Extended Eudravigilance Medicinal Product Dictionary
What is xEVMPD and who must comply?
xEVMPD or Extended Eudravigilance Medicinal Product Dictionary is a database (xEVMPD database) designed to support the collection, reporting, coding and evaluation of medicinal product data in a standardized and structured way. The information is utilized by the European Medicinal Agency (EMA) & European National Authorities for all authorized medicines in the Europe in support of Article 57 requirements.
xEVMPD’s purpose is to collect the data of the medicinal products that are already existing or still in development. This collected information is used for evaluation of adverse reactions during the new drug development and for following the marketing authorizations of medicinal products within Europe.
Submitting medicinal product information by xEVMPD standards has been mandatory since 2012 and is still required today. All marketing authorisation holders (MAHs) and sponsors of clinical trial must submit information to xEVMPD database.
Your xEVMPD submissions with cune-xEVMPD
Easy to Use
User friendly interface, that helps acclimate users to the system quickly.
cune-xEVMPD enables compliance with Article 57, FDA 21 CFR Part 11, GxP Processes, EMA/717178/2011, EMA/800577/2011, EMA/327516/2011, EMA/135580/2012, EMA/718844/2011, EMA/661709/2014
Connects your external business partners (i.e. CRO’s, CMO’s etc.) via a secure data management Portal to have them share their xEVMPD-relevant data with you.
Get to know your future xEVMPD software!
1st, 2nd & 3rd acknowledgments from EMA via the gateway quickly!
your xEVMPD! Before submitting, ensure your information is complete and internally approved using built-in workflows that are quick and painless! Plus, view your overall submission status via standard reports that you can personalize, save and share.
your controlled vocabularies that are implemented in the system. EMA libraries including ATC, Medical Device Organizations, Pharmaceutical Dose Forms, Routes of Administration, Substances, Units of Measurements, Le Basis, Medicinal Product Types, Authorisation Procedures/Status/Types. Plus automated comprehensive MedDRA coding.
workﬂow driven processes such as xEVMPD data approval and xEVMPD submission approval. Efficiencies when working with multiple revisions. cune-xEVMPD enables bulk submissions & bulk updates to save time!