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CGA M-21

Guideline for Determining Pharmacovigilance Reporting Requirements in North America

standard by Compressed Gas Association , 10/06/2022

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Full Description

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.

 

Product Details

Edition:
2nd
Published:
10/06/2022
Number of Pages:
12
File Size:
1 file , 370 KB
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Document History

  1. CGA M-21

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    Guideline for Determining Pharmacovigilance Reporting Requirements in North America

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  2. CGA M-21


    Guideline for Determining Pharmacovigilance Reporting Requirements in North America (for the U.S. & Reference for Canada)

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