Advisory on Fair Balance Headings


The guidance document, Guidance on Generating the Three Base Fair Balance Levels, with respect to the highest level fair balance section headings, states that:

  • Headings must be employed to signal the key fair balance sections. Each section heading is underlined and bolded.
  • A line of white space separates each of the key sections.

With the development of new platforms which may not allow for underlining functionality, or in situations where the underlined copy may be misinterpreted as a hyperlink, the sponsor may opt to replace underlining with a notably larger font size. Note that bolding and white space are still required.


"Utilisation clinique” vs. “Usage clinique”

Upon recent consultation, PAAB has ruled that, moving forward, both translations of the fair balance headline “Utilisation clinique” and “Usage clinique” will be acceptable regardless of the specific translation used within the sponsor’s French Terms of Market Authorization.

Advisory on Fair Balance Headings EN - 07.21.pdf



Do you have questions? We have answers!

Learn More


Powered by Innovasium