CEN ISO/TS 20440:2023

Health informatics - Identification of medicinal products - Implementation guidelines 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/TS 20440:2023)

This document describes 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.
Based on the principles outlined in this document, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts.
This document is intended for use by:
—    any organization that might be responsible for developing and maintaining such controlled vocabularies;
—    any regional authorities or software vendors who want to use the controlled vocabularies in their own systems and need to understand how they are created;
—    owners of databases who want to map their own terms to a standardized list of controlled vocabularies;
—    other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept.
This document does not specify a particular terminology for the implementation of ISO 11239.

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für ISO 11239 Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen über pharmazeutische Darreichungsformen, pharmazeutische Konventionseinheiten, Verabreichungswegen und Verpackungen (ISO/TS 20440:2023)

Dieses Dokument beschreibt Datenelemente und Strukturen zur eindeutigen Identifizierung und zum Austausch von vorgeschriebenen Informationen über pharmazeutische Darreichungsformen, pharmazeutische Konventionseinheiten, Verabreichungswege und Verpackungen.
Auf der Grundlage der in diesem Dokument dargestellten Grundsätze werden harmonisierte kontrollierte Terminologien nach einem vereinbarten Datenpflegeprozess entwickelt, wodurch es den Nutzern ermöglicht wird, die Terminologien heranzuziehen und die geeigneten Benennungen für die Begriffe zu finden, die sie beschreiben möchten. Außerdem werden auch Maßnahmen entwickelt, die eine Abbildung der vorhandenen regionalen Terminologien gegenüber den harmonisierten kontrollierten Terminologien ermöglichen, damit die Identifizierung der entsprechenden Benennungen erleichtert wird. Die für die Benennungen bereitgestellten Codes können dann in den entsprechenden Feldern im PhPID (Identifikator eines pharmazeutischen Produkts), PCID (verpackungsbezogener Arzneimittel-Identifikator) und MPID (Arzneimittel-Identifikator) angewendet werden, um diese Begriffe zu identifizieren.
Das vorliegende Dokument ist vorgesehen zur Anwendung durch:
   alle Organisationen, die für die Entwicklung und Pflege derartiger kontrollierter Vokabularien verantwortlich sein könnten;
   alle regionalen Behörden oder Softwareanbieter, die die kontrollierten Vokabularien in ihren eigenen Systemen anwenden wollen und verstehen müssen, wie sie erzeugt werden;
   Datenbankbesitzer, die ihre eigenen Benennungen auf eine genormte Liste von kontrollierten Vokabularien abbilden wollen;
   weitere Nutzer, die die Hierarchie der kontrollierten Vokabularien verstehen wollen, damit sie die zur Beschreibung eines bestimmten Begriffes am besten geeignete Benennung identifizieren können.
Dieses Dokument legt keine bestimmte Terminologie für die Implementierung von ISO 11239 fest.

Informatique de santé - Identification des produits médicaux - Guide de mise en œuvre des éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les formes des doses pharmaceutiques, les unités de présentation, les voies d'administration et les emballages de l'ISO 11239 (ISO/TS 20440:2023)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Vodilo za uporabo ISO 11239 podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih odmerkih, predstavitvenih enotah, administrativnih poteh in pakiranju (ISO/TS 20440:2023)

Ta dokument navaja podatkovne elemente in strukture za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih odmerkih, predstavitvenih enotah, administrativnih poteh in pakiranju.
Na podlagi načel, navedenih v tem dokumentu, bo razvita usklajena nadzorovana terminologija v skladu z dogovorjenim procesom vzdrževanja, kar bo uporabnikom omogočalo vpogled v terminologijo in odkrivanje ustreznih izrazov za koncepte, ki jih želijo opisati. Razvita bodo tudi določila, ki bodo omogočala preslikavo obstoječe regionalne terminologije v usklajeno nadzorovano terminologijo za lažjo identifikacijo ustreznih izrazov. Kode za izraze bo nato mogoče uporabiti na ustreznih področjih v PhPID, PCID in MPID za identifikacijo teh konceptov.
Ta dokument je namenjen:
–    vsem organizacijam, ki so morda odgovorne za razvoj in vzdrževanje takšnih nadzorovanih slovarjev;
–    vsem regionalnim organom ali dobaviteljem programske opreme, ki želijo uporabljati nadzorovane slovarje v svojih sistemih in se morajo seznaniti z načinom njihove izdelave;
–    lastnikom zbirk podatkov, ki želijo preslikati lastne izraze v standardizirani seznam nadzorovanih slovarjev;
–    drugim uporabnikom, ki se želijo seznaniti s hierarhijo nadzorovanih slovarjev kot pomoč pri prepoznavanju najustreznejšega izraza za opis določenega koncepta.
Ta dokument ne določa posebne terminologije za izvajanje standarda ISO 11239.

