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Guidance on Submission Procedures

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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.
  • Annotated PM when no changes to APS, and no content is referenced

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    Jennifer CarrollJ
    Good Morning @MondayMover In general, what people do is upload the “track changes” version between the original and updated PM. When there are multiple version updates, they provide (upload) the sequential PM track changes PDFs. You do not need to annotate each version of the TMA to the APS, only the most recent PM. In the case described, it sounds like there would be no annotations within the PM as no copy is referenced back to it. If that is the case, it’s likely sufficient to upload the most recent clean PM with an explanation of why the new TMA with annotated changes may not be necessary. Please feel free to reach out to admin for support during the submission process.
  • NEW Renewals Management Dashboard

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    @palanski We're so glad to hear your team is excited to use the new dashboard! We hope it makes tracking and resubmission more streamlined for everyone.
  • Renewal: Layout Only

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    palanskiP
    @jennifer-carroll Hi there! Thank you for the clarification. I'd like to note that your initial reply has been the basis of many successful renewal submissions, whereby only EN layout has been provided by our agency and others for renewal of originally EN+FR efiles. It was very clear that this was the correct approach: Q: "Does this mean that for renewals, we only need to send in the English layout without English and French copy decks?" A: "You are correct for straight renewals if the previous file contained a copy correct layout." This latest reply is a change to this previously clear policy; it may be simpler to delete the original post to prevent confusion if this is the way things will be moving forward.
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  • Percent Pick-Up Highlighting

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    Jennifer CarrollJ
    Hey @stet The base highlighting for previously approved copy should remain throughout the review process. It should not change. The reviewer still needs to be able to easily locate and assess the areas of the piece that are “new” content. The only highlighting that would be changing is in the sections which are “new content”. These sections would have no background highlighting so if you are picturing overlapping highlighting, this would not happen.
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  • Clarity on RMT PAAB guidance

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    @jennifer-carroll Thanks very much for clarifying!
  • Fee schedule payment purchase order or company credit card

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    Jennifer CarrollJ
    @SKW , The PAAB does not require a PO. We currently accept EFT or cheque. We do not accept credit cards. For additional information you may find helpful, please see https://www.paab.ca/about-review-fees.htm.
  • Manufacturers versus Agency eFiles

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    Jennifer CarrollJ
    Hey @SKW We did some digging and here's what we found: In the last 6 months, there have been approximately 4087 distinct APS submitted for review from 65 manufacturers. Of these, 87 (just over 2%) were submitted directly from 6 manufacturers. Of these, 2 manufacturers did not use an agency at all during that period.
  • PAAB Clarification regarding escalations

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  • PAAB Policy and Procedure for Exemption Requests 2011/08/30

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  • PAAB Opinion Policy

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  • e-Detail Aid Submission Best Practices

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  • Guidance on Submission Process - (June Update)

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  • APS Checklist

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  • References Checklist

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  • Tips for each step of the PAAB approval process (October 2015)

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  • Extension Request form

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  • How To Tag a PAAB letter or Phone Call

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