+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Insertion into XEVMPD database

Regulation 235/2010/EC and Directive 2010/84/EU provides for that pharmaceutical companies that are Marketing Authorisation (MA) Holders of human medicinal products comply with the obligation of populating the European Medicine Agency (EMA) database XEVMPD with data regarding their own medicines authorised in the EU.

The Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) is the reference for the codification of substances and drugs reported in the safety reports (Individual Case Safety Reports, ICSRs) based on the information provided by MA holders as provided for by article 57(2) second subparagraph, of Regulation (EC) no. 726/2004.

MA holders are also responsible for the suitable maintenance of this information and are obliged to update the XEVMPD database in case of variations, transfers or new authorisations.

Di Renzo Regulatory Affairs has a special unit dedicated to pharmacovigilance, and can therefore assist companies in uploading data and updating the XEVMPD database.