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BW315_00_960e_FO Form Adverse Reaction Report CT ATMP (DOCX, 379 kB, 19.09.2025)
BW315_00_961e_MB Information sheet Mandatory reporting of adverse reactions during a clinical trial with ATMPs, other products (bacteriophages, etc.) and procedures (PDF, 355 kB, 19.09.2025)
BW314_00_991e_FO Form Notification of a release into environment, transmission to a person/animal of an authorized GT/GMO (DOCX, 370 kB, 19.09.2025)
BW630_40_001e_PU swissdamed UDI Data Dictionary (XLSX, 122 kB, 18.09.2025)
I-301.AA.05-A05d Gesuch Betriebsbewilligung - Zusatzblatt FVP Mehrfachmandate Arzneimittel (inkl. Blut) (DOCX, 362 kB, 15.09.2025)
ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 08.09.2025)
OS000_00_003d_WL Guidance eDok (PDF, 376 kB, 02.09.2025)
IN615_20_003d_CL Checkliste für die Inspektion von Aufbereitungseinheiten von flexiblen, thermolabilen Endoskopen (PDF, 1 MB, 01.08.2025)
OS000_00_005_VZdfe Template CTD HMV4 (ZIP, 48 kB, 01.09.2025)
ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 137 kB, 01.09.2025)
ZL000_00_014e_WL Guidance document Time limits for authorization applications (PDF, 677 kB, 01.09.2025)
ZL000_00_020e_WL Guidance document Formal requirements (PDF, 1 MB, 01.09.2025)
ZL000_00_027e_WL Guidance document Product information for human medicinal products (PDF, 1 MB, 01.09.2025)
ZL000_00_028e_WL Guidance document Product information for veterinary medicinal products (PDF, 309 kB, 01.09.2025)
ZL106_00_888e_WL Guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (PDF, 388 kB, 01.09.2025)
ZL201_00_001e_WL Guidance document Renewal and discontinuation of authorisation or change of status (main authorisation/export licence) (PDF, 388 kB, 01.09.2025)
ZL201_00_008e_FO Form Renewal of authorisation (DOCX, 159 kB, 01.09.2025)
ZL300_00_002e_WL Guidance document Variations TAM (PDF, 423 kB, 01.09.2025)
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