Advertising and endorsements

10 February 2016

In Australia, there are certain rules about how therapeutic goods can be advertised to the general public. These restrictions are in place to protect the health and safety of consumers.

Advertisements that refer to the Therapeutic Goods Administration (TGA), use a government logo, or imply that any government body (including a foreign government agency) endorses a therapeutic good are not permitted in consumer advertising.

Implying government approval

  • Do not make reference to government agencies (domestic or foreign), including the TGA, in any advertising or promotional material as this potentially implies endorsement by that agency. This includes:
    • statements such as "TGA approved" or "Government endorsed"
    • using the TGA logo or the Commonwealth Coat of Arms
    • statements that a therapeutic good is 'included in the ARTG by the TGA', 'registered by the TGA', 'TGA listed' or similar.

Advertising entry in the ARTG

The Australian Register of Therapeutic Goods (ARTG) contains information about therapeutic goods that can be supplied in Australia.

Advertisers are encouraged to provide consumers with a product's ARTG details.

However a broad statement that a therapeutic good is listed, registered, or included in the ARTG, even where factually correct, is not permitted unless it forms part of a statement of the ARTG number.

Advertisers may use 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>

Advertisers should also be aware of the important differences between TGA classifications for products entered in the ARTG; registered products are assessed as having a higher level of risk than listed products.

Penalties for non-compliance

The TGA seeks to inform, educate and assist advertisers to comply with the rules relating to advertising. However if an advertisement fails to follow these rules, fines for such offences can be up to $10,800 for individuals and $54,000 for corporations1.

The Australian Competition and Consumer Commission (ACCC) has issued infringement notices to advertisers of therapeutic goods for advertising products:

  • as approved by the TGA, the Department of Health and/or the Australian Government
  • with a picture of the Commonwealth Coat of Arms
  • with other false representations.

Relevant legislation

Advertising therapeutic goods, including endorsements and testimonials, must comply with the Therapeutic Goods Act 1989 (the Act), Therapeutic Goods Advertising Code 2015 (the Code) and the Competition and Consumer Act 2010 (incorporating the Australian Consumer Law other relevant legislation).

  • Advertisements for therapeutic goods must not state, suggest or imply that goods have been recommended, approved or endorsed by a government authority (section 42DL(1)(e)(ii) of the Act and section 4(6)(b)(i) of the Code).
  • An advertisement for therapeutic goods must not mislead, or be likely to mislead, directly or by implication or through emphasis, comparisons, contrasts or omissions (section 4(2)(c) of the Code)

Further information

For information about the content of advertisements, see Advertising therapeutic goods or consult a regulatory affairs consultant.

For further information about advertising therapeutic goods:


Footnotes

  1. These amounts are current at February 2016.