ISO 11616:2017
Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information

Standard No.

ISO 11616:2017

Release Date

2017

Published By

International Organization for Standardization (ISO)

Latest

ISO 11616:2017

Scope

This document is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, this document is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. This document is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of this document. Medicinal products for veterinary use are out of scope of this document.

ISO 11616:2017 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 11615:2017 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal 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 6709:2008 Standard representation of geographic point location by coordinates
• ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times
• ISO/HL7 27951:2009 Health informatics - Common terminology services, release 1
• 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 2382:2015 Information technology - Vocabulary
• ISO/IEC 5218:2004 Information technology - Codes for the representation of human sexes
• ISO/IEC GUIDE 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)
• 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 11616:2017 history

• 2017 ISO 11616:2017 Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
• 2012 ISO 11616:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information