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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
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 StandardDetails 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 StandardDetails, 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.
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