Art 57 Xevmpd Services

Article 57 (xEVMPD).

Managing the details that keep you compliant.

MAHs and Applicants for medicines in the EU must submit information on authorized 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 and Applicant must keep its organization details, EU QPPV details, and location of the PSMF updated in the xEVMPD.

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

Selected PV Case Studies.

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ICSRs, Local literature screening, Regulatory intelligence
Strategic Planning case study
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system TH
Local PV, regulatory strategy
Complex pharmacovigilance local support

What our clients say about us.