scholarly journals LEGAL FRAMEWORK OF GOOD MANUFACTURING PRACTICE (GMP) FOR VETERINARY MEDICINAL PRODUCTS IN THE EU: EXPERIENCE FOR UKRAINE

2018 ◽  
pp. 65-76
Author(s):  
I. Berezovska
Keyword(s):  
Legal Framework ◽  
Legal Regulation ◽  
Good Manufacturing Practice ◽  
Eu Law ◽  
The European Union ◽  
Medicinal Products ◽  
Association Agreement ◽  
Organizational Work ◽  
The Eu ◽  
Veterinary Medicinal Products

The article comprehensively analyzes current legislation of the European Union on Good Manufacturing Practice (GMP) for veterinary medicinal products in particular the provisions of Directives No. 91/412 and No. 2001/82, and describes GMP main elements. It is noted that as a result of EU-Ukraine Association Agreement signing a new stage in the development of Ukrainian legislation regarding the turnover of veterinary medicinal products has begun, which is characterized by the increased impact of EU law on the legal regulation of this industry. The state of the appropriate national legislation reforming was analyzed. It was proved that today the main directions of such reforming are related to the integrated introduction of Good Manufacturing Practice and to the restoration of the production of veterinary medicinal products licensing. The importance of prompt and effective completion of these reforms which will have significant consequences not only for the national pharmaceutical industry, but also for the protection of the health of animals and people in general, was underscored. It was emphasized that the scale of the obligations undertaken by Ukraine to harmonize the legislation on the circulation of veterinary medicinal products requires prompt and qualified organizational work by the Ukrainian competent authorities.

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 Security of personal data: legal standards of the European Union and modern applied problems

2021 ◽  
pp. 17-28
Author(s):  
V. BRYZHKO ◽  
V. PYLYPCHUK
Keyword(s):  
Social Relations ◽  
Personal Data ◽  
Legal Regulation ◽  
Digital Transformation ◽  
Eu Law ◽  
The European Union ◽  
Personal Data Protection ◽  
Legal Standards ◽  
Key Aspects ◽  
The Eu

The article is a continuation of a number of scientific works on the state, trends and further ensuring security of personal data in the context of digital transformation and related problems of legal regulation of new social relations in this area. The key aspects of the EU documents approved in recent years, in particular, the GDPR Regulation, the NIS Directive and the draft legal act on e-Privacy, are considered and evaluated. The main criteria and topical issues that need to be addressed in the context of the implementation of EU law and the development of national legislation on personal data protection are highlighted.

scholarly journals Legal Regulation of Energy Safety in Ukraine and the European Union: Problems and Perspective

2019 ◽  
Vol 8 (3) ◽  
pp. 439
Author(s):  
Ievgenii Shulga ◽  
Volodymyr Kurylo ◽  
Inna Gyrenko ◽  
Serhii Savych
Keyword(s):  
Legal Regulation ◽  
General State ◽  
The European Union ◽  
Association Agreement ◽  
Strategy Of Development ◽  
Single View ◽  
Current State ◽  
Legal Security ◽  
Energy Law ◽  
The Eu

Nowadays in Ukraine there is no single view on understanding of the strategy of development of energy safety, which profoundly and negatively affected the general state of national safety of the country. The purpose of the article is to analyze the current state of legal security of energy safety in Ukraine, check it for compliance with its obligations under the Association Agreement with the EU and other EU acts that proclaim the standards in the field of energy safety. This paper refers to the experience of the EU energy safety legislation. Furthemore, this study provides analysis of Ukrainian legislation in this field, draws attention to the existing conflicts and gaps, emphasizing the need to optimize legislation of Ukraine's energy safety according to the EU standards. Keywords: energy safety, energy law, the EU energy safety, energy safety of Ukraine, legislation of energy safety, adaptation of Ukrainian energy legislation to the EU standards.

