Legislation:
- Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02019R0006-20220128)
- Medicinal Products Act (Zakon o zdravilih (ZZdr-2) https://pisrs.si/pregledPredpisa?id=ZAKO6295
- Pravilnik o načinu in postopku kliničnega preskušanja zdravil za uporabo v veterinarski medicini https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0245
See also CMDv guidance on clinical trials https://www.hma.eu/veterinary-medicines/cmdv/procedural-guidance/clinical-trials.html.
FORMS for submissions are available here.
