CGA M-21
Original price was: $27.00.$13.00Current price is: $13.00.
Guideline for Determining Pharmacovigilance Reporting Requirements in North America
Compressed Gas Association , 10/06/2022
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.
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CGA M-21
Original price was: $27.00.$13.00Current price is: $13.00.
Guideline for Determining Pharmacovigilance Reporting Requirements in North America (for the U.S. & Reference for Canada)
Compressed Gas Association , 11/01/2017
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.
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