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May 2025

28.05.2025

BW610_20_025e_FO Form Modifications, notifications, reports MD IVD (PDF, 1 MB, 23.05.2025)

26.05.2025

BW690_00_001defi_FO Orders for export certificates for medical devices (PDF, 1 MB, 26.05.2025)

MU680_20_009e_WL Incident economic operators (PDF, 385 kB, 20.05.2025)

ZL000_00_047e_WL Guidance document MAGHP Procedure (PDF, 609 kB, 22.05.2025)

21.05.2025

I-SMI.TI.22e Notifications according to Article 41, MPLO (PDF, 216 kB, 21.05.2025)

14.05.2025

MU105_00_809d_MB Merkblatt Cannabis für medizinische Zwecke (PDF, 551 kB, 01.05.2025)

ZL108_00_002e_WL Guidance document Authorisation of co-marketing medicinal product (PDF, 346 kB, 09.05.2025)

09.05.2025

BW301_10_003d_FO No-Objection Certificate (DOCX, 360 kB, 01.05.2025)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 09.05.2025)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 09.05.2025)

MU680_20_017e_FO Manufacturer Incident Report (MIR), V7.3.1 (PDF, 229 kB, 21.07.2025)(mandatory from November 2025)

MU680_20_815e_WL Guidance document CH Guide Manufacturer Incident Report (MIR) (PDF, 409 kB, 06.05.2025)

01.05.2025

BW630_30_829d_WL Wegleitung In-house Medizinprodukte (PDF, 303 kB, 01.05.2025)

MU100_00_003e_MB Products containing cannabidiol (CBD) and other cannabinoids that are not subject to narcotics legislation – Overview and implementation guide (PDF, 408 kB, 01.05.2025)

ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 137 kB, 01.09.2025)

ZL000_00_020e_WL Guidance document Formal requirements (PDF, 1 MB, 01.09.2025)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 449 kB, 14.07.2025)

ZL101_00_009e_WL Guidance document Authorisation of Asian medicinal products (PDF, 415 kB, 01.05.2025)

ZL103_00_002e_WL Guidance document Authorisation for homeopathic and anthroposophic medicinal products and medicinal products for gemmotherapy without indication in the notification procedure (PDF, 769 kB, 01.05.2025)

ZL106_00_002e_FO Form Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (DOCX, 171 kB, 01.05.2025)

ZL106_00_888e_WL Guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (PDF, 388 kB, 01.09.2025)

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