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EudraVigilance (EV)

Pharmacovigilance

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What is the purpose of the EudraVigilance Organisation and User Management?

The EudraVigilance organisation and user management is based on an active directory service to manage all partners of the EMA that have a legal obligation to report serious adverse drug reactions for medicinal products authorised in the EEA and clinical trials performed in the EEA. The organisation and user management component of the European pharmacovigilance database is a key element for:

  • Uniquely identifying any registered organisation able to exchange safety, acknowledgement and medicinal product report messages in an electronic data interchange environment
  • Implementing and monitoring security tracking functions within the DBMS
  • Defining access rights to the DBMS based on the overall access policies defined at Community level

Uniquely identifying any registered organisation. During the registration process, each registering organisation has to specify an organisation identifier (ID), which is a precondition to exchange safety, acknowledgement and medicinal product report messages in an electronic data interchange (EDI) environment. This organisation ID is used in a message to indicate the sender and the receiver and allows the EudraVigilance Gateway to correctly identify the two unique partners in the EDI process.

Implementing and monitoring security elements. Based on the implemented organisation and user hierarchy, EudraVigilance enables the administration of individual users of each organisation and to monitor the individual user interactions with EVWEB and the EudraVigilance DBMS.

Further, each ICSR that is stored in the EudraVigilance Database Management System (DBMS) is flagged with the sender’s organisation ID. This allows the ownership definition of the report in the DBMS and the rights of organisations and their individual users to view the ICSRs.

Defining access rights to the EudraVigilance Database Management System. Based on the overall access policies defined at Community level, only registered partners and their registered individual users are granted access to the DBMS. Competent Authorities have access to all ICSRs stored in the two EudraViglance modules, MAHs can currently only view ICSRs that they have submitted to the EMA. The organisation and user management directory is controlling this access and visibility rights in the EudraVigilance DBMS.

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Last update: Monday, 29 May 2006.

 

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