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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 568 - Questions in regards to provincial formularies: 1. Would providing the name of the "product now on province formulary" statement with the inclusion of the din number for ordering be considered exempt from PAAB? 2. If the link to the complete provincial formulary is included would this be considered the same as including the coverage criteria for the product? 3. Is including the complete provincial formulary link and directing to the section or page for product "X" be considered as providing the coverage criteria and thus requiring PAAB review?
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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.

568 - Questions in regards to provincial formularies: 1. Would providing the name of the "product now on province formulary" statement with the inclusion of the din number for ordering be considered exempt from PAAB? 2. If the link to the complete provincial formulary is included would this be considered the same as including the coverage criteria for the product? 3. Is including the complete provincial formulary link and directing to the section or page for product "X" be considered as providing the coverage criteria and thus requiring PAAB review?

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

    Inclusion of the DIN on a piece does not in and of itself, disqualify it from being exempt from PAAB preclearance. Copy restricted to the product name, message of “now on formulary” and the DIN would be considered exempt from preclearance. Inclusion of the link to the full formulary listing would create a link between the product and the therapeutic use and would render the piece subject to PAAB review (no longer PAAB exempt). Inclusion of the link does not negate the need for the coverage criteria to exist on some pieces. For example, if the coverage code is presented on the piece, the coverage criteria must be presented within that piece. Linking to the coverage criteria would not be sufficient. Please also be advised that the Regie de l’assurance maladie du Quebec has specific requirements for coverage claims. Please see the advisory document on the PAAB website.

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