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  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 629 - Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks
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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.

629 - Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks

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 following guidance is provided under the assumption that this is the entire content of the piece. The Food and Drug Regulations prohibit discussion of the approval process within advertising. If we were to reframe the question to a message of “Now available in Canada”, while the message itself would be considered exempt from PAAB review, it is still advertising and subject to the standards of the PAAB code. Messages of “new” are restricted to one year post marketing. Stating that the product is “now available” without limiting the claim to the new 2nd indication, would be misleading. The 2nd indication would need to be included to accurately limit the ”new” claim and this would render the piece non-exempt. See code section 1.5D for a list of exempt messages.

    G 1 Reply Last reply
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    • Jennifer CarrollJ Jennifer Carroll

      The following guidance is provided under the assumption that this is the entire content of the piece. The Food and Drug Regulations prohibit discussion of the approval process within advertising. If we were to reframe the question to a message of “Now available in Canada”, while the message itself would be considered exempt from PAAB review, it is still advertising and subject to the standards of the PAAB code. Messages of “new” are restricted to one year post marketing. Stating that the product is “now available” without limiting the claim to the new 2nd indication, would be misleading. The 2nd indication would need to be included to accurately limit the ”new” claim and this would render the piece non-exempt. See code section 1.5D for a list of exempt messages.

      G Offline
      G Offline
      GMC
      wrote on last edited by
      #2

      @jennifer-carroll said in 629 - Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks:

      he Food and Drug Regulations prohibit discussion of the approval process within advertising

      @Jennifer-Carroll Does the note regarding the Food and Drug regulations not allowing us to use the term "approved" in a message still apply in 2024? Wanted to ask given that this response is from 2019. Thanks.

      Jennifer CarrollJ 1 Reply Last reply
      0
      • G GMC

        @jennifer-carroll said in 629 - Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks:

        he Food and Drug Regulations prohibit discussion of the approval process within advertising

        @Jennifer-Carroll Does the note regarding the Food and Drug regulations not allowing us to use the term "approved" in a message still apply in 2024? Wanted to ask given that this response is from 2019. Thanks.

        Jennifer CarrollJ Offline
        Jennifer CarrollJ Offline
        Jennifer Carroll
        wrote on last edited by
        #3

        @gmc

        Yes. The Food and Drug Regulations have not changed with respect to this.

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        • G Offline
          G Offline
          GMC
          wrote on last edited by
          #4

          Jennifer, I can't for the life of me find the support to your comment in the Food and Drug Act. I was hoping to annotate the document to send to the client. Can you direct my eyes i.e., section number and page. Thanks.

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          • Jennifer CarrollJ Offline
            Jennifer CarrollJ Offline
            Jennifer Carroll
            wrote on last edited by
            #5

            Hey @gmc

            Food and Drug Regulations – C.01.007

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