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EudraVigilance user manual for marketing authorisation holders

This manual includes following topics: Introduction to the EudraVigilance Data Analysis System, EVDAS access to MAHs – General principles, Accessing EVDAS, The electronic Reaction Monitoring Report (eRMR), The EVDAS line listing report, The EVDAS active substance grouping report, Prompts page options, Working with returned reports, User manual of the eRMR for MAHs and the List of acronyms used in the document.


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