Administrative Guideline for the Review of Pre-NOC Advertising Submissions

Administrative Guideline for the review of Pre-NOC advertising submissions

The PAAB mandate is to review advertising and promotional systems (APS) for approved pharmaceutical products. However, PAAB recognizes the importance of product launch timelines, and in this guideline, clarifies procedures for advertising review before Notice of Compliance (NOC) has been granted.

  1. Prior to NOC, when the Product Monograph negotiations with the Therapeutic Products Directorate (TPD) have reached the final-draft stage, the advertiser or its agency may contact the PAAB to arrange a pre-NOC review.
  2. PAAB will accommodate pre-NOC submissions at the discretion of the PAAB Commissioner with respect to workload at the time of submission, and will not be subject to the standard turnaround time.
  3. Only core APS should be submitted for pre-NOC review. The number of core APS is limited to two (2) and must be submitted at the same time. These APS should contain most of the proposed claims of the campaign. Submitting only the core APS at this stage can save the advertiser effort, time and money by avoiding the necessity to make the same revision in multiple APS and re-submitting all of them several times. If necessary, PAAB will determine which APS are considered to be core. The APS requires approval by the advertiser's medical/regulatory staff prior to PAAB review.
  4. Meetings between the advertiser and PAAB are not required for every product launch. Reasons for a meeting include: first in a new therapeutic class, new indication for existing product, novel marketing methods, competitive environment, complex pharmacology issues, cost-effectiveness issues, and ethical issues. The advertiser may contact PAAB to determine whether a meeting would be appropriate.
  5. 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.
  6. When the pharmaceutical company receives its NOC, they should resubmit the final revised core APS along with the NOC and Product Monograph (formal, written PAAB acceptance cannot be provided until the signed NOC and final Product Monograph are received). The advertiser should highlight additional revisions that may have been made to facilitate the review process. At this time, other launch APS may be submitted for PAAB review in one package.
  7. After the launch campaign has been reviewed and accepted, any additional APS for the product would be processed within the customary PAAB procedure and timelines.
  8. The Guideline is effective January 1, 2003.

Advertisers should be aware that under PAAB's mandate, it can only provide acceptances for advertising for use post-NOC. PAAB does not issue acceptances for any branded promotional activities carried on pre-NOC.

Updated: For more information please speak to PAAB Commissioner Patrick Massad or Senior Reviewer of Preclearance Yin Man.

Patrick Massad

Commissioner

/resources/pdfs/administrative-guideline_Pre-NOC 2020.pdf

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