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ISO/HL7 27953-2:2011

Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR

Publication date:   Nov 21, 2011

General information

90.93 Standard confirmed   Jul 19, 2022

ISO/HL7

ISO/TC 215 Health informatics

International Standard

35.240.80   IT applications in health care technology

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Scope

ISO 27593-2:2011 seeks to create a standardized framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination.


Life cycle

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PUBLISHED
ISO/HL7 27953-2:2011
90.93 Standard confirmed
Jul 19, 2022