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  3. Terms of Market Authorization
  4. 327 - Hi There, Our client has just received NOC to a new product. They do not have a large Sales Force and therefore is not looking to develop comprehensive materials. They would like to take their approved Product Monograph and highlight key messages within it - not changing any copy/content - but just simple draw attention to specific sections, such as patient groups, efficacy and adverse events. We would submit the highlighted PM through PAAB for approval - but before we go into development I just wanted to confirm this would be something PAAB would allow.

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327 - Hi There, Our client has just received NOC to a new product. They do not have a large Sales Force and therefore is not looking to develop comprehensive materials. They would like to take their approved Product Monograph and highlight key messages within it - not changing any copy/content - but just simple draw attention to specific sections, such as patient groups, efficacy and adverse events. We would submit the highlighted PM through PAAB for approval - but before we go into development I just wanted to confirm this would be something PAAB would allow.

Scheduled Pinned Locked Moved Terms of Market Authorization
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Please refer to the Guidance document about promotional monographs on our website:

    http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Promotional_Monographs.pdf

    PAAB would not accept placing highlighting over some sections of the monograph content. Modifications should be presented in such a way as to be clearly distinguished from the PM itself. Per the aforementioned document, you could employ callouts in the margin of the document to meet your desired objective.

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    The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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