Europe – EudraVigilance – Inclusion/exclusion criteria for the ‘Important medical events’ list

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. The criteria – and the proposed additions and deletions to the upversioned list – were based on the official ICH definition of seriousness and of an “important medical event” as noted below…