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EMA To Clarify Member State-Specific Requirements For New EudraVigilance System

 
• By Neena Brizmohun

Drug makers preparing for the launch of the enhanced EudraVigilance database in the EU will soon be told about any plans, arrangements and requirements that are specific to the national competent authorities.

European Union
Companies will learn about member state-specific Eudravigilance requirements • Source: Shutterstock

Europe’s enhanced EudraVigilance database for managing and analyzing suspected adverse reactions to authorized medicines is still on track to go live on Nov. 22, and drug companies should in September learn about any specific requirements the national competent authorities (NCAs) might have.

Marketing authorization holders (MAHs) and clinical trial sponsors will be given information on such things as the use of local languages, according to a document from the European...

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