FXConferences: Complying with EMA's New Mandatory Requirements for Medicinal Product Information (EVMPD)

The European Medicines Agency (EMA) recently announced that Marketing Authorisation Holders will have to provide medicinal product information for all authorised products in the European Union by July 2, 2012. This means an additional 400,000 records will need to be added to the Eudravigilance Medicinal Product Dictionary in less than 12 months, and information for 100,000 previously submitted products will need to be updated to meet new data and document requirements. This massive undertaking will impact every company with a medicinal product registered in the EU.

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