Clinical trials
A clinical trial is a study which aims to assess, under field conditions, the safety or efficacy of a veterinary medicinal product under normal conditions of animal husbandry or as part of normal veterinary practices, for the purpose of obtaining a marketing authorisation or a change thereof.
A pre-clinical trial does not require prior authorisation from the FAMHP; a clinical trial however does.
Clinical trials involving the use of medicinal products for veterinary use
A clinical trial involves testing the effectiveness or safety of one or more medicinal products on an animal or a group of animals. If such tests are performed on non-laboratory animals, prior authorisation is required from famhp (the Belgian Federal Agency for Medicines and Health Products) before testing starts. If a trial is conducted in a laboratory environment and involves laboratory animals only (a pre-clinical trial), no prior authorisation from famhp is required.
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Contact
Contact via infovet@fagg.be.