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To access an unapproved therapeutic good for multiple patients you can become an Authorised Prescriber.
The prescriber named on the TGA approval letter is the only practitioner authorised to access the unapproved therapeutic good using the specific approval letter.
How you apply depends on if you want to prescribe an unapproved therapeutic good which is not on the list of medicines with an established history of use.
To prescribe an unapproved therapeutic good not on the list, you will need endorsement or approval from a human research ethics committee (HREC) or specialist college. This is called the standard pathway.
To prescribe biologicals or medical devices, use the standard pathway. These unapproved therapeutic goods aren't on the established history of use list.
As an Authorised Prescriber, you can access an unapproved therapeutic good for a particular indication. You won’t need to seek approval for each individual patient. You must report:
- any suspected adverse event or product defect
- how many patients you have treated every 6 months.
To become an Authorised Prescriber you must use the Special Access Scheme (SAS) and Authorised Prescriber (AP) Online System. You must register an account to do so.
Before you apply
Read about what you need to do before you apply to prescribe an unapproved therapeutic good (health practitioners).
Unapproved therapeutic good is on the established history of use list
Check if the unapproved therapeutic good you want to prescribe is on the lists of medicines with an established history of use.
The unapproved therapeutic good 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.
Standard pathway
If the unapproved therapeutic good 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 therapeutic good.
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- external site.
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- external site.
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 therapeutic good you want to prescribe
- clinical justification for use of the unapproved therapeutic good.
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
After you apply
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 therapeutic good, you can access it for patients in your care.
The prescriber named on the TGA approval letter is the only practitioner authorised to access the unapproved therapeutic good using the specific approval letter.
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
Read more about the SAS and AP Online System.
To find out more about making a formal appeal read the guidance for requesting reconsideration of an initial decision.
Obtain unapproved therapeutic goods
As the prescriber, it is your responsibility to source the unapproved therapeutic good.
You can do this in conjunction with the dispensing pharmacy.
If you can't source an unapproved therapeutic good contact someone experienced with importing unapproved therapeutic goods. For example:
- a hospital pharmacy
- wholesalers
- sponsors.
We give health practitioners approval to access unapproved therapeutic goods.
We don't arrange the supply of unapproved therapeutic goods.
Reporting requirements
As an Authorised Prescriber, you must report the number of patients you have treated.
You must report this every 6 months for each unapproved therapeutic good you are authorised to access.
You are responsible for reporting adverse events or defects from the use of unapproved therapeutic goods 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
To report patient numbers:
- Go the SAS and AP online system and log in.
Follow the step-by-step guide in the Authorised Prescriber Scheme online system guidance (pages 29 to 32).
Read more about the SAS and AP Online System.
Report adverse events and unapproved therapeutic good defects
You must report any suspected adverse events or defects within 15 days of learning of them.
If you don't meet conditions of approval
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 therapeutic good becomes available and is entered on the ARTG
- we become aware of any significant concerns about a therapeutic good’s safety.
Frequently asked questions (FAQ)
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.
For the Special Access Section to assist with all online system enquiries, 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:
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) approval to report the number of patients treated using your specific AP approval in the 6-month period. If you fail to meet your reporting requirements, the TGA may move to revoke your AP approval(s).
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 approval for. You will be unable to submit your report if any fields are incomplete. If you are no longer using your approval, see question What if I want to withdraw my Authorised Prescriber approval 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 approvals, you must report the number of patients treated, not the number of prescriptions provided.
If your AP approval 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 approval 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 approval will have the below reference number:
- All medicine approvals start with ‘M’ (e.g. MAP24-0000000).
- All biological approvals start with ‘B’ (e.g. BAP24-0000000).
- All device approvals 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 approval 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- external site number
To get help email this information to SAS.Support@health.gov.au.
Human Research Ethics Committees and Specialist Colleges
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.
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 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.
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 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
- 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.
Contact us
To find out more email authorised.prescribers@health.gov.au
Contact us
To find out more email authorised.prescribers@health.gov.au