EudraVigilance

The European Medicines Agency is responsible for the development, maintenance and coordination of EudraVigilance, a system designed for the reporting of suspected side effects.

Reports submitted to EudraVigilance include suspected side effects of medicines reported during both the pre- and post-authorisation phases. The system allows the detection of signals of suspected side effects that were previously unknown, and of new information on known side effects.

Data collected in EudraVigilance

Pre-authorisation module:

  • suspected unexpected serious adverse reactions (SUSARs) reported by sponsors of clinical trials;
  • data from interventional clinical trials.

Post-authorisation module:

  • suspected serious side effects;
  • healthcare professionals' spontaneous reporting;
  • post-authorisation studies (non-interventional);
  • worldwide scientific literature (spontaneous, non-interventional);
  • transmission of an infectious agent via a medicinal product.

EudraVigilance data for centrally authorised medicines are analysed on a regular basis, with a two-week or four-week frequency.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Working Party (PRAC) evaluate signals from EudraVigilance and may recommend regulatory action as a result.

EudraVigilance is used by national medicines regulatory authorities, the Agency and pharmaceutical companies.

The reporting obligations of the various stakeholders are defined in EU legislation, in particular Regulation (EC) No 726/2004, Directive 2001/83/EC as amended and Directive 2001/20/EC. Please refer to the main page of the EudraVigilance website for further information.
Details on the processes for the conduct of pharmacovigilance in the EU can be found in Volume 9A of the Rules governing medicinal products in the EU.

For more information on how the Agency interprets information on reported cases of suspected adverse reactions to medicines, see the Guide on the interpretation of spontaneous case reports of suspected adverse reactions to medicines (English only).

 EMA
EudraVigilance