Everything You Need to Know About Marketing Authorization Holders

bir ses eklendi Other

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...

0 Yorumlar 0 hisse senetleri 125 Views 0 önizleme