The Therapeutic Goods Advertising Code (Code) is the latest legislative instrument to be implemented as part of the Australian Government's response to the Review of Medicines and Medical Devices Regulation first released on 15 September 2016.

What is the Code?

The Code is the key legislative instrument underpinning the advertisement of therapeutic goods in Australia. Among other things, it sets out the minimum requirements that advertisers must follow.  The Code complements the advertising provisions set out in the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990.

What is an advertisement?

To assist advertisers, the TGA have published Australian Regulatory Guidelines for Advertising Therapeutic Goods to clarify activities likely to constitute advertising. 

In making this decision, the following factors will be considered:

  • the context in which the information or activity occurs;
  • the audience and key take-out messages of the material; and
  • use of non-verbal and unwritten messages, such as pictures.

Unsolicited or unbalanced information is likely to be considered promotional, as will the use of superlatives, adjectives or emotive statements such as 'the best' or 'changed my life'.

What are the key changes?

The new 2018 Code brings a number of changes. Key changes include:

  • clarification of what advertisements must contain for goods that are not available for physical examination before purchase i.e. internet advertising;
  • ·new required warning statements to be displayed or communicated for Schedule 3 (Pharmacist Only) medicines;
  • clarification that advertising must not be primarily directed to children under the age of 12 years;
  • clarification of the requirements for testimonials; and
  • a new complaints handling process.

When will it come into effect?

Although the new 2018 Code has already been registered, it will not take effect until 1 January 2019. This will give time for companies to familiarise themselves with the new Code and make any necessary changes to promotional materials (including on the internet).


The new Code will impact advertisements that require pre-approval. These include advertisements that appear in magazines, newspapers, TV, radio, billboard or cinematograph films. Applications for pre-approval lodged on or after 1 January 2019 will be assessed against the new 2018 Code. Applications lodged prior to this date will be assessed against the 2015 Code.

Next steps

Companies should use the next six months to review their current advertisements to ensure that any advertising/ promotion of their therapeutic goods after 1 January 2019 will be compliant with the new 2018 Code.

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