Національний юридичний університет імені Ярослава Мудрого ⚖ Головна ⓘ Довiдка
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1.
Pashkov, V. M..
    Legal Features of the Drug Advertising [Текст] / V. M. Pashkov, A. A. Olefir, O. Y. Bytyak // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue: 1 . - p. 133-138
   Перевод заглавия: Юридические особенности рекламы лекарств
УДК
ББК Р

Аннотация: Abstract INTRODUCTION:In the article discribed current trends of advertising in the pharmaceutical market and foreign experience of legal regulation of these relations. As for the advertising of medicines identified it's symptoms, types, basic rules and prohibitions. Modern pharmaceutical companies can not successfully carry out economic activities without advertising. Besides we can mention some fundamental changes in society (information overload, universal access to internet, social media, freedom of movement of goods, labor and finance), also self-medication becomes more popular. At the same time, the number of deaths after improper and uncontrolled use of drugs ranks fifth in the world among the causes of death. AIM:Investigate current trends of advertising on the pharmaceutical market, find advertising signs, basic restrictions and prohibitions on advertising of medicines, as well as foreign experience of legal regulation of these relations. MATERIAL AND METHODS:Despite the fact that pharmaceutical advertising were studied by such scholars as M. Abraham, L. Bradley, C. Dunn, J. Donoh'yu, D. Castro, M. Lipski, K. Taylor and others, number of issues related features of drug advertising, remained without proper theoretical studies. RESULTS:Based on the analysis can come to the conclusion that advertising of medicinal products are the subject of special attention from the state. Drugs, unlike other products, are a group of specialized consumer products. Risks increase when patients under the influence of «aggressive» advertising resort to self-medication. If a complete ban on advertising of medicines is inappropriate, you should set stricter requirements for the content of advertising and product placement rules. That is, in the national legislation to implement regulatory requirements of Directive 2001/83 / EC. CONCLUSIONS:Legal regulation of drug advertising can be improved by such legal means: - should provide for a mechanism of public control over the observance of ethical standards in the advertising of medicinal products; - Prohibit the advertising of medicines for children, as well as drugs for the treatment of infectious, parasitic diseases and pathogens of these diseases, chronic insomnia, cardiovascular diseases, and those costs are reimbursed by government programs or trade names may lead to mix with prescription drugs; - Adopt ethical standards (codes) promotion of drugs for pharmaceutical companies; - Advertising to the public shall not contain any reference to cost or pricing features for medicines.

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2.
Getman, A. P..
    Harmonization of Ukrainian Waste Treatment Laws with EU Legislation [Текст] / A. P. Getman, V. I. Lozo // Environmental Policy and Law. - 2017. - vol. 47, no. 1. - pp. 48-52
   Перевод заглавия: Гармонизация законов Украины об обращении с отходами с законодательством ЕС
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3.
Pashkov, V. .
    European Experience of Regulating Distance Selling of Medicines for Ukraine [Текст] / V. Pashkov, Y. Hrekov, M. Hrekova // Wiadomosci lekarskie. - 2017. - Vol. 70, № 1. - pp. 96-100
   Перевод заглавия: Европейский опыт регулирования дистанционной продажи лекарств для Украины
УДК
ББК Х623.211.84

Аннотация: INTRODUCTION: Some countries have already tried and tested mechanisms of regulating distance sales as form of distribution of medicines that have been used more or less effectively for a fairly long time. Herewith, so far, the approach of the competent authorities of some countries including Ukraine can be called prevailing in quantitative terms under which the official prohibition on distance sales of medicines is set. AIM: The aim of this study is a detailed examination of the nature of the prohibition of the medicines distance selling in Ukraine, namely the an analysis of advantages and disadvantages of this form of distribution of medicines and identification of appropriate ways for gradual repeal of the prohibition in terms of regulatory reform in Ukraine in the sphere of circulation of medicines due to the process of adaptation of statutory regulation in this area to the EU legislation. MATERIAL AND METHODS: This study is based on Ukrainian regulation acts, Council Directives 97/7/EC, 2000/31/EC, 2001/83/EC, scientific works and opinions of progressiveminded people in this sphere. Such methods as dialectical, comparative, analytic, synthetic and comprehensive have been used in the article. CONCLUSION: Reception of the described experience of regulation in EU will allow a further review of the principles of regulation in Ukraine in the sphere of medicines with a shift in the main emphasis in the direction of ensuring adequate consumer rights in this area and preventing the risks of patients' and public health.

