The Federal Act on Veterinary Medicinal Products (TAMG) comprehensively regulates the requirements and provisions relating to veterinary medicinal products in Austria. It comprises various sections, including general provisions, placing on the market, advertising and control, operating regulations, market surveillance and pharmacovigilance. The TAMG defines requirements for veterinary medicinal products, including the notification of veterinary medicinal products, applications for marketing authorization, the conduct of clinical trials and the labelling of medicinal products. It also lays down regulations for the placing on the market, the amendment of marketing authorizations, parallel trade in veterinary medicinal products and pharmacovigilance. Furthermore, the Act contains provisions on the advertising of veterinary medicinal products, company regulations, authorizations, company inspections, pharmacovigilance inspections and the reporting of adverse events. It also specifies how misleading advertising is to be dealt with and which controls are to be carried out in relation to the advertising of veterinary medicinal products. The TAMG serves to ensure the safety and efficacy of veterinary medicinal products, to regulate the distribution and use of veterinary medicinal products and to protect animal health. The text consists of 95 Articles divided into 6 Chapters.
Австрия · 2023-12-01