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September 2026

14.09.2026

Customs information sheet (PDF, 301 kB, 03.09.2026)

10.09.2026

BW690_00_001e_VL FSC - Examples of a Product List as well as a Product List for Systems and Procedure Packs (PDF, 213 kB, 09.09.2026)

07.09.2026

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 318 kB, 07.09.2026)

I-SMI.TI.06e Market release and distribution in cooperation with a pre-wholesaler (PDF, 155 kB, 07.09.2026)

02.09.2026

I-321.AA.01-A05e Guidance document Scientific GMDP Meetings for establishment licence holders (PDF, 217 kB, 01.09.2026)

BW630_40_002e_PU swissdamed Business Rules (PDF, 367 kB, 02.09.2026)

BW630_40_810e_PU swissdamed Machine-to-Machine REST API_DocumentationAPI_Documentation (PDF, 1010 kB, 02.09.2026)

01.09.2026

ZL000_00_020e_WL Guidance document Formal requirements (PDF, 809 kB, 01.09.2026)

ZL101_00_865e_FO Form for application under Art. 13 TPA VMP (DOCX, 465 kB, 01.09.2026)

ZL000_00_028e_WL Guidance document Product information for veterinary medicinal products (PDF, 263 kB, 01.09.2026)

ZL103_00_003e_WL Guidance document Authorisation of individual teas, cough and throat lozenges and pastilles in the notification procedure HMV4 (PDF, 325 kB, 01.09.2026)

MU102_10_001e_MB Notification of Quality Defects (PDF, 311 kB, 01.07.2026)

RN106_00_003d_MB Ph.Helv. / Anforderungen / Phyto (PDF, 196 kB, 28.08.2026)

MU100_00_001e_WL_Requirements of the Responsible Person for Pharmacovigilance (PDF, 268 kB, 01.09.2026)

ZL003_00_001e_SD Code of Conduct of the members of the Swissmedic Medicines Expert Committees (PDF, 358 kB, 18.08.2026)

MU102_20_002d_MB Prozessbeschrieb Zusammenarbeit im Rahmen von Out-of-Stock Gesuchen (PDF, 230 kB, 05.08.2026)

ZL108_00_002e_FO Form New authorisation for co-marketing of medicinal product HMV4 (DOCX, 165 kB, 30.06.2023)

ZL201_00_001e_WL Guidance document Renewal and discontinuation of authorisation or change of status (main authorisation/export licence) (PDF, 381 kB, 01.02.2026)

ZL300_00_004e_FO Variations TAM (DOCX, 685 kB, 01.09.2026)

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