Prescribing unapproved drugs

Some medicines may have clinical value but are not registered for general distribution within Australia.

However, under Australian therapeutic goods legislation, medical practitioners can request access to unregistered medicines for their patients in certain circumstances. Approval can be obtained from the Therapeutic Goods Administration (TGA) under either the:

• Special Access Scheme (SAS) for a single patient
• Authorised Prescriber Scheme (AP) for a class of patients under one practitioner’s immediate care.

Approval from TGA under the SAS or AP scheme is the first step.

If the medicine is a controlled substance, medical practitioners will then need to apply for an import licence from the Office of Drug Control (ODC). To find out if the substance you wish to import requires an import licence, please see the controlled substances list.

If the substance you wish to import requires an import permit and/or licence please see the guidance below on completing an application for a licence (if required) and permit to import.

Licence and permit applications can only be submitted by an Australian registered medical practitioner or pharmacist. An authorised prescriber (for example a general practitioner or specialist) approved by the TGA must also apply for appropriate licences and permits through the ODC to import substances directly or for clinical trials.

Licence and permit application forms

To obtain a licence and permit to import a medicine containing a controlled substance approved under the Special Access Scheme or Authorised Prescriber Scheme a medical practitioner must complete certain steps.

1. The Therapeutic Goods Administration (TGA) must grant the approval for a medicine to be obtained under the SAS or AP schemes.
2. Confirm if the substance is on our ‘controlled substances list’.
3. If the substance is on the list, then you must apply for an import licence (if required) and permit with the ODC. Please refer to our Guidance: Completing an application for a licence and permit to import drug substances under the Special Access Scheme (SAS) only.

Submitting an application

You can submit your application in the following ways:

We endeavour to process applications for permits within 20 business days from the date of receipt of a correctly completed application and requisite supporting documentation. While a very high proportion of applications are processed within 10 days, there will be times where high demand for permits may result in slightly longer processing times.

Application forms that contain incomplete or incorrect information will be returned to you for amendment, resulting in delays in processing.

It is the responsibility of the importer to ensure that the triplicate copy of the permit is completed at the time of importation and the hardcopy returned to Narcotics Control Section (NCS).

It is responsibility of the importer to return the endorsed triplicate copy to NCS no later than 14 days after the importation has occurred. Failure to comply with this condition may result in cancellation of import licenses.