PAAB exempt regulations
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Our Global colleagues are in the process of developing a website (housed and managed by Global team), that will provide safety information to HCPs on newly launched products.
We would like to reactively provide this information, including a website link, to our Canadian HCPs.This information would be provided by our Medical Associates only. Can you please confirm if this website is out of scope of PAAB review?
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Hello @skw
The fact that a website is created and controlled by a drug manufacturer’s parent company, outside of Canada, does not in and of itself render it exempt from Canadian drug advertising regulations (and the PAAB code). Even if the website URL is provided in a reactive manner, that website is likely subject to the regulations since the information that is available on the site far exceeds the question that prompted the URL to be shared.
The proposed activity could be considered exempt from the PAAB Code, PAAB Preclearance, and Canadian regulations if the mechanisms outlined in Q&A 176 were implemented. These mechanisms are provided to ensure the information provided is in response to the specific question asked. If all guiding principles from Q&A 176 are followed, this could be considered.
The PAAB can provide guidance on setting up a platform such as this, in the context of an opinion file.
As a reminder, one key aspect of the mechanism outlined, is “restricted access”. Canadians who are not HCPs must not have access to the site.
