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MU600_00_008e_MB Terms of Reference - Round Table on Medical Technology (PDF, 248 kB, 05.07.2024)
RN106_00_003d_MB Ph.Helv. / Anforderungen / Phyto (PDF, 428 kB, 23.07.2024)
RN106_00_004d_MB Anforderungen PhHelv KomplMedAM (PDF, 254 kB, 23.07.2024)
ZL003_00_001e_SD Code of Conduct of the members of the Swissmedic Medicines Expert Committees (PDF, 504 kB, 11.07.2024)
ZL103_00_001d HB Handbuch HOMANT Offline 2.4.7. (PDF, 1 MB, 17.07.2024)
ZL103_00_003d_HB Handbuch HOMANT Asia (PDF, 456 kB, 17.07.2024)
BW106_00_003d_FO Gesuch Werbebewilligung (DOCX, 368 kB, 08.07.2024)
BW301_30_001d_FO Einfuhr von immunologischen Arzneimittelnoder oder von Blut und Blutprodukten (DOCX, 359 kB, 07.08.2024)
MU102_20_001d_MB Out-of-Stock Situation (PDF, 327 kB, 08.07.2024)
MU680_10_007e_WL Vigilance contact person for medical devices (PDF, 689 kB, 27.06.2024)
MU680_20_004e_MB Medical devices FAQs Patients (PDF, 419 kB, 26.06.2024)
MU680_20_008e_WL Incident report user (PDF, 550 kB, 27.06.2024)
MU680_50_012e_WL Online help for the MD publication service (PDF, 558 kB, 27.06.2024)
OS000_00_007e_AA Swiss Module 1 Specification for eCTD Version 1.5 (PDF, 1 MB, 18.07.2024)
MU101_20_001e_MB Guidance for Industry on the electronic exchange of ICSRs in E2B(R2) format through PV Gateway (PDF, 596 kB, 16.08.2024)
ZL003_00_004e_FO Public Declaration of Interests and Confidentiality Undertaking of Swissmedic Medicines Expert Committee Members (PDF, 4 MB, 26.06.2024)
BW302_00_004e_FO Order form for a CPP (Certificate of a Pharmaceutical Product) (XLSX, 59 kB, 10.07.2024)
BW106_00_001d_MB Angaben zur Zulassungsinhaberin in der Publikumswerbung (PDF, 318 kB, 17.06.2024)
BW106_00_002d_CL Review Publikumswerbung (DOCX, 699 kB, 17.06.2024)
BW630_40_001e_HB Handbook swissdamed User Guide Actors (PDF, 2 MB, 31.07.2024)
BW690_00_002e_WL Export Certificates (PDF, 735 kB, 04.09.2024)
ZL000_00_027e_WL Guidance document Product information for human medicinal products (PDF, 1 MB, 15.11.2024)
IN615_30_836d_MB Pflichten von Fachanwendern und Dritten im Zusammenhang mit der Durchführung der Instandhaltung von Medizinprodukten (PDF, 602 kB, 03.07.2024)
BW600_00_015e_MB Clinical investigations with medical devices (PDF, 781 kB, 31.10.2024)
BW600_00_016e_MB Performance studies with IVD (PDF, 731 kB, 31.10.2024)
I-301.AA.05-A33d Gesuch Verzicht Betriebsbewilligung Arzneimittel (inkl. Blut) /TpP/GT/GVO (DOCX, 367 kB, 19.09.2024)
ZL300_00_003e_FO Form Variations and extensions HAM (DOCX, 706 kB, 01.07.2024)
BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 01.07.2024)
BW610_10_030e_VL Application fee reduction selfdeclaration (DOCX, 366 kB, 01.07.2024)
ZL000_00_020e_WL Guidance document Formal requirements (PDF, 899 kB, 01.07.2024)
ZL000_00_030e_WL Guidance document SwissPAR (PDF, 385 kB, 01.10.2024)
ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 191 kB, 01.09.2024)
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