Article57

Article 57 (xEVMPD) services.

Managing the details that keep you compliant.

What is Art 57 and xEVMPD?

xEVMPD (Extended EudraVigilance Medicinal Product Dictionary) is a database which supports the European Medicinal Agency (EMA) & European National Authorities requirements in accordance with Article 57(2) of Regulation (EC) No. 726/2004 which are mandatory since 2012.

Marketing Authorization Applicants (MAAs), Marketing Authorization Holders (MAHs) and clinical trials sponsors must submit information to the xEVMPD database. It allows the collection, reporting, coding and evaluation of medicinal product data in a standardized and structured way.

xEVMPD’s aim is to create a complete dictionary of medicines authorized for use throughout the EU and EEA, including centrally authorized and nationally authorized products. The information is used for the evaluation of development and authorized adverse drug reactions.

The EMA will in time migrate the database to ISO IDMP standards.

Our xEVMPD services.

Our experts can manage of all your product/people/safety information updates to the xEVMPD database from our internal Veeva Vault Safety system or your own database to keep you fully compliant.

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