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  • S.R. CEN ISO/TS 20451:2018

    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)

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    Language(s): 

    Published date:  17-06-2018

    Publisher:  National Standards Authority of Ireland

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

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

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    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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