ISO TS 19844-2018 PDF

Full title and description

Health informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2018). This Technical Specification gives element‑by‑element implementation guidance to support ISO 11238 (the IDMP Substances model), including definitions, data elements, structures, examples and business rules for defining and distinguishing Substances and Specified Substances (Groups 1–3) and related annexes.

Abstract

ISO/TS 19844:2018 provides practical implementation guidance for ISO 11238 (Substance identification within the IDMP suite). It focuses on describing data elements and logical usage required to define Substances and Specified Substances by scientific identity, supplying examples and business rules to trigger identifier assignment and to ensure consistent exchange of regulated substance information. The specification explicitly excludes business process design, specific database schemas, normative messaging formats, controlled‑vocabulary maintenance and choice of global identifier system.

General information

• Status: Published (Technical Specification).
• Publication date: July 2018 (published 2018‑07).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 35.240.80 (Health informatics / IT applications in health care technology).
• Edition / version: Edition 3 (2018).
• Number of pages: 887 (ISO bibliographic record).

Scope

Provides implementation‑level guidance to apply the conceptual model of ISO 11238 for uniquely identifying and exchanging regulated information on substances used in or as medicinal products. The scope covers data elements and structures for Substances and Specified Substances (Groups 1–3), the logical use of those elements, element‑level business rules for distinguishing materials and when to assign identifiers, and extensive worked examples and annex material. It does not address organisational data‑management processes, specific database schemas, maintenance of controlled vocabularies, or mandate any particular global identifier system.

Key topics and requirements

• Detailed element‑by‑element implementation guidance for ISO 11238 (Substance identification).
• Definitions and rules to represent Substances and Specified Substances by scientific identity (not by use or manufacture).
• Business rules for determining required data elements, distinguishing substances, and triggering assignment of unique identifiers.
• Data structures, examples for a wide range of substance types (Groups 1–3) and annexes with supplementary guidance.
• Clarifications on exclusions (e.g., no prescriptive messaging standard, no controlled‑vocabulary maintenance guidance, no specific identifier system mandated).

Typical use and users

Used by national regulators, pharmaceutical companies, pharmacovigilance units, regulatory affairs teams, terminology/ontology specialists and health‑IT implementers who need to represent, exchange or manage authoritative substance information for medicinal products. It is commonly applied when implementing IDMP‑compliant systems (e.g., regulatory submissions, safety reporting, product master data management and mapping between authoritative terminologies).

Related standards

Part of the IDMP family. Core related ISO standards include ISO 11238 (Substances — the conceptual model this document implements), ISO 11239 (dose forms, routes, packaging), ISO 11240 (units of measurement), ISO 11615 (regulated medicinal product information) and ISO 11616 (pharmaceutical product identification). Implementation‑level companion technical specifications for other IDMP standards (for example ISO/TS 20443 and ISO/TS 20451) are also relevant when implementing end‑to‑end IDMP solutions.

Keywords

IDMP, ISO 11238, substance identification, specified substance, medicinal product, implementation guidelines, data elements, business rules, pharmacovigilance, regulatory data exchange.

FAQ

Q: What is this standard?

A: ISO/TS 19844:2018 is a Technical Specification that provides implementation guidance for ISO 11238 (the IDMP Substances model), detailing the data elements, structures and business rules needed to represent and exchange regulated information on substances used in medicinal products.

Q: What does it cover?

A: It covers element‑level explanations, data structures, business rules and examples for defining Substances and Specified Substances (Groups 1–3) by scientific identity, and explains when unique identifiers should be assigned. It explicitly excludes data‑management processes, prescriptive database schemas, normative messaging standards and controlled‑vocabulary maintenance.

Q: Who typically uses it?

A: Regulators, pharmaceutical and biotech companies, regulatory affairs and pharmacovigilance teams, health‑IT implementers, and terminology/ontology specialists implementing IDMP‑compliant systems or exchanging authoritative substance data.

Q: Is it current or superseded?

A: As published, ISO/TS 19844:2018 is the active Technical Specification (published July 2018). ISO’s records indicate the document is subject to routine review and work items have been registered to evolve the implementation parts of the 19844 family into numbered parts (for example drafts and committee drafts for ISO/DTS 19844‑1, ISO/CD TS 19844‑2 and ISO/AWI TS 19844‑3). Users should check the ISO catalogue or national standards bodies for any amendments, part publications or replacements that may have appeared after 2018.

Q: Is it part of a series?

A: Yes — it is an implementation guideline in the broader IDMP family. ISO/TS 19844:2018 implements ISO 11238 and is complemented by other IDMP implementation specifications (e.g., those supporting ISO 11615 and ISO 11616) and by the related ISO 11239/11240 standards for dose forms and units. Current ISO work items show planned or in‑progress part authorship to split and extend 19844 into multiple parts focused on general guidance, chemical substances and protein substances.

Q: What are the key keywords?

A: IDMP, substance identification, ISO 11238, specified substance, data elements, implementation guidelines, pharmacovigilance, regulatory data exchange.