General Information

• Status: Published
• Publication Date: 11-Apr-2023
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251 - Medical informatics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 12-Apr-2023
• Completion Date: 12-Apr-2023
• Ref Project: SIST-TS CEN ISO/TS 20440:2023 - 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/TS 20440:2023)

Relations

• Replaces: CEN 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/TS 20440:2016)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2023
Nadomešča:
SIST-TS CEN ISO/TS 20440:2016
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Vodilo za uporabo
ISO 11239 podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo
predpisanih informacij o farmacevtskih odmerkih, predstavitvenih enotah,
administrativnih poteh in pakiranju (ISO/TS 20440:2023)
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/TS 20440:2023)
Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für
ISO 11239 Datenelemente und Strukturen zur eindeutigen Identifikation und zum
Austausch von vorgeschriebenen Informationen über pharmazeutische
Darreichungsformen, pharmazeutische Konventionseinheiten, Verabreichungswegen
und Verpackungen (ISO/TS 20440:2023)
Informatique de santé Identification des produits médicaux Guide de mise en oeuvre
des éléments de données et structures pour l'identification unique et l'échange
d'informations réglementées sur les formes des doses pharmaceutiques, les unités de
présentation, les voies d'administration et les emballages de l'ISO 11239 (ISO/TS
20440:2023)
Ta slovenski standard je istoveten z: CEN ISO/TS 20440:2023
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 20440
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
April 2023
TECHNISCHE SPEZIFIKATION
ICS 35.240.80 Supersedes CEN ISO/TS 20440:2016
English Version
Health informatics - Identification of medicinal products -
Implementation guidelines 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/TS 20440:2023)
Informatique de santé - Identification des produits Medizinische Informatik - Identifikation von
médicaux - Guide de mise en œuvre des éléments de Arzneimitteln - Implementierungsleitfaden für ISO
données et structures pour l'identification unique et 11239 Datenelemente und Strukturen zur eindeutigen
l'échange d'informations réglementées sur les formes Identifikation und zum Austausch von
des doses pharmaceutiques, les unités de présentation, vorgeschriebenen Informationen über
les voies d'administration et les emballages de l'ISO pharmazeutische Darreichungsformen,
11239 (ISO/TS 20440:2023) pharmazeutische Konventionseinheiten,
Verabreichungswegen und Verpackungen (ISO/TS
20440:2023)
This Technical Specification (CEN/TS) was approved by CEN on 10 March 2023 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 20440:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TS 20440:2023) 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.
This document supersedes CEN ISO/TS 20440:2016.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/TS 20440:2023 has been approved by CEN as CEN ISO/TS 20440:2023 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 20440
Second edition
2023-03
Health informatics — Identification
of medicinal products —
Implementation guidelines 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
Informatique de santé — Identification des produits médicaux —
Guide de mise en œuvre des éléments de données et structures pour
l'identification unique et l'échange d'informations réglementées sur
les formes des doses pharmaceutiques, les unités de présentation, les
voies d'administration et les emballages de l'ISO 11239
Reference number
ISO/TS 20440:2023(E)
ISO/TS 20440:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO/TS 20440:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Organization of controlled terms . 2
4.1 General . 2
4.2 Code-term pair and coded concept . 2
4.2.1 General . 2
4.2.2 Code-term pair . 2
4.2.3 Coded concept . 5
4.3 Versioning . 7
4.3.1 Versioning of the term . 7
4.3.2 Versioning of the terminology . 10
5 Terminologies .10
5.1 General . 10
5.2 Pharmaceutical dose form . 10
5.2.1 Pharmaceutical dose form overview . 10
5.2.2 Pharmaceutical dose form schema . 11
5.2.3 Pharmaceutical dose form example: Prolonged-release tablet . 17
5.2.4 Using pharmaceutical dose form attributes directly .22
5.3 Combined pharmaceutical dose form . 23
5.3.1 Combined pharmaceutical dose form overview .23
5.3.2 Combined pharmaceutical dose form schema . 24
5.3.3 Combined pharmaceutical dose form example: Powder and solvent for
solution for injection . 25
5.3.4 Other authorised combinations of terms — Combined terms and
combination packs . 26
5.4 Unit of presentation .28
5.4.1 Unit of presentation overview .28
5.4.2 Unit of presentation schema .28
5.4.3 Unit of presentation example: Tablet .29
5.5 Route of administration . 30
5.5.1 Route of administration overview .30
5.5.2 Route of administration schema .30
5.5.3 Route of administration example: Intravenous use . 31
5.6 Packaging . 31
5.6.1 Packaging overview . 31
5.6.2 Packaging schema .
...