The EudraVigilance Expert Working Group has coordinated the development of a Filelist of important medical event (IME) terms, together with the criteria to facilitate its maintenance.
The list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment for the day-to-day pharmacovigilance activities of stakeholders in the EU. The list is for guidance purposes only. Please kindly submit any comments on the IME list to the Agency via web form here.
Is it mandatory to consider all IME Terms as Serious, while coding Adverse Events?
No; Medical judgment should always be applied and, even though procedure terms are no longer included in the IME list, consideration should be given to reporting them as serious events, when appropriate.
The EudraVigilance Expert Working Group has coordinated the development of a Filelist of important medical event (IME) terms, together with the criteria to facilitate its maintenance.
The list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment for the day-to-day pharmacovigilance activities of stakeholders in the EU. The list is for guidance purposes only. Please kindly submit any comments on the IME list to the Agency via web form here.
Is it mandatory to consider all IME Terms as Serious, while coding Adverse Events?
No; Medical judgment should always be applied and, even though procedure terms are no longer included in the IME list, consideration should be given to reporting them as serious events, when appropriate.
