ISO 11615:2017
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information
- Standard No.
- ISO 11615:2017
- Release Date
- 2017
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 11615:2017/Amd 1:2022
- Latest
- ISO 11615:2017/Amd 1:2022
- Scope
- This document 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 this document.
ISO 11615:2017 Referenced Document
- ISO 1087-1:2000 Terminology work - Vocabulary - Part 1: Theory and application
- 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 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 11240:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement
- ISO 11616:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
- ISO 21090:2011 Health informatics - Harmonized data types for information interchange
- ISO 3166-1:2013 Codes for the representation of names of countries and their subdivisions.Part 1: Country codes
- ISO 639-1:2002 Codes for the representation of names of languages - Part 1: Alpha-2 code
- ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times
- ISO/HL7 27953-1:2011 Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting
- ISO/HL7 27953-2:2011 Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR
- ISO/IEC 11404:2007 Information technology - General-Purpose Datatypes (GPD)
- ISO/IEC 15415:2011 Information technology - Automatic identification and data capture techniques - Bar code symbol print quality test specification - Two-dimensional symbols
- ISO/IEC 15416:2016 Automatic identification and data capture techniques — Bar code print quality test specification — Linear symbols*， 2024-04-20 Update
- ISO/IEC 5218:2004 Information technology - Codes for the representation of human sexes
- ISO/IEC TR 24720:2008 Information technology - Automatic identification and data capture techniques - Guidelines for direct part marking (DPM)
- ISO/IEC TR 29158:2011 Information technology - Automatic identification and data capture techniques - Direct Part Mark (DPM) Quality Guideline
- ISO/TS 16791:2014 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers
- 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/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
- 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*， 2017-10-19 Update
- 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*， 2017-10-19 Update
ISO 11615:2017 history
- 2022 ISO 11615:2017/Amd 1:2022 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information — Amendment 1
- 2017 ISO 11615:2017 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information
- 2012 ISO 11615:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information
