The EMEA has prepared this special EudraVigilance Medicinal Product Dictionary (EVMPD) course in the light of the implementation of the EU Directive on Clinical Trials (Directive 2001/20/EC). This EVMPD course is addressing specifically all aspects related to the regulatory background, the definitions and procedures and the technical specifications for the handling and maintenance of IMP data and authorized medicinal product data in the EVMPD by the Sponsor or the MAH.