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Technical Specification [CURRENT]

DIN CEN ISO/TS 19844 ; DIN SPEC 13261:2017-12

Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016); English version CEN ISO/TS 19844:2017, only on CD-ROM
Edition 2017-12

Technical Specification [CURRENT]

DIN CEN ISO/TS 20451 ; DIN SPEC 13264:2018-11

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); English version CEN ISO/TS 20451:2018
Edition 2018-11

Technical Specification

DIN CEN ISO/TS 20440

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2023); German version CEN ISO/TS 20440:2023
Edition 2023-09

Technical Specification [CURRENT]

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

QM systems, procedures and terminology
Edition 2021-04

 
Edition 2016-10

Regulation

EUV 2022/140

Commission Implementing Regulation (EU) 2022/140 of 16 November 2021 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to the Union antigen, vaccine and diagnostic reagent banks
Edition 2021-11-16

Regulation

EUV 2022/139

Commission Delegated Regulation (EU) 2022/139 of 16 November 2021 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the management, storage and replacement of stocks of the Union antigen, vaccine and diagnostic reagent banks and the biosecurity, biosafety and bio-containment requirements for the operation of those banks
Edition 2021-11-16

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