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July 2025

29.07.2025

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

15.07.2025

BW690_00_002e_WL Export Certificates (PDF, 503 kB, 30.06.2025)

I-310.AA.02-A01d Meldung der Haemovigilanceverantwortlichen Person in Spitälern und anderen Institutionen (PDF, 480 kB, 15.07.2025)

08.07.2025

KO000_20_001dfi_FO Bestellung Heilmittelgesetz (DOCX, 590 kB, 01.07.2025)

01.07.2025

BW101_20_002e_MB Safety Reporting in clinical trials (PDF, 320 kB, 01.07.2025)(former: BW101_20_002e_MB Safety of Medicines)

I-SMI.TI.28e Requirements for the return of medicinal products (PDF, 171 kB, 30.06.2025)

MU101_20_002e_WL Guidance document DHPC HMP (PDF, 439 kB, 01.07.2025)

MU103_10_001e_WL Guidance document RMP / ICH E2E – Information for submission of RMP HMP (PDF, 960 kB, 01.07.2025)

Application Form Fast-Track (DOCX, 372 kB, 23.07.2025)

ZL101_00_016e_WL Guidance document Authorisation of Homeopathics, anthroposophics and other complementary medicinal products (PDF, 648 kB, 01.07.2025)

ZL404_00_001e_WL Guidance document Transfer of marketing authorisation (PDF, 282 kB, 01.07.2025)

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