ISO/TS 20443:2017

Indisponible en français

Publiée (Edition 1, 2017)

Cette norme a été révisée et confirmée pour la dernière fois en 2021. Cette édition reste donc d’actualité.

ISO/TS 20443:2017

CHF 216

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Résumé

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.

Informations générales

État actuel
: Publiée

Date de publication
: 2017-10

Stade
: Norme internationale à réviser [90.92]
Edition
: 1
Comité technique :
ISO/TC 215

ICS :
35.240.80
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