EudraVigilance (EV)



EudraVigilance Training Programme

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and XEVPRM messaging format

This training course was prepared by the Agency 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) in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004.

Participants will be provided with explanations of the eXtended EudraVigilance Product Report Message (XEVPRM) data elements and with various examples as to how to populate the XEVPRM taking into account different types of medicinal products authorised in the EU.

At least one user from each marketing authorisation holder should be trained to understand how to submit medicinal product data to the Agency and to ensure quality of medicinal product data submitted to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). A notification of successful completion of the XEVMPD knowledge evaluation will be required for one user before the electronic submission process can be initiated by an MAH.

At the end of this course, participants should be able to:

  • Understand the concepts related to the electronic submission of information on medicines authorized in the EU to the XEVMPD
  • Describe the format and the data elements of the XEVPRM for authorised medicinal products
  • Discuss practical examples of medicinal products and substances
  • Use of the XEVMPD data entry tool also known as EVWEB (hands-on-training)

This training is available as a two day face-face training course as well as an e-learning course module.

The training courses dates are accessible here.

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Last update: Tuesday, 5 July 2016.



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