SN-CEN ISO/TS 20443:2018
Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017)

Standard No.
SN-CEN ISO/TS 20443:2018
Release Date
2018
Published By
Standards Norway
Latest
SN-CEN ISO/TS 20443:2018
 
Scope
ADOPTED_FROM:CEN ISO/TS 20443:2018 ISO/TS 20443:2017 defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange.

SN-CEN ISO/TS 20443:2018 history

  • 2018 SN-CEN ISO/TS 20443:2018 Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017)

Standard and Specification

DANSK DS/CEN ISO/TS 20443:2018 Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017) UNE-CEN ISO/TS 20443:2018 Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017) (Endorsed by Asoc... DIN CEN ISO/TS 20443:2018-11*DIN SPEC 13263:2018-11 Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017); English version ... DIN CEN ISO/TS 20443:2018 Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017); English version ... prCEN ISO/TS 20443 rev Health informatics - Identification of medicinal products — Implementation guidelines for ISO 11615 data elements and structures for the unique identification NS-EN ISO 11615:2017 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal BS EN ISO 11615:2017 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product GSO ISO 11615:2015 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated medicinal DS/EN ISO 11615:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal


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