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30 March 2016 EMA/99666/2016 Information Management EudraVigilance Form A Appointment of a 'responsible person for EudraVigilance by a sponsor organization or an organization acting as the legal representative,
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Eudravigilance Form A is a form used for reporting suspected adverse reactions to medicines in the European Union.
Marketing authorization holders (MAHs) are required to file Eudravigilance Form A.
Eudravigilance Form A can be filled out electronically on the Eudravigilance website by providing information about the suspected adverse reaction.
The purpose of Eudravigilance Form A is to report and monitor suspected adverse reactions to medicines in order to ensure patient safety.
Information such as the patient's details, the suspected medicinal product, the adverse reaction, and the reporter's contact information must be reported on Eudravigilance Form A.
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