Overview
EN ISO 11615:2017/A1:2022 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (Amendment 1) is a CEN-endorsed amendment to ISO 11615:2017. Approved by CEN on 12 August 2022 and endorsed for national adoption by March 2023, this document supports consistent, machine-readable representation of regulated medicinal product information across regulatory, clinical and healthcare systems.
Key topics and technical updates
- Scope: defines data elements and data structures used for the unique identification and exchange of regulated medicinal product information (IDMP).
- Amendment highlights:
- Revision to the Introduction to reference other normative IDMP and messaging standards to support successful information exchange.
- Addition to clause 7.5.4 pointing implementers to new translation/synonym resources.
- New informative Annex C providing language translations and synonyms for class names and attributes used in the IDMP data model (complements Annexes A and B).
- Content emphasis:
- Consistent semantic definitions for class names, attributes and data elements in the IDMP model.
- Implementation considerations for regional/local language translations and synonym usage to ensure semantic interoperability.
- Maintenance and provenance:
Practical applications
- Improves interoperability of medicinal product data across:
- National medicines agencies and regulatory submissions
- Pharmacovigilance and safety reporting systems
- Clinical information systems, e‑prescribing and pharmacy IT
- Healthcare data exchanges and public health reporting
- Helps implementers map local terminology and multilingual labels to standard IDMP concepts, reducing ambiguity in cross-border data exchange and regulatory workflows.
Who should use this standard
- Regulatory authorities and national competent authorities
- Pharmaceutical companies (regulatory affairs, data management)
- Health informatics vendors, EHR and e-prescribing system developers
- Pharmacovigilance and safety surveillance teams
- Hospitals, health insurers and governmental health IT programs seeking consistent medicinal product identification
Related standards and keywords
- Related: ISO 11615 family (IDMP), IDMP messaging standards referenced in the amendment
- SEO keywords: EN ISO 11615:2017/A1:2022, IDMP, identification of medicinal products, data elements, medicinal product information, health informatics, interoperability, pharmacovigilance, regulatory exchange, translations and synonyms
