Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency

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Download document Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency
Reference number EMA/161530/2014
Status draft: consultation open
First published 05/06/2014
Last updated 05/06/2014
Consultation start date 05/06/2014
Consultation end date 27/07/2014
Email address for submissions mlm@ema.europa.eu

Summary

Scientific and medical literature is an important source of information on suspected adverse-reaction case reports (also referred to as individual case safety reports). This detailed guide describes the technical aspects of the literature-monitoring services to be provided by the Agency in line with the requirements set out in Article 27 of Regulation (EC) 726/2004 and good-pharmacovigilance-practice guideline, module VI, 'management and reporting of adverse reactions to medicinal products'.