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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 363 - Can you please remind me of the rules related to printing and distributing your product monograph? I believe you can reprint it exactly as is and to do so would be PAAB exempt. However, if you add a cover with your brand identity, your logo and indication statement(s), yet no claims, is that now classified as a "commercial" PM and thus requires PAAB review? Or is it only if you make a claim on a branded front cover? TIA
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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.

363 - Can you please remind me of the rules related to printing and distributing your product monograph? I believe you can reprint it exactly as is and to do so would be PAAB exempt. However, if you add a cover with your brand identity, your logo and indication statement(s), yet no claims, is that now classified as a "commercial" PM and thus requires PAAB review? Or is it only if you make a claim on a branded front cover? TIA

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    We have a concise but comprehensive external guidance for promotional PMs on our website. It answers your question and also provides a broader reminder. For your convenience, click here: http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Promotional_Monographs.pdf.

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