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Centralised Marketing Authorisation Procedure under EMA: A Complete Regulatory Guide

Posted on May 11, 2025 digi By digi

Centralised Marketing Authorisation Procedure under EMA: A Complete Regulatory Guide Navigating the EMA’s Centralised Marketing Authorisation Procedure The Centralised Marketing Authorisation Procedure is the key pathway for obtaining drug approval across the European Union (EU) through a single application submitted to the European Medicines Agency (EMA). This regulatory route is essential for companies aiming to…

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EMA (European Medicines Agency) Guidelines, Regulatory Guidelines

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