The submission of data on medicines by marketing-authorisation holders is a legal requirement from Article 57(2) of Regulation (EC) No. 726/2004, as amended by Regulation (EU) 1235/2010 and Regulation (EU) 1027/2012.
The EMA has prepared this eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) virtual live training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU.
The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVMPD data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.
Participants who successfully pass the knowledge evaluation following the training course will receive a notification of successful completion of this training course from the European Medicines Agency that will allow them to register with EudraVigilance for the electronic submission of information on medicinal products. At least one user from each marketing-authorisation holder organisation should receive training. The aim is to ensure the quality of data submitted to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).
The course also includes instructions for sponsors of clinical trials on how to provide information on Investigational Medicinal Products (IMPs) in the medicinal product dictionary before completing the clinical trials application form.