Everything You Need to Know About Marketing Authorization Holders
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...
0 Anteile
267 Ansichten
0 Vorschau
English
Arabic
French
Spanish
Portuguese
Turkish
Dutch
Italiano
Russian
Romaian
Portuguese (Brazil)
Greek
Urdu
Amharic
Swahili