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ZL000_00_019e_WL Guidance document Authorisation human medicinal product under Art. 13 TPA (PDF, 3 MB, 15.01.2024)
ZL000_00_022e_WL Guidance document Authorisation in accordance with Art. 14 para. 1 abis-quater TPA (PDF, 2 MB, 15.01.2024)
ZL000_00_986e_WL Guidance document Authorisation of immunological veterinary medicinal products in the event of an epizootic outbreak (PDF, 1 MB, 15.01.2024)
ZL101_00_004e_FO Form Information for application Art.13 TPA (DOCX, 194 kB, 15.01.2024)
ZL101_00_007e_WL Guidance document Authorisation of human medicinal product with known active pharmaceutical substance (PDF, 878 kB, 01.04.2024)
ZL104_00_002e_WL Guidance document Fast-track authorisation procedure (PDF, 2 MB, 15.01.2024)
ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products (PDF, 3 MB, 15.01.2024)
I-301.AA.05-A17e Application establishment licence for medicinal products or TP/GT/GMO (PDF, 263 kB, 22.04.2024)
I-301.AA.05-A33d Gesuch Verzicht Betriebsbewilligung Arzneimittel (inkl. Blut) /TpP/GT/GVO (DOCX, 367 kB, 09.01.2024)
BW630_10_003e_MB Swiss Single Registration Number - CHRN (PDF, 365 kB, 01.01.2024)
BW690_00_002e_WL Export Certificates (PDF, 3 MB, 27.03.2024)
MU600_00_008e_MB Terms of Reference - Round Table on Medical Technology (PDF, 247 kB, 01.01.2024)
SF201_00_003d_SD Organisationsreglement Swissmedic (PDF, 1 MB, 01.01.2024)
ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 129 kB, 01.01.2024)
ZL000_00_011e_VZ Directory List countries with comparable control of human medicinal products (PDF, 390 kB, 01.01.2024)
ZL000_00_021e_WL Guidance document Packaging for human medicinal products (PDF, 744 kB, 01.01.2024)
ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 189 kB, 15.04.2024)
ZL101_00_009e_WL Guidance document Authorisation of Asian medicinal products (PDF, 1 MB, 01.01.2024)
ZL106_00_002e_FO Form Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (DOCX, 169 kB, 01.01.2024)
ZL106_00_888e_WL Guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (PDF, 517 kB, 01.05.2024)
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