Authority to Supply Unregistered Therapeutic Drugs - Australian Government

Description

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. 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

Licence

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.

Duration

As specified on the authority.

Fees

Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application Sole Trader, Partnership, Company, Trust, Co-operative, Incorporated Association, Other

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

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.

Information Officer

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Phone: 02 6232 8644
Phone: 1800 020 653
Fax: 02 6203 1605
Email: info@tga.gov.au