The EudraVigilance Expert Working Group (EV-EWG) has co-ordinated 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 EU. The IME list is intended for guidance purposes only.

The new IME list based on MedDRA version 19.0 is now available here, together with the inclusion and exclusion criteria which have been developed to help maintain it. To obtain a copy, please click here.

Building upon the experience gained with the use of the IME list and the comments received from stakeholders, it is recognised that the distinction between Core serious and Extended serious terms is often difficult to apply, since many MedDRA Preferred Terms (PTs), with the provision of additional clinical information, may become serious. As a result of that, it has been agreed by the EV-EWG that as of version 15.0 the IME list contains Core Serious events only, e.g. events that are serious per se, independent of information on the context in which the Adverse Drug Reaction occurs.

We invite you to submit any comments you may have on those documents to MedDRAIMElist@ema.europa.eu.

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Last update: Friday, 18 March 2016.