ISO 11615:2017/Amd 1:2022
(Amendment)Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1
Informatique de santé — Identification des médicaments — Éléments de données et structures pour l'identification unique et l'échange d'informations sur les médicaments contrôlés — Amendement 1
General Information
- Status
- Published
- Publication Date
- 24-Aug-2022
- Technical Committee
- ISO/TC 215 - Health informatics
- Drafting Committee
- ISO/TC 215/WG 6 - Pharmacy and medicines business
- Current Stage
- 6060 - International Standard published
- Start Date
- 25-Aug-2022
- Due Date
- 20-May-2022
- Completion Date
- 25-Aug-2022
Relations
- Effective Date
- 11-Dec-2021
Overview
ISO 11615:2017/Amd 1:2022 is an important amendment to the international standard focused on health informatics and the identification of medicinal products (IDMP). This standard specifies data elements and structures required for the unique identification and exchange of regulated medicinal product information. It supports global harmonization by enabling consistent, reliable, and interoperable communication of medicinal product data across different health systems, regulatory bodies, and stakeholders worldwide.
Developed by ISO Technical Committee ISO/TC 215 in collaboration with the European Committee for Standardization (CEN/TC 251), this amendment enhances the original 2017 edition by adding important clarifications related to language translations and semantic interoperability, ensuring greater usability and international adoption.
Key Topics
Unique Identification of Medicinal Products
Establishes data elements and structural models to uniquely identify regulated medicinal products over their lifecycle.Data Consistency and Exchange
Focuses on standardized structures facilitating efficient and accurate information exchange between regulatory agencies, healthcare providers, pharmacovigilance entities, and governmental organizations.Inclusion of Language Translations and Synonyms (Annex C)
Provides guidance on translations and synonyms of class names and attributes used within the IDMP framework. This addition addresses the semantic challenges involved in international implementation and promotes consistent interpretation across different languages and regions.Support for IDMP Messaging Standards
Aligns with other normative IDMP and messaging standards, ensuring compatibility and successful information exchange in health informatics ecosystems.Implementation Guidance
Assists businesses, local authorities, health insurers, hospitals, and other stakeholders in leveraging the IDMP model effectively by overcoming language and semantic barriers.
Applications
ISO 11615:2017/Amd 1:2022 serves as a critical foundation for multiple use cases that rely on precise medicinal product information management, including:
Regulatory Affairs
Enables regulatory agencies to maintain authoritative databases of medicinal products, aiding in market authorization, compliance monitoring, and reporting.Pharmacovigilance
Supports safety monitoring by providing clear identification and data exchange for medicinal products implicated in adverse event reporting.Healthcare Delivery
Assists clinicians and pharmacists in accessing standardized medicinal product information for better patient care and medication management.International Trade and Compliance
Facilitates global trade by ensuring the medicinal products meet uniform regulatory requirements, thereby reducing technical barriers.Health Informatics Systems Integration
Guides the integration of medicinal product datasets into electronic health records (EHRs), clinical decision support systems (CDSS), and supply chain management tools.
Related Standards
ISO 11615:2017/Amd 1:2022 aligns and interoperates with other health informatics standards, enhancing the overall IDMP framework:
- ISO 11238 – Identification of substances used in medicinal products
- ISO 11239 – Dosage forms, units of presentation, strength units
- ISO 11240 – Units of measurement for medicinal products
- ISO 13940 – System of concepts to support continuity of care
- HL7 FHIR – Health Level Seven Fast Healthcare Interoperability Resources for messaging
These complementary standards collectively ensure a comprehensive approach to medicinal product data management and interoperability across global healthcare systems.
Adopting ISO 11615:2017/Amd 1:2022 enables healthcare organizations and regulators to achieve accurate, standardized identification and seamless exchange of medicinal product information, supporting patient safety, regulatory compliance, and efficient healthcare delivery worldwide. For more information and access to the full class names and attribute translations, visit the ISO Standards Maintenance Portal.
ISO 11615:2017/Amd 1:2022 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information — Amendment 1 Released:25. 08. 2022
ISO 11615:2017/Amd 1:2022 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information — Amendment 1 Released:25. 08. 2022
Frequently Asked Questions
ISO 11615:2017/Amd 1:2022 is a standard published by the International Organization for Standardization (ISO). Its full title is "Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1". This standard covers: Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1
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 is classified under the following ICS (International Classification for Standards) categories: 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 11615:2017/Amd 1:2022 has the following relationships with other standards: It is inter standard links to ISO 11615:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 11615:2017/Amd 1:2022 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 11615
Second edition
2017-10
AMENDMENT 1
2022-08
Health informatics — Identification
of medicinal products — Data
elements and structures for the
unique identification and exchange
of regulated medicinal product
information
AMENDMENT 1
Informatique de santé — Identification des médicaments — Éléments
de données et structures pour l'identification unique et l'échange
d'informations sur les médicaments contrôlés
AMENDEMENT 1
Reference number
ISO 11615:2017/Amd.1:2022(E)
ISO 11615:2017/Amd.1:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 11615:2017/Amd.1:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on techni
...
NORME ISO
INTERNATIONALE 11615
Deuxième édition
2017-10
AMENDEMENT 1
2022-08
Informatique de santé —
Identification des médicaments —
Éléments de données et structures
pour l'identification unique et
l'échange d'informations sur les
médicaments contrôlés
AMENDEMENT 1
Health informatics — Identification of medicinal products — Data
elements and structures for the unique identification and exchange of
regulated medicinal product information
AMENDMENT 1
Numéro de référence
ISO 11615:2017/Amd.1:2022(F)
ISO 11615:2017/Amd.1:2022(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2022
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii
ISO 11615:2017/Amd.1:2022(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes
nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est
en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude
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été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir
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Le présent document a été élaboré par le comité technique ISO/TC 215, Informatique de santé, en
collaboration avec le comité technique CEN/TC 251, Informatique de santé, du Comité européen de
normalisation (CEN) conformément à l’Accord de coopération technique entre l’ISO et le CEN (Accord
de Vienne).
Il convient que l’uti
...
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