APS stating removal of conditions associated with NOC
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?
Jennifer Carroll last edited by
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).