Удосконалення правового регулювання у сфері ліцензування торгівлі лікарськими засобами (на прикладі аптечних закладів столиці)

Буличева, Наталія Анатоліївна and Буличев, А.О. and Гудаль, К.С. and Чернега, Р.Т. (2023) Удосконалення правового регулювання у сфері ліцензування торгівлі лікарськими засобами (на прикладі аптечних закладів столиці) Наука і правоохорона (2(60)). pp. 62-71. ISSN 2072-8670

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Abstract

The article examines the state of functioning of national pharmacies since the beginning of the full-scale russian invasion of Ukraine on February 24, 2023. The authors of the article studied the concept and provided a general description of the licensing of economic activity for the sale of medicinal products. Licensing of business activities for the sale of medicinal products means a set of legally defined procedures that must be followed by a business entity that seeks to produce and/or trade in medicinal products and obtain a license for such activities. Licensing is a means of state regulation of economic activity to ensure the safety and protection of the life and health of every person, his right to quality and certified medicinal products and a safe natural environment. The peculiarities of the modern mechanism of legal regulation of licensing of economic activity in the trade of medicinal products were clarified. Trade in medicinal products is carried out exclusively through pharmacies and cannot take place in other types of establishments. According to the current legislation, distribution and trade in our country is possible only with medicinal products registered in Ukraine, with a quality certificate. The legal regulation of the licensing of economic activity in the trade of medicinal products was also significantly affected by the martial law introduced in Ukraine on February 24, 2022 because of the russian military aggression against our state and which continues to this day. The main shortcomings and gaps in the current legislation regarding the licensing of the sale of medicinal products were highlighted, among them: the discrepancy of national legislation in this area with international legal norms, including EU legislation; low-quality and not always licensed system of remote (electronic) trade in medicinal products; a significant number of secondary regulatory legal acts, which contain legal norms that contradict each other. We identified directions for improving the legislation of Ukraine in the context of licensing business activities for the sale of medicinal products, among them: bringing the current national legislation in this area into line with the best international models, including the EU legal system; improvement of the legislative regulation of remote (electronic) trade in medicinal products and the process of licensing such trade; removing from current laws and by-laws all conflicting legal norms in the field of drug trade licensing and bringing them to a codified form and others.

Item Type:	Article
Uncontrolled Keywords:	licensing; sale of medicines; war period; pharmacy establishments; state supervision
Subjects:	Це архівна тематика Київського університету імені Бориса Грінченка > Статті у журналах > Фахові (входять до переліку фахових, затверджений МОН)
Divisions:	Це архівні підрозділи Київського університету імені Бориса Грінченка > Факультет права та міжнародних відносин > Кафедра приватного права
Depositing User:	Наталія Анатоліївна Буличева
Date Deposited:	28 Nov 2023 11:47
Last Modified:	28 Nov 2023 11:47
URI:	https://elibrary.kubg.edu.ua/id/eprint/47458

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