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CEN ISO/TS 20451:2018

(Main)

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)

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 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.

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für ISO 11616 Datenelemente und -strukturen zur eindeutigen Identifikation und zum Austausch von Informationen über pharmazeutische Produkte (ISO/TS 20451:2017)

Informatique de santé - Identification des médicaments - Lignes directrices pour l’implémentation des éléments de données et structures ISO 11616 pour l’identification unique et l’échange d’informations réglementées sur les produits pharmaceutiques (ISO/TS 20451:2017)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za uporabo ISO 11616 podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO/TS 20451:2017)

Standard ISO/TS 20451:2017 določa opredelitve, ki so potrebne za povezavo farmacevtskih izdelkov z ustreznim naborom PhPID-jev v skladu s standardom ISO 11616.
Namen farmacevtskih identifikatorjev in elementov je predstaviti farmacevtske izdelke, kot so predstavljeni v medicinskem izdelku in kot to določa Regulativni organ za zdravila (MRA). Zbirka standardov ISO IDMP se lahko uporabi za izjemno uporabo medicinskih izdelkov, vendar trenutno ne spada na področje uporabe standarda ISO/TS 20451:2017.
Sklice na standarde ISO 11238, ISO 11239, ISO 11240 in ISO 11615 ter standarde o sporočanju HL7 (HL7 – referenčni informacijski model (RIM), HL7 V3 – splošni model za izdelke (CPM) in HL7 V3 – strukturirano označevanje izdelkov (SPL)) je mogoče uporabiti za informacije o farmacevtskih izdelkih v kontekstu standarda ISO/TS 20451:2017.

General Information

Status
Published
Publication Date
15-May-2018
ICS
35.240.80 - IT applications in health care technology
Technical Committee
CEN/TC 251 - Medical informatics
Drafting Committee
CEN/TC 251/WG 1 - Information models
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-May-2018
Due Date
09-Apr-2017
Completion Date
16-May-2018
Ref Project
SIST-TS 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)

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SLOVENSKI STANDARD
01-september-2018
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za
uporabo ISO 11616 podatkovnih elementov in struktur za enotno identifikacijo in
izmenjavo predpisanih informacij o farmacevtskih izdelkih (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 (ISO/TS 20451:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für
ISO 11616 Datenelemente und -strukturen zur eindeutigen Identifikation und zum
Austausch von Informationen über pharmazeutische Produkte (ISO/TS 20451:2017)
Informatique de santé - Identification des médicaments - Lignes directrices pour
l’implémentation des éléments de données et structures ISO 11616 pour l’identification
unique et l’échange d’informations réglementées sur les produits pharmaceutiques
(ISO/TS 20451:2017)
Ta slovenski standard je istoveten z: CEN ISO/TS 20451:2018
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TS 20451
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
May 2018
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
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)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Lignes directrices pour l'implémentation des Arzneimitteln - Implementierungsleitfaden für ISO
éléments de données et structures ISO 11616 pour 11616 Datenelemente und -strukturen zur eindeutigen
l'identification unique et l'échange d'informations Identifikation und zum Austausch von Informationen
réglementées sur les produits pharmaceutiques über pharmazeutische Produkte (ISO/TS 20451:2017)
(ISO/TS 20451:2017)
This Technical Specification (CEN/TS) was approved by CEN on 13 May 2018 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 20451:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Endorsement notice . 3

European foreword
This document (CEN ISO/TS 20451:2018) has been prepared by Technical Committee ISO/TC 215 "
Health informatics " in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 20451:2017 has been approved by CEN as CEN ISO/TS 20451:2018 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 20451
First edition
2017-10
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
Informatique de santé — Identification des médicaments — Lignes
directrices pour l’implémentation des éléments de données et
structures ISO 11616 pour l’identification unique et l’échange
d’informations réglementées sur les produits pharmaceutiques
Reference number
ISO/TS 20451:2017(E)
©
ISO 2017
ISO/TS 20451:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

ISO/TS 20451:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Conformance . 2
5 Concepts required for the unique identification of pharmaceutical products .2
5.1 General considerations for elements required for the unique identification of
pharmaceutical products . 2
5.2 Principles required for the unique identification of a pharmaceutical product . 2
6 Identifying characteristics for the identification of pharmaceutical products .3
6.1 Pharmaceutical product identification strata and levels . 3
6.2 PhPID specified substance . 4
6.3 Pharmaceutical product specified substance identification (PhPID SpSub) . 5
6.4 Cardinality . 5
6.5 Representation of strength concentration . 6
6.6 Pharmaceutical product identifier (PhPID) . 6
6.7 PhPID algorithm and product code concept. 7
7 Ingredient, substance and strength . 8
7.1 General considerations . 8
7.2 Ingredient . 9
7.2.1 Ingredient role . 9
7.2.2 Substance .10
7.2.3 Specified substance .10
7.2.4 Specified substance group .10
7.2.5 Confidentiality indicator .11
7.2.6 Strength .11
7.2.7 Pharmaceutical product code concept for representing the normalised
strength for liquid preparations .11
7.2.8 Strength (presentation) .12
7.2.9 Strength (concentration) .12
7.2.10 Measurement point .13
7.2.11 Country . .13
7.2.12 Reference strength .13
7.2.13 Reference substance .13
7.2.14 Reference specified substance .13
7.2.15 Reference strength .13
7.2.16 Reference strength measurement point .14
7.2.17 Reference strength country .14
8 Pharmaceutical product: adjuvants and devices .14
8.1 General considerations .14
8.1.1 Detailed description of pharmaceutical product and device information .14
8.1.2 Pharmaceutical product .15
8.1.3 Pharmaceutical product characteristics .17
8.1.4 Device (pharmaceutical product) .
...

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