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ENV 12610 : DRAFT 1997

Current
Current

The latest, up-to-date edition.

MEDICAL INFORMATICS - MEDICINAL PRODUCT IDENTIFICATION
Published date

01-12-2013

Content
0. Foreword
    0.0 Mandate and Task Description
    0.1 Domain Description
    0.2 Structure of the document
    0.3 Users of the Prestandard
    0.4 Further developments
1. Scope
2. Normative References
3. Definitions (Normative)
4. Identifying Characteristics (Normative)
    4.0 Introduction
    4.1 Characteristics related to the ingredients
         4.1.0 Pharmaceutical class
         4.1.1 Ingredient designation
                4.1.1.0 Ingredient name
                4.1.1.1 Ingredient code value
         4.1.2 Ingredient manufacturer
         4.1.3 Ingredient batch number
         4.1.4 Ingredient description
         4.1.5 Ingredient territory
    4.2 Characteristics related to the pharmaceutical and the
         medicinal product
         4.2.0 Therapeutic group
         4.2.1 Medicinal product designation
                4.2.1.0 Medicinal product name
                4.2.1.1 Medicinal product code value
                4.2.1.2 Medicinal product name spoecifiers
         4.2.2 Marketing authorisation holder
         4.2.3 Marketing authorisation number
         4.2.4 Pharmaceutical product manufacturer
         4.2.5 Medicinal product manufacturer
         4.2.6 Strength
         4.2.7 Pharmaceutical form
         4.2.8 Dosage form
         4.2.9 Pharmaceutical product description
         4.2.10 Imprint
         4.2.11 Medicinal product batch number
         4.2.12 Pharmaceutical product batch number
         4.2.13 Medicinal product cluster
         4.2.14 Route of administration
         4.2.15 Medicinal product territory
    4.3 Characteristics related to the medicinal product
         packages
         4.3.0 Medicinal product package designation
         4.3.1 Medicinal product package responsible body
         4.3.2 Medicinal product package authorisation
                number
         4.3.3 Medicinal product package batch number
         4.3.4 Medicinal product package content
         4.3.5 Medicinal product package manufacturer
         4.3.6 Medicinal product package cluster
         4.3.7 Medicinal product package label
         4.3.8 Medicinal product package territory
    4.4 Overview of Identifying Concepts
5. Identifiers (Informative)
    5.0 Introduction
    5.1 Ingredient Identifiers
    5.2 Medicinal Product Identifiers
    5.3 Medicinal Product Package Identifiers
6. Conformity to the Standard
Annex A - List of Identifying Concepts
Annex B - List of Identifiers as proposed in this document
Annex C - Model Representation (Informative)
Annex D - Structure for a Concept System (Informative)
          D.0 Introduction
          D.1 Conceptual model at ingredient level
          D.2 Conceptual model at medicinal product level
          D.3 Conceptual model at medicinal package level
Annex E - Acronyms
Annex F - PT2-014 Team
Annex G - Index

Defines the semantic categories that are related to the identification of medicinal products and to establish a categorial structure that allows the description of the organisation of the semantic categories that represent the underlying system of characteristics.

Committee
TC 251
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
DIN V ENV 12610:1997-07 Identical
I.S. ENV 12610:1997 Identical
UNE-ENV 12610:1998 Identical
NEN NVN ENV 12610 : 1997 Identical
UNI ENV 12610 : 1997 Identical
DD ENV 12610:1998 Identical
NBN ENV 12610 : 1997 Identical

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)
10/30229867 DC : 0 BS EN ISO 11615 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION
ISO/TR 22790:2007 Health informatics Functional characteristics of prescriber support systems
BS EN 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
10/30229870 DC : 0 BS EN ISO 11616 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION
10/30229861 DC : 0 BS EN ISO 11239 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON PHARMACEUTICAL DOSE FORMS, UNITS OF PRESENTATION AND ROUTES OF ADMINISTRATION
UNE-EN ISO 11616:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012)
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
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)
EN 12264:2005 Health informatics - Categorial structures for systems of concepts
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)
I.S. EN 12264:2005 HEALTH INFORMATICS - CATEGORIAL STRUCTURES FOR SYSTEMS OF CONCEPTS
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 11615:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical 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
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)
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)
BS EN 14822-3:2005 Health informatics. General purpose information components Clinical
ISO 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
06/30150535 DC : 0 EN 15521 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY
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)
DD ENV 13607:2000 Health informatics. Messages for the exchange of information on medicine prescriptions
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
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)
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)
I.S. ENV 13607:2000 HEALTH INFORMATICS - MESSAGES FOR THE EXCHANGE OF INFORMATION ON MEDICINE PRESCRIPTIONS
ENV 13607:2000 HEALTH INFORMATICS - MESSAGES FOR THE EXCHANGE OF INFORMATION ON MEDICINE PRESCRIPTIONS
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
DIN EN ISO 11239:2013-03 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 (ISO 11239:2012)
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)
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
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)
16/30344632 DC : 0 BS EN ISO 11616 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION
UNE-EN ISO 11239:2013 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 (ISO 11239:2012)
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)
BS EN 12264:2005 Health informatics. Categorial structures for systems of concepts
EN 14822-3:2005 Health informatics - General purpose information components - Part 3: Clinical
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)
EN 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 (ISO 11239:2012)
ISO/TR 25257:2009 Health informatics Business requirements for an international coding system for medicinal products
UNI EN 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
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
I.S. EN 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 (ISO 11239:2012)
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
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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