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
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Unique Identification of Medicinal Products
Establishes data elements and structural models to uniquely identify regulated medicinal products over their lifecycle.
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Data Consistency and Exchange
Focuses on standardized structures facilitating efficient and accurate information exchange between regulatory agencies, healthcare providers, pharmacovigilance entities, and governmental organizations.
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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.
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Support for IDMP Messaging Standards
Aligns with other normative IDMP and messaging standards, ensuring compatibility and successful information exchange in health informatics ecosystems.
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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:
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Regulatory Affairs
Enables regulatory agencies to maintain authoritative databases of medicinal products, aiding in market authorization, compliance monitoring, and reporting.
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Pharmacovigilance
Supports safety monitoring by providing clear identification and data exchange for medicinal products implicated in adverse event reporting.
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Healthcare Delivery
Assists clinicians and pharmacists in accessing standardized medicinal product information for better patient care and medication management.
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International Trade and Compliance
Facilitates global trade by ensuring the medicinal products meet uniform regulatory requirements, thereby reducing technical barriers.
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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.
Open preview (PDF)Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information — Amendment 1