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    I.S. EN ISO 11615:2017

    Current The latest, up-to-date edition.

    HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO 11615:2017)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms, definitions, symbols, abbreviated terms
    4 Message exchange format
    5 Conformance terminology and context as
       it relates to the ISO IDMP standards and
       corresponding IDMP technical specifications
    6 Concepts required for the unique
       identification of Medicinal Products
    7 Description of the information modelling
       principles and practices
    8 Identifying characteristics for authorised
       Medicinal Products
    9 Information for an authorised Medicinal
       Product
    10 Identifying characteristics for Investigational
       Medicinal Products
    11 Information for an Investigational Medicinal
       Product
    Annex A (normative) - Full model - Authorised Medicinal
            Products detailed diagram
    Annex B (normative) - Full model - Investigational
            Medicinal Products detailed diagram
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

    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
    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    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/IEC 15416:2016 Automatic identification and data capture techniques — Bar code print quality test specification — Linear symbols
    ISO/IEC TR 24720:2008 Information technology Automatic identification and data capture techniques Guidelines for direct part marking (DPM)
    ISO/HL7 27953-2:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR
    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 15415:2011 Information technology Automatic identification and data capture techniques Bar code symbol print quality test specification Two-dimensional symbols
    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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