Here is what EudraVigilance states about their database:
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. (Source.)
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