Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2015
Technical Specification
Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2015
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 1
2015-12
Withdrawn
Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2015
65715
Withdrawn (Edition 1, 2015)

Abstract

Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2015 is used in the implementation of Ïã¸ÛÁùºÏ²Ê¿ª½± 11238. Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2015 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. Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2015 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 first edition of Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2015 will only address substances, and Groups 1 to 3 of the specified substances as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 11238 and Annexes A, B, C, and D. It is anticipated that specified substances Group 4, as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 11238, will be addressed in a subsequent edition of Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2015. Some information that would typically fall under specified substances Group 4 may be covered in the Annexes of Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2015. This information, although not defining of either a substance or a specified substance Group 1, may be essential to distinguishing substances.

Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19844:2015 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.

General information

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