APS stating removal of conditions associated with NOC
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What information should be provided in an APS that is intended to inform HCPs that Health Canada is satisfied that all the conditions (NOC/c) have been met, and the conditions associated with market authorization of a product have been removed? Is it possible to simply state that "the conditions associated with the NOC have been met" and link to the updated Product Monograph?
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What information should be provided in an APS that is intended to inform HCPs that Health Canada is satisfied that all the conditions (NOC/c) have been met, and the conditions associated with market authorization of a product have been removed? Is it possible to simply state that "the conditions associated with the NOC have been met" and link to the updated Product Monograph?
Hey @mbos
There are a few regulatory issues that must be considered. For example, the approval process must not be discussed in advertising per C.01.007 of the F&DR. Another issue is that one cannot convey a message that implies a Health Canada endorsement/recommendation.
We could consider a message which is factual such as “the indication of Product X has changed from NOC/c to NOC”. This message should be presented in a manner that is separate and distinct from other messages (e.g., pivotal trial data that may or may not be the basis for the change).
