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EN ISO 11616:2012

(Main)

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (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

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SLOVENSKI STANDARD
SIST EN ISO 11616:2013
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
SIST EN ISO 11616:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11616:2013

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SIST EN ISO 11616:2013


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.

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SIST EN ISO 11616:2013
EN ISO 11616:2012 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 11616:2013
EN ISO 11616:2012 (E)
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 R
...

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