Pharmacovigilance: research and development

Sponsors of clinical trials must submit reports of suspected unexpected serious adverse reactions to EudraVigilance, the electronic system for managing and analysing information on suspected adverse reactions to medicines in the European Economic Area (EEA).

United Kingdom's (UK) withdrawal from the European Union (EU)

EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the EEA. For more information, see UK's withdrawal from the EU.

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In other sections

Sponsors should also consider the regulatory information in the sections below:

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