EudraVigilance (EV)





Secure e-transmission of ICSRs via EVWEB?

In addition to the automated message generation and processing, the EudraVigilance Database Management System also provides interactive tools to allow for a ‘manual’ safety and acknowledgement message as well as medicinal product report generation and administration by a user via a web interface, called EVWEB.

EVWEB is specifically designed for Small and Medium Size Enterprises (SMEs) and non-commercial sponsors, which do not have a fully ICH E2B (R2) compliant pharmacovigilance system and/or ESTRI gateway in place. As such it provides the necessary tool to allow SMEs secure electronic reporting to the EMA and all Competent Authorities in the EEA.

EVWEB allows the sending and receiving of safety and acknowledgement messages in compliance with the latest ICH M2 standards. It also allows the saving of all messages at the local computer as well as the standardisation of message senders and receivers registered with the EMA as part of the EudraVigilance community. The same principles apply for medicinal product report messages.

The two main functionalities, that support the secure exchange of safety and acknowledgement messages, are integrated:

The WEB Trader component of EVWEB:
This is a component of the EudraVigilance Gateway that is made available by the EMA to registered parties that do not have their own ESTRI Gateway and pharmacovigilance system established.

The WEB Trader provides a mechanism to securely send and receive safety and acknowledgement messages, in a semi-automatic way. It provides its users with an inbox, where incoming messages can be located, viewed and further processed e.g. stored at the users local computer. The outbox, displays all safety and acknowledgement messages that have been created by WEB Trader users and sent to one or several receivers of the EudraVigilance community. Tracking functions are also available that allow the monitoring of the actual status of a transmitted message.

The Message Posting function of EVWEB:
This allows web trader users to upload Safety and Acknowledgement Messages that have been generated by the sender using his local pharmacovigilance system, to the EudraVigilance Gateway, from where the messages will be re-routed to the specified receiver.

Creation of Safety and Acknowledgement Messages via EVWEB

EVWEB has online functions available to create fully ICH E2BM and M2 compliant safety and acknowledgement messages. It further provides access to all relevant standard terminology such as MedDRA in the latest version, the EudraVigilance Medicinal Product Dictionary and other ICH defined terminology.

The creation of follow-up reports is possible and query functions permit restricted or full access to the ICSRs stored in the EudraVigilance DBMS.

Creation of Medicinal Product Reports via EVWEB

EVWEB has a medicinal product section, which provides with all functionality that allows the insert, update or of a new medicinal product in the EudraVigilance Medicinal Product Dictionary

What are the technical requirements to use EVWEB?

From a technical point of view, an EVWEB user needs to have a computer and an Internet connection, preferably ADSL or faster.

EVWEB will work with Internet Explorer V6 and Internet Explorer V8.  It will not work with any other IE version or other browsers.  The only browser for which the EMA offers EVWEB support is Internet Explorer V8.

Who can use EVWEB?

Any marketing authorisation holder, applicant or sponsor of clinical trials in the EEA can use EVWEB. To get access the tool, marketing authorisation holders, applicants and sponsors must register with the EMA and attend a training course. For details on these courses click here. EVWEB can also be used by regional pharmacovigilance centres to report to the local Competent Authority.

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Last update: Friday, 26 October 2012.



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