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Clinical trials of pharmaceuticals
Horáková, Kateřina ; Svoboda, Petr (advisor) ; Millerová, Ivana (referee)
Clinical trials of medicinal products is increasingly important area of pharmaceutical law. Number of clinical trials and amount of financial resources is constantly rising and therefore the rules and principles of the clinical trials itself are being clarified overtime. This diploma thesis aims to provide an overview of the basic aspects of clinical trials of medicinal products for human use from a legal point of view. The author focuses in particular on the national legislation of clinical trials, which is complemented by the legislation of the European Union and important sources of the international law. Author is more closely analysing the particular procedures performed within the clinical trials, especially from the point of view of the administrative law. Particular attention is paid to the ethical review of the clinical trials, their particular aspects and the overall concept. The thesis is divided into twelve chapters. In the introduction, the author focuses on the development of the clinical trials and mentions the crucial moments that contributed to the formulation of the basic rules of the clinical trials. The following chapter focuses on the sources of law. Firstly, sources of international law are described, where more general sources and specific sources of law of medicinal products...
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Legal regulation of firearms
Flax, Lukáš ; Millerová, Ivana (advisor) ; Rajchl, Jiří (referee)
1 Legal regulation of firearms Abstract in english: The thesis sets up three main objectives. Firstly to enrich the public debate by verifying numerous historical arguments, which objectivity and relevancy is unclear. Three chapters of the thesis delve in to these matters, presenting cultural, historical and scientific context for evaluating legal regulation in Europe at large. For substantial demography the right to own and carry a weapon is a symbol of their freedom, while the restrictions represent authoritarian breach of their rights. To an extend this thesis verifies this notion based on historical analysis of past czech and czechoslovakian legal regulation. On the other hand presented outcome of sociological research brings up the fact that weapon at the societal level private possession of firearms does not increase the safety of individual citizens. Sociology also offers enlightement on the reasons why we seek to own and carry weapon and why we fear them. Often these reasons are similarily questionable. The second objective was to provide deeper analysis of tangible outcomes of the debate itself. At the level of European union such an outcome is the Directive 2017/853 of the European Parliament and Council of May 2017 amending Council Directive 91/477/EEC on control of the acquisition and possession...
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Re-use of public sector information
Gaertner, Petr Josef ; Korbel, František (advisor) ; Millerová, Ivana (referee)
69 The re-use of public-sector information This thesis considers the re-use of public-sector information in the context of freedom of information. The thesis describes the following: a) the implications of freedom of information (transparency of public administration, involvement of citizens in public affairs, fight against information poverty, protection of the environment or the fight against corruption); b) the implications of the re-use of public-sector information (from an economic and social view); c) principle of publicity and principle of confidentiality (their application in democratic and nondemocratic regimes); d) the evolution of freedom of information legislation (inspiration in China, origin in Sweden, transposition into international law, influence of the United States of America, examples of modern information regulations and the right to information in European Union law); e) freedom of information in international law (The Universal Declaration of Human Rights, the European Convention for the Protection of Human Rights and Fundamental Freedoms, the International Covenant on Civil and Political Rights, the Recommendation of the Committee of Ministers of the Council of Europe No. R (81) 19 on the access to information held by public authorities, Úmluva Rady Evropy o přístupu k úředním...
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Decision-making practice of the Ministry of Health on administrative delicts under the Act on Pharmaceuticals
Heflerová, Markéta ; Svoboda, Petr (advisor) ; Millerová, Ivana (referee)
Ministry of Health Decision Practice in the area of Administrative Offences according to The Act on Pharmaceuticals Key Words: Medicinal Products, Administrative Offence, Ministry of Health In the first chapter of this master thesis I dealt with the general issue of administrative offences. I also introduced the Act on Pharmaceuticals and explained the fundamental term "a pharmaceutical," which includes medicinal products and active substances. The state administration is provided by State Institute for Drug Control which adjudicates in administrative offences in the first instance, and Ministry of Health that hears appeals against these decisions. In the second chapter, there is interpreted a material law part of the Act on Pharmaceuticals. I also introduced the elements of administrative offences, responsibility for them, sanctions, speciality and subsidiarity, analogy within the administrative sentencing etc. The third chapter is dedicated to procedural matters concerning the Act on Pharmaceuticals. The whole procedure starts with a control of an operator. If he/she does not abide the relevant rules of law, State Institute for Drug Control will initiate an administrative procedure and after finding necessary facts this institution renders a meritorious decision. If the operator was not satisfied...
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Development of legal regulation of gambling
Plecháč, Ondřej ; Rajchl, Jiří (advisor) ; Millerová, Ivana (referee)
This diploma thesis analyses the historical development of gambling legislation in the Czech Republic, from the first mention of the regulation in the Middle Ages to present days, while the primary (but not exclusive) subject of my research are the basic sources of gambling regulation in the field of administrative law. In my thesis, I identify and examine the main reasons for implementation of new institutes and other changes into the gaming law. In this context, I assess the degree of restrictiveness or liberality of each regulation while focusing on whether there were any long-term tendencies to make the legislation more or less strict. All of this is done through the interpretation of legal norms with the help of legal methodology - methods of subjectively historical, teleological and logical interpretation are used in the thesis. These forms of legal methodology were chosen with regard to the resources used in the thesis, which include mainly legislation and its explanatory statements. The whole thesis is divided into three chronologically subsequent chapters representing the main periods of the gambling legislation development. The first chapter deals with the evolution of gaming law from its beginnings in the 13th century until 1989; its subchapters then divide this long period into several...
