Background

This website was launched by the European Medicines Agency in 2012 to provide public access to reports of suspected side effects (also known as suspected adverse drug reactions). These reports are submitted electronically to EudraVigilance by national medicines regulatory authorities and by pharmaceutical companies that hold marketing authorisations (licences) for the medicines.

EudraVigilance is a system designed for collecting reports of suspected side effects. These reports are used for evaluating the benefits and risks of medicines during their development and monitoring their safety following their authorisation in the European Economic Area (EEA). EudraVigilance has been in use since December 2001.

This website was launched to comply with the EudraVigilance Access Policy, which was developed to improve public health by supporting the monitoring of the safety of medicines and to increase transparency for stakeholders, including the general public.

The Management Board of the European Medicines Agency first approved the EudraVigilance Access Policy in December 2010. A revision was adopted by the Board in December 2015 based on the 2010 pharmacovigilance legislation. The policy aims to provide stakeholders such as national medicines regulatory authorities in the EEA, the European Commission, healthcare professionals, patients and consumers, as well as the pharmaceutical industry and research organisations, with access to reports on suspected side effects.

Transparency is a key guiding principle of the Agency, and is pivotal to building trust and confidence in the regulatory process. By increasing transparency, the Agency is better able to address the growing need among stakeholders, including the general public, for access to information.

Legal basis

In accordance with the provisions of Article 24, paragraph (2) and Article 57, paragraph (1)(d) of Regulation (EC) No 726/2004, access to EudraVigilance data is provided to the public as described in the EudraVigilance Access Policy in the following ways:

  • In accordance with the provisions of Article 24, paragraph (2) of Regulation (EC) No 726/2004 as amended, access to EudraVigilance data is provided to the public as described in the EudraVigilance Access Policy.
  • Subsets of data from spontaneous reports as described in Annex 1 of the EudraVigilance Access Policy are released, taking into account the need to comply with Regulation (EC) No 45/2001 on personal data protection. This applies to all types of medicines, independent of the authorisation procedure and the source of the report (e.g. healthcare professional, patient).
    Spontaneous reports are unsolicited reports by healthcare professionals or patients that do not derive from a study or any organised data-collection scheme. For centrally authorised medicines, access to reports is granted both by the name of the medicine or the name of the active substance or combination thereof. For non-centrally authorised medicines, access is granted based on the name of the active substance.

Statement on data privacy

  • Reports on suspected side effects are used for monitoring the benefits and risks of medicines: an activity that contributes to the protection of public health. As part of this, it is necessary to process certain personal data, in line with relevant data-protection legislation (Recital 23 of Regulation (EU) No 1235/2010) .
  • Reports on suspected side effects are processed by national medicines regulatory authorities and marketing authorisation holders and submitted to EudraVigilance in line with applicable data protection rules as set out in Directive 95/46/EC.
  • Reports of suspected side effects submitted to EudraVigilance are processed by the European Medicines Agency in line with applicable data-protection rules as set out in Regulation No (EC) 45/2001.
  • Dissemination of information from the Eudravigilance database is further detailed in Article 24 (2) of Regulation (EC) No 726/2004.
  • For information on the processing of personal data by EMA, please contact dataprotection@ema.europa.eu ; For requests about specific individual reports please contact directly your national medicines regulatory authority.
 EMA
EudraVigilance