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February 2026

01.02.2026

BW303_00_003e_WL Guidance document Change name or domicile of the authorisation holder (PDF, 242 kB, 01.02.2026)

MU101_20_001e_WL Guidance document Drug Safety Signals HMP (PDF, 446 kB, 01.02.2026)

MU101_10_796e_FO Signal Notification Form (DOCX, 371 kB, 01.02.2026)

ZL000_00_020e_WL Guidance document Formal requirements (PDF, 992 kB, 01.02.2026)

ZL000_00_021e_WL Guidance document Packaging for human medicinal products (PDF, 630 kB, 01.02.2026)

ZL000_00_022e_WL Guidance document Authorisation in accordance with Art. 14 para. 1 abis-quater TPA (PDF, 431 kB, 01.02.2026)

ZL000_00_024e_WL Guidance document Document protection (PDF, 325 kB, 01.02.2026)

ZL000_00_033e_FO Form New authorisation variation antivenin (DOCX, 165 kB, 01.02.2026)

ZL000_00_043d_VL Fachinformation Tierarzneimittel (DOCX, 98 kB, 01.02.2026)

ZL000_00_044d_VL Packungsbeilage Tierarzneimitte (DOCX, 77 kB, 01.02.2026)Available in German, French or Italian only.

ZL000_00_054d_VL Fachinformation immunologisches Tierarzneimittel (DOCX, 93 kB, 01.02.2026)

ZL103_00_003e_FO Form New authorisation variation in notification procedure KPTPO (DOCX, 180 kB, 01.02.2026)

ZL106_00_002e_FO Form Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (DOCX, 172 kB, 01.02.2026)

ZL106_00_888e_WL Guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (PDF, 362 kB, 01.02.2026)

ZL108_00_002e_WL Guidance document Authorisation of co-marketing medicinal product (PDF, 303 kB, 01.02.2026)

ZL201_00_001e_WL Guidance document Renewal and discontinuation of authorisation or change of status (main authorisation/export licence) (PDF, 342 kB, 01.02.2026)

ZL300_00_001e_WL Guidance document Variations and extensions HAM (PDF, 397 kB, 01.02.2026)

ZL300_00_003e_FO Form Variations and extensions HAM (DOCX, 814 kB, 01.02.2026)valid from 1 February 2026

ZL300_00_004e_FO Variations TAM (DOCX, 683 kB, 01.02.2026)

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