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  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 330 - Does "coming soon" on an approved product require PAAB approval?
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330 - Does "coming soon" on an approved product require PAAB approval?

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

    A piece containing only the message "Drug X is coming soon" with absolutely no other message (implied or stated) within the piece AND absolutely no link to therapeutic or promotional messages is exempt. Note that the manufacturer is responsible for ensuring that this message is employed only AFTER the product has been approved by Health Canada. It is prohibited to advertise a drug product prior to Health Canada approval.

    C 1 Reply Last reply
    0
    • Jennifer CarrollJ Jennifer Carroll

      A piece containing only the message "Drug X is coming soon" with absolutely no other message (implied or stated) within the piece AND absolutely no link to therapeutic or promotional messages is exempt. Note that the manufacturer is responsible for ensuring that this message is employed only AFTER the product has been approved by Health Canada. It is prohibited to advertise a drug product prior to Health Canada approval.

      C Offline
      C Offline
      Constance
      wrote on last edited by
      #2

      @jennifer-carroll does this also apply to a new indication of an already approved product? In other words, "New indication coming soon"

      Jennifer CarrollJ 1 Reply Last reply
      0
      • C Constance

        @jennifer-carroll does this also apply to a new indication of an already approved product? In other words, "New indication coming soon"

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

        Morning @constance

        If the product has not received NOC, a manufacturer cannot promote that a new indication is coming soon as this would be off-label promotion.

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