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.
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).
