This publication provides guidance for pharmacovigilance reporting to FDA and acts as a reference for Health Canada pharmacovigilance reporting. This guidance is intended to aid companies that market medical gases classified as drugs in the United States or Canada in setting up a pharmacovigilance (drugs) reporting system that satisfies local and regional regulatory requirements, bearing in mind any global requirements when applicable.
Although both reporting for drugs and devices is required, this publication only addresses medical gases classified as drugs (pharmacovigilance) and does not address reporting requirements for gases or medical gas equipment classified as medical devices (materiovigilance).
In the United States, this publication should be used as a guideline for companies to comply with 21 CFR Part 314. In Canada this publication may only be used for a reference.