ISO 11615:2012 PDF

Scope: This International Standard 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, characterize and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorization, postmarketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterization of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of this International Standard.

ISO 11615:2012 Referenced Document

ISO 11238 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances*， 2018-07-01 Update
ISO 11239 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and…*， 2023-06-06 Update
ISO 11240 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement
ISO 11616 Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information*， 2017-10-01 Update
ISO 21090 Health informatics - Harmonized data types for information interchange
ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code*， 2020-08-25 Update
ISO 639-2 Codes for the representation of names of languages - Part 2: Alpha-3 code
ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times
ISO/IEC 5218 Information technology — Codes for the representation of human sexes*， 2022-06-01 Update

2022 ISO 11615:2017/Amd 1:2022 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information — Amendment 1
2017 ISO 11615:2017 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information
2012 ISO 11615:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information