EN ISO 11616:2017

Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)

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.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen pharmazeutischen Produktkennzeichen (ISO 11616:2017)

Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les produits pharmaceutiques (ISO 11616:2017)

ISO 11616:2017 vise à fournir des niveaux d'informations spécifiques pertinents pour l'identification d'un médicament ou d'un groupe de médicaments. Elle définit les éléments de données, les structures et les relations entre des éléments de données nécessaires à l'échange d'informations réglementées visant à identifier de façon unique des produits pharmaceutiques. Cette identification est destinée à être appliquée tout au long du cycle de vie du produit afin de soutenir sur le plan mondial les activités réglementaires, de pharmacovigilance et autres. De plus, le présent document est essentiel pour garantir que les informations sur un produit pharmaceutique sont rassemblées dans un format structuré pouvant être transmis entre différentes parties prenantes, à des fins aussi bien réglementaires que cliniques (par exemple, ordonnances électroniques, aide à la décision clinique). Cela permet d'assurer l'interopérabilité et la compatibilité entre émetteur et destinataire.
ISO 11616:2017 n'est pas destiné à constituer une classification scientifique des produits pharmaceutiques. Il s'agit plutôt d'une association formelle d'éléments de données en particulier, catégorisés en combinaisons spécifiées et identifiés de manière unique lorsque les informations d'un niveau parmi une hiérarchie de niveaux sont insuffisantes. Cela permet l'identification des médicaments sans ambiguïté au niveau mondial.
Des références à d'autres normes IDMP et de messagerie relatives aux informations sur les produits pharmaceutiques sont incluses dans l'Article 2, pour application dans le contexte du présent document.
Les médicaments à usage vétérinaire ne relèvent pas du domaine d'application du présent document.

Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO 11616:2017)

Namen tega dokumenta je zagotoviti specifične ravni informacij v zvezi z identifikacijo medicinskega izdelka ali skupine medicinskih izdelkov. Določa podatkovne elemente, strukture in odnose med podatkovnimi elementi, ki so potrebni za izmenjavo predpisanih informacij, da se enotno identificirajo farmacevtski izdelki. Ta identifikacija se mora uporabljati skozi celoten življenjski cikel izdelka, da se podpirajo farmakovigilanca, regulativne dejavnosti in druge dejavnosti na globalni ravni. Poleg tega je ta dokument bistvenega pomena za zagotavljanje zbiranja informacij o farmacevtskih izdelkih v strukturirani obliki s prenosom med raznolikimi interesnimi skupinami v zakonodajne in klinične namene (npr. e-predpisovanje, podpora za klinično odločanje). To zagotavlja interoperabilnost in usklajenost za pošiljatelja in prejemnika.
Namen tega dokumenta ni znanstvena klasifikacija farmacevtskih izdelkov. To je
uradna zbirka posebnih podatkovnih elementov, ki so kategorizirani v predpisanih kombinacijah in enoznačno prepoznavni, kadar so ravni informacij nepopolne. To omogoča nedvoumno identifikacijo medicinskih izdelkov na globalni ravni.
Sklici na druge normativne standarde za identifikacijo medicinskih izdelkov in sporočanje informacij o farmacevtskih izdelkih so vključeni v točki 2 in namenjeni uporabi v okviru tega dokumenta.
Medicinski izdelki za uporabo v veterini niso del področja uporabe tega dokumenta.

General Information

• Status: Published
• Publication Date: 05-Dec-2017
• Withdrawal Date: 29-Jun-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: 06-Dec-2017
• Completion Date: 06-Dec-2017
• Ref Project: SIST EN ISO 11616:2018 - Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)

Relations

• Replaces: EN ISO 11616:2012 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012)
• Effective Date: 13-Dec-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2018
1DGRPHãþD
SIST EN ISO 11616:2013
Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za
enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih
(ISO 11616:2017)
Health informatics - Identification of medicinal products - Data elements and structures
for the Unique Identification and Exchange of regulated Pharmaceutical Product
Information (ISO 11616:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation und zum Austausch von pharmazeutischen
Produktkennzeichen (ISO 11616:2017)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations réglementées sur les
produits pharmaceutiques (ISO 11616:2017)
Ta slovenski standard je istoveten z: EN ISO 11616:2017
ICS:
11.120.10 Zdravila Medicaments
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.

