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Therapeutic goods advertising: Update 31 October 2018
The Therapeutic Goods Advertising Code 2018 (the 2018 Code) was made on 29 June 2018.
Today, the TGA revised the 2018 Code, and made the Therapeutic Goods Advertising Code (No.2) 2018 (the 2018 Code No.2) which will come into effect on 1 January 2019.
This update contains important information about the 2018 Code No.2.
The 2018 Code has been revised
The TGA consulted extensively while developing the 2018 Code, and through the development of the detailed guidance in support of the code that followed. Through these consultations, as well as through the Therapeutic Goods Advertising Consultative Committee, opportunities for further clarification and improvement to the 2018 Code were identified.
The 2018 Code No.2 made today replaces the code that was made on 29 June 2018, and will take effect on 1 January 2019. An Explanatory Statement accompanies the code.
To assist advertisers with interpreting and implementing the 2018 Code No.2 we have published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
Key issues that have been addressed by the 2018 Code No.2 include:
- Simplification and clarification of 'prominently displayed or communicated'
- Streamlining definitions and providing a more specific definition of health warnings in relation to the advertising of medicines, with greater alignment with the implementation of TGO92 - Standard for labels of non-prescription medicines
- Specifying the transition period for advertising that has been pre-approved under the Therapeutic Goods Regulations 1990
- Clarifying requirements for scientific or clinical claims and consistency with public health campaigns
- Clarifying certain requirements relating to endorsements and testimonials
- Improved ordering of provisions for greater clarity
A summary of these changes has been published. A number of consequential changes have been made to aid readability and interpretation.
We understand that advertisers are working hard to revise their advertisements against the new requirements, please see our statement on enforcement discretion for further information on the transition to the new code.
Education, training and events
The TGA is supporting the changes to the Therapeutic Goods Advertising Code by participating in and hosting a range of education activities. We will also be publishing a series of fact sheets to support advertisers in learning about the 2018 Code No.2. Further information about our education, training and events is available on the Advertising Hub. Our program of education and support to advertisers will be ongoing throughout 2019.