Prescribe an unapproved therapeutic good (health practitioners)

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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 therapeutic goods.

How to apply

How you apply to access unapproved therapeutic goods 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 therapeutic goods 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 therapeutic goods for individual patients as a registered health practitioner. This is through the Special Access Scheme.

Whether you can prescribe depends on:

• the unapproved therapeutic good
• the patient's condition (indication)
• your profession
• state and territory requirements.

You can’t become an Authorised Prescriber.

The prescriber named on the TGA approval letter or notification form is the only practitioner authorised to access the unapproved therapeutic good using the specific approval letter or notification form. 

Read how to access unapproved products for individual patients (Special Access Scheme).

Who can't apply

You can’t apply to access unapproved therapeutic goods if you are:

• non-practising
• a student
• provisional or with other registration limits
• not licenced to prescribe in Australia.

Table 1. Who can access unapproved therapeutic goods 

What you can access

As the prescriber, you are best placed to determine the needs of your patient.

This includes treatment with an unapproved therapeutic good.

You can apply to access any unapproved therapeutic good within your scope of practice that will benefit your patient. This includes:

• medicines
• biologicals
• medical devices.

You can’t prescribe Schedule 10 therapeutic goods.

Before you apply

Before you apply to access an unapproved therapeutic good, you should:

• consider approved therapeutic goods 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 unapproved therapeutic good is available and affordable for the patient.

Consider approved therapeutic goods for your patient's medical condition

Before you apply to access an unapproved therapeutic good, you must consider treatment options included in the Australian Register of Therapeutic Goods.

You can apply to access unapproved therapeutic goods to patients who are not responding to standard approved treatments.

You must have appropriate knowledge of:

• the condition being treated
• the unapproved therapeutic good.

The intended use of the unapproved therapeutic good must be within your scope of practice.

Consider risks of treatment

You must consider the risks of using an unapproved therapeutic good before prescribing it.

We haven’t evaluated unapproved therapeutic goods 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 an unapproved therapeutic good.

You are responsible for the use of an unapproved therapeutic good 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 therapeutic goods.

You should record your patient’s consent in their medical record or patient file.

You don't need to send proof of your patient's consent to us.

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 therapeutic goods.

To find out more contact your state or territory drug and poisons regulation unit.

Check the unapproved therapeutic good is available and affordable for the patient

You should check with the supplier to ensure they can supply the unapproved therapeutic good.

The price of an unapproved therapeutic good is determined by the supplier.

Unapproved therapeutic goods are not subsidised through the Pharmaceutical Benefits Scheme (PBS).