scholarly journals Novelties of the legislation on veterinary medicinal products

2021 ◽  
Vol 66 ◽  
pp. 142-146
Author(s):  
Y.P. Burylo
Keyword(s):  
European Union ◽  
Veterinary Medicine ◽  
Animal Husbandry ◽  
State Regulation ◽  
The European Union ◽  
Medicinal Products ◽  
Association Agreement ◽  
Veterinary Medicines ◽  
State Registration ◽  
Veterinary Medicinal Products

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.

scholarly journals Some aspects of analysis of the Ukrainian legislation regulating the production of veterinary medicines

2021 ◽  
Vol 14 (2) ◽  
pp. 245-250
Author(s):  
I. V. Bushuieva ◽  
K. V. Petrova ◽  
Zh. M. Polova
Keyword(s):  
State Regulation ◽  
The European Union ◽  
Medicinal Products ◽  
Economic Activities ◽  
Strategic Development ◽  
Veterinary Medicines ◽  
Current State ◽  
Domestic Legislation ◽  
Business Entities ◽  
Veterinary Medicinal Products

The aim of the work was to study the current state of domestic legislation of state regulation in the field of licensing the activities of business entities manufacturing veterinary medicinal products and its harmonization with the requirements of the European Union. Materials and methods. The research materials were regulatory and legislative acts, regulations and principles of the state policy of Ukraine connected with licensing the activities of business entities manufacturing veterinary medicinal products, in force from 2015 to the present. To carry out this study, the methods of information retrieval, systematization, analytics, graphic, comparison, and data generalization were used. Results. The article presents the main results of the analysis of the Ukrainian legislation which regulates the production of veterinary medicines and preparations. According to the results of the analysis, it was found that in the period from 2015 to 2018, Ukrainian manufacturers of veterinary medicinal products worked in such conditions that did not require a license for this type of activity. By the decree of the President of Ukraine, the program of sustainable strategic development of the country “Ukraine-2020” was approved which provided for reforms in the format of deregulation and the development of entrepreneurship and excluded the necessity of licenses for veterinary drugs production. Conclusions. Based on the study, it can be concluded that the Law of Ukraine “On Licensing of Types of Economic Activities” dated March 3, 2015 No. 222-VIII was actually aimed at reducing the governmental influence and regulatory pressure on the activities of business entities involved in the production of veterinary medicinal preparations.

scholarly journals Critical discussion of the current environmental risk assessment (ERA) of veterinary medicinal products (VMPs) in the European Union, considering changes in animal husbandry

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Ruth Haupt ◽  
Céline Heinemann ◽  
Jason Jeremia Hayer ◽  
Simone Magdalene Schmid ◽  
Miriam Guse ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Phase I ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Animal Husbandry ◽  
The European Union ◽  
Medicinal Products ◽  
The Eu ◽  
Veterinary Medicinal Products

Abstract Background Veterinary medicinal products (VMPs) administered to livestock might affect the environment. Therefore, an environmental risk assessment (ERA) is conducted during the approval process of VMPs. In the European Union (EU), the ERA, which was established approximately 10 years ago, consists of two phases. In the present review, we examined the first phase. In this phase, VMPs are subjected to a decision-making process comprising 19 questions and several tables with default values published in the “Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (European Medicines Agency 2016).” Since a proportion of livestock husbandry systems is currently shifting toward ecological husbandry and free-range production systems, there is a lower risk of VMP consumption in general, but livestock excretions possibly containing VMPs might be directly released into the environment instead of being stored and applied as manure. In the present study, the first phase of the current ERA of VMPs in the EU was critically discussed with respect to the changes in animal husbandry. The large number of default values used in the ERA were checked for topicality. In a three-step approach, firstly trends and changes in animal husbandry in Europe that might be relevant for the ERA were collected, secondly, the interactions between Phase I and animal husbandry were evaluated and thirdly, the default values used in Phase I were verified in order to identify research gaps. Results Several default values used in the current ERA were identified as outdated. Together with the lack of valid data (e.g., on animal husbandry systems or VMP treatments), this may have an impact on the predicted environmental concentration (PEC) as the central decision threshold of the ERA. Conclusions The results of the present study indicate that an update of the ERA of VMPs in the EU is required to consider the changes in animal husbandry. Several aspects related to this issue are critically discussed.

