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Ottobre 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_018i_MB Sistemi e kit procedurali (PDF, 397 kB, 31.10.2025)

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

17.10.2025

OS000_00_015i_MB Piattaforma-eGov eSubmissions (PDF, 295 kB, 14.10.2025)

OS000_00_020i_MB Servizio Portale-eGov safety communication (PDF, 124 kB, 14.10.2025)

15.10.2025

ZL000_00_040i_FO Tecnologie mobili (DOCX, 376 kB, 15.10.2025)

13.10.2025

I-SMI.TI.24i Fabbricazione e immissione in commercio di medicamenti preparati secondo una formula (PDF, 193 kB, 13.10.2025)

MU100_00_005i_MB Scheda informativa per il settore cosmetico - prodotti parenterali senza destinazione d’uso medica (PDF, 451 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_023i_WL Guida complementare Piano d’indagine pediatrica (PDF, 343 kB, 01.10.2025)

ZL100_00_001i_FO Formulario Nuova omologazione di medicamenti per uso umano (DOCX, 190 kB, 01.10.2025)

ZL100_00_002i_FO Formulario Nuova omologazione per medicamenti veterinari (DOCX, 180 kB, 01.10.2025)

ZL101_00_012i_WL Guida complementare Omologazione di biosimilari (PDF, 422 kB, 01.10.2025)

ZL105_00_003i_WL Guida complementare Meeting aziendali nel settore titolari omologazione (PDF, 334 kB, 01.10.2025)

ZL105_00_004i_FO Formulario Meeting aziendali (DOCX, 383 kB, 01.10.2025)

ZL105_00_006i_FO Formulario Verbale del meeting aziendale (DOCX, 155 kB, 01.10.2025)

ZL203_00_002i_FO Formulario Mancata immissione in commercio interruzione della distribuzione HAM (DOCX, 160 kB, 01.10.2025)

ZL203_00_002i_WL Guida complementare Non immissione in commercio / Interruzione della distribuzione (PDF, 257 kB, 01.10.2025)

ZL203_00_850i_FO Formulario Mancata immissione in commercio/Interruzione dello smercio di TAM (DOCX, 371 kB, 01.10.2025)

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