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ISO 11615:2017

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information

Publication date:   Oct 19, 2017

General information

90.92 Standard to be revised   Nov 29, 2023

ISO

ISO/TC 215 Health informatics

International Standard

35.240.80   IT applications in health care technology

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Scope

ISO 11615:2017 establishes definitions and 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, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, 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 use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11615:2012

NOW

PUBLISHED
ISO 11615:2017
90.92 Standard to be revised
Nov 29, 2023

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 11615:2017/Amd 1:2022

REVISED BY

IN_DEVELOPMENT
ISO/AWI 11615