Name: CEN ISO/TS 20451:2018
Brand: CEN

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)

Published date

05-16-2018

Publisher

Comite Europeen de Normalisation

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 : 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 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