scholarly journals Legal Framework for Green Finance in the EU and Russia

2021 ◽  
Vol 13 (5) ◽  
pp. 29-43
Author(s):  
Larisa V. Sannikova ◽  
Keyword(s):  
Global Climate ◽  
Legal Framework ◽  
Legal Regulation ◽  
National Standards ◽  
The European Union ◽  
Investor Confidence ◽  
Green Finance ◽  
Sustainable Finance ◽  
Verification Process ◽  
The Eu

The climate agenda has recently taken on new significance with global climate change threatening all of humanity. The regulation of green finance instruments needs to be improved in order to attract more money to fight global warming. To ensure investor confidence in green instruments, a common standard for them must be created. The European Union and Russia have been forming a regulatory framework aiming to create national standards for green bonds. The present article analyses the European Commission’s proposed package of measures to help improve the flow of money toward financing the transition to a sustainable economy. The author explores the problems of developing legal regulation of sustainable finance in Russia, especially with regard to the creation of a national taxonomy of green projects and national verification of sustainable financial instruments. The comparative legal study of the EU and Russian draft laws on green finance has demonstrated similar approaches to establishing regulatory rules. The article describes the prospects for green finance in the context of digitalization. Based on a study of best practices (Green Assets Wallet, green bonds, etc.), it is concluded that digital solutions for sustainable finance are currently still not well-developed. In the future, however, their use will significantly increase investor trust in green instruments and reduce costs, in particular through digitalization of the verification process.

The European ombudsman as a body for the protection of the rights of individuals and legal entities in the European Union

2021 ◽  
pp. 55-61
Author(s):  
Ivanna Maryniv ◽  
Andriy Kotenko
Keyword(s):  
European Union ◽  
Human Rights ◽  
Legal Status ◽  
Legal Framework ◽  
Annual Reports ◽  
Main Body ◽  
The European Union ◽  
Association Agreement ◽  
The Eu

Formulation of the problem. Today, the EU faces new challenges due to the globalization policy pursued by most EU member states, migration and the global pandemic - COVID-19. In the new conditions, the protection of human rights acquires a fundamentally new meaning. Therefore, the question of the role of the EU Ombudsman in the process of protection of individual rights and control over the activities of bodies is very relevant. By choosing the path of European integration and committing itself under the Association Agreement to adapt a number of areas in line with the acquis communautaire, Ukraine should also focus on the experience of the European Ombudsman. Since taking office as the Ukrainian Parliamentary Commissioner for Human Rights in 1998, it will not be an exaggeration to state that there are a number of problems in overseeing the proper activities of the authorities in respecting human and civil rights and freedoms. That is why, given the shortcomings and the chosen vector of development, the experience of the European Ombudsman is of great importance for Ukraine in order to improve the activities of the Ukrainian Parliament’s Commissioner for Human Rights. Target of research is to examine the role of the EU Ombudsman in the process of investigating good governance in the EU institutional mechanism. Article’s main body. The article is devoted to the study of the legal status of the European Ombudsman as a body that must investigate improper bodies of the activities of institutions, agencies to ensure the restoration of violated rights guaranteed by the Charter of Fundamental Rights of the European Union. The analysis of the practice of the European Ombudsman in the official annual reports, as well as the development strategy is carried out. With the help of EU legislation research and conducting of the legal analysis of the Ombudsman’s annual reports, strategic development documents and enquiries, opened by the Ombudsman in the last decade, the complexity of the European ombudsman’s contribution to the implementation of the sustainable development principle within EU’s supranational legal framework. Conclusions. After analyzing the development of Ombudsman’s legal status and the results of his enquiries, conducted in the last decade, a conclusion has been made, that the European ombudsman considerably influences all the institutional system of the EU. His initiatives have far-reaching consequences which might have caused their effect on the whole legal framework of the EU, in case if the European ombudsman had been given some more legal powers. Though, having only recommendation mechanisms in possession, this body influences the governing system of the EU largely, causing positive changes, meeting the leading principles of the functioning of the EU.