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4.
Lutsenko, O. .
    Bringing Civil Servants to Liability for Disciplinary Misconduct in Judicial Practice of Ukraine, Poland, Bulgaria and Czech Republic [Текст] / O. Lutsenko // Journal of Advanced Research in Law and Economics. - 2017. - Vol. VIII, № 1 (23). - p. 103-112
   Перевод заглавия: Привлечение государственных служащих к ответственности за дисциплинарные проступки в судебной практике Украины
УДК
ББК Х621.023

Аннотация: A discipline of public servants within an organization requires four characteristics: a number of disciplinary offences, proportionate punishments clearly linked to the disciplinary offences, oversight and appeals from disciplinary decisions, and independence from politicians. This paper examines public sector legislation in Ukraine, Poland, the Czech Republic, and Bulgaria to show the peculiarities of legal regulation of each of these criteria. We argue – a claim that creation of arbitrary powers to punish or dismiss staff is unjust if the legislation does not fully inform staff of what a breach of discipline constitutes, if it does not guarantee proportionate punishments to offences, and/or allow the disciplinary process to be used as a tool to coerce staff to perform in a politicized or otherwise unethical manner. In the article all four criteria are disclosed by comparative analysis with certain EU members (Poland, Bulgaria, Czech Republic). Intermediate and key conclusion about the peculiarities of bringing civil servants to disciplinary liability in Ukraine, Poland, Bulgaria and the Czech Republic and some recommendations are made on the basis of the comparative study.

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5.
Pashkov, V. .
    Advertising of Medical Devices: Foreign Experience and Ukrainian Practice [Текст] / V. Pashkov, A. Harkusha, O. Bytiak // Wiadomosci lekarskie. - 2017. - Vol. 70. Issue: 3 pt 1. - P. 456-461
   Перевод заглавия: Реклама медицинских приборов: зарубежный опыт и украинская практика
УДК
ББК Р

Аннотация: INTRODUCTION: Chosen European foreign policy vector for Ukraine establishes its obligation to enforce the process of adaptation of the EU law regulations in the internal legal policy. The approximation of Ukrainian law to the European Union (EU) "acquis communautaire" is not only the instrument for deepening our economic cooperation with the European Union, but also the important measure to enhance further development of Ukraine in general. National legislation, which regulate advertising and promotion of medical devices (MD), is not an exception. Some key points on legal regulation of abovementioned sphere is a base of this study. MATERIALS AND METHODS: Ukrainian legislation, European Union`s Law Acts, EU's member-states law, WHO Acts and Recommendations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. DISCUSSION: In accordance with Ukrainian legislation, there is no special law that concerns advertising on MD in Ukraine, this sphere is regulated by general law that named ≪About advertisement≫, but it doesn't take into account even main characteristics of such a special object as medical devices (MD). Moreover, the law ≪About advertisement≫ contain discrepancies in terms that are used, these contradictions, in our opinion, must be eliminated by appropriate law reforms. CONCLUSION: The advertising and promotion of MD in EU is regulated by a combination of EU and national legislation of EU Member States, national advertising and promotion of MD are not harmonized with the EU MDD for now, resulting in a fragmented legal landscape that differs from one EU Member State to the other. Practice of adopting different codes and guides that regulate advertising, including advertising of MD, is widespread in EU and EU Member States and thus must be used in Ukraine with appropriate reformation of national law.

