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ZL404_00_004e_WL Guidance document Drug Safety Signals VMP (PDF, 566 kB, 31.01.2025)
BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 30.01.2025)
IN615_00_005d_CL Checkliste für die Inspektion der Instandhaltung von Medizinprodukten (DOCX, 2 MB, 30.01.2025)
I-308.AA.02-A01e General procedure for foreign governmental inspections in Switzerland related to therapeutic products (PDF, 229 kB, 30.01.2025)
I-308.AA.02-A04e GMP/GCP/GVP/Medical Devices Inspections in Switzerland (DOCX, 362 kB, 30.01.2025)
Meldung Transfusionsreaktion (PDF, 1 MB, 29.01.2025)
BW101_10_817e_MB Preparation for blinded dispensing (PDF, 292 kB, 01.11.2024)
BW630_30_010e_MB FAQ on in vitro diagnostic medical device notifications (PDF, 326 kB, 17.01.2025)
MU680_20_009e_WL Incident economic operators (PDF, 822 kB, 05.02.2025)
BW610_20_021e_FO Modifications, notifications, reports MD IVD (PDF, 1 MB, 20.01.2025)
BW610_20_025e_FO Form Modifications, notifications, reports MD IVD (PDF, 1 MB, 20.01.2025)
I-301.AA.05-A19d Gesuch Betriebsbewilligung - Zusatzblatt TpP/GT/GVO (DOCX, 439 kB, 17.01.2025)
ZL100_00_002e_WL Guidance document Orphan Drug (PDF, 307 kB, 15.01.2025)
MU600_00_006e_MB Procurement of medical devices in health institutions (PDF, 600 kB, 01.01.2025)
MU600_00_016e_MB Obligations Economic Operators CH (PDF, 1 MB, 01.01.2025)
ZL000_00_024e_WL Guidance document Document protection (PDF, 369 kB, 01.01.2025)
ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 01.01.2025)
ZL003_00_002e_SD Rules of the Swissmedic Medicines Expert Committees (SMECs) (PDF, 276 kB, 01.01.2025)
ZL003_00_003df_VZ Mitgliederverzeichnis HMEC (PDF, 305 kB, 01.01.2025)
ZL003_00_004df_VZ Mitgliederverzeichnis VMEC (PDF, 210 kB, 01.01.2025)
ZL101_00_004e_FO Form Information for application Art.13 TPA (DOCX, 193 kB, 01.01.2025)
ZL106_00_002e_FO Form Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (DOCX, 170 kB, 01.01.2025)
ZL106_00_888e_WL Guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (PDF, 364 kB, 01.01.2025)
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