ISO/TS 20451:2017

Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

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Referenced standards

ISO 1087-1:2000ISO 11238:2012ISO 11239:2012ISO 11240:2012ISO 11615:2012ISO 11616:2012ISO 21090:2011ISO 3166-1:2013ISO 639-1:2002ISO 6709:2008ISO 8601:2004ISO/HL7 27953-1:2011ISO/HL7 27953-2:2011ISO/IEC 11404:2007ISO/IEC 2382:2015ISO/IEC 5218:2004ISO/TS 16791:2014ISO/TS 19844:2016ISO/TS 20440:2016ISO/TS 20443:2017
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ISO/TS 20451:2017

Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.

Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017.

Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of ISO/TS 20451:2017.

Edition2017
Published Date2017
Published ByISO/TS
Page Count48