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Standards [CURRENT]

UNE-EN ISO 27953-1

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting (ISO 27953-1:2011) (Endorsed by AENOR in January of 2012.)
Edition 2012-01-01

Standards [CURRENT]

UNE-EN ISO 27953-2

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011) (Endorsed by AENOR in January of 2012.)
Edition 2012-01-01

Standards [CURRENT]

DIN EN ISO 27953-2

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011); German and English version EN ISO 27953-2:2011, only on CD-ROM
Edition 2012-09

Standards [CURRENT]

DIN EN ISO 27953-1

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting (ISO 27953-1:2011); German and English version EN ISO 27953-1:2011, only on CD-ROM
Edition 2012-09

Standards [CURRENT]

DIN EN ISO 11616

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2017); German version EN ISO 11616:2017
Edition 2018-04

Draft standard

DIN EN ISO 16791

Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/DIS 16791:2025); German and English version prEN ISO 16791:2025
Edition 2025-05

Standards [CURRENT]

DIN EN ISO 11240

Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of units of measurement (ISO 11240:2012); German version EN ISO 11240:2012
Edition 2013-03

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

Draft standard [New]

DIN EN ISO 11616

Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information (ISO/DIS 11616:2025); German and English version prEN ISO 11616:2025
Edition 2025-11

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