DIN CEN ISO/TS 19844:2017-12

This document provides comprehensive implementation guidelines for DIN EN ISO 11238. It describes an information model for defining and identifying substances contained in medicinal products or used for medical purposes, including food supplements, food and feed additives, and cosmetics. Since this document is based on DIN EN ISO 11238 and the latter - at least in the original ISO version - is referenced in the pharmacovigilance legislation, this document is also of great importance. Compared to DIN CEN ISO/TS 19844:2016-08, in addition to editorial changes, four further normative annexes have been added to describe further substance groups. This document (CEN ISO/TS 19844:2017) has been prepared by Technical Committee ISO/TC 215 "Health Informatics" (secretariat: ANSI, United States) with the participation of German experts and adopted by Technical Committee CEN/TC 251 "Medical Informatics" (secretariat: NEN, the Netherlands). The responsible German standardization committee is Working Committee NA 063-07-03 AA "Terminologie" ("Terminology") at DIN Standards Committee Medicine (NAMed).