BS EN 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 this document.


Cross References:
ISO 3166-1:2013 ED3
ISO 639-1
ISO 8601
ISO/TS 20451
ISO/TS 19844
ISO 11240
HL7 Version 3 Standard
ISO 11239
ISO 11616
ISO/TS 20440
ISO/TS 20443
ISO 11238
ISO/IEC 5218
ENV 13607:2000
ISO/HL7 27953-1
ISO 1087-1
ISO/IEC/TR 24720
ISO/TS 16791
ISO 21090
ENV 12610:1997
ISO/IEC 29158
ISO/IEC 15415
ISO/IEC 15416
ISO/HL7 27953-2
HL7 Version 3 Standard
ISO/IEC 11404:2007 Ed 2


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