This Regulation sets out the requirements for conducting clinical trials on veterinary medicines, including the procedural steps for obtaining approval from the relevant authorities and ensuring that trials adhere to both national and European standards for safety, efficacy, and the ethical treatment of animals. It establishes that all trials must be ethically reviewed, with particular attention given to animal welfare and minimizing harm to test subjects. Therefore, it strictly defines the roles and responsibilities of key stakeholders such as trial sponsors and investigators, ensuring that all parties are accountable for adhering to the prescribed procedures and standards. In addition to detailing the approval process, the Regulation mandates continuous monitoring throughout the trial phase. Sponsors are required to submit periodic progress reports, safety data, and notify authorities of any adverse events. At the conclusion of the trial, a final report must be submitted, summarizing the results and ensuring that any potential risks associated with the medicinal product are properly addressed.
Slovenia · 2026-01-19