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BW301_20_001e_VL Template for medical certificate for sick travellers (DOCX, 45 kB, 02.09.2024)
I-303.AA.04-A08e Guidance document SwissGMDP Database (PDF, 3 MB, 19.09.2024)
I-301.AA.05-A33d Gesuch Verzicht Betriebsbewilligung Arzneimittel (inkl. Blut) /TpP/GT/GVO (DOCX, 367 kB, 19.09.2024)
BW105_00_002e_VZ List Countries with recognised GMP control systems (PDF, 190 kB, 04.09.2024)
MU101_20_832e_MB Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway (PDF, 564 kB, 04.09.2024)
MU101_40_001d_FO Meldung unerwünschter Tierarzneimittelwirkungen Synthetika oder Impfstoffe (UAW Tamvigilance) (PDF, 213 kB, 09.08.2024)
MU101_40_001d_Meldung unerwünschter Tierarzneimittelwirkungen Synthetika oder Impfstoffe (UAW Tamvigilance) (DOCX, 370 kB, 09.08.2024)
BW301_20_001e_FO Schengen Certificate (PDF, 178 kB, 30.09.2024)Printable version
BW301_20_001e_FO Schengen Certificate (DOCX, 59 kB, 30.09.2024)
BW690_00_002e_WL Export Certificates (PDF, 735 kB, 04.09.2024)
OS000_00_018e_FO Terms of use Master CT contract (PDF, 331 kB, 14.08.2024)
BW600_00_015e_MB Clinical investigations with medical devices (PDF, 781 kB, 31.10.2024)
BW600_00_016e_MB Performance studies with IVD (PDF, 731 kB, 31.10.2024)
BW600_00_017e_MB Combined studies (PDF, 348 kB, 31.10.2024)
BW610_10_026e_FO Authorisation combined study IMP and MD (PDF, 1 MB, 01.09.2024)
BW610_10_027e_FO Authorisation combined study IMP and IVD (PDF, 1 MB, 01.09.2024)
BW610_10_028e_FO Application Confidentiality Restrictions (PDF, 1 MB, 01.07.2024)
BW610_20_025e_FO Form combined study MP/ATMP and MD/IVD Amendments, notifications, reports (PDF, 1 MB, 01.07.2024)
BW610_20_026e_FO Notifications of safety measures combined studies (PDF, 1 MB, 01.09.2024)
OS000_00_001e_MB Swissmedic eGov Portal – Standard functions (PDF, 2 MB, 01.09.2024)
OS000_00_002e_MB Swissmedic Portal standard functions questions and answers (PDF, 541 kB, 01.09.2024)
ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 128 kB, 01.09.2024)
ZL000_00_014e_WL Guidance document Time limits for authorization applications (PDF, 676 kB, 01.09.2024)
ZL000_00_029e_WL Guidance document Packaging texts for veterinary medicinal products (PDF, 443 kB, 01.09.2024)
ZL000_00_040e_FO Mobile technologies (DOCX, 372 kB, 01.09.2024)
ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 191 kB, 01.09.2024)
ZL101_00_005e_WL Guidance document Authorisation of human medicinal product with new active substance (PDF, 406 kB, 01.09.2024)
ZL101_00_007e_WL Guidance document Authorisation of human medicinal product with known active pharmaceutical substance (PDF, 683 kB, 01.11.2024)
ZL104_00_001e_FO Decision minutes Accelerated Application Hearing (DOCX, 172 kB, 01.09.2024)
ZL203_00_002e_FO Form No marketing / interruption of distribution (DOCX, 159 kB, 01.09.2024)
ZL203_00_002e_WL Guidance document No marketing / interruption of distribution (PDF, 282 kB, 01.09.2024)
ZL203_00_850e_FO Form No marketing / interruption of distribution TAM (DOCX, 368 kB, 01.09.2024)
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