620 - I have two questions as it relates to pre-NOC submissions. (1) What constitutes a 'final draft' PM? Typically a PM is not deemed 'final draft' by Health Canada until approximately 1 week prior to actual NOC. We would like to make pre-NOC submissions earlier than this. (2) Can we submit a full HCP Detail Aid as a pre-NOC opinion request, or are opinions limited to simple reviews, such as core creative?
Jennifer Carroll last edited by
“Final draft stage” means that the sponsor is not expecting any changes to the draft copy submitted. Prior to this point, you are limited to submitting an opinion. An opinion is not a full review, it entails the provision of a single set of comments from PAAB. Prior to final draft of the PM, an opinion will only be provided on the core creative using only the draft monograph as a reference. Other types of opinions are not provided prior to final draft (e.g. we would not provide an opinion on a study). Other types of opinions can be submitted after final draft but these would count toward the maximum of two APS for pre-NOC submission.
Once the PM is at final draft stage, then submitting the detail aid for a pre-NOC review would result in a detailed line-by-line review. Once all PAAB comments are addressed, approval for pre-NOC reviews is not granted until the product receives NOC from Health Canada. For more information, please refer to the guidance document “Administrative Guideline for the Review of Pre-NOC Advertising Submissions “ on the PAAB website.