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BW101_10_002e_MB Questions and answers on clinical trials with medicinal products (PDF, 523 kB, 18.08.2025)
BW101_10_006e_MB Instructions for filling the eDok_KLV folder structure (PDF, 435 kB, 18.08.2025)
BW101_10_007e_MB Guidance on the Submission Process for Clinical Trials with Medicinal Products (PDF, 273 kB, 18.08.2025)
BW630_40_001e_HB Handbook swissdamed User Guide Actors (PDF, 3 MB, 15.08.2025)
BW630_40_002e_PU swissdamed Business Rules (PDF, 416 kB, 15.08.2025)
BW630_40_808e_PU swissdamed Quick Guide (PDF, 322 kB, 15.08.2025)
BW630_40_809e_PU swissdamed Quick Guide - Registration in the UDI Devices Module (PDF, 215 kB, 15.08.2025)
BW630_40_841e_HB swissdamed User Guide UDI Devices Module (PDF, 1 MB, 01.10.2025)
BW630_40_870e_WL swissdamed Privacy Notice and Terms of Use (PDF, 298 kB, 05.08.2025)
BW630_40_871e_WL swissdamed Service Agreement (PDF, 308 kB, 15.08.2025)
MU100_00_004e_MB POSITION PAPER: Parenterals without an intended medical purpose – Enforcement at product level (PDF, 402 kB, 18.08.2025)
OS000_00_012dfe_VZ Template eDok KLV (ZIP, 21 kB, 18.08.2025)
OS000_00_027e_MB eGov-Portal CT standard functions (PDF, 1 MB, 18.08.2025)
ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 137 kB, 01.09.2025)
ZL000_00_050e_WL Guidance document Mobile technologies (PDF, 305 kB, 15.08.2025)
BW102_50_004d_FO Gesuchsformular Betriebsbewilligung zum Umgang mit kontrollierten Substanzen (DOCX, 168 kB, 15.07.2025)
MU600_00_018e_MB Systems and procedure packs (PDF, 369 kB, 31.10.2025)
MU680_20_017e_FO Manufacturer Incident Report (MIR), V7.3.1 (PDF, 229 kB, 21.07.2025)
ZL000_00_034e_WL Guidance document Authorisation radiopharmaceutical (PDF, 687 kB, 01.08.2025)
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