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 - Part 1: ISO 11238 implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
Abstract
This document is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production. ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high-level model for the structuring of information for substances. This document provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of Substances and Specified Substances. In current edition of the document, the previous version is split into a series of documents. This first edition of this document addresses the following: - The data elements necessary for describing Substances and Specified Substances Groups 1 to 4; - The data elements necessary for the unique definition of Substances and Specified Substances Groups 1; - The logical use of data elements as defined in ISO 11238; This document does not address the following: - Business processes for data management; - Implementation of a specific data information system (e.g. a relational database schema); - Normative messaging standards for substances; - The maintenance of controlled vocabularies; - The specific global identifier system that should be used; - Nomenclature standards for substances. This document does not address the following, which may be addressed in the other documents of the series: Substances and Specified Substances Groups 1 to 4 business rules for - determining necessary data elements, - distinguishing and defining material types according to ISO 11238, - triggering the assignment of identifiers. Due to their inherent complexity, the specific case of Advanceed Therapies will be addresses in future versions of this document. An overview of Advanceed Therapies is available in the informative Annex A.
Begin
2024-07-02
WI
00251421
Planned document number
DIN CEN ISO/TS 19844-1
Project number
17600108
Responsible national committee
Responsible european committee
CEN/TC 251 - Health informatics
Responsible international committee
ISO/TC 215/WG 6 - Pharmacy and medicines business
