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June 2024

26.06.2024

BW101_10_019e_FO Confirmation electronic submission (AM_KlinV)(AM_KlinV) (DOCX, 359 kB, 13.06.2024)

BW690_00_001e_VL FSC-Example of a product list (PDF, 481 kB, 21.06.2024)

IN615_10_004d_CL Checkliste für die Inspektion von Systemen der Vigilance betreffend Medizinprodukten (PDF, 1 MB, 20.06.2024)(Notification of serious incidents in connection with medical devices and safety notices) Document only available in German, French or Italian

ZL000_00_017e_WL Guidance document Authorisation of veterinary medicinal products (PDF, 487 kB, 03.06.2024)

20.06.2024

BW302_00_001e_WL Guidance document for requesting product certificates (CPP) (PDF, 470 kB, 06.05.2024)

15.06.2024

ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 128 kB, 01.09.2024)

ZL112_00_002e_FO Form New authorisation by notification procedure veterinary medicinal products (DOCX, 167 kB, 15.06.2024)

ZL201_00_001e_WL Guidance document Renewal and discontinuation of authorisation or change of status (main authorisation/export licence) (PDF, 505 kB, 15.06.2024)

07.06.2024

LA400_00_001e_MB Swissmedic eGov Portal – OCABR standard functions-2023 (PDF, 992 kB, 03.06.2024)

MU680_20_009e_WL Incident economic operators (PDF, 561 kB, 03.06.2024)

OS000_00_003e_MB Archive access (PDF, 397 kB, 30.05.2024)

OS000_00_005e_MB eMessage functions (PDF, 483 kB, 30.05.2024)

OS000_00_008e_MB eIAM Portal Administrator (PDF, 1 MB, 15.11.2023)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 01.11.2023)

ZL112_00_002e_WL Guidance document Notification procedure for veterinary medicinal products (PDF, 437 kB, 01.06.2024)

01.06.2024

ZL000_00_014e_WL Guidance document Time limits for authorization applications (PDF, 676 kB, 01.09.2024)

ZL000_00_035e_FO Form DMF (DOCX, 166 kB, 01.06.2024)

ZL105_00_003e_WL Guidance document Meeting for applicants held with the Authorisation sector (PDF, 474 kB, 01.06.2024)

ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products (PDF, 571 kB, 15.10.2024)

ZL300_00_001e_WL Guidance document Variations and extensions HAM (PDF, 2 MB, 01.06.2024)

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