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Adverse drug reaction reporting

Marketing authorisation holders (MAHs) shall submit all suspected adverse drug reactions (ADRs) reported spontaneously by healthcare professionals and patients or originating from a non-interventional study to the European Medicines Agency (EMA) via EudraVigilance (EV), the data processing network and management system of the European Economic Area (EEA).

On 22 November 2017 EMA has launched a new and improved version of EV, which has brought about significant changes in the management of suspected adverse drug reactions. For more information on these changes, please consult EV Go-live in the left menu. For detailed guidance on ADR reporting requirements concerning marketing authorisation holders in Hungary, please click on Reporting requirements. (Please note that reporting requirements regarding SUSARs occurring in clinical trials falling under the scope of Directive 2001/20/EC are detailed elsewhere.)

With the implementation of the new pharmacovigilance legislation EV data warehouse (EVDWH) and EV data analysis system (EVDAS) have been assigned central roles in the signal detection activities of the EMA and the member states (MSs). The effectiveness and success of signal detection in EV highly depends on the quality of reports submitted to the database, mainly through the correct population of the structured fields based on EV business rules and the provision of a clear and detailed narrative. Please consult Quality of ICSRs in the left menu for the most common mistakes encountered in electronic individual case safety reports (ICSRs) and some hints and tips how to avoid them. 

Obligations concerning the reporting of post-authorisation adverse drug reactions in Hungary – changes of requirements due to the go-live of the new EudraVigilance system

Call for action for marketing authorisation holders in relation to the quality of reports of adverse reactions originating from spontaneous sources and non-interventional studies submitted via EudraVigilance

Information for marketing authorisation holders on the go-live of the new, improved EudraVigilance and consequent changes in the adverse drug reaction reporting obligations

Last updated: 2018.10.05 16:14