PLEASE NOTE:

New EudraVigilance webpages now available – current EV website to be decommissioned July 2016.

Mandatory e-reporting essentials

EudraVigilance is a data processing network and management system for reporting and evaluating suspected adverse drug reactions (ADRs) during the development, and following the marketing authorisation of medicinal products in the European Economic Area (EEA). The first operating version was launched in December 2001.

EudraVigilance supports:

• The electronic exchange of suspected adverse drug reaction reports known as Individual Case Safety Reports) between the European Medicines Agency (EMA), National Competent Authorities (NCAs), Marketing Authorisation Holders (MAHs), and sponsors of clinical trials in the EEA.
• Early detection of possible safety signals associated with medicinal products for human use.
• Continual monitoring and evaluation of potential safety issues in relation to reported adverse reactions.
• Decision making process, based on a broader knowledge of the adverse reaction profile of medicinal products especially in the form of Risk Management.

Taking into account the pharmacovigilance activities in the pre- and post- authorisation phase, EudraVigilance provides two reporting modules:

• The EudraVigilance Clinical Trial Module (EVCTM) to facilitate the electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) as required by Directive 2001/20/EC
  

• The EudraVigilance Post-Authorisation Module (EVPM) for post-authorisation Individual Case Safety Reports (ICSRs) as required by Regulation (EC) No 726/2004, Directive 2001/83/EC as amended.

EudraVigilance is also one of the main pillars of the European Risk Management Strategy, a joint effort between the EMA and NCAs to strengthen the conduct of pharmacovigilance in the EEA. EudraVigilance facilitates the process of risk management at several levels including aspects of risk detection, risk assessment, risk minimisation and risk communication.

Consequently, EudraVigilance contributes to the protection and promotion of public health in the EEA, and provides a powerful tool for the EMA and NCAs in monitoring the safety of medicinal products and in minimising potential risks related to suspected adverse reactions.

The reporting obligations of the various stakeholders are defined in the Community legislation, in particular Regulation (EC) No 726/2004, Directive 2001/83/EC as amended and Directive 2001/20/EC.

Please consult the relevant sections on this website for further information:

up |go back

Last update: Monday, 20 June 2016.