Single Market in Pharmaceuticals: Comparative Analysis of Legal Regulation in the European Union and in the Eurasian Economic Union

Key words: single market in pharmaceuticals, European Union Law, Eurasian Economic Union Law A graduate qualification work is dedicated to comparative analysis of legal regulation of single market in pharmaceuticals in the frameworks of the European Union and the Eurasian Economic Union. The final aim of the bachelor work is to examine potential consequences of determined commonalities and differences for circulation of medicines within single market and to make suggestions how Eurasian legal regulation may be developed. As part of the study the author came to conclusion that single market in pharmaceuticals is a complex of economic, legal and political relations focused on free movement of medicines that is provided by common rules for (i) access to the market, (ii) turnover of pharmaceuticals and (iii) ex-post control over such circulation in the conditions of single information space. The key elements of single market are system of market access, including mutual recognition of results of clinical trials and system of marketing authorization, common information area as well as system of good pharmaceutical practices (laboratory, clinical, manufacturing, distribution, pharmacovigilance, pharmacy practices) regulating turnover of medicines indirectly on the single market. The crucial differences are due to different degree of integration of the EU and the EEU and are not critical. However, determined dissimilarities in such aspects as mutual recognition of results of clinical trials, procedure of dispute settlement within marketing authorization as well as certain institutions of pharmaceutical realization (parallel trade and pricing) may influence free movement of goods in the frameworks of single market, and meeting the requirements to quality, safety and effectiveness of pharmaceuticals.