Global and Local Pharmacovigilance Services, since 2008

Article 57 (xEVMPD).

Managing the details that keep you compliant.

Marketing authorisation holders (MAH) for medicines in the European Union (EU) must submit information on  authorised medicines to the eXtended Eudravigilance Medicinal Product dictionary (xEVMPD), also known as the Article 57 database, and keep this information up-to-date. 

In addition, every MAH must keep its organization details, EU QPPV details, and register the location of the Pharmacovigilance System Master File (PSMF) updated in the xEVMPD.

We can manage all these requirements for you, keeping your xEVMPD updated and fully compliant.