ISO 11615:2017

Overview

ISO 11615:2017 - Health informatics - Identification of medicinal products - specifies the data elements and structures needed for the unique identification and exchange of regulated medicinal product information. It establishes definitions, information modelling principles, message exchange format guidance and the structural relationships of data elements that uniquely characterise regulated medicinal products for human use across their full life cycle - from development and authorisation to post‑marketing, renewal or withdrawal. ISO 11615 is part of the ISO IDMP (Identification of Medicinal Products) family and supports interoperable regulatory and clinical data exchange.

Key Topics and Technical Requirements

• Unique identifiers and code segments for authorised and investigational products, including identifiers referenced in the standard (e.g., MPID, PCID, BAID1/BAID2, IMPID, IPCID).
• Data elements and relationships describing medicinal products, packaged products, pharmaceutical products, ingredients, strengths and clinical particulars.
• Information modelling principles: conceptual overviews, high‑level and detailed diagrams, class relationships and attribute definitions to ensure consistent data structure.
• Message exchange format and conformance guidance to support interoperable data sharing between regulatory bodies, industry systems and health IT.
• Product lifecycle coverage: mapping identification and metadata needs for development, marketing authorisation, post‑marketing surveillance and withdrawal.
• Investigational medicinal product considerations and separate identifier schemes for clinical trial contexts.
• Emphasis on translation, language handling and organisation/manufacturer data required for regulatory exchange.

Applications and Who Uses ISO 11615

ISO 11615 is intended for organizations that need consistent, machine‑readable representation of regulated medicinal product information:

• Regulatory authorities for submissions, approval tracking, pharmacovigilance and product lifecycle management.
• Pharmaceutical companies and contract research organizations (CROs) for regulatory dossiers, product master data and clinical trial packaging.
• Health IT vendors, EHR/EMR integrators and interoperability architects implementing IDMP‑aligned data exchange and master data management (MDM).
• Supply chain and serialization systems that need to associate product identifiers with packaging and batch data.
• Data modelers and informaticians mapping product data to standardised schemas for analytics, safety reporting and compliance.

Related Standards

ISO 11615 is part of the broader ISO IDMP suite and is designed to be used together with other IDMP messaging standards and technical specifications to enable complete, standardised exchange of medicinal product information across regulatory and healthcare ecosystems.

Keywords: ISO 11615, IDMP, medicinal product identification, MPID, PCID, IMPID, health informatics, regulatory data exchange, unique identification, medicinal product data elements.