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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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Legal regulation of advertising of medicinal products in the Czech Republic
Kučerová, Jana ; Patěk, Daniel (advisor) ; Eichlerová, Kateřina (referee)
Legal regulation of advertising of medicinal products in the Czech Republic Abstract This thesis deals with the advertising of medicinal products for human use and its development and legislation. The introductory part is set the objectives of this thesis and the reasons for choosing this topic. The first chapter is devoted to advertising, its legislation, the definition of advertising, history of advertising and this chapter also highlights the institution supervising advertising. The second chapter is to set the legal regulation of advertising in the Czech Republic. Regulation can be divided into the regulation of advertising public and private, together are in this dividing developed individual laws regarding advertising and is not omitted non-legal regulation of advertising. Ethical self-controller in this case especially the Rada pro reklamu and professional organizations. The third chapter is devoted to advertising of medicinal products for human use. This part is essential, because interpret basic definition related to medicinal products for human use. Further subdivision is dividing of medicinal product for human use. The basic consideration is whether product is successively authorised as a human medicinal product or not. In the case of an authorized as a human medicinal product dividing is...
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Administration of medication in hospital wards
Fuková, Tereza ; Hošťálková, Monika (advisor) ; Pavlíková, Pavla (referee)
This thesis concerns the administration of medication in hospital wards. The theoretical section describes the process followed by the nurses, the most common types of medication, and drug classification. The thesis then assesses the level of pharmacological and legal knowledge among the nursing staff, and the incidence of clinical mistakes. The data was obtained by means of a 19- question questionnaire, in a survey of 100 nurses in medical, surgical, geriatric and psychiatric wards. Key words: Nurse, medicine, medicament, administration of medication, hospital ward
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Tax Regulation of Medical Products and Foods for Special Medical Purposes
Terschová, Kateřina ; Adamu, Zdeňka (referee) ; Kopřiva, Jan (advisor)
This thesis focuses in its content on the impact of changes in the rate of value added tax on the subjects of the pharmaceutical market. Thesis explains the basic concepts of taxation and simultaneously describes the theoretical basement of price and reimbursement regulation of medicines and foods for special medical purposes. The thesis contains an analysis of the actual impact of changes in the rate of value added tax on the expenses of health insurance companies and patients.
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Consumer protection in the food supplements area
Luptáková, Marcela ; Vavrečka, Jan (advisor) ; Grmelová, Nicole (referee)
The topic of this diploma thesis is the Consumer protection in the food supplements area. The work has been devided into three parts. The first part is devoted to the overview about categorization of the products with the impact on health. This part of this work also includes the elementary terms, which are: food, food supplements, medicinal products, cosmetics products and medical devices. The second chapter is devoted to the matter of food supplements as such. The third chapter deals with the terms health and nutrition claims. The last chapter includes the survey between the consumers of the food suplements and also the survey between the pharmacies.
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Demarcation between the categories of products with physiological function on human body in EU law
Vavrečka, Jan ; Švarc, Zbyněk (advisor) ; Boháček, Martin (referee) ; Jakl, Ladislav (referee)
The thesis is focused on theoretical principles of demarcation of products with health effects in the EU law and on the reflection of these issues in the application and administrative practice in commercial law. The thesis developed yet been brought judicial interpretation with the scientific interpretation of certain key and decisive problems that separate from each other law-regimes of regulation: medicinal product for human use, foods, cosmetics products, medical devices and biocides. Correct law-regime for a particular product is determinating of the general legal basis in the EU internal market. It is therefore a important problem not only in EU law, but also in EU economic. Thesis results are highly critical of current practice in the local markets of EU member states, especially Czech Republic, and in many instances documented sub-optimal application of this law in general practice.
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Business plan – Pharmaceutical Parallel Trade
Šašek, Otakar ; Tyll, Ladislav (advisor) ; Strouhal, Jiří (referee)
Master thesis is primarily focused on parallel trade with medicinal drugs within European Union. In regard to attractive offer for cooperation with strong supplier of mentioned goods was required to valorise realization possibility and potential of idea. Business plan estimates different variants or realization and progress, describes it in numbers and wide context. Object of thesis is absolutely real case of starting intermediary company in pharmaceutical field specifically in parallel "reexport" of pharmaceutical drugs and accessories between states of European Economic Area. In first two passages study remembers methodology of business plan and passes to bases of legislative frame related with. Subsequently are described market movements, thoroughly analysed its weak points and also strengths and opportunities. Everything is simultaneously reflected with object of our business plan to support reality of whole master thesis. After short marketing passage comes the largest part dealing with financial calculations. Considered are three variants of potential reality and in each of them are calculated costs, revenues, profit and cash flow for single months and whole year. Conclusion summarizes and evaluate project as whole. Considering infestation of input costs against its rentability and potential other opportunities of the pharmaceutical market. Evolution of European market mostly depends on legislation regulations of EU and single countries.
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