Registration or Listing of Therapeutic Goods - Australian Government

Description

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
  • 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.

Application for registration or listing of an item may include additional information to be accompanied with the application. Please refer to relevant guidelines or legislative instruments.

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

Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application All

Fees are listed on the attached document.

Forms

Task Business Structure Resources
Apply All Australian Register of Therapeutic Goods - Please consult the Contact Officer for more information regarding registration forms.
Apply All TGA Business Services Forms (Opens in new window)
Apply All TGA Business Services: Getting Started with the TGA (Opens in new window)

Other resources

Task Business Structure Resources
Comply All Summary of Fees and Charges - PDF (Opens in new window)

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
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)