We are updating our content for unapproved therapeutic goods. Please give your feedback.
Generally, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG).
This must be done before they can be legally supplied, imported to or exported from Australia.
Products not included in the ARTG are referred to as unapproved therapeutic goods.
If conditions are met, you can prescribe unapproved products.
How to prescribe
How you prescribe unapproved products depends on whether you want to do it for:
- an individual patient on a case-by-case basis
- multiple patients with the same condition.
To prescribe for an individual patient use the Special Access Scheme (SAS).
For multiple patients with the same condition, consider becoming an Authorised Prescriber.
If you need help to decide what pathway is right for you, try the accessing unapproved therapeutic goods tool.
Prescribe for individual patients (Special Access Scheme)Prescribe for multiple patients (Authorised Prescriber)
Who can prescribe
You must be registered or licensed by the Australian Health Practitioner Regulation Agency (AHPRA).
Medical practitioners
As a medical practitioner, you can apply to prescribe unapproved products to:
- individual patients on a case-by-case basis through the Special Access Scheme
- multiple patients with the same condition as an Authorised Prescriber.
Other health practitioners
Through the Special Access Scheme, you can apply to prescribe unapproved products for individual patients as a registered health practitioner.
Whether you can prescribe depends on:
- the product
- the patient's condition (indication)
- your profession
- state and territory requirements.
You can’t become an Authorised Prescriber.
Read how to prescribe unapproved products for individual patients (Special Access Scheme).
Who can't apply
You can’t prescribe unapproved products if you are:
- non-practising
- a student
- provisionally registered
- registration has conditions applicable to your application
- not licenced to prescribe in Australia.
| Application eligibility | SAS Category A | SAS Category B | SAS Category C | Authorised Prescriber | |
|---|---|---|---|---|---|
| Medical practitioners | Prescribe | Yes | Yes | Yes | Yes |
| Submit on behalf of prescriber | Yes | Yes | Yes | No | |
| Health practitioners | Prescribe | No | Yes | Yes | No |
| Submit on behalf of prescriber | Yes | Yes | Yes | No |
What you can prescribe
As the prescriber, you are best placed to determine the needs of your patient.
This includes treatment with an unapproved therapeutic good.
You can prescribe any product within your scope of practice that will benefit your patient. This includes:
You can’t prescribe Schedule 10 products.
Before you apply
Before you apply to prescribe an unapproved product, you should:
- consider approved products for your patient's medical condition
- consider risks of treatment
- obtain informed consent
- adhere to relevant standards of good medical practice
- check state and territory requirements
- check the product is available and affordable for the patient.
Consider approved products for your patient's medical condition
Before you prescribe an unapproved good, you must consider treatment options included in the Australian Register of Therapeutic Goods.
You can prescribe unapproved products to patients who are not responding to standard approved treatments.
You must have appropriate knowledge of:
- the condition being treated
- the unapproved product.
The intended use of the product must be within your scope of practice.
Consider risks of treatment
You must consider the risks of using an unapproved product before prescribing it.
We haven’t evaluated unapproved products for:
- quality
- safety
- efficacy
- performance.
You can refuse to prescribe if you believe there is insufficient clinical justification or evidence to support the use of a product.
You are responsible for the use of an unapproved product and all outcomes. This includes adverse reactions.
Obtain informed consent
You must obtain the informed consent of your patient or their legal guardian before prescribing unapproved products.
You should record your patient’s consent in their medical record or patient file.
Read more about informed consent.
Adhere to relevant standards of good medical practice
You are expected to adhere to relevant standards of good medical practice in the treatment of patients.
Medical practitioners
You must operate in accordance with principles outlined by the Medical Board of Australia.
Read good medical practice: a code of conduct for doctors in Australia.
Other health practitioners
Refer to your appropriate governing body for guidance.
Check state and territory requirements
You may also need to meet state and territory requirements to prescribe unapproved products.
To find out more contact your state or territory drug and poisons regulation unit.
Check the product is available and affordable for the patient
You should check with the supplier to ensure they can supply the product.
The price of a therapeutic good is determined by the supplier.
Unapproved products are not subsidised through the Pharmaceutical Benefits Scheme (PBS).