EN ISO 11616
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11616:2012
English Version
Health informatics - Identification of medicinal products -
Data elements and structures for the Unique Identification
and Exchange of regulated Pharmaceutical Product
Information (ISO 11616:2017)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Éléments de données et structures pour Arzneimitteln - Datenelemente und -strukturen zur
l'identification unique et l'échange d'informations Identifikation und zum Austausch von
réglementées sur les produits pharmaceutiques (ISO pharmazeutischen Produktkennzeichen (ISO
11616:2017) 11616:2017)
This European Standard was approved by CEN on 17 November 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

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
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11616:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11616:2017) 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.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2018, and conflicting national standards shall be
withdrawn at the latest by June 2018.
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 EN ISO 11616:2012.
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 11616:2017 has been approved by CEN as EN ISO 11616:2017 without any modification.

INTERNATIONAL ISO
STANDARD 11616
Second edition
2017-10
Health informatics — Identification
of medicinal products — Data
elements and structures for unique
identification and exchange of
regulated pharmaceutical product
information
Informatique de santé — Identification des médicaments — Éléments
de données et structures pour l'identification unique et l'échange
d'informations réglementées sur les produits pharmaceutiques
Reference number
ISO 11616:2017(E)
©
ISO 2017
ISO 11616:2017(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
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Tel. [phone]
Fax [phone]
[e-mail]
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ii © ISO 2017 – All rights reserved

ISO 11616:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 2
4 Conformance terminology and context as it relates to the ISO IDMP standards and
corresponding IDMP technical specifications . 9
5 Requirements . 9
5.1 Elements required for the unique identification of pharmaceutical products . 9
5.2 Exchange of pharmaceutical product information .10
6 Description of the information modelling principles and practices .10
6.1 General considerations .10
6.2 Conceptual overview diagrams .11
6.3 High-level diagrams .11
6.4 Detailed description diagrams .12
6.4.1 General.12
6.4.2 Relationships between classes .13
6.4.3 Attributes of classes .14
6.4.4 Generalised classes and patterns .14
6.4.5 Translation and language .14
7 Identifying characteristics for the identification of pharmaceutical products .14
7.1 Pharmaceutical product identification strata and levels .14
7.1.1 General.14
7.1.2 PhPID specified substance .15
7.1.3 Pharmaceutical product specified substance identification (PhPID SpSub) .16
7.2 Cardinality .17
7.3 Representation of strength concentration .17
7.4 Pharmaceutical product identifier (PhPID) .18
7.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx) .18
7.5.1 Construct of the pharmaceutical product substance stratum .18
7.5.2 Substance set.18
7.5.3 Administrable dose form .19
7.5.4 Unit of presentation .19
7.5.5 Medical device .19
7.6 Pharmaceutical product specified substance stratum elements (PhPID_SpSUB_Lx) .19
7.6.1 Construct of the pharmaceutical product specified substance stratum .19
7.6.2 Specified substance set .20
7.6.3 Administrable dose form .20
7.6.4 Unit of presentation .20
7.6.5 Medical device .20
7.7 Identifying characteristics to express strength .20
7.7.1 Expressing strength .20
7.7.2 Attributes for representation of strength in PhPID stratum elements .21
7.7.3 Representation of strength for a patch .23
8 Relationship between MPID/PCID and PhPID .23
8.1 Concepts required for the unique identification of a Medicinal Product and the
association with PhPIDs .23
8.2 Pharmaceutical product identification criteria .25
8.2.1 General considerations .25
8.2.2 Multiple products packaged as a kit and administer
...