How are Messages exchanged with the EudraVigilance gateway?

• About the EudraVigilance Gateway
• What are the benefits of the EudraVigilance Gateway?
• How do I connect to the EudraVigilance Gateway?
• How are Messages exchanged with the EudraVigilance Gateway?
• Contacts and Help

The precondition to exchange ICSRs and SUSARs electronically via the EudraVigilance gateway is to create ICH M2 compliant safety messages that may contain one or more ICSRs. While there can be any number of ICSRs within a message, all of them must be for a single receiver. The message should also not exceed two megabytes in size. This will prevent problems in sending to a receiver with a limitation in the size of an email.

To acknowledge the receipt of a safety or medicinal product report message the receiver must generate an acknowledgement message in the ICH M2 format.

In order to transport a safety or acknowledgement message to the correct receiver it is required to correctly specify the message sender identifier (ICH DTD version 2.1 M.1.5) and the message receiver identifier (ICH DTD version 2.1 M.1.6). The EudraVigilance gateway reads the sender and receiver information specified in the safety, acknowledgement or medicinal product report messages and routes the message to the appropriate receiver.

The Message Sender Identifier (ICH DTD version 2.1 M.1.5) must be the sender’s own profile ID and must be identical to the MAH, applicants , sponsors or CA name in each safety report (ICSR) attached to the Safety Message.

Both, the Message Sender Identifier (ICH DTD version 2.1 M.1.5) and the Message Receiver Identifier (ICH DTD version 2.1 M.1.6) must correspond with the organisation identifier list maintained by the EMA i.e. only those parties that are registered with the EMA are able to exchange safety messages either with the EMA or other registered parties (EudraVigilance community).

Possible partners are marketing authorisation holders (MAH), sponsors of clinical trials and CAs in the EEA.

There are three possible ways of exchanging safety, acknowledgement and medicinal product report messages between registered pharmacovigilance parties in the EEA:

1. Using an ESTRI gateway:
   A tool providing a fully automated way to exchange safety and acknowledgement messages e.g. between the locally established pharmacovigilance system of a MAH or sponsor and the pharmacovigilance system of a partner of the EudraVigilance community.
2. Using the Web Trader component of EVWEB:
   An integrated component of the EudraVigilance gateway that is made available by the EMA to registered parties that do not have their own ESTRI gateway established, providing a way to securely exchange safety and acknowledgement and medicinal product report messages in a semi-automatic way.
3. Message Posting function of EVWEB:
   A tool providing a semi-automatic way to upload safety, acknowledgement and medicinal product report 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.

Inside the EudraVigilance community, the possible communication scenarios are the following:

Reporting to the EMA:
In this scenario, MAHs, applicants, sponsors and CAs in the EEA send e.g. safety messages to the EudraVigilance Database Management System (DBMS) of the EMA. The EudraVigilance Database Management System (DBMS) of the EMA returns an acknowledgement message to the original sender.

Re-routing via the EMA:
MAH, applicants and sponsors can send a safety message to the EudraVigilance Gateway from where the safety message is re-routed to the CA specified as the receiver in the message. The acknowledgement message generated by the receiving CA is re-routed via the EudraVigilance Gateway to the sender of the original safety message.

CAs can send safety messages to the EudraVigilance gateway from where the safety message is re-routed to the MAH or sponsors specified as the receiver in the message. The acknowledgement message generated by the receiving MAH or sponsor is re-routed via the EudraVigilance gateway to the sender of the original safety message

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Last update: Monday, 29 May 2006.