Authority to Supply Unregistered Therapeutic Drugs - Australian Government


You will require this authority if you are a registered medical practitioner and you intend to provide therapeutic drugs that are not registered or listed on the Australian Register of Therapeutic Goods (ARTG). There are some legal exemptions to the requirement for a prescription medicine to be registered on the ARTG.

These are implemented through:

  • the Special Access Scheme (SAS)
  • the clinical trials systems (CTX and CTN).

Please consult the Contact Officer for more information.

Service type


A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.

Eligibility requirements

To be eligible for this authority you must be a registered medical practitioner.

Please consult the Contact Officer for more information regarding eligibility requirements.


As specified on the authority.


Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application All

Please consult the Contact Officer for information on fees to be submitted.


Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Please use these contact details for help or more information:

Information Officer

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Phone: 02 6232 8644
Fax: 02 6203 1605
Website: Therapeutic Goods Administration (Opens in new window)