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Medical devices regulatory framework
Honegr, Jan ; Staša, Josef (advisor) ; Vedral, Josef (referee)
Charles University in Prague, Faculty of Law Department of Administrative law Candidate: PharmDr. Jan Honegr, Ph.D. Supervisor: JUDr. Ing. Josef Staša, CSc. Title of diploma thesis: Medical devices regulatory framework The subject of this diploma thesis is the regulatory framework for the so-called "general" medical devices with a slight overlap in the field of in-vitro medical devices. The presented work aims to describe the impact of the planned change in the regulatory framework for medical devices on economic operators in the field of production and distribution of medical devices in the Czech Republic. In this work I gradually deal with the historical development of the regulatory framework for goods in the European Communities and subsequently the European Union and the specific regulation of for medical devices. I deal in detail with the multilevel regulatory framework and the relationships between its components. I focus in more detail on the key change in the regulatory framework, which is represented by the hitherto ineffective EU Medical Devices Regulation 2017/745 and government bills to prepare the Czech legal system for the adoption of this directly effective European Union legislation. The main parts of the work are chapters 5 and 6 in which, I deal with the potential impacts of the...
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Special powers of the building offices
Pražák, Matouš ; Petrmichl, Václav (advisor) ; Staša, Josef (referee)
Special powers of the building offices Abstract This diploma thesis deals with the special powers of the building offices. These can be understood as defined legal instruments with which are building offices equipped in order to protect public priority. The main goal of the thesis is to provide complex legal analysis and evaluation of the legal regulation of special powers of the building offices. The text of the thesis outlines general conception, characteristics and principles common to all of the special powers of the building offices, but also provides more detailed analysis of particular instruments that represent them. The author primarily relies on the legal regulation of Act No. 183/2006 Coll., on town and country planning and building code (Building Act), however the comparison with its "successor", meaning Act No. 283/2021 Coll., Building Act, is not left out either. The thesis is divided into eight parts. The first part provides definitions of relevant concepts, subjects, authorities and institutes, the knowledge of which is necessary for a deeper understanding of the topic. The second part sets the issue into a broader context and presents features common to all the special powers that the building offices have. The content of this section therefore mainly concerns the basic characteristics of...
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Resolution of Road Traffic Delicts in Theory and Practice
Žabenský, Martin ; Vopálka, Vladimír (advisor) ; Staša, Josef (referee)
Resolution of Road Traffic Offences in Theory and Practice The aim of my thesis is to analyze current situation in the Czech Republic in the field of road traffic offences resolution. The reason why I have chosen this topic is the fact that road traffic offences are an illegal conduct that you are very likely to come across every day, and, despite this fact, there is not much literature about it. Most road traffic offences are committed by a motor vehicle driver. In the Czech Republic, there are about 6.5 million driving license holders, i.e. almost two thirds of the Czech population. In my thesis I have focused on offences which are specified in section 22 of the Administrative Offences Act (No. 200/1990 Coll.), i.e. offences that are directly related to driver's behaviour on the road and which are very often capable of causing a traffic accident. The thesis is divided into six chapters, starting with a short introduction in Chapter One. Chapter Two introduces the principal sources of road traffic offences law. Chapter Three briefly explains which public authorities are involved in the resolution of road traffic offences. Chapter Four is the most important part of the thesis; in its nine sub-chapters it describes the entire procedure of road traffic offences resolution. First, it points out the...
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The position and activities of an authorized inspector under the Building Act
Fisenková, Tereza ; Staša, Josef (advisor) ; Svoboda, Petr (referee)
Presented thesis deals with approved inspector as a major entity of simplified procedure. It is focused on the origin of his function, internal organization and impact of his functioning. Author brings comprehensive view of current problems, primarily from point of view of judicature, specialized literature and comparison with foreign legislation. Author considers a possibility of amendment of the act besides an analysis of current legislation. Grammatical or teleological interpretation of the provisions governing the simplified procedure doesn't bring a satisfactory answer to the question of whether the legislation intended for governing bodies applies on the activity of authorized inspector. Whether through negligence or intent the legislature concerning authorized inspector is conceptual hybrid. In an attempt to clarify its functioning and to define it either a subject of public or private law, concept of simplified procedure deforms to disadvantage of different group of subjects and loses partly its original meaning. The only way out of this confusing situation is amendment of Building Act in favor of unambiquous concept of simplified procedure. The author deals with position of the authorized inspector in initial chapters. The procedure of nomination and assumptions that an applicant must meet...
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Construction of buildings and their alterations
Surovcová, Vendula ; Staša, Josef (advisor) ; Svoboda, Petr (referee)
The theme of this thesis is the construction of buildings and their alterations. The aim is to describe and analyze legislation permitting constructin of buildings and their alterations, and draw attention to the news, which brought major amendment to the Building Act effective from 1. 1. 2013. The thesis consists of eight chapters, an introduction and a conclusion. At the beginning there is a brief historical development of legislation of construction of buildings and their alterations in the Czech Republic. The second chapter is divided into four parts and is focused on sources of public construction law. In the third chapter defines the basic concepts of building law, which is relevant in the context of the construction of buildings and their alterations. The fourth chapter describes the problems of public administration. The fifth chapter describes possibility of construction of buildings and their alterations. In the sixth chapter discussed the various modes of construction of buildings. The chapter is divided into four parts according to each mode. There is a detailed analysis of the free mode, the reporting mode and authorization regime. The following are alternatives to building permits - notice of building projects certified by an authorized inspector and public contract. Seven last...
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Easements in telecommunications
Hronková, Vladimíra ; Staša, Josef (advisor) ; Kopecký, Martin (referee)
Resume in English. Easement in Telecommunication This thesis deals with the easements in the specifically chosen and therefore dedicated area - in Telecommunication field. The easement has its primary regulation in the Civil Code No. 64/1964 Sb., however the easements are regulated also within the public law area, namely the public law codes e.g. Water Act, Railway Act etc. In its very basic effect they represent the limitation of the property owner. We divide them into two groups easements ad personam and ad rem. The easement in the telecommunication belongs into the public law. They are currently regulated by the Telecommunication Act No. 127/2005 which has it's specific procedure of establishing these easements. Before this Act there were two previous Acts - the Act. No. 110/1964 Sb. which was replaced by Act No. 151/2000 Sb. The Act No. 151/2000 Sb was replaced by above mentioned valid act. Each of the Acts maintained the area of easement in different way. When we take into consideration the first and the oldest Act No. 110/1964 Sb. the easements were considered like public limitation of owner rights until the year 1992, when was the Act updated and specifically renamed the public limitation of the owner rights into the easements. The Act No. 151/2000 Sb. was clear since it's beginning about the...
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