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Luglio 2024

30.07.2024

MU600_00_008i_MB Terms of Reference - Roundtable sulla tecnologia medica (PDF, 244 kB, 05.07.2024)

RN106_00_003d_MB Ph.Helv. / Anforderungen / Phyto (PDF, 428 kB, 23.07.2024)

RN106_00_004d_MB Anforderungen PhHelv KomplMedAM (PDF, 254 kB, 23.07.2024)

ZL003_00_001i_SD Codice per la gestione dei conflitti d’interesse per gli Swissmedic Medicines Expert Committees (PDF, 482 kB, 11.07.2024)

ZL103_00_001f_HB Manuel utilisateurs HOMANT Offline 2.4.7. (PDF, 1 MB, 17.07.2024)

ZL103_00_003f_HB Manuel HOMANT Asia (PDF, 473 kB, 17.07.2024)

25.07.2024

BW101_30_001e_FO Application form for Temporary Authorization (DOCX, 382 kB, 04.06.2024)

24.07.2024

BW106_00_003f_FO Demande d'autorisation d'une publicite (DOCX, 409 kB, 08.07.2024)

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

MU102_20_001f_MB Commentaires Out of Stock (PDF, 578 kB, 08.07.2024)

MU680_10_007i_WL Persona di contatto per la vigilanza dei dispositivi medici (PDF, 650 kB, 27.06.2024)

MU680_20_004i_MB FAQ per i pazienti in relazione ai dispositivi medici (PDF, 433 kB, 26.06.2024)

MU680_20_008i_WL Notifica incidenti utilizzatori (PDF, 515 kB, 27.06.2024)

MU680_50_012i_WL Guida in linea per il servizio di pubblicazione DM (PDF, 561 kB, 24.06.2024)

OS000_00_007e_AA Swiss Module 1 Specification for eCTD Version 1.5 (PDF, 1 MB, 18.07.2024)

23.07.2024

MU101_20_001e_MB Guidance for Industry on the electronic exchange of ICSRs in E2B(R2) format through PV Gateway (PDF, 596 kB, 16.08.2024)

ZL003_00_004e_FO Public Declaration of Interests and Confidentiality Undertaking of Swissmedic Medicines Expert Committee Members (PDF, 4 MB, 26.06.2024)

12.07.2024

BW302_00_004e_FO Order form for a CPP (Certificate of a Pharmaceutical Product) (XLSX, 59 kB, 10.07.2024)

05.07.2024

BW106_00_001f_MB Informations relatives au titulaire de lautorisation dans la publicite destinee au public (PDF, 327 kB, 17.06.2024)

BW106_00_002f_CL Examen Publicité destinée au public (DOCX, 740 kB, 17.06.2024)

BW630_40_001i_HB Guida per l’utente Operatori swissdamed (PDF, 2 MB, 31.07.2024)

BW690_00_002i_WL Certificati di esportazione (PDF, 730 kB, 04.09.2024)

MU102_20_001f_MB Commentaires Out of Stock (PDF, 578 kB, 08.07.2024)

ZL000_00_027i_WL Guida complementare Informazioni sul medicamento per medicamenti per uso umano (PDF, 1 MB, 01.07.2024)

04.07.2024

IN615_30_836i_MB Obblighi per utenti professionali e terzi in relazione all’esecuzione della manutenzione dei dispositivi medici (PDF, 561 kB, 03.07.2024)

02.07.2024

BW302_00_004e_FO Order form for a CPP (Certificate of a Pharmaceutical Product) (XLSX, 59 kB, 10.07.2024)

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)

I-301.AA.05-A33i Richiesta d'autorizzazione d'esercizio - Rinuncia all'autorizzazione di esercizio Medicamenti (sangue incluso) /Est/TG/OGM (DOCX, 368 kB, 19.09.2024)

ZL300_00_003i_FO Formulario Modifiche ed estensioni dell’omologazione HAM (DOCX, 668 kB, 01.07.2024)

01.07.2024

BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 01.07.2024)

BW610_10_030e_VL Application fee reduction selfdeclaration (DOCX, 366 kB, 01.07.2024)

ZL000_00_020i_WL Guida complementare Requisiti formali (PDF, 915 kB, 01.07.2024)

ZL000_00_030i_WL Guida complementare SwissPAR (PDF, 396 kB, 01.10.2024)

ZL100_00_001i_FO Formulario Nuova omologazione di medicamenti per uso umano (DOCX, 190 kB, 01.09.2024)

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