Cooperatives in Ukraine: Applicative Peculiarities of Legal Integration up to the EU Standards

2019 ◽  
Vol 9 (5) ◽  
pp. 1789
Author(s):  
Valentyna A. VASYLIEVA ◽  
Alla V. ZELISKO ◽  
Olga I. ZOZULIAK
Keyword(s):  
European Union ◽  
Legal Framework ◽  
Legal Regulation ◽  
Entrepreneurial Activity ◽  
The European Union ◽  
European Union Law ◽  
Social Nature ◽  
The Social ◽  
Market Relations ◽  
The Eu

The article deals with the peculiarities of the processes of adaptation of the legal regulation of cooperatives in post-socialist states (as exemplified by Ukraine) to the requirements of the European Union. Such features are formed taking into account historical, social and economic prerequisites of the development of the modern legal framework of Ukraine. Authors are focused on problems of pecuniary autonomy of cooperatives; the possibility of its full-fledged activities as the parties to market relations; implementation of legal mechanisms that can increase competitive advantage of cooperatives in present-day conditions; increase the level of security and protection of rights and interests of cooperative members. It is proved that the effective entrepreneurial activity of the cooperative is rather compatible with the social nature of the latter, moreover – it contributes to the implementation of such a nature. Behind the arguments in favor of such an approach there is the principle declared in the practices of the European Union law – the focus of cooperatives on the affirmation of the interests of its members.

scholarly journals A regulatory take on cannabis and cannabinoids for medicinal use in the European Union

2020 ◽  
Vol 71 (1) ◽  
pp. 12-18
Author(s):  
Metoda Lipnik-Štangelj ◽  
Barbara Razinger
Keyword(s):  
European Union ◽  
Public Interest ◽  
Marketing Authorisation ◽  
Synthetic Cannabinoids ◽  
Endocannabinoid System ◽  
Legal Framework ◽  
The European Union ◽  
Medicinal Products ◽  
Medicinal Use ◽  
The Eu

AbstractThe discovery of the endocannabinoid system has raised public interest in the medicinal use of cannabis, phytocannabinoids, and synthetic cannabinoids, which has always been closely regulated due to their psychotropic effects and potential abuse. The review takes a quick look at the current legal framework in the European Union, which regulates cannabis use and cultivation for medicinal purposes in line with the United Nations Conventions on the production, trade, and use of cannabis, phytocannabinoids, and synthetic cannabinoids. And while the EU legislation precisely defines requirements and marketing authorisation procedures for medicinal products for all EU member states, there is no common regulatory framework for magistral and officinal preparations containing cannabinoids, as they are exempt from marketing authorisation. Instead, their regulation is left to each member state, and it is quite uneven at this point, mainly due to cultural and historical differences between the countries, leading to different access to non-authorised medicinal products. Therefore, to meet great public interest, harmonised approaches on cannabinoid-containing products without marketing authorisation would be welcome to level the playing field in the EU.

scholarly journals The Relationship Between the Charter and General Principles: Looking Back and Looking Forward

2020 ◽  
pp. 1-25
Author(s):  
Emily HANCOX
Keyword(s):  
European Union ◽  
Case Law ◽  
Legal Framework ◽  
Fundamental Rights ◽  
Eu Law ◽  
The European Union ◽  
Rights Protection ◽  
Transformative Potential ◽  
The Relationship ◽  
The Eu

Abstract Article 6 Treaty on European Union sets out two sources of fundamental rights in the EU—the Charter and the general principles of EU law—without specifying a hierarchy between them. Even though the Charter became binding over a decade ago, the Court of Justice of the European Union (‘CJEU’) is yet to clarify unequivocally how these two sources interact. In this article I argue based upon the relevant legal framework that the Charter ought to replace the general principles it enshrines. This leaves a role for general principles in the incorporation of new and additional rights into the EU legal framework. Such an approach is necessary to ensure that the Charter achieves its aims in enhancing the visibility of the rights protected by EU law, while also providing the impetus for more coherent rights protection within the EU. What an extensive survey of CJEU case law in the field of non-discrimination shows, however, is that the CJEU has struggled to let its general principles case law go, potentially hampering the transformative potential of the Charter.

