Regulatory Focus™ > News Articles > EMA Releases New Eudravigilance Medicinal Product Dictionary SOPs

EMA Releases New Eudravigilance Medicinal Product Dictionary SOPs

Posted 31 January 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released three standard operating procedures (SOPs) for the Eudravigilance Medicinal Product Dictionary (EVMPD) on 30 January.

Eudravigilance "is a data processing network and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorisation of medicinal products in the European Economic Area (EEA)," according to the Eudravigilance website. The Eudravigilance dictionary is used "to ensure that information on all medicinal products for human use authorized or registered in the EU" is standardized and does not duplicate pre-existing information.

The three SOPs cover the validation of substances in the EVMPD, provision of medicinal products in the EVMPD and validation of medicinal product information in the EVMPD.

All three SOPs contain a process map for the EVMPD process and a detailed procedure checklist. They will remain in effect until 30 January 2015, at which time they will be subject to another round of review by EMA.



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