I.S. EN ISO 11615:2017
Current
The latest, up-to-date edition.
HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO 11615:2017)
Hardcopy , PDF
English
01-01-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, symbols, abbreviated terms
4 Message exchange format
5 Conformance terminology and context as
it relates to the ISO IDMP standards and
corresponding IDMP technical specifications
6 Concepts required for the unique
identification of Medicinal Products
7 Description of the information modelling
principles and practices
8 Identifying characteristics for authorised
Medicinal Products
9 Information for an authorised Medicinal
Product
10 Identifying characteristics for Investigational
Medicinal Products
11 Information for an Investigational Medicinal
Product
Annex A (normative) - Full model - Authorised Medicinal
Products detailed diagram
Annex B (normative) - Full model - Investigational
Medicinal Products detailed diagram
Bibliography
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