EN 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 11615:2017)

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.
Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Arzneimittelinformationen (ISO 11615:2017)

Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations sur les médicaments contrôlés (ISO 11615:2017)

ISO 11615:2017 établit des définitions et des concepts, et décrit des éléments de données et leurs relations structurelles, nécessaires à l'identification unique et à la description détaillée des médicaments.
Considérées ensemble, les normes listées dans l'introduction définissent, caractérisent et identifient de façon unique des médicaments réglementés à usage humain pendant leur cycle de vie complet, c'est-à-dire depuis leur développement jusqu'à leur autorisation, leur mise sur le marché consécutive et leur renouvellement ou leur retrait du marché, le cas échéant.
En outre, pour garantir l'échange satisfaisant des informations relatives à l'identification unique et à la caractérisation des médicaments, le recours à d'autres normes IDMP et de messagerie à appliquer dans le contexte du présent document est inclus.

Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o zdravilih (ISO 11615:2017)

Ta dokument določa opredelitve in pojme ter opisuje podatkovne elemente in njihove strukturne povezave, ki so potrebni za enotno identifikacijo in podroben opis medicinskih izdelkov.
V uvodu navedeni standardi torej opredeljujejo, označujejo in enotno določajo predpisane medicinske izdelke za ljudi v času njihovega celotnega življenjskega cikla, tj. od razvoja do izdaje dovoljenja, poprodaje in podaljšanja ali umika s trga, kjer je to primerno.
Poleg tega je zaradi podpore uspešne izmenjave informacij v zvezi z enotno identifikacijo in določanjem lastnosti medicinskih izdelkov vključena uporaba drugih normativnih standardov o sporočanju in identifikaciji medicinskih izdelkov (IDMP) za uporabo v okviru 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 11615:2018 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)

Relations

• Replaces: EN ISO 11615:2012 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2012)
• Effective Date: 13-Dec-2017
• Amended By: EN ISO 11615:2017/A1:2022 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1 (ISO 11615:2017/Amd 1:2022)
• Effective Date: 03-Jun-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2018
1DGRPHãþD
SIST EN ISO 11615:2013
Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za
enotno identifikacijo in izmenjavo predpisanih informacij o zdravilih (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 11615:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation von Arzneimitteln für den Austausch von behördlich
genehmigten Arzneimittelinformationen (ISO 11615:2017)
Informatique de santé - Identification des médicaments - Éléments de données et
structures pour l'identification unique et l'échange d'informations sur les médicaments
(ISO 11615:2017)
Ta slovenski standard je istoveten z: EN ISO 11615:2017
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 11615
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11615:2012
English Version
Health informatics - Identification of medicinal products -
Data elements and structures for the unique identification
and exchange of regulated medicinal product information
(ISO 11615:2017)
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 sur Identifikation von Arzneimitteln für den Austausch von
les médicaments contrôlés (ISO 11615:2017) behördlich genehmigten Arzneimittelinformationen
(ISO 11615:2017)
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 11615:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11615:2017) 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 11615:2012.
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 11615:2017 has been approved by CEN as EN ISO 11615:2017 without any modification.

INTERNATIONAL ISO
STANDARD 11615
Second edition
2017-10
Health informatics — Identification
of medicinal products — Data
elements and structures for the
unique identification and exchange
of regulated medicinal product
information
Informatique de santé — Identification des médicaments — Éléments
de données et structures pour l'identification unique et l'échange
d'informations sur les médicaments contrôlés
Reference number
ISO 11615:2017(E)
©
ISO 2017
ISO 11615:2017(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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 11615:2017(E)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 2
4 Message exchange format .13
5 Conformance terminology and context as it relates to the ISO IDMP standards and
corresponding IDMP technical specifications .14
6 Concepts required for the unique identification of Medicinal Products.14
6.1 General considerations .14
6.2 Authorised Medicinal Products .14
6.3 Investigational Medicinal Products .15
6.4 Concepts required for the unique identification of a Medicinal Product and the
association with PhPID(s) .15
6.5 Concepts required for the unique identification of Medicinal Products and the
association with the marketing authorisation number .15
6.6 Concepts required for the unique identification of Medicinal Products and the
association with data carrier identifiers .16
7 Description of the information modelling principles and practices .17
7.1 General considerations .17
7.2 Conceptual overview diagrams .17
7.3 High-level diagrams .18
7.4 Detailed description diagrams .18
7.4.1 General.18
7.4.2 Relationships between classes .19
7.4.3 Attributes of classes .20
7.4.4 Generalised classes and patterns .20
7.4.5 Translation and language .20
8 Identifying characteristics for authorised Medicinal Products.20
8.1 Primary identifiers — General considerations .20
8.2 Medicinal Product Identifier (MPID) .21
8.2.1 General considerations .21
8.2.2 MPID code segments .21
8.3 Packaged Medicinal Product Identifier (PCID) .22
8.3.1 General considerations .22
8.3.2 Package description (PCID) code segment.23
8.4 Medicinal Product Batch Identifier (BAID1) .23
8.5 Medicinal Product Batch Identifier (BAID2) .23
9 Information for an authorised Medicinal Product .24
9.1 Authorised Medicinal Product — Information overview .24
9.1.1 General.24
9.1.2 Medicinal Product .24
9.1.3 Medicinal Product name .24
9.1.4 Header .25
9.1.5 Manufacturer/Establishment (organisation) .25
9.1.6 Marketing authorisation .25
9.1.7 Packaged Medicinal Product .25
9.1.8 Pharmaceutical product .25
9.1.9 Ingredient .
...