Cabinet Regulation No. 401 of 2004 on Procedures for Monitoring of Adverse Reactions Caused by Veterinary Medicinal Products

These Regulations prescribe the procedures by which the monitoring of possible adverse reactions caused by veterinary medicinal products shall be performed. These Regulations apply to the adverse reactions caused to animals - by the use of veterinary medicinal products (also medical treatment pre-mixture added to medicated feed); by the medicinal products, which are intended for humans, used in veterinary medicine; and by the use of veterinary medicinal products in a manner incompatible with the information indicated on a labelling and package leaflet; humans - by the incidental use of veterinary medicinal products or their use for animals; possible - by the veterinary medicinal products getting into the environment (pollution); by the inefficiency of veterinary medicinal products; and by the changes during withdrawal period of the veterinary medicinal products from the organism.