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.

'Gateway' or 'EV Post' function: new organisations need to register separately to use the external compliance testing environment (XCOMP) and the production environment.

Eligible for a fee waiver for MedDRA subscriptionĪn organisation can use two different types of electronic transmission mode for reporting:.

Micro and small-sized enterprises qualified by the SME office are eligible for a low revenue EudraVigilance MedDRA fee waiver.

Obtain EudraCT number from the EudraCT database

Vmix 14 manual registration