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Liability for administrative delicts
Hojková, Eva ; Prášková, Helena (advisor) ; Millerová, Ivana (referee)
This Master's thesis main theme is the liability for administrative delicts and mainly the expiry of the liability for administrative delicts. With the commencement of an act number 250/2016, about the liability for administrative delicts and the proceedings about them, there raised a question about how far this act is complex and unitary. The goal of this thesis is evaluation of the new act and comparison with the old act mainly in the field of the expiry of the liability for administrative delicts. In the second chapter the thesis deals with the development and history of the liability for administrative delicts and with the acceptance of new act. The chapter ends with the sources of the law of administrative delicts. The third chapter is devoted to foundations of the liability for administrative delicts. Reader can find there the basis of the liability of natural persons, legal persons and natural persons who are entrepreneurs and basis about circumstances that exclude the liability. This chapter is the foundation for chapter four which is devoted to the main theme of the thesis - expiry of the liability for administrative delicts. The fourth chapter deals with the reasons for expiry of the liability for administrative delicts. The author introduce and analyze particular problems chained with...
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Development and issues of subjectmatter and territorial jurisdiction in administrative infraction proceedings
Budil, Petr ; Prášková, Helena (advisor) ; Millerová, Ivana (referee)
The main objective of this master thesis is to provide a view into the development of subject matter and territorial jurisdiction in administrative infraction proceedings as a part of administrative punishment law. The thesis handles this issue in its entirety, that is form its origins up to considerations on the future legal regulation, and, furthermore, analyses the issue into more depth. The thesis relies mainly on legal regulation and relevant literature as its primary sources and is divided into three chapters. The first chapter, firstly, deals with the development of subject matter and territorial jurisdiction in the 18th and 19th century and focuses on the formation of the concept of infraction itself, its division into the categories of administrative and judicial infraction and the gradual obsolescence of the phenomenon of judicial infraction. Secondly, it handles the transfer of subject matter jurisdiction in "judicial" infraction proceedings from administrative authorities to courts and, thirdly, defines the three bodies authorized to conduct administrative infraction proceedings. In the second chapter, the issue of subject matter and territorial jurisdiction in the 20th century is dealt with. Its primary aim is to describe several unsuccessful legislative proposals in the area of...
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Launching medical devices on the market
Dvořáková, Jitka ; Svoboda, Petr (advisor) ; Millerová, Ivana (referee)
The issue of launching medical devices on the market became more intense in the last few decades in connection to the expansion of the pharmaceutical industry and legal area. This legal area is still mostly undescribed and it stands in the shadow of known and more discussed medical products. Proper legal theoretical analysis is often completely absent. This master thesis aims to complexly describe and analyse theoretical bases of current legislative regulating the launching of the medical devices on the market, including other processes related to this issue. Emphasis is places on the concept of medical device, the responsibility of the manufacturer and the nature of notified body. The author focuses on the subsequent conformity assessment process and process of registration. The process of notification and exemption from this obligation and administrative nature of selected documents. The thesis is divided into eleven chapters and the introductory chapter focuses on a general introduction to the field of pharmaceutical law, namely the regulation of medical devices, including the definition of basic questions in the work under study. The second chapter deals with the analysis of sources of legal regulation of medical devices. The chapter is divided into sources of the law of the Czech Republic and...
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Summary hearing of administrative delicts
Lepáček, Jaroslav ; Prášková, Helena (advisor) ; Millerová, Ivana (referee)
This thesis deals with the abbreviated forms of administrative misdemeanour procedure (or summary procedures), which can also be referred to as a special type of administrative proceedings by literature. These proceedings are known as ticket procedure and order procedure. These traditional legal concepts of administrative law were already included in the legal system of Austria-Hungary and later in the legal system of Czechoslovakia. One of the main reasons for regulation of ticket procedure was attempt to affect the offender immediately after the commitment of misdemeanour and thus mitigate the pressure on the respective administrative body. On the other hand, the purpose of the order procedure is to simplify the proceedings regarding offences in cases, where there is no dubiety about the offender. For these reasons, the evidence is not presented and proving of facts and law is absent from both mentioned proceedings. The main legal regulation is contained in the Misdemeanours Act. The Administrative Procedure Code applies subsidiarily. However, other individual subject-matters of misdemeanours possibly fulfilled by offenders are present in special laws, which allow to deal with the offences in ticket and order procedure as well. This thesis is divided into 6 chapters, of which the first one deals...
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Public law context of ownership of a dog
Putík, Miroslav ; Kopecký, Martin (advisor) ; Millerová, Ivana (referee)
A dog owner does not only have rights, but also (and mainly) a lot of obligations. One of the aims of this work was to look at different areas concerning the ownership (holding) of a dog in relation to the actual public law regulations. Particular chapters reflect possible life situations, which have (especially from a point of view of public law) an effect on coexistence with a dog and (often negative) the impact (penalties) for a dog holder. Thematic areas are addressed, for example, purchasing a dog, his vaccination and other health and life conditions, the possibility of shortening a tail or ears, the admissible conditions and methods that permit the killing of a dog or the conditions and ways to bury a dog. Further mention is made of the possibilities of travelling with a dog (and also abroad), also described are the law regulations of dog fees and the generally binding ordinances of municipalities. Deeper consideration was essential in respect of the areas concerning misdemeanours and criminal offences, which can be commited both on a dog and by a dog (incl. veterinarian demands or animal cruelty). There are follow-up chapters concerning liability for damage and compensation for damage. A part of the work is dedicated to breed specific legislation concerning breeding some (so called "fighting" or...
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