529 - Hi, I have a question about 3.1 specifically the section regarding claims consistent with the limitations of the Health Canada Terms of Marketing Authorization. There are some on our team that believe this means we are not able to use data that is not within the PM regardless. There are others that believe if a claim is based on a similar study population, endpoint and outcomes are consistent with the monograph, it appropriate. We seem to go back and forth on this a great deal and I like to hear PAABs thoughts. Thanks
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Study findings which are in the TMA can be presented in advertising provided they are presented in a manner which reflects the TMA context & emphasis. Study findings which are not presented in the TMA (whether because that study is not in the TMA or because the portion of the study in question is not in the TMA) can be considered in drug advertising provided the study meets all provisions in the PAAB code and guidances.
