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    Pre-NOC submissions

    Non-product branded APS, pre-NOC teasers
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      brendaarmit1 last edited by

      We are planning on submitting 2 pieces for pre-NOC review and was wondering if the Health Canada directed requirement for a risk minimization tool (RMT) would count as one of the pre-NOC pieces for review since it isn't a 'usual' PAAB review piece.

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      • Moved from About by  Jennifer Carroll Jennifer Carroll 
      • Jennifer Carroll
        Jennifer Carroll @brendaarmit1 last edited by

        Hey @brendaarmit1

        No, RMTs would not fall under the 2 core APS. As a reminder, per the pre-NOC submissions guidance, the PM is required to be at Final Draft stage (not expecting any major changes) as confirmed by a letter from the sponsors regulatory department. If changes occur which would impact the piece, the file would be closed and a new file with a new fee would be required.

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          brendaarmit1 @Jennifer Carroll last edited by

          @jennifer-carroll Thank you. So, I just want to be really clear on this. We can submit 2 pre-NOC pieces following the submission guidance and we can submit the RMT pre-NOC for the standard opinion review.

          Jennifer Carroll 1 Reply Last reply Reply Quote 0
          • Jennifer Carroll
            Jennifer Carroll @brendaarmit1 last edited by

            Hey @brendaarmit1

            You are correct. With the one caveat being that the pieces are still "pre-NOC" so the timeline for review is still at the discretion of PAAB based on file load. Hope that helps.

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              brendaarmit1 @Jennifer Carroll last edited by

              @jennifer-carroll Thank you Jennifer. That does help.

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