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ICH ICSR Implementation Guide 12 April 2013
INTERNATIONAL CONFERENCE ON HARMONISATION OF
TECHNICAL REQUIREMENTS FOR REGISTRATION OF
PHARMACEUTICALS FOR HUMAN USE
ICH E2B Expert Working Group
Implementation Guide for
Electronic Transmission of Individual Case Safety Reports
(ICSRs)
E2B(R3) Data Elements and Message Specification
Version 5.01, 12 April 2013
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