531 - Re: Q#522 for use of Summary Basis Decision in advertising and you replied: "Yes. Provided the content referenced from it is not inconsistent with the product monograph", if data from the SBD does not appear in the PM, can we use it? It would not be 'inconsistent'. If PAAB considers the SBD the same weight as the PM, then it should be acceptable. Is this an accurate assessment?



  • It’s not a matter of “same weight” per se. It’s simply a matter of appearance in the SBD being evidence of approval by Health Canada. In response to your question, yes the SBD data would generally be accepted (in a similar context). However, if the presentation were to appear to contradict something in the monograph, we would first consult with Health Canada for clarification of the disparity.


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