Australia: The Claim ‘TGA approved’ Must Not Be Used in Advertising

Therapeutic Goods Medical Devices

On 13 September 2021, the Therapeutic Goods Administration (TGA) emphasised that terms such as ‘TGA approved’ or ‘TGA registered’ must not be used on therapeutic goods advertising, including on labels or packaging. The use of a TGA logo or Commonwealth Coat of Arms is also strictly prohibited.

Statements not permitted for use are as follows:

  • ‘TGA approved’ or ‘TGA endorsed’
  • ‘U.S. Food & Drug Administration (FDA) approved’
  • ‘Government endorsed’

However, advertisers can include details of the product’s ARTG number ( number is mandatory on medicine labels and packaging).

Advertisers can use the permitted terms below:

  • For devices: ‘Product X is entered in the ARTG, (ARTG number)’
  • For medicines and other therapeutic goods that are:
    1. listed in the ARTG: ‘Product X is listed in the ARTG, AUST L (ARTG number)’
    2. registered in the ARTG: ‘Product X is registered in the ARTG, AUST R (ARTG number)’

Reach out to RegASK to identify the potential impact on your products and ways to mitigate. Get in touch with RegASK’s experts.


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