Standard

NS-EN ISO 27953-2:2011

Mar 2012 Published

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Language English

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Abstract

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.

Document information

Standard from SN
Published: 1 March 2012
Edition: 1
Version: 1
Document type: NAT
ISBN:

ICS 35.240.80
National Committee SN/K 120

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Refers: ISO/TS 22224:2009
Refers: ISO/HL7 21731:2006
Refers: ISO/HL7 21731:2006
Refers: ISO/HL7 21731:2006
Adopted from: EN ISO 27953-2:2011 , 0

NS-EN ISO 27953-2:2011

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Abstract

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Abstract

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