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EudraVigilance Medicinal Product Dictionary (EVMPD)

The EVMPD has been developed by the European Medicines Agency in collaboration with the EudraVigilance implementation fora. The main objective of the EVMPD was to assist the pharmacovigilance activities in the European Economic Area (EEA). As such, the EVMPD was designed to support the collection, reporting, coding and evaluation of authorised and investigational medicinal product information in a standardised and structured way.

Extended Medicinal Product Dictionary (XEVMPD)

In December 2010 new pharmacovigilance legislation amending existing legislation was adopted in the European Union (EU) resulting in the need to update the EVMPD in accordance with the format for of the electronic submission of information on medicines published by the Agency on 1 July 2011.

Based on the new format, the EVMPD has been re-branded as Extended Medicinal Product Dictionary (XEVMPD), enabling the Agency to:

  • Create a list of all medicines authorised and registered in the EU
  • Identify medicines accurately, especially medicines included in reports of suspected adverse reactions
  • Co-ordinate the regulation and safety monitoring of medicines across the EU

Use of the Extended EudraVigilance Investigational Medicinal Product Dictionary (XEVIMPD) for Sponsors of clinical trials

On 11 June 2011, the Commission published in the Official Journal (OJ 2011/C 172/01) a Communication on the detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’).

In this context sponsors should provide, before completing the clinical trials application form, information on the Investigational Medicinal Product (IMP) in the Extended EudraVigilance Investigational Medicinal Product Dictionary (‘XEVIMPD’).

For this purpose, Sponsors and if applicable, their affiliates/subordinates (e.g. clinical research departments) must be registered with EudraVigilance. Registration is a prerequisite to be able to enter IMP information in the XEVIMPD.

The EudraVigilance Registration Team will assist if further information is required (eudravigilanceregistration@ema.europa.eu)

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Last update: Tuesday, 5 June 2012.

 

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