Decree on prescribing medicinal products in the provision of veterinary care.

This Decree of the Ministry of Health lays down provisions concerning good veterinary clinical practice and the conditions for clinical trials of veterinary medicinal products in the Czech Republic: (a) the structure of the data provided in the application for approval of the clinical evaluation of the veterinary medicinal product; (b) rules of good veterinary clinical practice; (c) the content of the clinical evaluation protocol; (d) method of informing about the start of the clinical evaluation; (e) changes in the contact details of the contracting authority that can be made and immediately reported to the veterinary institute; (f) method of labeling veterinary medicinal products in clinical evaluation; (g) the scope of the data presented in the report on the completion of the clinical evaluation; (h) clinical evaluation documents kept by the investigator. The present Decree aims to ensure that clinical trials for veterinary medicinal products are conducted ethically, scientifically, and in compliance with legal standards.