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6.
Pashkov, V. M..
    3-D Bioprinting Law Regulation Perspectives [Текст] / V. M. Pashkov, A. Harkusha // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue: 3 pt 1. - p. 480-482
   Перевод заглавия: 3-D перспективы регулирования биопринтинга
УДК
ББК Х833

Аннотация: INTRODUCTION: Achieved level of technical progress moves us closer and closer to practical use of 3-d bioprinting technologies in real life. Such perspective raise a wide variety of crucial legal issues from the acceptable model of regulation of the science and its' societal effects to problems of the commercialization of the technology and potential restrictions of its use. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Scientific discussion on 3-D bioprinting, European Union`s and US experience in patenting of 3-D bioprinting technologies, European Medicine Agency (EMA) or the US Food and Drug Administration (FDA) regulations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. DISCUSSION: General debate of last few years comes down to an attempt to resolve hesitation between legal attempts for regulation of 3-D biobrinting and concept of complete prohibition of such activities. An adequate response to the mentioned challenge is a reasonable position between some aspects of prohibition and self-regulation, resulting in a moderate number of regulations and standards for developing and marketing. Such regulations may concern an intellectual property (IP) rights, regulation of distribution, premarket restrictions, control mechanism etc. CONCLUSION: Scientific approach and regulatory settlement of 3-D bioprinting sphere must unite to achieve a fair balance between the interests of humanity and of individuals - on the one hand, and development of science and business benefits for stakeholders - on the other. The main instruments for this must be balanced regulation of intellectual property (IP) rights, regulation of access and distribution, premarket restrictions, control mechanism etc.

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7.
Pashkov, V. M..
    Legal Regulation of the Production and Trade of Medical Devices and Medical Equipment in the EU and US: Experience for Ukraine [Текст] / V. M. Pashkov, А. Kotvitska, A. O. Harkusha // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:3 pt 2. - P. 614-618
   Перевод заглавия: Правовое регулирование производства и торговли медицинскими приборами и медицинским оборудованием в ЕС и США: опыт для Украины
УДК
ББК Х623.211.84

Аннотация: INTRODUCTION: The need for effective legal regulation of production and sale of medical products in Ukraine due to its social effect is obvious and requires a high level of clarity. The experience of more advanced countries in this area, given the way chosen by Ukraine to harmonize our laws with EU legislation, is certainly could be a useful source of information. The urgency of issues need further intensification of national legal reforms. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Legislation of Ukraine, European Union, United States of America, Guidelines, developed by European Commission & Food and Drug Administration's (FDA), recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. DISCUSSION: This study provide a possibility to state that main difference of regulatory systems in EU and US is that the legal framework of the EU is more flexible. This flexibility is grounded on main principle that only basic quality requirements for medical devices is defined by legislative acts however more detailed requirements are defined in standards, technical regulations, specifications, which are discretionary in nature. Contractors are free to choose any technical solution that provides compliance with the essential requirements, they can choose among different conformity assessment procedures and between accredited conformity assessment bodies to which they want to apply. The contractors themselves is interested to pass the conformity assessment procedure and have the right to put a conformity mark on their medical device because it will give them a real competitive advantage. In contrast, US State regulatory system provides strict control over business entities and law act establishes the quality requirements of medical products. The only body that can authorize the introduction of medical products and perform post-market monitoring is Food and Drug Administration (FDA), which has almost unlimited competence in this sphere. CONCLUSION: Taking into account further deepening of the European integration process of Ukraine, establishing of the regulatory system as much similar to that of the EU as possible is a main goal of legal reforms in abovementioned sphere. On the one hand, such system allows to implement effective control of contractors in the sphere of production and sale of medical products and provide safety of medical devices that are introduced, on the other hand, it does not afflict contractors with excessive and total control, allowing them to choose behavior that is most acceptable, understandable and user-specific. However, US's experience also has some positive characteristics, which could be taken into account. Therefore, such complex symbiosis of approaches from our point of view will balance controversial interest of manufacturers, sellers and consumers of medical devices.

