CEN ISO/TS 20451:2018
Current
The latest, up-to-date edition.
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)
16-05-2018
European foreword
Endorsement notice
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Conformance
5 Concepts required for the unique identification of pharmaceutical
6 Identifying characteristics for the identification of pharmaceutical
7 Ingredient, substance and strength
8 Pharmaceutical product - adjuvants and devices
Annex A (normative) - Messaging - Ingredient, substance and strength
Annex B (normative) - Messaging - Pharmaceutical product and device
Annex C (informative) - Examples
Annex D (informative) - Examples of representation of strength
Bibliography
ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017.Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of ISO/TS 20451:2017.
| Committee |
CEN/TC 251
|
| DocumentType |
Technical Specification
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| UNE-CEN ISO/TS 20451:2018 | Identical |
| NEN NVN CEN ISO/TS 20451 : 2018 | Identical |
| UNI CEN ISO/TS 20451 : 2018 | Identical |
| S.R. CEN ISO/TS 20451:2018 | Identical |
| ISO/TS 20451:2017 | Identical |
| DIN CEN ISO/TS 20451;DIN SPEC 13264:2018-11 | Identical |
| PD CEN ISO/TS 20451:2018 | Identical |
| 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 |
| 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 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 |
| 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 12610:1997 | 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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