Access to Unapproved Therapeutic Goods
Most medicines and devices are required to undergo an evaluation for quality, safety and efficacy, and be included on the Australian Register of Therapeutic Goods (ATRG) before they can be supplied in Australia.
There are circumstances where patients may require access to medicines or medical devices that are not listed on the ARTG.
Two schemes managed by the Therapeutic Goods Administration (TGA) enable supply of such unapproved therapeutic goods by medical practitioners via a submission to the TGA.
- The Special Access Scheme facilitates supply of an unapproved therapeutic good for a single patient.
- The Authorised Prescriber Scheme facilitates ‘authorisation of a medical practitioner’ to prescribe an unapproved therapeutic good for multiple patients under their care.
Unsure which pathway is more suitable? The TGA have a guidance tool to assist you.
Special Access Scheme Applications
The TGA manages the Special Access Scheme (SAS). The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good, for a single patient, on a case by case basis.
At Barwon Health, our Pharmacy Department oversee the SAS.
For comprehensive information on the SAS, please refer to;
- TGA website Special Access Scheme
- Barwon Health Pharmacy Medication Approval Processes (download from Prompt)
Informed Patient Consent
Medical practitioners are responsible for obtaining informed patient consent prior to use of an SAS drug.
Unapproved therapeutic goods have undergone little or no evaluation of quality, safety or efficacy by the TGA. Accordingly, use of all such goods carries with it some risks that have not been defined in the Australian context. As such, use of these products is considered to be experimental and should be guided by the principles and practices outlined in the National Statement. The National Statement contains detailed guidance in relation to informed consent.
Specifically in relation to the supply of unapproved therapeutic goods, the TGA recommends that the consent forms and/or patient information convey the following information adequately:
- The product is not approved (i.e. registered or listed) in Australia
- Any risks and side effects that are known
- The possibility of unknown risks and late side effects
- Any alternative treatments using approved products which are available.
Please email [email protected] for advice/review of your SAS informed consent form.
Barwon Health approvals
Medical practitioners working in an institution may also need approval from the Barwon Health Human Research Ethics Committee and/or the Barwon Health Drug and Therapeutics Committee. Please refer to Barwon Health Pharmacy Medication Approval Processes document for further information. Please contact [email protected] if Pharmacy indicate a HREC submission is required.
Special Access Scheme Applications
Please complete the SAS application forms found on the TGA SAS webpage, and forward to the Barwon Health Pharmacy Department for processing.
The Pharmacy Department can make an SAS submission via the TGA SAS portal on your behalf, following their review.
Authorised Prescriber Applications
- TGA – Authorised Prescriber webpage
- Authorised Prescriber application form (download)
- Authorised Prescriber 6 monthly report form
- Authorised Prescriber Guidance Document
The Authorised Prescriber Scheme allows authorised medical practitioners to supply therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) to a class of patients with a particular medical condition.
An Authorised Prescriber is allowed to supply the product directly to specified patients under their immediate care without requiring separate approval for individual patients.
Who can become an Authorised Prescriber?
Only medical practitioners can apply to become Authorised Prescribers under the Therapeutic Goods Act 1989. The therapeutic goods legislation defines a medical practitioner as 'a person who is registered, in a state or internal territory, as a medical practitioner'. In addition, the HREC (if applicable) and TGA Delegate must be assured that the medical practitioner has the qualifications and experience necessary to appropriately manage the medical condition and use the product.
To become an Authorised Prescriber, applicants must:
- be a fully registered medical practitioner, and must have the training and expertise appropriate for the condition being treated and the proposed use of the product
- be an employee of, and practicing at, Barwon Health, and should not use the product in a private setting
- The applicant must be able to best determine the needs of the patient and must be able to monitor the outcome of the therapy
- The intended unapproved product should not be intended for use in a clinical trial
- There should be no conflicts of interest.
An Authorised Prescriber is allowed to supply the product directly to specified patients under their immediate care and not to other practitioners who prescribe/administer the product. Use of the product under an authorisation must be at all times in line with the conditions specified in the authorisation.
Once a medical practitioner becomes an 'Authorised Prescriber' they do not need to notify the TGA when they are prescribing the unapproved product, however they must report to the TGA the number of patients treated on a six monthly basis.
There are 2 pathways to apply to become an Authorised Prescriber, depending on the product to be prescribed.
1. Established history of use pathway
The 'Established history of use pathway' requires one application to be submitted to the TGA for medicines deemed to have an established history of use.
Human Research Ethics Committee (HREC) approval or specialist college endorsement is not required before applying to the TGA. Prescribers will still need to check institutional requirements.
Medicines deemed to have an established history of use are specified in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990.
Apply via TGA online Special Access Scheme and Authorised Prescriber online system
2. Standard pathway
The 'Standard pathway' requires a 2-step application process for products that are not included in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990.
Approval from a human research ethics committee (HREC) or endorsement by specialist college must be obtained before applying to the TGA.
Authorised Prescribers must report the number of patients treated every 6 months. Use of the product must be reported twice yearly covering each period between 1 January to 30 June and 1 July to 31 December. See template at Authorised Prescriber forms.
How to prepare an Authorised Prescriber Application
Last Modified: Thursday, 12 May 2022