Pre-NOC submissions
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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
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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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@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.
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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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@jennifer-carroll Thank you Jennifer. That does help.