prEN ISO 11615 rev

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

General information

10.99 New project approved   Nov 30, 2023

CEN

CEN/TC 251 Health informatics

European Norm

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

PUBLISHED
EN ISO 11615:2017/A1:2022

PUBLISHED
EN ISO 11615:2017

NOW

IN_DEVELOPMENT
prEN ISO 11615 rev
10.99 New project approved
Nov 30, 2023