’ (e.g. DAP24-0000000).

You must ensure that all outstanding 6-month reports are submitted through the SAS and AP Online System prior to requesting a withdrawal. Once all reports are submitted, please email SAS.Support@health.gov.au with your AP authority number you would like withdrawn.

Gather the following information before you ask for help:

• username for SAS and AP Online System
• email address used for SAS and AP Online System
• AHPRA number

To get help email this information to SAS.Support@health.gov.au.

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 unapproved therapeutic good(s) 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.

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 is listed in Schedule 1 of 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 therapeutic 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 therapeutic good. 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 unapproved therapeutic good 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.

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 good(s) for which approval or endorsement has been given
• the site(s) at which use is covered by the approval or endorsement
• any conditions that have been applied to the approval or endorsement
• specify if the approval is specific to patients under 18 years
• 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.

To assist HRECs or specialist colleges with preparing a letter of approval or endorsement, we have provided the below template as a guide. Use of this template is optional and at the discretion of the HREC or specialist college.