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Maggio 2024

28.05.2024

BW101_10_003e_AA Guideline Amendments Clinical Trials (PDF, 535 kB, 25.04.2024)Valido fino al 31.10.2024

IN615_00_005i_CL Lista di controllo per un’ispezione relativa alla manutenzione di dispositivi medici (PDF, 1 MB, 23.05.2024)

OS000_00_006e_AA Swiss M1 Implementation Guidance (PDF, 426 kB, 01.04.2020)

27.05.2024

BW101_10_004e_AA Guideline Clinical Trial Application Dossier (PDF, 545 kB, 24.04.2024)Valido fino al 31.10.2024

BW302_00_001f_MB Portail eGov de Swissmedic Fonctions standard du service CPP (PDF, 938 kB, 06.05.2024)

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 781 kB, 01.09.2024)

BW600_00_016e_MB Performance studies with IVD (PDF, 728 kB, 01.09.2024)

15.05.2024

BW101_10_005e_MB Quick instruction for use of the FO_submission form (PDF, 1 MB, 30.04.2024)

BW101_10_007e_MB Guidance on the Submission Process for Clinical Trials with Medicinal Products (PDF, 460 kB, 30.04.2024)

BW101_30_001e_LL Guideline Temporary Authorisation to use an unauthorised medicinal product (PDF, 1 MB, 29.04.2024)

BW105_00_002f_VZ Liste pays dont le système de contrôle des BPF (PDF, 194 kB, 04.09.2024)

BW301_30_001f_FO Importation de médicaments immunologiques ou de sang et de produits sanguins (DOCX, 407 kB, 07.08.2024)

BW301_30_001i_MB Autorizzazione per importazione singola di medicamenti immunologici o sangue ed emoderivati (PDF, 837 kB, 06.05.2024)

BW303_00_003i_WL Guida Modifica del nome o del domicilio del titolare dell’omologazione (PDF, 799 kB, 06.05.2024)

BW313_00_996f_MB Aide-mémoire Exigences ZL TrSt/TG/OGM (PDF, 3 MB, 08.05.2024)

14.05.2024

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

IN615_20_002i_CL Lista di controllo per l’ispezione dei servizi di ricondizionamento di dispositivi medici (SRDM) (PDF, 7 MB, 01.05.2024)

RN108_00_001i_SD Regolamento Organismi svizzeri della Farmacopea (PDF, 423 kB, 07.05.2024)

03.05.2024

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

MU101_20_001i_FO Notifica di reazioni avverse (RA) da farmaci (DOCX, 100 kB, 25.04.2024)

01.05.2024

ZL106_00_888i_WL Guida complementare Importazione di un medicamento per uso umano ai sensi dell’art. 14 cpv. 2 e 3 LATer (importazione parallela) (PDF, 514 kB, 01.05.2024)

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