prescription for medicinal cannabis with marijuana plant on top

Authorised Prescriber Scheme

Information for patients and medical professionals

To prescribe medicinal cannabis for a group of patients with the same condition (for example, children with treatment-resistant epilepsy), a medical practitioner can apply to become an Authorised Prescriber.

When a medical practitioner becomes an Authorised Prescriber, this means they do not need to notify the Therapeutic Goods Administration (TGA) each time they prescribe the cannabis product, but instead must report to the TGA the number of patients treated every 6 months.

The medical practitioner must also seek endorsement for their application from an ethics committee who will assess not only the safety of the cannabis product for the condition, but also the suitability of the medical practitioner.

As stated on the TGA website, it is not possible to find out who is an Authorised Prescriber due to privacy reasons.

Patient access to medicinal cannabis products via the Authorised Prescriber scheme is summarised below:  

Authorised Prescriber Scheme

Information for medical practitioners.
1

a. Who and what are you treating?

Review clinical evidence for using cannabis products for a group of patients with a particular medical condition.

b. What medicinal cannabis product will you use?

Identify a specific cannabis product (trade name, formulation, route of administration and dose) appropriate for your patient’s medical condition. Identify a GMP-accredited supplier that can provide this cannabis product.

View a list of sponsors authorised to import medicinal cannabis for an Australian stock supply.

2

TGA approval: Authorised Prescriber (AP)

Submit a completed Authorised Prescriber form to the TGA, which summarises information in Steps 1 a to b.

3

Obtain endorsement from an Ethics Committee

Your completed AP form must be endorsed by an ethics committee in the form of a letter. Once obtained, submit the AP form along with the endorsement letter and supporting evidence to the TGA.

4

Check your state and territory requirements

Contact your relevant state/territory department regarding additional requirements for prescribing medicinal cannabis products.

5

Is the product available in Australia?

If stock is available in Australia, contact supplier and provide AP authorisation and state/territory approval (if required).

If the product must be imported from overseas, import licence and permit must be obtained by the supplier from the Office of Drug Control (ODC).

Contact details for enquiries about the Authorised Prescriber Scheme

Fax
  • 61 2 6232 8112
Address
  • The Medical Officer Experimental Products Pharmacovigilance and Special Access Branch Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia