Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2016
Technical Specification
Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2016
Health informatics — Identification of medicinal products — Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
Edition 2
2016-12
Withdrawn
Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2016
70594
Withdrawn (Edition 2, 2016)

Abstract

Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2016 is used in the implementation of Ïã¸ÛÁùºÏ²Ê¿ª½± 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production.

Ïã¸ÛÁùºÏ²Ê¿ª½± 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the Ïã¸ÛÁùºÏ²Ê¿ª½± IDMP standards. Ïã¸ÛÁùºÏ²Ê¿ª½± 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 Ïã¸ÛÁùºÏ²Ê¿ª½± 11238, and examples for a variety of Substances and Specified Substances.

This second edition of the document addresses substances, Groups 1 to 3 of the Specified Substances as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 11238 and Annexes A, B, C, D, E, F, G and H. It is anticipated that Specified Substances Group 4, as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 may be covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, may be essential to distinguishing substances. This document addresses the following:

· Data elements necessary for defining Substances and Specified Substances Groups 1 to 3;

· The logical use of data elements as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 11238;

· Substances and Specified Substances Groups 1 to 3 business rules for

- determining necessary data elements,

- distinguishing and defining materials according to Ïã¸ÛÁùºÏ²Ê¿ª½± 11238,

- triggering the assignment of identifiers.

Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2016 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.

General information

Got a question?

Check out our Help and Support

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)