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EudraVigilance User Manual
22 January 2018. EMA/249220/2016. Inspections, Human Medicines Pharmacovigilance & Committees Division EudraVigilance User Manual Individual Case Safety Report form Version 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website An agency of the European Union European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. Contents Contents .. 2. Version .. 4. Overview .. 5. 1. Introduction .. 5. General 5. 2. Access to the ICSR form.
EudraVigilance User Manual EMA/249220/2016 Page 6/36 . populated in the same way (text, numbers, figures) as they have been submitted by the sender, or
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