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MU100_00_001e_MB Injectable products for wrinkle treatment (PDF, 275 kB, 25.06.2025)
MU600_00_007e_MB Products without an intended medical purpose (PDF, 810 kB, 30.05.2025)
BW690_00_002e_WL Export Certificates (PDF, 503 kB, 30.06.2025)
ZL103_00_004e WL Guidance document Criteria Annexes 4–10 KPTPO (PDF, 310 kB, 01.06.2025)
I-302.AA.03-A01d Gesuch Betriebsbewilligung - Basisformular EpG_Labor (DOCX, 370 kB, 10.06.2025)
OS000_00_008e_MB eIAM Portal Administrator (PDF, 1 MB, 15.05.2025)
I-SMI.RL.03d Richtlinie Fütterungsarzneimittel (PDF, 319 kB, 26.05.2025)
I-SMI.RL.03-A02d Merkblatt Kennzeichnung für zum Handel bestimmte Fütterungsarzneimittel (PDF, 132 kB, 26.05.2025)
BW101_10_003e_MB Guideline Amendments Clinical Trials (PDF, 413 kB, 02.06.2025)
BW101_10_004e_MB Guideline Clinical Trial Application Dossier (PDF, 556 kB, 02.06.2025)
BW101_10_006e_MB Instructions for filling the eDok_KLV folder structure (PDF, 435 kB, 18.08.2025)
BW101_10_007e_MB Guidance on the Submission Process for Clinical Trials with Medicinal Products (PDF, 273 kB, 18.08.2025)
MU103_10_002e_FO Form PSUR/PBRER for human medicines (DOCX, 371 kB, 01.06.2025)
ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 137 kB, 01.09.2025)
ZL000_00_014e_WL Guidance document Time limits for authorization applications (PDF, 677 kB, 01.09.2025)
ZL000_00_020e_WL Guidance document Formal requirements (PDF, 1 MB, 01.09.2025)
ZL000_00_027e_WL Guidance document Product information for human medicinal products (PDF, 1 MB, 01.09.2025)
ZL000_00_028e_WL Guidance document Product information for veterinary medicinal products (PDF, 309 kB, 01.09.2025)
ZL000_00_986e_WL Guidance document Authorisation of immunological veterinary medicinal products in the event of an epizootic outbreak (PDF, 293 kB, 01.06.2025)
ZL003_00_003df_VZ Mitgliederverzeichnis HMEC (PDF, 311 kB, 01.06.2025)
ZL003_00_004df_VZ Mitgliederverzeichnis VMEC (PDF, 207 kB, 17.03.2025)
ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products (PDF, 550 kB, 01.06.2025)
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