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Marketing authorisation in the Czech Republik
Švestka, Miroslav ; Svoboda, Petr (advisor) ; Handrlica, Jakub (referee)
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...
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Marketing authorisation in the Czech Republik
Švestka, Miroslav ; Svoboda, Petr (advisor) ; Handrlica, Jakub (referee)
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...
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Distribution network of the pharmaceutical industry
Novotná, Ivana ; Drozen, František (advisor) ; Šípek, Ladislav (referee)
This thesis deals with the descriptive analysis of entire process of the pharmaceutical industry's distribution and the verification of its effective functioning in the Czech Republic. The first part is focused on the definition of key terms and presents the theoretical basis for this thesis (specifics of pharma industry, history of pharmaceutics and pharma industry, actual situation and predictions of pharma industry). The second part is concerned the individual subjects of the distribution - pharmaceutical company, wholesaler and pharmacy.
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