Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
78 - Further to the question #76, could you distinguish what 'special conditions' refers to? Also, can the key clinical trial be used as support for NOCC advertising, even if it does not appear in the PM in its entirety?
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The "special conditions" are stated in the product monograph approved by Health Canada. Hence "Notice of Compliance with Conditions" or "NOC/C". It is a tentative approval based on preliminary data and thus the expressed caution about the advertising approved by the PAAB. The conditions can vary by product and state which data the company must generate to remove the "conditions" tag. As with all claims based on data from a clinical trial that appears in the product monograph (PM), we would want to know if Health Canada (HC) has reviewed and accepted that data as relevant for promotion. It is up to the sponsor to prove that to the PAAB. We have had a few cases that HC had purposely left out data from the PM and the company did not tell us that. When in doubt, the PAAB will ask HC formally, with the advertisers consent. To repeat, the PAAB takes a cautious approach to approving advertising for products with an NOC/C and generally, data claims not in the PM for a product with NOC/C will not be accepted for advertising purposes. See Code s2.4.2 and the guidance on the PAAB web-site.