scope:

This publication provides guidance for pharmacovigilance reporting to FDA and Health Canada. This guidance is intended to aid United States and Canadian companies that market common medical gases (i.e., oxygen, nitrogen, medical air, carbon dioxide, nitrous oxide, helium, and carbon monoxide and medically appropriate mixtures thereof) in setting up a pharmacovigilance reporting system that satisfies local and regional regulatory requirements, bearing in mind any global requirements when applicable.

This publication does not address reporting requirements for gases or medical gas equipment classified as medical devices (materiovigilance).

CGA continues to work with the FDA and Health Canada on pharmacovigilance requirements for common medical gases.