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.
