ISO 11616:2017
Current
Current
The latest, up-to-date edition.
Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French
Published date
19-10-2017
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ISO 11616:2017 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, ISO 11616:2017 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.
ISO 11616:2017 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 ISO 11616:2017.
Medicinal products for veterinary use are out of scope of ISO 11616:2017.
| Committee |
ISO/TC 215
|
| DevelopmentNote |
Supersedes ISO/DIS 11616. (10/2017)
|
| DocumentType |
Standard
|
| Pages |
33
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11616:2018-04 | Identical |
| UNI EN ISO 11616 : 2018 | Identical |
| BS EN ISO 11616:2012 | Identical |
| DIN EN ISO 11616:2016-09 (Draft) | Identical |
| EN ISO 11616:2017 | Identical |
| UNI EN ISO 11616 : 2012 | Identical |
| NEN EN ISO 11616 : 2018 | Identical |
| ONORM EN ISO 11616 : 2018 | Identical |
| UNE-EN ISO 11616:2018 | Identical |
| SN EN ISO 11616 : 2013 | Identical |
| NF EN ISO 11616 : 2018 | Identical |
| NBN EN ISO 11616 : 2013 | Identical |
| NS EN ISO 11616 : 2017 | Identical |
| UNE-EN ISO 11616:2013 | Identical |
| GOST R ISO 11616 : 2014 | Identical |
| I.S. EN ISO 11616:2017 | Identical |
| BS EN ISO 11616:2017 | Identical |
| PN EN ISO 11616 : 2018 | 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) |
| 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 |
| 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) |
| 14/30267009 DC : 0 | BS EN ISO 17523 - HEALTH INFORMATICS - REQUIREMENTS FOR ELECTRONIC PRESCRIPTIONS |
| S.R. CEN ISO/TS 19256:2017 | HEALTH INFORMATICS - REQUIREMENTS FOR MEDICINAL PRODUCT DICTIONARY SYSTEMS FOR HEALTH CARE (ISO/TS 19256:2016) |
| ISO/TR 23022:2018 | Traditional Chinese medicine Controlled vocabulary on Japanese Kampo formulas and the indication codes for the products |
| CEN ISO/TS 19293:2018 | Health Informatics - Requirements for a record of the dispense of a medicinal product (ISO/TS 19293:2018) |
| PD CEN ISO/TS 17251:2016 | Health informatics. Business requirements for a syntax to exchange structured dose information for medicinal products |
| ISO 11238:2012 | Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances |
| 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) |
| I.S. EN 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 11238:2012) |
| 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) |
| UNE-EN ISO 11238:2013 | Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012) |
| UNI EN ISO 11238 : 2012 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES |
| DIN EN ISO 11238:2013-03 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012) |
| S.R. CEN ISO/TS 19293:2018 | HEALTH INFORMATICS - REQUIREMENTS FOR A RECORD OF THE DISPENSE OF A MEDICINAL PRODUCT (ISO/TS 19293:2018) |
| 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) |
| ISO 11240:2012 | Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement |
| 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) |
| 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 |
| 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) |
| ISO 11615:2017 | Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information |
| PD CEN ISO/TS 19256:2017 | Health informatics. Requirements for medicinal product dictionary systems for health care |
| ISO/TS 18062:2016 | Health informatics — Categorial structure for representation of herbal medicaments in terminological systems |
| ISO/TS 19293:2018 | Health informatics — Requirements for a record of a dispense of a medicinal product |
| EN 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 11238:2012) |
| PD CEN ISO/TS 19844:2015 | Health informatics. Identification of medicinal products. Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances |
| BS EN ISO 11238:2012 | Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on substances |
| 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) |
| ISO/TS 24620-1:2015 | Language resource management — Controlled natural language (CNL) — Part 1: Basic concepts and principles |
| S.R. CEN ISO/TS 19844:2017 | 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 19844:2016) |
| 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 |
| 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 |
| 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) |
| PD ISO/TS 18062:2016 | Health informatics. Categorial structure for representation of herbal medicaments in terminological systems |
| 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) |
| CEN ISO/TS 19844:2017 | 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 19844:2016) |
| ISO/TS 17251:2016 | Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products |
| ISO 17523:2016 | Health informatics — Requirements for electronic prescriptions |
| ISO/TS 19256:2016 | Health informatics — Requirements for medicinal product dictionary systems for health care |
| EN ISO 17523:2016 | Health informatics - Requirements for electronic prescriptions (ISO 17523:2016) |
| 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) |
| 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 |
| BS EN ISO 17523:2016 | Health informatics. Requirements for electronic prescriptions |
| 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 |
| BS ISO 18668-4:2017 | Traditional Chinese medicine. Coding system for Chinese medicines Codes for granule forms of individual medicinals for prescriptions |
| 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) |
| ISO 18668-4:2017 | Traditional Chinese medicine — Coding system for Chinese medicines — Part 4: Codes for granule forms of individual medicinals for prescriptions |
| 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 |
| S.R. CEN ISO/TS 17251:2016 | HEALTH INFORMATICS - BUSINESS REQUIREMENTS FOR A SYNTAX TO EXCHANGE STRUCTURED DOSE INFORMATION FOR MEDICINAL PRODUCTS (ISO/TS 17251:2016) |
| 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) |
| I.S. EN ISO 17523:2016 | HEALTH INFORMATICS - REQUIREMENTS FOR ELECTRONIC PRESCRIPTIONS (ISO 17523:2016) |
| 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 |
| CEN ISO/TS 19256:2017 | Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016) |
| CEN ISO/TS 17251:2016 | Health Informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2016) |
| ENV 1613 : 1995 | MEDICAL INFORMATICS - MESSAGES FOR EXCHANGE OF LABORATORY INFORMATION |
| 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 |
| ISO 11615:2017 | Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information |
| 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/HL7 27953-2:2011 | Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR |
| ISO/HL7 27951:2009 | Health informatics Common terminology services, release 1 |
| ISO 6709:2008 | Standard representation of geographic point location by coordinates |
| 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 |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| 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 |
| ENV 12610:1997 | 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 2382:2015 | Information technology — Vocabulary |
| 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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