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EN ISO 11616:2017

(Main)

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

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SLOVENSKI STANDARD
SIST EN ISO 11616:2018
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
SIST EN ISO 11616:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11616:2018

---------------------- Page: 2 ----------------------

SIST EN ISO 11616:2018


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.

---------------------- Page: 3 ----------------------

SIST EN ISO 11616:2018
EN ISO 11616:2017 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 11616:2018
EN ISO 11616:2017 (E)
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, Esto
...

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