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October 2025

31.10.2025

BW600_00_017e_MB Combined studies (PDF, 452 kB, 27.10.2025)

BW610_10_021e_FO Application clinical investigation MD (PDF, 1 MB, 30.10.2025)

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 30.10.2025)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 30.10.2025)

BW610_10_024e_FO Application performance study IVD (PDF, 2 MB, 30.10.2025)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 30.10.2025)

BW610_10_026e_FO Application combined study MP / ATMP and MD (PDF, 2 MB, 30.10.2025)

BW610_10_027e_FO Application combined study MP / ATMP and IVD (PDF, 2 MB, 30.10.2025)

BW610_10_028e_FO Application Confidentiality Restrictions (PDF, 1 MB, 30.10.2025)

BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 30.10.2025)

MU600_00_018e_MB Systems and procedure packs (PDF, 369 kB, 31.10.2025)

ZL404_00_002e_FO Signal Notification Form VMP (DOCX, 374 kB, 20.10.2025)

17.10.2025

OS000_00_015e_MB eSubmissions eGov-Portal (PDF, 294 kB, 14.10.2025)

OS000_00_020e_MB eGov-Portal safety communication service (PDF, 121 kB, 14.10.2025)

15.10.2025

ZL000_00_040e_FO Mobile technologies (DOCX, 377 kB, 15.10.2025)

13.10.2025

I-SMI.TI.24d Herstellung und Inverkehrbringen von Formula-Arzneimitteln (PDF, 195 kB, 13.10.2025)

MU100_00_005e_MB Information sheet for the cosmetic sector – Parenterals without an intended medical Purpose (PDF, 414 kB, 13.10.2025)

01.10.2025

BW630_40_841e_HB swissdamed User Guide UDI Devices Module (PDF, 1 MB, 01.10.2025)

ZL000_00_023e_WL Guidance document Paediatric investigation plan (PDF, 351 kB, 01.10.2025)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 190 kB, 01.10.2025)

ZL100_00_002e_FO Form New authorisation of veterinary medicinal products (DOCX, 180 kB, 01.10.2025)

ZL101_00_012e_WL Guidance document Authorisation biosimilar (PDF, 412 kB, 01.10.2025)

ZL105_00_003e_WL Guidance document Meetings for applicants for authorisation procedures (PDF, 331 kB, 01.10.2025)

ZL105_00_004e_FO Form Meeting for applicants for authorisation procedures (DOCX, 384 kB, 01.12.2025)

ZL105_00_006e_FO Form Company meeting record (DOCX, 155 kB, 01.10.2025)

ZL203_00_002e_FO Form No marketing / interruption of distribution HAM (DOCX, 161 kB, 01.10.2025)

ZL203_00_002e_WL Guidance document No marketing / interruption of distribution (PDF, 253 kB, 01.10.2025)

ZL203_00_850e_FO Form No marketing / interruption of distribution TAM (DOCX, 370 kB, 01.10.2025)

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