COMPETENCE OF THE STATE SERVICE OF UKRAINE FOR MEDICINAL PRODUCTS AND DRUG CONTROL IN THE FIELD OF ADMINISTRATIVE AND LEGAL ENSURANCE OF THE CIRCULATION OF MEDICAL PRODUCTS

Abstract

The competence of the State Service of Ukraine on Medicines and Drugs Control, as a central executive authority, is substantiated as a systemic legal construct that integrates its powers, functions, jurisdictional scope, and territorial reach. These powers exhibit a dual nature–combining administrative-service functions with binding authoritative prerogatives–and are operationalized through the adoption of enforceable administrative decisions within the domain of medical device circulation. The Service’s activities are directed toward the effective implementation of normative legal acts governing technical regulation and product quality assurance. In this context, competence functions as a key legal instrument for safeguarding legality and advancing the public interest. Its substantive content is intrinsically linked to the implementation of state policy aimed at ensuring the safety and reliability of medical devices. The legal status of the Service as a specialized субъект of public administration is characterized by the predominance of administrative-procedural activities focused on the provision of administrative services and the protection of the rights and legitimate interests of private actors. Its competence encompasses the implementation of state policy through regulatory mechanisms such as licensing, registration, and supervisory control. Institutional coordination is ensured by the Cabinet of Ministers of Ukraine through the Minister of Health, thereby maintaining coherence within the executive branch. In addition to its service-oriented role, the Service exercises auxiliary analytical and control functions. The integration of service delivery and supervisory oversight defines its functional specificity and enhances its institutional effectiveness. The realization of the Service’s competence is primarily manifested through control and supervisory powers aimed at protecting the public interest and ensuring the safety of medical devices. These functions include state market surveillance, technical regulation, maintenance of official registers, and the imposition of administrative and economic sanctions. The Service exerts regulatory influence over economic operators through both service-based mechanisms and imperative administrative-legal instruments, including binding orders, restrictive measures, and financial penalties. Its activities demonstrate a combined functional and organizational-authoritative character, thereby ensuring the efficiency and enforceability of state oversight.