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EudraVigilance (EV)

Pharmacovigilance

MedDRA

E-Reporting to Member States

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Registration with EudraVigilance

Introduction

The registration with EudraVigilance is necessary to identify and manage organisations in the European Economic Area (EEA) for the electronic reporting of suspected adverse reactions and the electronic submission of information on medicines. This is to ensure that proper privacy and security measures are in place and that the principles of data integrity, accountability and availability are adhered to. More specifically the registration process applies to:

  • The electronic transmission of Individual Case Safety Reports (ICSRs) (Safety messages) and ICSR acknowledgements in the context of clinical trials and post-authorisation of medicinal products

  • The electronic submission of information on authorised medicinal products in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 by means of the Extended EudraVigilance Medicinal Product Report Messages (XEVPRMs) and XEVPRM acknowledgements

  • The electronic submission of information on Investigational Medicinal Products (IMPs) in accordance with the detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) by means of the Extended EudraVigilance Medicinal Product Report Messages (XEVPRMs) and XEVPRM acknowledgements

The Electronic Data Interchange (EDI) process is based on the electronic exchange of a Safety or XEVPR Message between a Sender and a Receiver. The Acknowledgement Message confirms the receipt and the outcome of the validation of a Safety or a XEVPR Message and completes the EDI process.

Only registered organisations are permitted to exchange Safety, XEVPR and Acknowledgement Messages by means of the EudraVigilance Gateway, the European data-processing network as defined in EU legislation. A list of registered organisations, which are part of the EudraVigilance user community is maintained by the Agency and is accessible for all registered partners in the restricted area of the EudraVigilance website.

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Last update: Friday, 11 May 2012.

 

 

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