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

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

21-11-2011

Publisher

International Organization for Standardization

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.

DevelopmentNote	Supersedes ISO/DIS 27953-2. (11/2011) Available in CD-ROM format (contains program files). (12/2013)
DocumentType	Standard
Pages	0
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
NF EN ISO 27953-2 : 2013	Identical
NBN EN ISO 27953-2 : 2012	Identical
NEN EN ISO 27953-2 : 2011	Identical
NS EN ISO 27953-2 : 2011	Identical
PN EN ISO 27953-2 : 2012	Identical
UNI EN ISO 27953-2 : 2012	Identical
BS EN ISO 27953-2:2011	Identical
EN ISO 27953-2:2011	Identical

DIN EN ISO 11240:2013-03	Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
PD CEN ISO/TS 16791:2015	Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers
I.S. EN ISO 11238:2012	HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012)
S.R. CEN ISO/TS 19256:2017	HEALTH INFORMATICS - REQUIREMENTS FOR MEDICINAL PRODUCT DICTIONARY SYSTEMS FOR HEALTH CARE (ISO/TS 19256:2016)
S.R. CEN ISO/TS 16791:2015	HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS (ISO/TS 16791:2014)
BS PD ISO/TS 16791 : 2014	HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS
PD CEN ISO/TS 20443:2018	Health informatics. Identification of medicinal products. Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
CEN ISO/TS 20443:2018	Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017)
UNE-EN ISO 11238:2013	Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)
UNE-EN ISO 11615:2013	Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2012)
UNI EN ISO 11238 : 2012	HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES
I.S. EN ISO 11616:2017	HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION (ISO 11616:2017)
CEN ISO/TS 20451:2018	Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017)
ISO 11240:2012	Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
S.R. CEN ISO/TS 20451:2018	HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - IMPLEMENTATION GUIDELINES FOR ISO 11616 DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION (ISO/TS 20451:2017)
UNE-EN ISO 11240:2013	Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
ISO 11615:2017	Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
PD CEN ISO/TS 19256:2017	Health informatics. Requirements for medicinal product dictionary systems for health care
ISO/TS 20451:2017	Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
EN ISO 11238:2012	Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)
BS EN ISO 11238:2012	Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on substances
EN ISO 11615:2017	Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)
CEN ISO/TS 16791:2015	Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2014)
BS EN ISO 11240:2012	Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of units of measurement
16/30344636 DC : 0	BS EN ISO 11615 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION
BS EN ISO 11616:2017	Health informatics. Identification of medicinal products. Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
EN ISO 11616:2017	Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)
ISO/TS 19256:2016	Health informatics Requirements for medicinal product dictionary systems for health care
EN ISO 11240:2012	Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
S.R. CEN ISO/TS 20443:2018	HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - IMPLEMENTATION GUIDELINES FOR ISO 11615 DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO/TS 20443:2017)
BS EN ISO 11615:2017	Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO 11238:2012	Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances
DIN EN ISO 11238:2013-03	HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012)
I.S. EN ISO 11615:2017	HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO 11615:2017)
UNI EN ISO 11240 : 2012	HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF UNITS OF MEASUREMENT
ISO 11616:2017	Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
I.S. EN ISO 11240:2012	HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF UNITS OF MEASUREMENT (ISO 11240:2012)
ISO/TS 20443:2017	Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
CEN ISO/TS 19256:2017	Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)