This thesis deals with advertising of medicinal products for human use and its public law regulation contained especially in administrative law regulations. The thesis aims to bring information on the existing law in this area, explain particular legal institutes and propose potential amendments of the existing regulation in appropriate cases. The first chapter is devoted to definition of crucial terms of a medicinal product, advertising and public regulation, since their correct understanding is decisive for the following text. The second chapter concerns regulation of advertising, firstly in general and consequently concretely advertising of medicinal products for human use. The thesis is structured so that it concerns advertising focused on wide public separately from advertising focused on experts. The third chapter is devoted to responsibility, supervision, administrative proceedings and decisions in administrative judiciary, offences and sanctions in the area of regulation of advertising of medicinal products for human use. The fourth chapter analyzes main articles of the last proposal for amendment of the Act no. 40/1995 Coll., on Advertising Regulation, as amended, which was submitted to the legislative process in 2012, and contains de lege ferenda proposals. Annexes of the thesis contain...

Marketing authorisation in the Czech Republic The purpose of the thesis is to provide an overview of essential principles of a process of medicinal products' marketing authorisation in the Czech Republic. Every medicinal product produced on a large-scale must be registered by responsible authority before launching on the market, this process guarantees its effectiveness and safety. Even though the topic is a subject of quickly evolving legislation, in the Czech Republic has not been elaborated any coherent monograph on the issue yet. The diploma thesis is composed of seven chapters, starting with the overview of the historical legislation of medicinal products' marketing authorisation and ending with today's legislation affected by European Union legislation. The second chapter is dealing with the history of the marketing authorisation of medicinal products, which has its beginnings in 1920s, such dating argues that this is not a new field of a legislation. Following a brief outline of the history the third chapter of the diploma thesis explains today's legislation and gives an overview of European legislation and jurisdiction of Court of Justice of the European Union that have important impact on the Czech legislation. In the fourth chapter the thesis focuses on State Institute for Drug Control...

This thesis deal with problems of marketing communication in pharmaceutical industry.The thesis is separated on theoretical and practical part. Theoretical part concern importance of marketing communication, describe and compare of particular tools of communication mix. Practical part is concentrated on doctor's marketing survey and the evaluation of actual marketing propagation tools. The final chapter analyzes the position of pharmaceutical companies, it reveals the main problems and gives possible suggestions for solutions.

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...

Dispensing of medicinal products under the Act on Pharmaceuticals Medicinal products are an important part of almost everyone's life due to their ability to minimize, prevent or eliminate undesirable external influences. Given the need to ensure the safety of the use of medicinal products and the protection of public health, the dispensing of medicinal products needs to be highly regulated. The aim of this thesis is to analyze and describe the legal regulation of the process of dispensing medicinal products in pharmacies, with emphasis on the mail-order dispensing of medicinal products, to point out to legislative shortcomings and to propose changes de lege ferenda. In order to fulfil these objectives, the thesis is divided into five parts. The first part of this thesis deals with basic legislative concepts in the field of dispensing of medicinal products and sources of legislation at the Czech and European level, including a detailed analysis of the guidelines of the State Institute for Drug Control and their ability to regulate the rights and obligations of their recipients in a binding manner. Finally, the first part covers the public authorities regulating the dispensing of medicinal products. The second part of the thesis provides an analysis of the current regulation of dispensing of...

Environmental protection against the harmful effects of human medicinal products Abstract Medicinal products help humanity, but can they be a risk for it? In recent years, the occurrence of their residues in the environment and their impact on it has been monitored. Their occurrence is found to be widespread. Despite the small concentrations in which they occur, they have been shown to affect, for example, aquatic organisms. The issue of residues of medicinal products in the environment is a current topic, beginning to be also addressed by the European Union. The diploma thesis presents the legal regulations of environmental protection against the adverse effects of human medicinal products; it evaluates their effectiveness and, contains proposals de lege ferenda. First, it outlines the issue and the extent of the occurrence of residues of medicinal products in the environment and their risks for it. Furthermore, the work deals with the legal process of registration of medicinal products regulated by European Union law, within which an environmental risk assessment is created. There are described the shortcomings of the risk assessment procedure, the lack of a link to it that would effectively protect the environment, and the non-disclosure of results, which violates the right to information of the...

