348 - We have an app that has already received PAAB approval last year. The client will receive NOC early July for a new indication and the app will have to be updated to include this new data. How much in advance can we submit the document pre the NOC for the new indication and what documents would we be required to submit ie annotated product monograph.
Jennifer Carroll last edited by
When the Product Monograph update is at Final Draft stage as confirmed by a letter from the manufacturer's regulatory department, the PAAB will accommodate up to two pre-NOC submissions incorporating content relating to the new indication. These submissions will not be subject to the standard turnaround time. As with all submissions for review, these APS require approval by the advertiser's medical/regulatory staff prior to PAAB review.While waiting for the final approval of the Product Monograph, the company should apply PAAB revision requests to all the items that form the launch campaign.Once the update to the product monograph is approved (and the pharmaceutical company receives its NOC letter with an updated control number), additional launch APS may be submitted for PAAB review. Please read the guidance document "Guidance on Submission Process" on the PAAB website for more information.