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MU680_21_010e_WL FSCA economic operators (PDF, 327 kB, 05.02.2025)
MU680_10_007e_WL Vigilance contact person for medical devices (PDF, 573 kB, 18.02.2025)
MU680_20_008e_WL Incident report user (PDF, 474 kB, 18.02.2025)
MU680_20_009e_WL Incident economic operators (PDF, 822 kB, 05.02.2025)
BW101_10_006e_MB Instructions for filling the eDok_KLV folder structure (PDF, 453 kB, 05.02.2025)
ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 129 kB, 31.01.2025)
ZL000_00_020e_WL Guidance document Formal requirements (PDF, 746 kB, 01.02.2025)
ZL100_00_002e_FO Form New authorisation of veterinary medicinal products (DOCX, 179 kB, 01.02.2025)
ZL101_00_835e_FO Form Information on GMO-containing veterinary medicinal products (DOCX, 365 kB, 01.02.2025)
ZL300_00_003e_FO Form Variations and extensions HAM (DOCX, 707 kB, 01.02.2025)
ZL300_00_004e_FO Variations TAM (DOCX, 683 kB, 01.02.2025)
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