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)

ISO 11616:2012 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 11616:2012 is essential to ensuring that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders. This ensures interoperability and compatibility for both the sender and the recipient.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation und zum Austausch von pharmazeutischen Produktkennzeichen (ISO 11616:2012)

Diese Internationale Norm definiert Datenelemente, Strukturen und Beziehungen zwischen Datenelementen, die für den Austausch zulassungsbezogener Informationen zwecks Identifikation pharmazeutischer Produkte erforderlich sind. Sie ist anwendbar auf weltweit stattfindende Aktivitäten im Zusammenhang mit der Zulassung von Arzneimitteln und der Pharmakovigilanz.
Mit dieser Norm sollen Definitionen und Begriffe eingeführt sowie Datenelemente und deren strukturelle Beziehungen untereinander festgelegt werden, um eine detaillierte Beschreibung und eindeutige Identifikation pharmazeutischer Produkte zu ermöglichen.
Es sind Verweisungen auf weitere Normen zur Identifikation von Arzneimitteln und zur Nachrichtenübertragung im Zusammenhang mit Informationen zu pharmazeutischen Produkten angegeben, die in Verbindung mit der vorliegenden Norm anzuwenden sind.
Tierarzneimittel liegen außerhalb des Anwendungsbereichs dieser Norm.

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 11616:2012)

L'ISO 11616:2012 vise à fournir des niveaux d'informations spécifiques pertinents pour l'identification d'un médicament ou d'un groupe de médicaments. Elle doit définir des éléments de données, des structures et des relations entre des éléments de données nécessaires pour l'échange d'informations réglementées pour identifier de façon unique des produits pharmaceutiques. Cette identification doit être appliquée tout au long de la durée de vie du produit afin de soutenir sur le plan mondial les activités réglementaires, de pharmacovigilance et autres. De plus, l'ISO 11616:2012 est essentielle pour assurer que les informations sur un produit pharmaceutique sont rassemblées dans un format structuré pouvant être transmis entre différentes parties prenantes et permettant d'assurer l'interopérabilité et la compatibilité entre émetteur et destinataire.

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO 11616:2012)

Namen tega mednarodnega standarda 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 in druge dejavnosti na globalni ravni. Poleg tega je ta mednarodni standard nujen za zagotavljanje zbiranja informacij o farmacevtskih izdelkih v strukturirani obliki s prenosom med raznolikimi interesnimi skupinami. To zagotavlja interoperabilnost in usklajenost za oba, pošiljatelja in prejemnika. Namen tega mednarodnega standarda ni znanstvena klasifikacija farmacevtskih izdelkov. To je uradna zbirka posebnih podatkovnih elementov, kategoriziranih v predpisanih kombinacijah in enoznačno prepoznavnih, ko so ravni informacij nepopolne. To omogoča nedvoumno identifikacijo medicinskih izdelkov. Sklici na druge normativne standarde za identifikacijo medicinskih izdelkov (IDMP) in sporočanje informacij o farmacevtskih izdelkih so vključeni v točki 2 in namenjeni uporabi v okviru tega mednarodnega standarda. Medicinski izdelki za uporabo v veterini niso del področja uporabe 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 11616:2013 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012)

Relations

• Replaced By: 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)
• 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
farmacevtskih izdelkih (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)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation und zum Austausch von pharmazeutischen
produktkennzeichen (ISO 11616:2012)
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 11616:2012)
Ta slovenski standard je istoveten z: EN ISO 11616:2012
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 11616
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 pharmaceutical product information (ISO
11616:2012)
Informatique de santé - Identification des médicaments - Medizinische Informatik - Identifikation von Arzneimitteln -
Éléments de données et structures pour l'identification Datenelemente und -strukturen zur Identifikation und zum
unique et l'échange d'informations réglementées sur les Austausch von pharmazeutischen Produktkennzeichen
produits pharmaceutiques (ISO 11616:2012) (ISO 11616:2012)
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 11616:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11616:2012) 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 11616:2012 has been approved by CEN as a EN ISO 11616:2012 without any modification.

INTERNATIONAL ISO
STANDARD 11616
First edition
2012-11-01
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 11616:2012(E)
©
ISO 2012
ISO 11616:2012(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 11616:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviations . 2
3.1 Terms and definitions . 2
3.2 Abbreviations . 7
4 Requirements . 8
4.1 Elements required for the unique identification of pharmaceutical products . 8
4.2 Exchange of pharmaceutical product information . 9
5 Identifying characteristics for the identification of pharmaceutical products . 9
5.1 Pharmaceutical product identification strata and levels . 9
5.2 Cardinality . 11
5.3 Representation of strength concentration .12
5.4 Pharmaceutical product identifier (PhPID) .12
5.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx) .13
5.6 Pharmaceutical Product Specified Substance Stratum Elements (PhPID_SpSUB_Lx) .15
5.7 Identifying characteristics to express strength .17
6 Relationship between MPID and PhPID .19
6.1 Concepts required for the unique identification of a medicinal product and the association
with PhPIDs .19
6.2 Pharmaceutical product identification criteria .21
7 Relationship between IMPID and PhPID .23
8 Conceptual model .25
Annex A (informative) Examples .27
Annex B (informative) Tabled examples .35
Bibliography .38
ISO 11616:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11616 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2012 – All rights reserved

ISO 11616:2012(E)
Introduction
This International Standard was developed in response to a worldwide demand for internationally harmonized
specifications for medicinal products. It is one of five standards which together provide the basis for the unique
identification of medicinal products. The group of standards comprises:
ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated medicinal product information;
ISO 11616, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated pharmaceutical product information;
ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated information on substances;
ISO 11239, Health informatics — Identification of medicinal products — 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 11240, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of units of measurement.
The purpose of this International Standard is to present data elements, structures and their relationships in
order to uniquely identify and exchange regulated pharmaceutical product information. This International
Standard provides an accurate and consistent mechanism to fully represent the relationship of Pharmaceutical
Product Identifier(s) (PhPID) with the following:
— Medicinal Product Identifier(s) (MPIDs);
— Investigational Medicinal Product Identifier(s) (IMPIDs).
These standards for the Identification of Medicinal Products (IDMP) support the activities of medicines
regulatory agencies worldwide by jurisdiction. These include a variety of regulatory activities related to
development, registration and life cycle management of medicinal products, as well as pharmacovigilance and
risk management.
To meet the primary objectives of the regulation of medicines and pharmacovigilance, it is necessary to reliably
exchange medicinal product information in a robust and reliable manner. The IDMP standards therefore support
the following interactions:
— Regulatory Medicines Authority to Regulatory Medicines Authority;
— pharmaceutical company to Regulatory Medicines Authority;
— sponsor of a c
...