Registration or Listing of Therapeutic Goods - Australian Government

Service summary

You will require this licence if you intend to market therapeutic goods or biologicals as an individual or organisation under your own name or brand. This covers any drug or device used for the prevention, diagnosis or treatment of diseases or other bodily functions.

Registrable products include prescription or non-prescription medicines, and implantable medical devices, such as active implantables, and devices of animal origin.

Listable goods include:

  • Vitamins;
  • Minerals;
  • Herbal medicines;
  • Sunscreens; and
  • Most medical devices.

Therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.

The ARTG is a database of information about therapeutic goods for human use approved for supply in, or exported from, Australia. Information held on the database includes the product name and formulation details and sponsor and manufacturer details.

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

Please consult with the Contact Officer for information on any eligibility requirements.

Duration

Ongoing.

Fees

 TypeDescription
ApplyApplication

Fees are listed on the attached document.

Forms

 Resources
Apply

Australian Register of Therapeutic Goods - Please consult the Contact Officer for more information regarding registration forms.

Other resources

 Resources
Comply Summary of Fees and Charges Opens in a new browser window

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.