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New Therapeutic Goods Advertising Code 1 January 2022

3 December 2021

The Therapeutic Goods Advertising Code (the Code) prescribes the minimum requirements for the lawful advertising of therapeutic goods to Australian consumers. It ensures the marketing and advertising of therapeutic goods is conducted in a way that promotes the quality use of the product, is socially responsible and does not mislead or deceive the consumer.

After 18 months of consultation with our stakeholders, the TGA is pleased to provide the Therapeutic Goods Advertising Code 2021 (the 2021 Code) which comes into effect on 1 January 2022.

Advertisers have until 30 June 2022 to transition from the current Code to the 2021 Code. During this 6 month transition period advertisers may apply either the current Code or the 2021 Code.

The 2021 Code has been prepared with an overarching objective of greater ease of reading for easier application of the advertising rules, while still meeting the requirements for a legal instrument prepared under the Therapeutic Goods Act 1989.

In January 2022, we will publish updated guidance materials on the TGA website to ensure advertisers are supported in complying with the 2021 Code. In the first half of 2022 we will also host webinars about the Code changes.

The key changes in the 2021 Code are as follows:

  1. Mandatory statement requirements have been simplified. Following consumer research, the mandatory statement requirements have been simplified, including a reduction in the number of required mandatory statements. The simplified requirements will be supported by consumer education in 2022.

    The 2021 Code also includes a new mandatory statement for products that cannot be purchased by consumers (i.e. for those products that are only supplied through a health professional); THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC.

    It also distinguishes between those products that can be physically viewed by consumers prior to purchase and those that cannot. The 2021 Code relies on the regulatory requirements for consumer health warnings on labelling and packaging for purchases in person, and where the goods cannot be inspected prior to purchase, i.e. in online sales, relevant warnings must be published in the advertisement at point of purchase. This approach provides the consumer with relevant health warnings prior to purchase, both in person and online.

  2. The rules around testimonials and endorsements in advertising have been clarified. Following extensive stakeholder consultation, the 2021 Code retains the 2018 Code rules allowing genuine unpaid testimonials in advertising. The 2021 Code clarifies that paid or incentivised testimonials cannot be included in advertisements, including from anyone engaged in the production, marketing or supply of the goods. This includes paid or incentivised testimonials from influencers. Clarification has also been made that the prohibition on endorsements from health professionals extends to former health professionals.
  3. The list of permitted product samples has been expanded. The 2021 Code includes additional samples that can be offered in, or as, advertising of therapeutic goods, such as face masks and gloves, certain sanitary products, hand sanitisers, certain nicotine replacements therapies and COVID-19 rapid antigen tests. It also clarifies that these products must be entered in the Australian Register of Therapeutic Goods. The TGA will provide guidance on how requests for additions to the list will be assessed, in the interests of public health.
  4. Prohibited representation rules have been consolidated in the regulations. References to prohibited representations have been removed from the 2021 Code and consolidated in the Therapeutic Goods Regulations 1990.
  5. The definitions of terms used in the Code have been modified and expanded to improve clarity.
  6. The rules regarding 'safe and proper use' in the Code have been expanded to prohibit an advertisement from causing undue alarm, fear or distress.

If you have an enquiry about the 2021 Code please contact us through the online enquiry form at https://compliance.health.gov.au/ac-enquiry/.