11
ICH ICSR Implementation Guide 12 April 2013
-12-
Sections of this document referencing the ISO/HL7 standard ‘ISO/HL7 27953-2: 2011 Health
informatics --Individual case safety reports (ICSRs) in pharmacovigilance --Part 2: Human
pharmaceutical reporting requirements for ICSR’ are used with the publishers’ permission.
Copyright of the ISO/HL7 27953-2: 2011 standard is held jointly by ISO and Health Level
Seven International. ALL RIGHTS RESERVED.

Purchased from RAPS Library (library.raps.org) for the exclusive use of unknown.
© 2026 RAPS Library. Please report unauthorized use to raps@raps.org