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8.
Pashkov, V. M..
    The Directions of Development of Legal Regulation of Patenting the Methods of Treatment in Ukraine Considering the European and World Experience [Текст] / V. M. Pashkov, Y. A. Hrekov, M. M. Hrekova // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:3 pt 2. - P. 628-632
   Перевод заглавия: Направления развития правового регулирования патентования методов лечения в Украине с учетом европейского и мирового опыта
УДК
ББК Р

Аннотация: INTRODUCTION: the current state of patenting legal regulation of medical treatment in Ukraine and in the world is analyzed, the directions for the further development are determined. The author defines "non-industrial medical" and socio-ethical theories in the field of medical treatment patent protection. The existence of exclusively formal "monopoly" of the patent owner is noted, as well as the inapplicability of the majority of the patented achievements in this field in Ukraine. AIM: the purpose of this article is to investigate the current state of patenting legal regulation of medical treatment in Ukraine and in the world, to analyze the limitation of patent protection basic conception in the medical field and to determine the tendencies and perspectives of the legal protection mechanism of further development in this field in Ukraine, considering the European and world regulation experience. MATERIAL AND METHODS: this study is based on Ukrainian regulation acts, The European Patent Convention, The Code of Laws of the United States of America, judgments, scientific works and opinions of progressive-minded people in this sphere. Such methods as dialectical, comparative, analytic, synthetic and comprehensive are used in the article. CONCLUSION: The experience analysis of the medical treatment patenting regulation in EU and in other countries of the word made it possible to substantiate the tendencies of development the patenting legal regulation of treatment methods mechanism, based on the needs of creation conditions for the availability of the recent treatment developments and technics for citizens, without increasing the cost of such treatment through license fees.

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9.
Komarova, T. .
    The Court of Justice of the European Union and International Legal Order [Текст] / T. Komarova // Russian Law Journal. - 2017. - Vol. 5, No. 3. - P. 140-167
   Перевод заглавия: Суд Европейского союза и Международный правовой порядок
УДК
ББК Х91

Аннотация: The author discusses the relationship between two legal orders: international law and European Union (EU) law. The main provisions of this relationship have been established through the precedential practice of the Court of Justice of the European Union – the EU’s main judicial body. This kind of research seems important because of the gap in the theory of international law caused by the immutable dogma of the supremacy of international law. However, modern legal practice demonstrates a certain fragmentation of the international legal order because of the impact of the existence and development of regional supranational legal orders. The EU legal order, with its own special nature (sui generis), is undoubtedly one of the most developed among them. The Court of Justice of the European Union performs a crucial role in the EU legal system concerning application and interpretation of EU law. It provides auniform interpretation of this law for the purposes of development of supranational integration. In this context the Court of Justice the European Union establishes the status of European law and its relationship with the national legal systems and international law. The Court acts as protector of the EU legal order against the influence of other legal orders. The Court’s precedential practice reveals EU law’s tendency towards its constitutionalization and the development of its autonomy. The latest practice indicates the Court’s powers to review the EU institutions’ acts in relation to the implementation of UN Security Council resolutions. This proves the Court’s ability to establish indirect control even over UN acts.

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10.
Pashkov, V. .
    Vat Rates on Medical Devices: Foreign Experience and Ukrainian Practice [Текст] / V. Pashkov, N. Hutorova, A. Harkusha // Wiadomosci lekarskie. - 2017. - Vol. 70. Issue:2 pt 2. - P. 345-347
   Перевод заглавия: Тарифы на медицинские приборы: зарубежный опыт и украинская практика
УДК
ББК Р

Аннотация: Abstract INTRODUCTION: In Ukraine differentiated VAT rates is a matter of debate. Today the Cabinet approved a list of medical products that has been changed three times resulting in changed VAT rates for specific products. European Union provides another method of regulation of VAT rates on medical devices. The abovementioned demonstrates the relevance of this study. MATERIAL AND METHODS: Comparative analysis of Ukrainian and European Union legislation based on dialectical, comparative, analytic, synthetic and comprehensive research methods were used in this article. DISCUSSION: In Ukraine general rate of VAT for all business activities is 20 %. But for medical devices, Tax Code of Ukraine provides special rules. VAT rate of 7% for transactions supplies into Ukraine and imported into the customs territory of Ukraine of medical products on the list approved by the Cabinet. The list generated by the medical product name and nomenclature code that does not correspond to European experience and Council Directive 2006/112/EC. CONCLUSION: In our opinion, reduced VAT rates should to be established for all medical devices that are in a stream of commerce, have all necessary documents, that proved their quality and safety and fall under definition of medical devices.

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