ISO 11616:2017

Overview

ISO 11616:2017 - Health informatics - Identification of medicinal products - defines the data elements, structures and relationships needed to uniquely identify and exchange regulated pharmaceutical product information. Part of the IDMP (Identification of Medicinal Products) family, ISO 11616:2017 specifies how to build pharmaceutical product identifiers (PhPID) and how these relate to Medicinal Product Identifiers (MPID), Package Component Identifiers (PCID), Investigational Medicinal Product Identifiers (IMPID) and Investigational Package Component Identifiers (IPCID). The standard supports lifecycle activities such as regulatory submissions, pharmacovigilance, e-prescribing and clinical decision support while ensuring global interoperability. (Veterinary products are out of scope.)

Key topics and technical requirements

• Data elements and structures: Defines mandatory and optional data elements to represent a medicinal product at specified levels of detail.
• Identifiers and relationships: Formalizes PhPID and its association with MPID, PCID, IMPID and IPCID to enable unique global identification.
• Identification strata and levels: Describes strata for substance-based and specified-substance product identification and rules for incomplete information.
• Representation of strength: Rules and attributes to express strength/concentration (including special cases such as patches).
• Information modeling: Conceptual, high‑level and detailed diagrams and modeling practices to represent classes, attributes and relationships.
• Exchange and messaging: Requirements to assemble product information in a structured format for secure exchange between stakeholders, supporting interoperability and compatibility.
• Conformance and context: Guidance on conformance terminology within the broader IDMP technical specifications and messaging standards.

Applications and who uses it

ISO 11616:2017 is applied where reliable, consistent identification and exchange of regulated pharmaceutical product information is required:

• Regulatory authorities - for submissions, registration, lifecycle management and cross-border regulatory exchange.
• Pharmaceutical companies - to prepare compliant submission data and exchange product master data.
• Pharmacovigilance teams - to trace products, report adverse events and manage safety across regions.
• Health IT vendors / EHR and e‑prescribing systems - to enable clinical decision support, prescribing accuracy and interoperability.
• Standards implementers and data modelers - for mapping, integration and building messaging workflows (e.g., to HL7 SPL/CPM).

Related standards

ISO 11616:2017 is part of the IDMP suite and references other normative documents:

• ISO 11615 (Medicinal Product data elements)
• ISO 11238 (Substances)
• ISO 11239 (Dose forms, units, routes, packaging)
• ISO 11240 (Units of measurement)
• ISO/TS 20443, ISO/TS 19844, ISO/TS 20451, ISO/TS 20440 and HL7 Structured Product Labeling (SPL) / Common Product Model (CPM)

ISO 11616:2017 enables standardized, interoperable medicinal product identification and exchange - a foundation for global regulatory compliance, pharmacovigilance and safe clinical use of medicines.