XEVMPD: The Extended Eudravigilance Medicinal Product Dictionary of the European Medicinal Agency (EMA): Controlled Vocabulary for Marketing Authorisation
XEVMPD is the Extended Eudravigilance Medicinal Product Dictionary of the European Medicinal Agency (EMA) which defines controlled vocabulary to be used for the marketing authorisation of medicinal products.
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area (EEA). XEVMPD is a vocabulary to be used for the marketing authorisation of medicinal products. XEVMPD has been developed, maintained and published by EMA since 2007. XEVMPD is based on existing terminology standards including SNOMED CT. Pharmaceutical companies can use the XEVMPD data entry tool (EVWEB) provided by the Agency; this was specifically developed for Small and Medium Sized Enterprises (SMEs) but can be made available to any pharmaceutical company for the purpose of electronic submission of information on medicinal products to the Agency. XEVMPD has been designed and maintained to ensure consistency in terminology, as XEVMPD will be used for the submission of information on medicinal products.
The XEVMPD controlled vocabulary defines terms relevant to eudravigilance administration or assessment.