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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 apply
How you apply to access 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 apply 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 apply
You must be registered or licensed by the Australian Health Practitioner Regulation Agency (AHPRA).
Medical practitioners
As a medical practitioner, you can apply to access 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
You may be able to apply to access unapproved products for individual patients as a registered health practitioner. This is through the Special Access Scheme.
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 access unapproved products for individual patients (Special Access Scheme).
Who can't apply
You can’t apply to access unapproved products if you are:
- non-practising
- a student
- provisional or with other registration limits
- not licenced to prescribe in Australia.