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November 2024

29.11.2024

BW610_10_021e_FO Application clinical investigation MD (PDF, 1 MB, 29.11.2024)

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 29.11.2024)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 29.11.2024)

BW610_10_024e_FO Application performance study IVD (PDF, 1 MB, 29.11.2024)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 29.11.2024)

BW610_10_026e_FO Authorisation combined study IMP and MD (PDF, 1 MB, 29.11.2024)

BW610_10_027e_FO Authorisation combined study IMP and IVD (PDF, 1 MB, 29.11.2024)

BW610_10_028e_FO Application Confidentiality Restrictions (PDF, 1 MB, 29.11.2024)

BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 29.11.2024)

BW610_20_021e_FO Modifications, notifications, reports MD IVD (PDF, 1 MB, 29.11.2024)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 29.11.2024)

BW610_20_023e_FO SAE-CH and DD-CH MD (PDF, 1 MB, 29.11.2024)

BW610_20_024e_FO SAE-CH and DD-CH IVD (PDF, 1 MB, 29.11.2024)

BW610_20_025e_FO Form Modifications, notifications, reports MD IVD (PDF, 1 MB, 29.11.2024)

BW610_20_026e_FO Notifications of safety measures combined studies (PDF, 1 MB, 29.11.2024)

22.11.2024

Meldung schwerwiegendes Vorkommnis im Umgang mit labilen Blutprodukten (PDF, 603 kB, 22.11.2024)

19.11.2024

BW630_30_008e_MB Notifications devitalised human tissue (PDF, 315 kB, 12.11.2024)

I-301.AA.05-A17e Application establishment licence for medicinal products or TP/GT/GMO (PDF, 269 kB, 19.11.2024)

I-310.AA.01-A14e Information sheet Reporting a serious incident relating to the handling of labile blood products (PDF, 360 kB, 19.11.2024)

15.11.2024

ZL000_00_027e_WL Guidance document Product information for human medicinal products (PDF, 1 MB, 15.11.2024)

ZL000_00_046d_VL Patienteninformation für Komplementärarzneimittel (DOCX, 74 kB, 15.11.2024)

12.11.2024

BW315_00_961e_MB Information sheet Mandatory reporting of adverse reactions during a clinical trial with ATMPs, other products (bacteriophages, etc.) and procedures (PDF, 368 kB, 01.11.2024)

04.11.2024

BW600_00_017e_MB Combined studies (PDF, 348 kB, 31.10.2024)

01.11.2024

BW101_20_002e_MB Safety Reporting in clinical trials (PDF, 313 kB, 01.11.2024)(former: BW101_20_002e_MB Safety of Medicines)

ZL003_00_003df_VZ Mitgliederverzeichnis HMEC (PDF, 574 kB, 01.11.2024)

ZL101_00_007e_WL Guidance document Authorisation of human medicinal product with known active pharmaceutical substance (PDF, 683 kB, 01.11.2024)

ZL404_00_001e_FO Form Transfer of authorisation (DOCX, 162 kB, 01.11.2024)

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