615 - Hi, I have a question regarding receiving pre-clearance from PAAB regarding promotional material related to a new product that has been approved under the NOC/c (Notice of Compliance with conditions) policy, as stated in the Qualifying Notice received from HC? Is this mandatory, or optional? Thank you!
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If this was a “requirement” stated in the Qualifying Notice, then the request from Health Canada would be mandatory. Otherwise, note that preclearance is generally voluntary. Although preclearance is not required by law, compliance with Food and Drugs Act section 9.1 is mandatory. The essence of this act is that advertising must not be misleading. Little direction is provided in the Act on how not to mislead. This is what the PAAB code is for in HCP advertising. As PAAB adjudicates the PAAB code, PAAB preclearance is the most objective and effective mechanism to attain compliance with the code and, as a result, the Food and Drugs Act. In my mind, this is the most compelling argument in favour of preclearance. In the interest of promoting self-regulation, we report cases of willful non-compliance to Health Canada upon learning about them through our monitoring activities and the complaint system (i.e. the competitor’s monitoring activities). As a secondary point, some trade organizations require preclearance as a condition of membership. Further guidance for NOC/c advertising requirements can be found on the PAAB website in the document “Guidance on Advertising for Drugs with Notice of Compliance with Conditions (NOCc)“.
