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The claim 'TGA approved' must not be used in advertising
The inclusion of a therapeutic good in the Australian Register of Therapeutic Goods (ARTG) is not an endorsement of that good by the Therapeutic Goods Administration (TGA). Advertisers must not use terms such as 'TGA approved' or 'TGA registered' in therapeutic goods advertising, including on labels or packaging. The use of a TGA logo or Commonwealth Coat of Arms is also prohibited.
However, advertisers can include details of the product's ARTG number (and this number is mandatory on medicine labels and packaging). For certain medicines, a 'TGA assessed claim' can also be used in advertising1.
This fact sheet explains how to include the ARTG number in an advertisement.
'TGA Approved' or 'TGA Registered'
Advertisers are prohibited from using a government logo, or implying that any government body (including a foreign government agency) endorses a therapeutic good.
This includes statements such as:
- 'TGA approved' or 'TGA endorsed'
- "U.S. Food & Drug Administration (FDA) approved"
- 'Government endorsed'
Including the ARTG number in advertising
The ARTG contains information about therapeutic goods that can be supplied in Australia.
Advertisers are encouraged to provide the public with a product's 'AUST L', 'AUST R' or ARTG number in advertising as it assists consumers to identify a product, and to look up the entry in the ARTG if they wish to.
Advertisers can refer to the product's ARTG entry in a compliant way by using terms such as:
- For devices: 'Product X is entered in the ARTG, (ARTG number)'
- For medicines and other therapeutic goods that are:
- listed in the ARTG: 'Product X is listed in the ARTG, AUST L (ARTG number)'
- registered in the ARTG: 'Product X is registered in the ARTG, AUST R (ARTG number)'
However, advertisers should not make a broad statement that a therapeutic good is listed, registered, or included in the ARTG unless it includes the ARTG number.
TGA assessed claim is permitted for some medicines
Assessed listed medicines and registered complementary medicines can be lawfully promoted with the 'TGA assessed claim'. However, the use of this claim must be consistent with the requirements published on the TGA website.
In particular, refer to:
- Advertising and endorsements
- Advertising to the public Section 16 of the Therapeutic Goods Advertising Code (No.2) 2018
- See sections 42DL(9) and 42DLB(6) of the Therapeutic Goods Act 1989 and section 16(2) of the Therapeutic Goods Advertising Code (No.2).