Lygiagretaus medicinos produktų importo teisinio reguliavimo teoriniai ir praktiniai aspektai
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Doctoral dissertation „Theoretical and practical aspects of legal regulations concerning parallel import of medical products“ analyses assumptions enabling parallel import of medical products – medicinal products intended for human use, veterinary medicinal products and medical devices – in the internal market of the European Union together evaluating specific formal requirements characteristic to the parallel trade of the just mentioned products while considering that the use of medical products is linked to the protection of public health and life. This work evaluates legal regulation concerning the parallel import of medical products, with particular focus on the regulatory interpretation of jurisprudence of the Court of Justice of the European Union and systematic analysis of laws and regulations of the Republic of Lithuania. The scientific study concludes, that in general the term „parallel import” can be defined as a legal form of trade within European Union internal market, which results from different price levels within the Member States, and which is based on Article 34 of the Treaty of the European Union and is carried out in accordance with the restrictions related to the protection of public health and safety and intellectual property rights which is based on Article 36 of the Treaty of the European Union. Dissertation research indicates that legal presumptions of parallel import of medical products derive from principle of freedom of trade enshrined in the Treaty of the Functioning of the European Union and from exhaustion of intellectual property rights. It is noted, that specificity of the parallel trade of medical products is also determined by the fact that these products are protected by intellectual property rights (patents, trademarks). When analysing the application of the principle of freedom of trade in the pharmaceutical sector dissertation states that Member States of the European Union has a different interpretation of this principle, thus, as shown by the practise of the Court of Justice of the European Union, such different interpretations lead to restrictions of freedom of trade especially when Member States make decisions regarding authorization of parallel import of medicinal products. According to the survey and analysis of jurisprudence of the Court of Justice of the European Union hindrances leading to the unfounded restrictions of parallel import of medical products are identified and proposals enabling better use of advantages coming from parallel import when intending to increase availability of medical products to the patients are given.