Registration and distribution of medicines from the administrative point of view

Registration and distribution of medicines from the administrative point of view This diploma thesis focuses on two major areas of the pharmaceutical law - a registration and a distribution of medicaments. The main goal is to explain how the medicinal products are registered and distributed to parmacies and other facilities, considering an activity of administrative authorities, or more precisely administrave offices. The thesis is mainly focused on a Czech law regulation of the given issue. In an introduction, the pharmaceutical law is systematically classified into a law area, there is briefly discussed its historical development in a territory of the Czech Republic, basic terms that are used throughout the thesis are mentioned, as well as a basic characteristic of administrative authorities. Then follows the first major segment that is dedicated to the registration of the medicinal products. It is divided into three smaller parts, that are successively focused on a national registration, then a specific procedure of mutual recognition and a centralized registration, where the most significant attention is paid to the national registration. In this section, the reader learns not only about the registration procedure, but also about some issues of a modification, an assumption and a transfer of..