Regulation of prices and reimbursement of medicinal products Abstract Medicinal products are essentially part of every human life. It is therefore desirable to ensure that they are offered on the market at a fair and affordable price, precisely through price and reimbursement regulation. The aim of this diploma thesis is to analyse how the regulation of prices and reimbursements applies to human medicinal products in the provision of outpatient health care, the price and reimbursement of which is decided by the State Institute for Drug Control in administrative proceedings. In order to achieve this goal, the thesis is divided into four parts. The first part defines the basic concepts needed understand the meaning and purpose of the system of price and reimbursement regulation, such as a medicinal product, price or reimbursement. Furthermore, this part is devoted to the types of administrative acts occurring in the field of price and reimbursement regulation and introduces the Ministry of Health and the State Institute for Drug Control as the most important administrative authorities operating in this field. The second part analyses the legislation effective until 31st December 2007. The forms of administrative activity then performed by the Ministry of Health and the Ministry of Finance are analysed in more...

International trade in pharmaceuticals Abstract The purpose of this thesis is to provide an analysis of the human pharmaceuticals international trade. This work examines the general questions of the diagonal relationships between states and private foreign pharmaceutical companies because there are a lot of many specific problems too. The author also focuses on questions concerning the contractual relationships of many stakeholders. There are many opportunities to beginning new directions in research innovative medicines and personalized medicine, but there are dangerous situations for the generic pharmaceutical market. Only a comprehensive knowledge and understanding of these relationships are efficient to develop new pathways to solving problems. The hypothesis of this dissertation text is the concept of efficiency good relationships to the stable distribution of the pharmaceutical products. There are many aspects of the relationships between stakeholders with possibility influencing of the final benefit from the business. Problems result from different interest, strength or weakness of stakeholders. In essence speaking, this thesis is divided into three parts. At first, with regard to our membership in the European Union, it was necessary to make the analysis some legislation of the European Union which...

Legislation for securing the availability of human pharmaceuticals Abstract Medicinal products are a specific type of goods necessary for effective provision of health services. The Act on Pharmaceuticals entrusts legal instruments to the Ministry of Health, the State Institute for Drug Control and other entities in order to prevent shortages of medicinal products. The goal of this thesis is to introduce and analyse specific instruments that can be used to resolve potential or existing shortages of medicinal products in the Czech Republic. For the purpose of clarity, the diploma thesis is divided into a total of 10 chapters. The first two chapters define the basic terms, which are then used throughout the thesis, and administrative bodies that are important participants in securing the availability of medicinal products. Regarding the basic terms, they are a medicinal product, availability of medicinal products, the marketing authorisation holder and placement of a medicinal product on the market in the Czech Republic. The competence of administrative bodies in the area of securing the availability of medicinal products is also elaborated in more detail in the second chapter. The third chapter introduces the sources of knowledge in determining the potential shortages of medicinal products. The market...

Magistro baigiamajame darbe nagrinėjamas farmakologinio budrumo teisinis reguliavimas. Pirmajame skyriuje analizuojama farmakologinio budrumo sąvoka, rūšys, pateikiama trumpa farmakologinio budrumo istorija. Antrame skyriuje analizuojami šiuo metu galiojantys Europos Sąjungos teisės aktai, reglamentuojantys farmakologinį budrumą, palyginant juos su 2012 m. liepą įsigaliosiančiais teisės aktais, pabrėžiant esminius pakeitimus ir jų reikšmę Europos Sąjungos farmakologinio budrumo sistemai. Trečiajame skyriuje yra atliekama Lietuvos Respublikos teisės aktų, reglamentuojančių farmakologinį budrumą, analizė bei įvertinamas nacionalinės farmakologinio budrumo sistemos efektyvumas. / The legal regulation of pharmacovigilance is overviewed in this master thesis. In the first part the concept, sorts and history of pharmacovigilance are analysed. In the second part the current European Union legislation on pharmacovigilance is analysed, comparing it to legislation that will come into force in july, 2012, pointing to the main changes and its meaning to the European Union system of pharmacovigilance. In the third part Lithuanian legislation on pharmacovigilance is analysed and the efficiency of national system of pharmacovigilance is assessed.