Hi there. I submitted a question a few weeks ago regarding whether PAAB needed to review market authorization announcements that do not include any statement of the indication, however my question was not answered, so I am asking it again: Under the PAAB code, it is clear that under section 1.5(D) that a formulary announcement (i.e., now on provincial formulary") does not require PAAB review if it is not linked to a therapeutic message in any way and does not include a coverage criteria or code. However, it is not clear whether to same principle applies to a market authorization/NOC announcement. Does a message (in an email from a rep to a physician) containing only the message "Health Canada has authorized for sale" required PAAB review, if it is not linked to a therapeutic message? Can such a message include a basic link to the full, unedited Product Monograph (as approved by Health Canada) without PAAB review?

Please see PAAB document Pre-NOC Corporate/Editorial Communications for guidance.


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