Open Access
Novelties of the legislation on veterinary medicinal products
Author(s) -
Ю.П. Бурило
Publication year - 2021
Publication title -
naukovij vìsnik užgorodsʹkogo nacìonalʹnogo unìversitetu. serìâ pravo
Language(s) - English
Resource type - Journals
eISSN - 2664-6153
pISSN - 2307-3322
DOI - 10.24144/2307-3322.2021.66.24
Subject(s) - legislation , veterinary drugs , european union , business , distribution (mathematics) , quality (philosophy) , veterinary medicine , human medicine , medicine , political science , law , traditional medicine , international trade , mathematical analysis , philosophy , mathematics , epistemology
The article is devoted to the analysis of the latest innovations in the legislation on veterinary medicine, namely the regulation of the production, distribution and use of veterinary medicines. The adoption of the new Law of Ukraine “On Veterinary Medicine” is caused by the need to approximate the relevant national legislation with the legislation of the European Union to fulfill Ukraine’s international obligations under the Association Agreement. This law reflects the latest trends in the development of legislation on veterinary medicinal products in the European Union.
The article pays attention to the strengthening of state regulation of production and distribution of veterinary medicines, in particular the introduction of licensing of imports, wholesale and retail sales of these medicines in Ukraine, due to the need to combat counterfeiting and veterinary medicinal products of dubious quality. It is also noted that the changes in the procedure of state registration of veterinary medicines provided by this law will on the one hand reduce the administrative burden on business due to the transition to indefinite state registration of veterinary drugs, and on the other hand new requirements for the registration dossier will improve the safety, quality and efficacy of veterinary medicinal products.
New requirements for the use of antibiotics are analyzed. Attention is drawn to the fact that along with the regulation of the use of antibiotics in animal husbandry, it is also necessary to regulate in more detail the issues of control of the circulation of active substances (active pharmaceutical ingredients). The article also deals with the mechanism of veterinary pharmacovigilance, which is new for Ukraine. At the same time, it is necessary to study the practical experience of implementing the European model of pharmaco to improve the relevant legislation in Ukraine.