Overview
EN ISO 11238:2018 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018) - defines an information model and data structures to identify and describe substances used in medicinal products and related products (including dietary supplements, foods and cosmetics). Published in 2018 and endorsed by CEN, this standard supports interoperable exchange of regulated substance information across human and veterinary domains.
Key topics and requirements
- Information model and data elements: standardized classes, attributes and relationships to represent substances for unique identification and data exchange.
- Types of substances covered: chemical substances, proteins, nucleic acids, polymers, structurally diverse substances, mixtures and more - with element sets for structure, isotopes, modifications, taxonomy and source material.
- Specified substance levels: definitions for Specified Substance Groups (Groups 1–4) to capture increasing levels of analytical and specification detail.
- Naming and identifiers: guidance on naming conventions and requirements for assigning and managing unique identifiers and referencing existing identifiers.
- Molecular representation and codes: references and mechanisms for including molecular structure representations and established external terminologies.
- Message exchange and conformance: guidance on message formats, conformance terminology and how implementations should reference related technical specifications.
- Special topics: authentication of herbal drugs, grades, manufacturing, analytical data, versioning and specification metadata.
Practical applications
- Create interoperable drug/substance registries and master data management for regulatory submissions.
- Support regulatory reporting, pharmacovigilance, product labeling and regulatory information exchange between national authorities and industry.
- Integrate substance-level detail in EHRs, clinical trial systems, and pharmacovigilance platforms for consistent medication-related data.
- Enable consistent supply chain and manufacturing documentation (grades, source materials, specifications) and cross-border exchange of regulated information.
- Serve as the backbone for drug terminology services, database vendors and APIs exchanging substance metadata.
Who should use this standard
- Regulatory agencies and medicines authorities
- Pharmaceutical and biotech companies (regulatory affairs, R&D, manufacturing)
- Health informatics architects, EHR and clinical systems vendors
- Data governance, terminology and interoperability teams
- Standards implementers and integrators of drug dictionaries
Related standards
EN ISO 11238:2018 is part of the international suite addressing unique identification of medicinal products (the IDMP family). Implementers should align it with complementary ISO/CEN standards and external terminologies referenced within the document for full end-to-end interoperability.
Keywords: EN ISO 11238:2018, ISO 11238, health informatics, identification of medicinal products, substance identification, data elements, unique identifiers, pharmaceutical data exchange, IDMP, regulatory interoperability.
