veterinary medicinal products, clinical trials, good clinical practice

Draft Decree on good veterinary clinical practice and detailed conditions for clinical trials of veterinary medicinal products

The draft Decree lays down the conditions of good clinical practice for conducting clinical trials on veterinarymedicinal products and lays down the details of certain conditions for conducting clinical trials of veterinarymedicinal products.

In relation to Regulation (EU) 2019/6, the Pharmaceuticals Act and in line with International Guidelines (VICHGL9), the draft Decree lays down:
• details of the submission of applications for the approval of a clinical trial;
• requirements for the clinical trial protocol;
• how to provide information about the initiation of a clinical trial;
• changes in the contact details of the contracting authority that can be made and immediately reported to theVeterinary Institute; permissible negative weight and volume deviations of packaging;
• labelling requirements for medicinal products used in a clinical trial;
• requirements for a clinical trial termination report;
• evidence kept by the investigator on a clinical trial.

Keywords: veterinary medicinal products, clinical trials, good clinical practice

a) the basic text of the draft Decree is Act No 378/2007 on pharmaceuticals and amending certain related acts,as amended
B) the TRIS database contains the version of the Act effective until 31. 5. 2024 as well as the text effectivefrom 1. 6. 2024
c) the Act, as a basic text, was entered in the TRIS database as part of notification 2023/0676/CZ.