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Standards [CURRENT]

DIN EN ISO 11615

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017 + Amd 1:2022); German version EN ISO 11615:2017 + A1:2022
Edition 2022-12

Draft standard [New]

DIN EN 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); German and English version prEN ISO 11615:2025
Edition 2025-10

Technical Specification

DIN CEN ISO/TS 5499

Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers (ISO/TS 5499:2024); English version CEN ISO/TS 5499:2024
Edition 2024-05

Technical Specification

DIN CEN ISO/TS 20443 ; DIN SPEC 13263:2018-11

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017); English version CEN ISO/TS 20443:2018
Edition 2018-11

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post-authorization comorbidity INVESTIGATION pharmacovigilance Arzneimittelinformationen contraindication
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