Everything You Need to Know About Marketing Authorization Holders

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2025-01-14 10:46:04

Summary The Marketing Authorization Holder (MAH) ensures drug quality, safety, and compliance with local regulations. The MAH maintains a pharmacovigilance system for collecting and processing safety data. The MAH submits Periodic Safety Update Reports (PSURs) and a Risk Management Plan for ongoing safety and compliance. The MAH must report adverse...

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