Restriction on the re-export of medicinal products and the supervision of compliance with it by public administration bodies

After years of mainly expert discussions (not only in the Slovak legal environment), the concept of and legislation on re-export offer a sort of solution provided for in the Act no. 306/2016 Coll. Said act amends the key legislation in this field, namely the Act no. 362/2011 Coll. on Medicinal Products and Medical Devices and on the amendment of certain acts, as amended (hereinafter referred to as the “Act on Medicinal Products”) and the Act no. 363/2011 Coll. on the Scope and Conditions of Payments for Medicinal Products, Medical Devices and Dietetic Foods from Public Health Insurance and on the amendment of certain acts, as amended (hereinafter referred to as the “Act on Payments”). The topic of the paper belongs in the area of medicinal products and pharmaceutical services, it offers, however, significant overlaps in the area of the constitutional, administrative and European law and is aimed at multidisciplinary research into the issue of the reverse export (re-export) of medicinal products. Besides these laws, also the Constitution of the Slovak Republic (“SR”) and the sources of the European Law have to be taken into account in relation to the subject in question. The main aim of legislation in this area of law was restriction on the re-export of selected products and protection of patients from adverse impacts of such business activity. The aim of the paper is the authors’ effort to analyse the issue of the re-export of medicinal products within the context of the adopted Act no. 306/2016 Coll., whose legislative solution is inevitable for the protection of life and health of the population of the Slovak Republic.