CGA M-21

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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 region-al 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:
2
Published:
10/06/2022
Number of Pages:
12
File Size:
1 file , 370 KB
Note:
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CGA M-21

Click here to purchase
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.

Product Details

Edition:
1st
Published:
11/01/2017
Number of Pages:
14
File Size:
1 file , 990 KB

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