PD CEN ISO/TS 20443:2018 - Page 4

Health informatics. Identification of medicinal products. Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information. | Status: Current, Project Underway

1 Scope This document defines 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, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to 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 normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in this document to support successful information exchange.