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Cortex - Life Sciences Insights

| 1 minute read

Clarity and Caution Ahead for Advertisers: Changes to the Australian Therapeutic Goods Advertising Code

After a lengthy industry consultation process by the Australian Therapeutic Goods Administration, the updated Therapeutic Goods Advertising Code (the 2021 Code) came into effect at the beginning of this year. Advertisers of therapeutic goods have until 30 June 2022 to transition to the new Code.

The Code not only provides much needed clarity through a simplified structure but also introduces new requirements for the marketing of and promotion of therapeutic goods.   

Key changes in the 2021 Code

1. Clarifying testimonials and endorsements in advertising 

The 2021 Code retains the 2018 Code rules allowing genuine unpaid testimonials in advertising.

However, under the 2021 Code, paid or incentivised testimonials of any nature will now be prohibited, regardless of whether the financial relationship is disclosed. This prohibition extends to include paid or incentivised testimonials from a broad range of people, including influencers and current and former health professionals.

2. Simplifying mandatory statement requirements

The number of required mandatory statements has been reduced, and will be supported by consumer education in 2022.

The Code has been streamlined by differentiating the mandatory statements that apply depending on:

  • how the products are supplied

for example, if they are only supplied through a health professional then they must be accompanied by the statement “this product is not available for purchase by the general public”;

  • whether the purchase is made in person or online

where goods cannot be inspected prior to purchase, such as online sales, relevant warnings must be published in the advertisement at the point of purchase;

  • the type of product being sold

additional mandatory statement requirements apply to analgesics, sunscreens and therapeutic goods for use in weight management.

3. Increasing the list of permitted product samples 

Samples of additional therapeutic goods can now be offered (provided they are included in the Australian Register of Therapeutic Goods), including:

  • face masks and gloves;
  • certain sanitary products;
  • hand sanitisers;
  • certain nicotine replacements therapies; and
  • COVID-19 rapid antigen tests.

4. Expanding the rules around ‘safe and proper use’ 

As a result of industry feedback which revealed that the Code did not adequately prevent advertisements from causing fear and anxiety in some consumers, the updated 2021 Code prohibits an advertisement from causing undue alarm, fear or distress.

In the TGA’s Consultation Paper, the “fear and distress” related to advertisements that caused people to believe that they were suffering or would suffer in the future from a serious illness.

For further information about the advertising or promotion of therapeutic goods in Australia, please contact Greg Bodulovic or Stephanie Wang.


asiapac, regulation