EN ISO 11615:2017

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

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.