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BW630_40_841e_HB swissdamed User Guide UDI Devices Module (PDF, 1 MB, 01.10.2025)
ZL000_00_023e_WL Guidance document Paediatric investigation plan (PDF, 351 kB, 01.10.2025)
ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 190 kB, 01.10.2025)
ZL100_00_002e_FO Form New authorisation of veterinary medicinal products (DOCX, 180 kB, 01.10.2025)
ZL101_00_012e_WL Guidance document Authorisation biosimilar (PDF, 412 kB, 01.10.2025)
ZL105_00_003e_WL Guidance document Meetings for applicants for authorisation procedures (PDF, 331 kB, 01.10.2025)
ZL105_00_004e_FO Form Company meeting (DOCX, 383 kB, 01.04.2025)
ZL105_00_006e_FO Form Company meeting record (DOCX, 155 kB, 01.10.2025)
ZL203_00_002e_FO Form No marketing / interruption of distribution HAM (DOCX, 161 kB, 01.10.2025)
ZL203_00_002e_WL Guidance document No marketing / interruption of distribution (PDF, 253 kB, 01.10.2025)
ZL203_00_850e_FO Form No marketing / interruption of distribution TAM (DOCX, 370 kB, 01.10.2025)
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