107 - For a launch product is the review time the same as an old product line. When a pharmaceutical submits to PAAB the promotional pieces needed at NoC does PAAB take their 10 full days for review or is it possible to take half of the time because it is a product in launch mode.
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Our mandate is to provide our initial comments within ten working days of receipt of all required materials (e.g. the advertisement & the supportive information). However, we make every effort possible to try to provide this first response within less than 10 working days. In fact, so far in 2009, approximately 60% of all first responses were provided in less than 10 working days. For the sake of fairness, on a policy level, we do not differentiate between the timelines for newly approved products and "old products". We do our best, however, to accommodate rush-requests when they are unlikely to affect the timelines for other projects. The PAAB is aware of the time crunch our clients face during product launches. This is why we have an "Administrative Guideline for the Review of Pre-NOC Advertising Submissions" posted on our website (www.paab.ca). If requested, we will begin to review a maximum of two core pieces prior to receipt of NOC provided that the product monograph is at final draft stage. This is meant to give the manufacturer a head-start in determining the approvability of core messaging. You are invited to refer to the complete guideline on the PAAB website. Note that since our mandate is to approve advertising for NOC products, you might not receive first response within 10 working days for pre-NOC submissions.
