prEN ISO 11615
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/DIS 11615:2025)
Draft Public enquiryProject stage codes
1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas
2. Projektas
3. Viešoji apklausa
From 2025-09-26
till 2025-11-25
4. Closure of enquiry
5. Submission to Formal Vote
Organisation
CEN Europos standartizacijos komitetasICS
35.240.80 - IT applications in health care technologyTechnical Committee
TK 99 Health InformaticsForeignTC'S
CEN/TC 251Number of comments
0Comment start date
2025-09-26Scope
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.Relations
Pakeis