Inclusion/Exclusion Criteria for the “Important Medical Events” List

On 24 March 2021 the EMA announced the availability of the updated guidance related to the current version of MedDRA.

The EudraVigilance Expert Working Group (EV-EWG) has coordinated the development of an Important Medical Event Terms (IME) list. This IME list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment in the frame of the day-to-day pharmacovigilance activities of stakeholders in the European Union. The IME list is intended for guidance purposes only. Inclusion/exclusion criteria for the “Important Medical Events” (IME) list were developed during review of the current list for maintenance related to MedDRA Version 12.1. They have been updated to the current version of MedDRA.

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