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Registration of medicines
Šubová, Irena ; Solich, Jan (advisor) ; Portych, Jiří (referee)
Marketing authorization of medicinal products Mgr. Irena Šubová Charles University in Prague, Faculty of Pharmacy Hradec Králové, Department of Social and Clinical Pharmacy Marketing authorization of medicinal products is process when the quality, safety and efficiency of product are checked based on submitted documentation. Registration in the Czech Republic is according to law No.79/1997 and No.473/2000 and it is harmonized with directives and regulations of European Union. A generic drug is medicinal product which has same qualitative and quantitative composition, as for active substances and same dose as the original formulation and whose bioequivalence with the original formulation has been proven by relevant studies of bioavailability. Structure of documentation describing medicinal program have been given united format, so called Common Technical Document (CTD). Documentation is divided in to 5 modules. Module 1 includes Administrative Information and Prescribing Information and its content is given by national drug regulatory agencies, Module 2 includes Common Technical Document Summaries, Module 3 includes Quality data, Module 4 includes Non-clinical study reports and Module 5 Clinical Study Reports. Important part of Module 1 is Summary of Product Characteristics, which is approved summarized...
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