Authority to Supply Unregistered Therapeutic Drugs - Australian Government

Service summary

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); and
  • 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

 TypeDescription
ApplyApplication

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

Forms

 Resources
Apply

Authority to Supply Unregistered Therapeutic Drugs - Please consult the Contact Officer for information on forms to be submitted.

Administering agency

Department of Health
Therapeutic Goods Administration

Act(s) name

Therapeutic Goods Act 1989 (Australian Government)

Regulation(s) name

Therapeutic Goods Regulations 1990 (Australian Government)

Contact details

Information Officer
Department of Health
Therapeutic Goods Administration


Operating address:
136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address:
PO Box 100
Woden
Australian Capital Territory 2606

Phone:

02 62328644

Phone:

1800020653

Fax:

02 62031605
info@tga.gov.au

Supporting information

Disclaimer

The information contained on the Australian Business Licence and Information Service (ABLIS) web site, or via packages or other sources is intended for general guidance only.

To the full extent permitted by law, the Federal, State, Territory and Local Governments make no representations or warranties (expressed or implied) in relation to the information, including its accuracy, currency or completeness.

The business information provided does not constitute professional or legal advice, nor is the use of any third party resource an endorsement of the information contained, the associated organisation, product or service. It is recommended that you obtain appropriate professional and /or independent legal advice to ensure that the material provided here is relevant to your particular circumstances.

To the full extent permitted by law the Federal, State, Territory and Local Governments, their employees and agents do not accept any liability for any reason, including without limitation, liability in negligence, to any person for the general information which is provided herein, or in respect of anything, including the consequences of anything done, or not done, by any such person in whole or partial reliance upon the information.