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Updating of various specification documents connected with HMV4

30.09.2018 

Various eDok and eCTD specification documents are being updated. This usually involves minor content-related and editorial changes. HMV4-related changes have also been incorporated. The following documents are affected:

  • eDok Guidance

OS000_00_003e_WL Guidance eDok (PDF, 1 MB, 19.07.2023)

  • Guidance Art. 13

OS000_00_005e_WL Guidance Article 13 TPA final Version 1.5 (PDF, 787 kB, 01.04.2020)

  • eCTD Guidance for Industry

OS000_00_004e_WL Guidance Industry eCTD (PDF, 4 MB, 11.03.2024)

  • MB Portal

OS000_00_001e_MB Swissmedic eGov Portal – Standard functions (PDF, 2 MB, 01.06.2022)

  • MB Portal Q&A

OS000_00_002e_MB Swissmedic Portal standard functions questions and answers (PDF, 462 kB, 31.01.2020)

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