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The access policy of European Medicines Agency (EMA) states that "No authorization for accessing the ICSR (Level 1) data set by means of the adrreports.eu portal is required i.e., all academic researchers can access adverse reaction data of interest Method The EudraVigilance is a centralized EU database maintained by the EMA and supports monitoring the safe and effective use of medicines that have been authorized or studied in clinical trials in the EU

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