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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) observed following administration of human medicines. In 2019 the website was extended to provide corresponding information on suspected adverse events following administration of veterinary medicines as well. |
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The information on this website relates to suspected adverse events, i.e. medical events that have been observed following the use of a veterinary medicine, but which may not necessarily be related to or caused by the medicine. |
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Reporting suspected adverse events in animals provides the opportunity to detect new adverse events and monitor already known adverse events. |
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Information on suspected adverse events is important for identifying and mitigating potential safety risks. The information from individual suspected adverse event reports, together with all other available information about the veterinary medicine, provides the basis for further detailed evaluation and scientific assessment of the benefits and risks of the veterinary medicine. |
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The European Medicines Agency publishes these data so that its stakeholders, including the general public, can access information used by European regulatory authorities to review the safety of a veterinary medicine or active substance. Transparency is a key guiding principle of the Agency. |
Reports on suspected side effects are processed by national medicines regulatory authorities and marketing authorisation holders and submitted to the European database of suspected adverse event reports (EudraVigilance Veterinary) in line with applicable data protection rules as set out in the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679) . Therefore, some of the information contained in the adverse event report, such as personal data, may not be published on this website.
Reports of suspected side effects submitted to EudraVigilance Veterinary are processed by the European Medicines Agency in line with applicable data-protection rules as set out in the EU DPR, Regulation (EU) 2018/1725 .
For information on the processing of personal data by the European Medicines Agency, please read the EMA Privacy Statement: https://www.ema.europa.eu/en/about-us/legal/privacy-statement .
In case you have any questions on data privacy matters, please contact dataprotection@ema.europa.eu .
Information on notifications in a given country may be available on the website of the relevant national authority. Please consult the HMA website here.
