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  • BS PD ISO/TS 16791 : 2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-09-2015

    Language(s):  English

    Published date:  01-01-2014

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Procedural background
    5 Usage requirements
    6 Economic aspects
    Annex A (informative) - Relationship between PhPID
            and MPID (Referencing ISO 11615 and ISO 11616)
    Annex B (informative) - Packaging hierarchy
    Annex C (informative) - Relationship between MPID, PCID
            and GTIN
    Annex D (informative) - Examples for Package Identifier
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance on identification and labeling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product.

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

    Committee IST/35
    Development Note Renumbered and superseded by BS PD CEN ISO/TS 16791. (10/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO/IEC 16022:2006 Information technology Automatic identification and data capture techniques Data Matrix bar code symbology specification
    ISO/IEC 8859-1:1998 Information technology 8-bit single-byte coded graphic character sets Part 1: Latin alphabet No. 1
    ISO/IEC 10646:2014 Information technology Universal Coded Character Set (UCS)
    ISO/IEC 15459-4:2014 Information technology Automatic identification and data capture techniques Unique identification Part 4: Individual products and product packages
    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/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/IEC 15459-2:2015 Information technology Automatic identification and data capture techniques Unique identification Part 2: Registration procedures
    ISO/HL7 27953-2:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR
    ISO/IEC 15459-3:2014 Information technology Automatic identification and data capture techniques Unique identification Part 3: Common rules
    ISO/IEC 15459-6:2014 Information technology Automatic identification and data capture techniques Unique identification Part 6: Groupings
    ISO 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
    ISO/IEC 15424:2008 Information technology Automatic identification and data capture techniques Data Carrier Identifiers (including Symbology Identifiers)
    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/IEC 15417:2007 Information technology Automatic identification and data capture techniques Code 128 bar code symbology specification
    ISO/IEC 19762-1:2008 Information technology Automatic identification and data capture (AIDC) techniques Harmonized vocabulary Part 1: General terms relating to AIDC
    ISO/TR 25257:2009 Health informatics Business requirements for an international coding system for medicinal products
    ISO 28219:2017 Packaging — Labelling and direct product marking with linear bar code and two-dimensional symbols
    ISO/IEC TR 29158:2011 Information technology Automatic identification and data capture techniques Direct Part Mark (DPM) Quality Guideline
    ISO/IEC 15459-1:2014 Information technology Automatic identification and data capture techniques Unique identification Part 1: Individual transport units
    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 15418:2016 Information technology Automatic identification and data capture techniques GS1 Application Identifiers and ASC MH10 Data Identifiers and maintenance
    ISO/IEC 15423:2009 Information technology Automatic identification and data capture techniques Bar code scanner and decoder performance testing
    ISO 22742:2010 Packaging — Linear bar code and two-dimensional symbols for product packaging
    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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