ISO 11238-2018 PDF

Full title and description

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances. This International Standard defines an information model and data elements to describe and uniquely identify substances used in medicinal products (including dietary supplements, food/feed additives and cosmetics) for human and veterinary use.

Abstract

ISO 11238:2018 specifies the conceptual model, data elements and structural relationships needed to represent substances and specified substances so they can be unambiguously identified and exchanged between organisations and information systems. It references external terminologies and provides a framework used by implementation guidance documents for IDMP (Identification of Medicinal Products).

General information

• Status: Published (under routine review; stage marked for revision).
• Publication date: July 2018 (Edition 2, 2018-07).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 35.240.80 — Health informatics.
• Edition / version: Edition 2 (2018).
• Number of pages: 61 (as published by ISO).

Note: a draft revision (ISO/DIS 11238) has been prepared and is/was under development to update the standard; refer to ISO committee outputs for current lifecycle status.

Scope

Provides an information model and defined data elements to identify substances that constitute medicinal products or are used for medicinal purposes, including active substances and specified substances, excipients, and carriers. The model is designed to be applicable across human and veterinary domains and to support regulated data exchange between regulators, manufacturers and downstream systems.

Key topics and requirements

• Information model for substance identity (substance vs specified substance) and relationships between elements.
• Defined data elements for names, codes, structural/chemical identifiers, roles and functional qualifiers.
• Rules to support the unique identification and exchange of regulated substance information between systems and authorities.
• Reference to external terminologies and ontologies and requirement to map to normative vocabularies for interoperability.
• Intended inputs to implementation guidance (e.g., ISO/TS 19844) that explain element-level implementation and examples.

Typical use and users

Used by national and regional medicines regulators, pharmaceutical manufacturers, pharmacovigilance organisations, EHR and drug‑safety system vendors, terminology/ontology providers, and data stewards implementing IDMP-compliant substance registries or exchanging substance information between organisations.

Related standards

Part of the IDMP suite. Key related ISO standards include ISO 11615 and ISO 11616 (regulated medicinal and pharmaceutical product information), ISO 11239 (dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (units of measurement). Implementation/technical specifications such as ISO/TS 19844 provide practical guidance for applying ISO 11238. The IDMP family and its purpose are documented by regulatory authorities (for example FDA summaries of the IDMP standards).

Keywords

ISO 11238, IDMP, substance identification, health informatics, medicinal product, specified substance, unique identifier, data elements, pharmacovigilance, interoperability.

FAQ

Q: What is this standard?

A: ISO 11238:2018 is an International Standard that defines data elements and an information model for the unique identification and exchange of regulated information on substances used in medicinal products.

Q: What does it cover?

A: It covers the conceptual model, required data elements and structural relationships to describe substances (including active and specified substances, excipients and carriers) so they can be unambiguously identified and exchanged between systems and authorities.

Q: Who typically uses it?

A: Regulators, pharmaceutical companies, pharmacovigilance organisations, EHR and drug‑information system vendors, terminology specialists and implementers of national/regional substance registries use this standard.

Q: Is it current or superseded?

A: ISO 11238:2018 is the published edition (2018). It has been placed under routine review and a draft revision (ISO/DIS 11238) has been developed; users should check ISO committee outputs or national bodies for the latest revision or DIS publication status.

Q: Is it part of a series?

A: Yes — ISO 11238 is part of the IDMP series of standards (with ISO 11615, ISO 11616, ISO 11239 and ISO 11240) that together provide a framework for uniquely identifying and exchanging medicinal product information internationally.

Q: What are the key keywords?

A: Substance identification, specified substance, IDMP, health informatics, unique identifier, drug substance data elements, regulatory exchange.