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 that 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
Quick Links
- 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 to become an Authorised Prescriber via the Therapeutic Goods Administration website.
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
Step 1. Generate a Barwon Health Reference Number
Generate a reference number for your AP application via the Barwon Health Research Reference Number Generator if you have not already done so.
Please ensure that your Barwon Health reference number is quoted at the time of your submission and included in your cover letter.
Step 2. Prepare AP Application Documents
1. A cover letter which includes the following information:
- the reason for the Authorised Prescriber application; and
- the name, contact details, qualifications and training of each registered medical practitioner seeking endorsement to become an Authorised Prescriber.
- Details of the site/s where the good is intended for use and demonstrating the facilities needed to appropriately administer and monitor treatment are present.
2. Agreement and details for obtaining the drug or device
Provide details of exactly how the drug or device will be obtained/supplied.
Will an agreement between Barwon Health and the provider be required? If so, provide an electronic copy of the agreement from the supplier for review by RDU and execution at RMC.
Authorised Prescribers are responsible for obtaining the unapproved therapeutic good. If the Authorised Prescriber is an employee of Barwon Health, these arrangements may be made by Barwon Health on behalf of the approved Authorised Prescriber.
3. Site specific authorisation
Complete the Authorised Prescriber Site Specific Authorisation form which requires Head of Department or Director sign off.
An Authorised Prescriber applicant must not approve their own authorised prescriber requests on behalf of their department. If an AP applicant is also Head of Department, approval must be sought from their Director.
4. Provide CV's
Submit a curriculum vitae (CV) for each registered medical practitioner.
5. Authorised prescriber application form
Complete the Authorised Prescriber Application form available on the TGA website for each medical practitioner.
6. Clinical justification
The clinical justification for use of the 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. Specifically, provide information on:
- the indication for which the good will be used
- the seriousness of the condition
- the 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?
- 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 - how long for, when and where
- the process for determining, investigating and reporting adverse events
- the duration of treatment
- how it will be determined if treatment is effective
- Supporting documents eg. RCTs, non RCTs, case studies, specialists consensus, literature.
7. Product information or investigator brochure
Provide product information or an investigator brochure including;
- Sponsor/Supplier of the drug/device/biological
- Trade name,
- Active ingredient,
- Strength/concentration,
- Dosage form and range,
- Toxicology and safety information, and
- whether the drug/device/biological is approved for the indication by an overseas regulatory body such as FDA.
8. Informed consent
Provide a copy of the template of the informed consent document to be provided to each patient receiving the unapproved therapeutic product. Often the template will be provided by the supplier of the unapproved therapeutic product. The Authorised Prescriber must obtain the written informed consent of each patient for whom they prescribe the unapproved product. This consent form must be in plain and simple English and include statements about the following:
- that the TGA has not evaluated the unapproved good’s safety, quality and efficacy
- that the product is not approved for marketing in Australia;
- the possible benefits of treatment and any risks and side effects that are known;
- the possibility of unknown risks and side effects; and
- any alternative treatments using approved products that are available.
9. Complete Fee Payment form
- Download and complete Authorised Prescriber Fee Form (coming soon). Fees are payable up-front, at the time of initial submission.
Step 3. Submit AP Application
- Submit electronically to [email protected] and include “Authorised Prescriber Request” in the subject line.
Step 4. Application Review
Authorised Prescriber applications are reviewed at the next HREC meeting.
Following consideration of an Authorised Prescriber application, the HREC will issue (if application is approved) a formal letter of approval. This letter should be provided to the TGA together with the completed Authorised Prescriber Application Form.
Step 5. Submit TGA Application
- Submit an application to the TGA via the Special Access Scheme and Authorised Prescriber online portal as per Authorised Prescriber Guidance Document and include the HREC letter of approval together with the completed Authorised Prescriber Application Form – ensure the indication listed on the application form is the indication approved by the HREC.
Last Modified: Friday, 08 March 2024