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EN ISO 11615:2017

Current
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)
Published date

12-06-2017

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

ISO 11615:2017 establishes 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.Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable.Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

Committee
CEN/TC 251
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

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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