scholarly journals EU Law and Mass Internet Metadata Surveillance in the Post-Snowden Era

2015 ◽  
Vol 3 (2) ◽  
pp. 53-62 ◽  
Author(s):  
Nora Ni Loideain
Keyword(s):  
Law Enforcement ◽  
Service Providers ◽  
Personal Data ◽  
Legal Framework ◽  
Private Life ◽  
Fundamental Rights ◽  
Eu Law ◽  
The European Union ◽  
Communication Service ◽  
The Eu

Legal frameworks exist within democracies to prevent the misuse and abuse of personal data that law enforcement authorities obtain from private communication service providers. The fundamental rights to respect for private life and the protection of personal data underpin this framework within the European Union. Accordingly, the protection of the principles and safeguards required by these rights is key to ensuring that the oversight of State surveillance powers is robust and transparent. Furthermore, without the robust scrutiny of independent judicial review, the principles and safeguards guaranteed by these rights may become more illusory than real. Following the Edward Snowden revelations, major concerns have been raised worldwide regarding the legality, necessity and proportionality standards governing these laws. In 2014, the highest court in the EU struck down the legal framework that imposed a mandatory duty on communication service providers to undertake the mass retention of metadata for secret intelligence and law enforcement authorities across the EU. This article considers the influence of the Snowden revelations on this landmark judgment. Subsequently, the analysis explores the significance of this ruling for the future reform of EU law governing metadata surveillance and its contribution to the worldwide debate on indiscriminate and covert monitoring in the post-Snowden era.

scholarly journals Tendencies in the transformation of the legal foundations of European integration of Ukraine at the present stage

2020 ◽  
pp. 66-70
Author(s):  
Oleksandr Perederii
Keyword(s):  
European Integration ◽  
Social Relations ◽  
Legal Protection ◽  
Legal Regulation ◽  
The State ◽  
Social Regulation ◽  
The European Union ◽  
Present Stage ◽  
Association Agreement ◽  
The Eu

The article presents and reveals the main tendencies of transformation of the legislative foundations of European integration of Ukraine at the present stage of state formation. While analyzing the problems of implementation of the Association Agreement between Ukraine and the European Union, the author highlights and reveals the content of three main tendencies that are characteristic for the development of the legislative basis of the European integration policy. In particular, the expanding of the current Constitution of Ukraine with the rules on the irreversibility of the European integration course, updating of normative documents regulating the planned character and gradual implementation of the provisions of the Association Agreement, amending the current version of the Association Agreement in order to update its provisions.  The attention is drawn to the fact that the modification of the legislative foundations of Ukraine's European integration course is an important political and legal factor for the transformation of not only the system of the legal system of the state in the formal sense, but also of the legal consciousness of the broad masses of the population. This is explained by the phenomenon of the action of so-called «future law». In practical terms, such a phenomenon manifests itself in the fact that in the society on the mental level there is an increasing level of expectations from the state to activate pro-European policy, further reforming of the national law in the direction of implementation of European models of social regulation. Accordingly, there is an impact on the minds of people by "future norms of law", which are designed to regulate social relations, which are just beginning to emerge.           Further priorities of expanding the legislative foundations of Ukraine's European integration are outlined. In particular, it is the optimization of the mechanism of substantial realization of European integration transformations in the practice of national state administration, as well as the preparation of legislative support to overcome the global political risks and economic threats that may occur in connection with the implementation of the Association Agreement. First of all, Ukraine should develop and accumulate the practice of applying the legislation in the sphere of increasing the investment attractiveness of Ukraine, guaranteeing the legal protection of foreign investments, adjusting the national manufacturing sector of Ukraine to the EU requirements, harmonizing the national model of legal regulation of the labor market with the EU, enhancing the institutional focus of the Ukrainian authorities to implement the EU Directives.

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