EudraVigilance Access Policy

The European Medicines Agency has published its plan for granting public access to the information held in the EudraVigilance database, the central repositories for reports of suspected adverse reactions related to medicines authorised in the European Economic Area and medicines being studied in clinical trials.

The EudraVigilance Access Policy explains the Agency's plans to release information held in the EudraVigilance database. It was developed as part of the Agency's ongoing drive to increase its levels of transparency. It aims to contribute to the protection of health, by providing the Agency's stakeholders, including other medicines regulatory authorities, healthcare professionals, patients, consumers, the pharmaceutical industry and research organisations, with as much information as possible from the EudraVigilance database. The Policy also takes European Union legislation on the protection of personal data into account. The Agency prepared the EudraVigilance Access Policy with input from its stakeholders and an explanatory note to provide additional information on it's implementation.

A revised version of the EudraVigilance Access Policy will enter into force six months following the announcement by the Agency's Management Board that, based on an independent audit report, the EudraVigilance database has achieved full functionality in July 2017.

• EudraVigilance access policy for medicines for human use (08/07/2011)
• Explanatory note: EudraVigilance access policy for medicines for human use (08/07/2011)
• Overview of comments received on draft EudraVigilance access policy and implemented amendments
• EudraVigilance Access Policy for medicines for human use – Revision 1 (17/12/2015)

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Last update: Wednesday, 6 July 2016.