![]() National competent authorities should register directly in the production environment (unless they are gateway users). They also need to upload a set of signed and scanned registration documents. To register a headquarters, affiliate or virtual affiliate of an organisation in EudraVigilance, please refer to the Organisations need to register electronically via the Organisation Management System (OMS) in the SPOR portal. These include the European clinical trials database ( EudraCT), EMA Service Desk, EudraVigilance data analysis system (EVDAS), European Union good manufacturing and distribution practices database (EudraGMDP), Substances, Products, Organisations and Referentials (SPOR) portal and the IRIS portal for orphan designation.Įach organisation registering with EudraVigilance needs to be represented by a designated individual from this organisation. Users with access to EMA-hosted websites or online applications already have an EMA account and they should use the same login credentials. Registration frequently asked questionsĪll users, including organisations, need an active EMA account created through the EMA Account Management portal.Organisations are advised to register a virtual affiliate if they intend to use a different electronic exchange solution for the submission of product reports. Organisations using a local gateway for safety reporting cannot be added to the extended EudraVigilance medicinal product dictionary (XEVMPD) community, unless their gateway solution supports submission of both safety and product reports. Organisations are not required to test the submission of product reports. The testing process is mandatory for organisations submitting safety reports using a gateway solution or the EV Post function, and these organisations therefore require an XCOMP profile which they will use to perform quality assurance testing. XCOMP mirrors the EudraVigilance production environment and allows organisations to test the submission of individual case safety reports (ICSRs) and extended EudraVigilance product report messages (XEVPRMs). if they wish to change from Webtrader to Gateway, they must raise a Service Desk request to make the change and add the corresponding documents.The EMA Gateway team will then send the organisation the connectivity details. ![]() when registering a new organisation, they should complete the.Gateway users need to activate transmission as follows: 'EVWEB' users (also known as 'Webtraders') will be registered in the production environment only, unless they also request to use the XCOMP environment. ![]()
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