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S.R. CEN ISO/TS 20451:2018

Current
Current

The latest, up-to-date edition.

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)
Published date

17-06-2018

National Foreword
European foreword
Endorsement notice
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Conformance
5 Concepts required for the unique identification of
  pharmaceutical
6 Identifying characteristics for the identification of
  pharmaceutical
7 Ingredient, substance and strength
8 Pharmaceutical product - adjuvants and devices
Annex A (normative) - Messaging - Ingredient, substance and strength
Annex B (normative) - Messaging - Pharmaceutical product and device
Annex C (informative) - Examples
Annex D (informative) - Examples of representation of strength
Bibliography

Specifies the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.

DocumentType
Standard
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
CEN ISO/TS 20451:2018 Identical

ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
ISO 639-1:2002 Codes for the representation of names of languages — Part 1: Alpha-2 code
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/TS 19844:2016 Health informatics Identification of medicinal products Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
ISO/HL7 27953-2:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR
ISO 6709:2008 Standard representation of geographic point location by coordinates
ISO 21090:2011 Health informatics — Harmonized data types for information interchange
ISO 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
ENV 13607:2000 HEALTH INFORMATICS - MESSAGES FOR THE EXCHANGE OF INFORMATION ON MEDICINE PRESCRIPTIONS
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 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
ENV 12610 : DRAFT 1997 MEDICAL INFORMATICS - MEDICINAL PRODUCT IDENTIFICATION
ISO/TS 20440:2016 Health informatics — Identification of medicinal products — Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
ISO/IEC 11404:2007 Information technology — General-Purpose Datatypes (GPD)
ISO 3166-1:2013 Codes for the representation of names of countries and their subdivisions Part 1: Country codes
ISO/HL7 27953-1:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 1: Framework for adverse event reporting
ISO/IEC 2382:2015 Information technology — Vocabulary
ISO/IEC 5218:2004 Information technology Codes for the representation of human sexes
ISO 11239:2012 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

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