scholarly journals Reforming of legislation on the residues of veterinary medicinal products in foodstuffs of animal origin as a component of Ukraine food security

2020 ◽  
Vol 22 (100) ◽  
pp. 108-115
Author(s):  
I. Berezovska
Keyword(s):  
Food Security ◽  
Legal Regulation ◽  
Economic Security ◽  
Animal Origin ◽  
The European Union ◽  
Medicinal Products ◽  
Association Agreement ◽  
National Legislation ◽  
The Eu ◽  
Veterinary Medicinal Products

It is known that the food security of the state, aimed at providing the population with quality and healthy food, is an important component of economic security. Recent developments in the world and national security challenges posed by the Covid-19 virus pandemic necessitate a reassessment of approaches to the legal regulation of issues that significantly affect human health. Today, the reform of the relevant national legislation on FAR residues in food requires a systematic and holistic approach and the definition of its priorities in such a way as to promote food safety and the development of domestic business. The article is devoted to the analysis of the current Ukraine legislation concerning regulation of residues of veterinary medicinal products in foodstuffs of animal origin. It was shown that the formation of such legislation was due to the development of international trade, including the fulfilment of the European Union requirements for the safety of foodstuffs imported into its market. At the same time, the conclusion of the Association Agreement and the introduction of a Free trade zone with the EU was a significant impetus to the reforming of national legislation on residues. The analysis of EU regulations, which serves as a legal basis for the residues control at the EU level, was carried out. It is noted that today in the Ukrainian legislation, despite the introduction of annual national plans for state monitoring of residues of veterinary medicinal products and contaminants in live animals and unprocessed foodstuffs of animal origin, there are a number of gaps that require urgent legislative regulation. It was proved that the completion of the reform of the national legislation on residues will contribute to improving safety of domestic foodstuffs, and therefore, will have important positive consequences not only for the development of trade with the EU, but primarily for the food security of Ukraine and the protection of the health of Ukrainian citizens.

scholarly journals Use of tetracyclines and sulfonamides for the treatment of infectious diseases in animals

2021 ◽  
pp. 10-17
Author(s):  
Yuri Kosenko ◽  
Svitlana Bilous ◽  
Natalia Ostapiv ◽  
Lyubov Zaruma
Keyword(s):  
Veterinary Medicine ◽  
Infectious Diseases ◽  
Clinical Relevance ◽  
Antimicrobial Agents ◽  
Medicinal Products ◽  
Antimicrobial Substances ◽  
Veterinary Medicines ◽  
Treatment Indications ◽  
The Usa ◽  
Veterinary Medicinal Products

The use of antimicrobial medicines in human and veterinary medicine has led to the problem of the development of acquired antimicrobial resistance, which causes a global threat. Were described principles of tetracyclines and sulfonamides use, which are the most common among antimicrobial substances in veterinary medicinal products for the treatment of infectious diseases of food-producing and domestic animals. The aim. To substantiate the clinical relevance of antimicrobial veterinary medicinal products containing tetracyclines and sulfonamides+trimethoprim in veterinary medicine. Materials and methods. Research materials: sales reports of antimicrobial veterinary medicinal products in Ukraine for 2015–2019, EU countries, and the USA. Methods used: written and electronic survey; bibliosemantic, analytical and generalization. Results and discussion. As a result of the annual monitoring for 2015–2019 sales volumes in Ukraine, it was determined that tetracyclines (29.5–37.91 %) and sulfonamides + trimethoprim (12.1–18.7 %) were most often used in the composition of veterinary medicines. The same trend regarding the use of these classes of antimicrobials exists in many countries around the world. Factors determining the clinical relevance of these groups of substances are based on the criteria for their selection. The principle proposed by the EMA for the choice of antimicrobial veterinary medicinal products is based on the following criteria: categories of target animal species; treatment indications; the route of administration; the type of pharmaceutical formulation; the choice of a dosage regimen. Following this principle was substantiated the feasibility of tetracyclines and sulfonamides+trimethoprim use in veterinary medicine. By pharmacokinetic and pharmacodynamic parameters evaluated the rationality of the choice of antimicrobial veterinary medicines. Conclusions. The study revealed clinical efficacy and safety of tetracyclines and sulfonamides+trimethoprim as Veterinary Critically Important Antimicrobial Agents of Category D “Prudence”

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