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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 197 - When submitting a file for review by the provincial governments for the purposes of securing or improving reimbursement status, do any of the materials need to be submitted to PAAB? Thank you for your help.

Forum Update: Supporting Community-Led Discussion

The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.

Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:

  • Correct any misunderstandings
  • Provide guidance when questions remain unanswered after a few days
  • Support discussions where official clarification is needed

Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.

Thank you for being part of the conversation.

197 - When submitting a file for review by the provincial governments for the purposes of securing or improving reimbursement status, do any of the materials need to be submitted to PAAB? Thank you for your help.

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

    The Health Canada Policy document "The Distinction Between Advertising and Other Activities" has a section on formulary kits. The kits are materials prepared for review by pharmaceutics and therapeutics formulary committees, on which a decision to include a drug product in a formulary may be based. Such information may not be advertising provided the information is limited to that which would normally be required to support such an application. If this is the case, there is no need for PAAB review. Where such an information package is disseminated, in whole or part, to a wider audience simultaneously, or at a later date, it may be advertising to promote the sale of the drug concerned. In these cases, the material should be submitted for PAAB review. Note that the PAAB has received complaints from provinces about unrequested promotion that should have been PAABed.

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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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