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)

ISO 11615:2012 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.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation von Arzneimitteln für den Austausch von behördlich genehmigten Arzneimittelinformationen (ISO 11615:2012)

Die in der Einleitung aufgelisteten Normen definieren, charakterisieren und identifizieren zulassungsbedürftige
Humanarzneimittel während ihres gesamten Lebenszyklus, d. h. von der Entwicklung bis zur Zulassung des
Arzneimittels, nachdem es in den Verkehr gebracht wurde, wenn eine Verlängerung der Zulassung ansteht
oder das Arzneimittel gegebenenfalls aus dem Verkehr zu ziehen ist.
Genauer gesagt, legt diese Norm Definitionen und Begriffe fest und beschreibt Datenelemente und deren
strukturelle Beziehungen, die für eine detaillierte Beschreibung und eine eindeutige Identifikation von
Arzneimitteln erforderlich sind.
Des Weiteren sind zur Unterstützung des erfolgreichen Informationsaustausches im Zusammenhang mit der
eindeutigen Identifikation und der Charakterisierung von Arzneimitteln weitere Normen zur
Nachrichtenübermittlung angegeben, die im Kontext der vorliegenden Norm ebenfalls anzuwenden sind.

Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les médicaments (ISO 11615:2012)

L'ISO 11615:2012 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 de médicaments.

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o medicinskih izdelkih (ISO 11615:2012)

Ta mednarodni standard 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 mednarodnega standarda.

General Information

• Status: Withdrawn
• Publication Date: 31-Oct-2012
• Withdrawal Date: 05-Dec-2017
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 06-Dec-2017
• Ref Project: SIST EN ISO 11615:2013 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2012)

Relations

• Replaced By: 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)
• Effective Date: 13-Dec-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o
medicinskih izdelkih (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)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen für den Austausch von zulassungsbezogenen Produktinformationen für
Arzneimittelverzeichnisse (ISO 11615:2012)
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VWUXFWXUHVSRXUO
LGHQWLILFDWLRQXQLTXHHWO
pFKDQJHG
LQIRUPDWLRQVUpJOHPHQWpHVVXUOHV
PpGLFDPHQWV,62
Ta slovenski standard je istoveten z: EN ISO 11615:2012
ICS:
11.020 0HGLFLQVNHYHGHLQ Medical sciences and health
]GUDYVWYHQRYDUVWYHQL care facilities in general
SULSRPRþNLQDVSORãQR
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.

EUROPEAN STANDARD
EN ISO 11615
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products - Data
elements and structures for the unique identification and
exchange of regulated medicinal product information (ISO
11615:2012)
Informatique de santé - Identification des médicaments - Medizinische Informatik - Identifikation von Arzneimitteln -
Éléments de données et structures pour l'identification Datenelemente und -strukturen zur Identifikation von
unique et l'échange d'informations réglementées sur les Arzneimitteln für den Austausch von behördlich
médicaments (ISO 11615:2012) genehmigten Arzneimittelinformationen (ISO 11615:2012)
This European Standard was approved by CEN on 24 May 2012.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11615:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Foreword
This document (EN ISO 11615:2012) 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 May 2013, and conflicting national standards shall be withdrawn at the
latest by May 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11615:2012 has been approved by CEN as a EN ISO 11615:2012 without any modification.

INTERNATIONAL ISO
STANDARD 11615
First edition
2012-11-01
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 réglementées sur les médicaments
Reference number
ISO 11615:2012(E)
©
ISO 2012
ISO 11615:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 11615:2012(E)
Contents Page
Foreword . v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviations . 1
3.1 Terms and definitions . 1
3.2 Abbreviations .12
4 Requirements .14
4.1 Concepts required for the unique Identification of Medicinal Products .14
5 Description of the information modelling principles and practices .17
5.1 General considerations .17
5.2 Conceptual overview diagrams .18
5.3 Section high-level diagrams .19
5.4 Detailed description diagrams .20
6 Identifying characteristics for authorized Medicinal Products .23
6.1 Primary identifiers .23
6.2 Medicinal Product Identifier (MPID) .23
6.3 Packaged Medicinal Product Identifier (PCID) .24
6.4 Medicinal Product Batch Identifier (BAID_1) .25
6.5 Medicinal Product Batch Identifier (BAID_2) .25
7 Information for an authorized Medicinal Product .25
7.1 Authorized Medicinal Product — Information overview .25
7.2 Medicinal Product .27
7.3 Marketing Authorization .32
7.4 Organization .38
7.5 Manufacturer/Establishment .40
7.6 Packaged Medicinal Product, including Manufactured Item and Device .41
7.7 Ingredient, Substance and Strength .50
7.8 Pharmaceutical Product and Device .54
7.9 Clinical Particulars .58
8 Identifying characteristics for Investigational Medicinal Products .66
8.1 General .66
8.2 Primary identifiers .66
8.3 Investigational Medicinal Product Identifier (IMPID).67
8.4 Investigational Medicinal Product Package Identifier (IPCID) .68
8.5 Investigational Medicinal Product Batch Identifier (IBAID_1) .68
8.6 Investigational Medicinal Product Batch Identifier (IBAID_2) .68
9 Information for an Investigational Medicinal Product .69
9.1 Conceptual overview of the information for an Investigational Medicinal Product .69
9.2 Investigational Medicinal Product .70
9.3 Clinical Trial Authorization .72
9.4 Manufacturer/Establishment .75
9.5 Investigational Packaged Medicinal Product .75
9.6 Pharmaceutical Product .76
9.7 Ingredient .77
9.8 Clinical particulars .77
Annex A (informative) Full model — Authorized Medicinal Products conceptual level .78
Annex B (informative) Full model — Authorized Medicinal Products detailed diagram .79
Annex C (informative) Full model — Investigational Medicinal Products conceptual level .80
ISO 11615:2012(E)
Annex D (informative) Full Model — Investigational Medicinal Products detailed diagram .81
Annex E (informative) Worked example in tabular form .82
Annex F (informative) Class and attribute listing .91
Annex G (informative) Example implementation of Medicinal Product information .105
Bibliography .113
iv © ISO 2012 – All rig
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