delSRPS CEN ISO/TS 6476:2022

Health Informatics -- Logical Model for the Identification of Medicinal Products for ISO 11615

Scope

The TS will describe a logical model representation of ISO the IDMP 11615:2017 conceptual data
model at a greater level of granularity, independent from any specific database design, data storage
requirements or data exchange (messaging) standard. The IDMP logical model can be used as
reference for any IDMP implementation and shall be enhanced by a subset of realistic examples
adapted from publicly available sources. The examples will be linked to the use cases described in
IDMP 11615, such as the submission of product information to a regulatory authority, reporting of
adverse events associated with the use of a product or supply chain management. The examples
described in this TS will be sufficient to demonstrate a realistic and consistent application of IDMP
11615 concepts, attributes, data types and terminology to support a variety of IDMP implementation
projects. It is expected that additional IDMP implementation guidance will be published by regulatory
authorities, especially in support of submissions that require strict compliance and/or alignment with
legislative/jurisdictional requirements. Therefore, this TS is intended to be complementary and
independent from formal or more binding regulatory guidance.