![]() The rerouting rules are defined in theĪnd can be further customised by NCAs, if required. These ICSRs are initially reported by marketing authorisation holders (MAHs) to EudraVigilance. It has been available since 22 November 2017. This EVWEB functionality provides for the automatic forwarding of ICSRs to the applicable national competent authority (NCA) in a member state of the European Economic Area (EEA). National competent authority (NCA) ICSR rerouting EVWEB also enables users to perform queries. The EudraVigilance web application (EVWEB) is the interface to the EudraVigilance database management system (EDBMS) and allows registered users to create, send and view ICSRs, safety and acknowledgement messages. ![]() ![]() Alternatively, they can use service providers for this purpose.ĮU Individual Case Safety Report (ICSR) Implementation GuideĮudraVigilance web reporting application (EVWEB) It ensures the protection of safety and acknowledgement messages against the risk of:Ĭompanies and sponsors are responsible for installing and operating software that is suitable for the successful transmission of encrypted and digitally signed safety and acknowledgement messages. This gateway process follows the ICH M2 Gateway Recommendation for the Electronic Transfer of Regulatory Information (ESTRI-Gateway). The safety messages contain individual case safety reports (ICSRs).Īn acknowledgement message confirms the receipt and outcome of the validation of a safety message and completes the EDI process. The EudraVigilance gateway supports the electronic data interchange (EDI) process, which is based on the secure electronic exchange of safety messages between a sender and a receiver.
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