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European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use London, 8 November 2004 Doc. Ref: EMEA/140327/2004 EUDRAVIGILANCE (EV) ACCESS SIMPLE DATABASE VERSION 2.0 ACCESS
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Eudravigilance ev access simple is a simplified online reporting tool for the submission of individual case safety reports (ICSRs) to the European Medicines Agency (EMA).
Marketing authorization holders (MAHs) and sponsors of clinical trials are required to file eudravigilance ev access simple.
Eudravigilance ev access simple can be filled out by logging into the EMA's electronic reporting system and following the step-by-step instructions.
The purpose of eudravigilance ev access simple is to facilitate the timely submission of ICSRs for the monitoring and evaluation of the safety of medicinal products in the European Union.
Information such as patient demographics, adverse events, concomitant medications, and reporter details must be reported on eudravigilance ev access simple.
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