Transcription of EudraVigilance User Manual - European Medicines …
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EudraVigilance User Manual - European Medicines …
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 .. 6. Access via portal .. 7. Access via EVDAS .. 7. Access via EVWEB .. 9. 3. Format and content of the ICSR form .. 9. General rules .. 9. Nullflavors flags .. 10. Dynamism of the ICSR form .. 10. Header .. 12. General information .. 12. Worldwide Unique Case Identification 13.
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