Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information (ISO/DIS 11616:2025); German and English version prEN ISO 11616:2025
Abstract
This document provides specific levels of information relevant to the identification of a pharmaceutical rpoduct or groups of pharmaceutical rpoducts. It defines the data elements, structures and relationships among data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification should be applied throughout the product lifecycle to support the exchange of data among all stakeholders from industries applications, regulatory activities, primary use in clinics and secondary use for research and statistics. This includes use cases such as pharmacovigilance, regulatory processes and other activities worldwide. In addition, this document ensures that pharmaceutical product information is assembled in a structured format with transmission among a diverse set of stakeholders for both regulatory and clinical purposes (e.g. risk management, monitoring/management of shortages, e-prescribing, e-dispensation, clinical decision support). This ensures interoperability and compatibility for both the sender and the recipient. This document is not a scientific classification for pharmaceutical products. Rather, it is a formal association of specific data elements categorised in prescribed combinations and uniquely identified. . This allows for hparmaceutical rpoducts to be unequivocally identified on a global level. Medicinal products for veterinary use are out of scope of this document.
Begin
2023-12-05
WI
00251409
Planned document number
DIN EN ISO 11616
Project number
17600057
Responsible national committee
NA 176-02-03 AA - Terminology and e-pharma
Responsible european committee
CEN/TC 251 - Health informatics
Responsible international committee
ISO/TC 215/SC 2/WG 1 - Medicines business
draft standard
Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information (ISO/DIS 11616:2025); German and English version prEN ISO 11616:2025
2025-11
Order from DIN Media
