Safety of Biocidal and Medical Products: Legal Guaranteeing in EU Countries and Challenges for Ukraine
Year: 2025
Type: article
Abstract: The article provides a comparative legal analysis of the European system for regulating the circulation of biocidal products and medical devices. It argues that legal safeguards for the safety of this category of products are an important tool for protecting human health, animals and the environment. Particular attention is paid to the analysis of the regulatory framework of Regulations (EU) No. 528/2012 and No. 2017/745, as well as the practices of their national implementation in EU member states, in particular in the Netherlands, Latvia, Lithuania, Germany, Poland, Finland and Austria. The aim of the study is to identify effective mechanisms for the legal regulation of biocidal products and medical devices in EU countries and to formulate recommendations for Ukraine, taking into account European standards. Control models, authorisation procedures, labelling requirements and mechanisms of liability for violations of legislation were studied. The methodological basis of the study is systemic-analytical, comparative-legal and formal-legal methods, which made it possible to assess the degree of compliance of national regulation with EU acquis standards. Effective practices of regulatory policy based on transparency, electronic accounting and the division of powers between competent authorities were identified. The state of legal regulation in the field of circulation of biocidal products and medical devices in Ukraine, which is characterised by fragmentation and inconsistency with European standards, has been analysed. The necessity of adopting basic legislation on biocides, updating technical regulations on medical devices, creating a single electronic register and introducing effective market surveillance is substantiated. The article contains specific proposals for adapting Ukrainian legislation to the EU acquis and promoting the formation of an effective consumer protection system in the field of healthcare.
Institutions: V. Mamutov Institute of Economic and Legal Research of the National Academy of Sciences of Ukraine, National Academy of Legal Sciences of Ukraine, Academician F. H. Burchak Scientific Research Institute of Private Law and Entrepreneurship of National Academy of Legal Sciences of Ukraine, Open International University of Human Development Ukraine, University of Modern Knowledge
Language: English
Topic: Healthcare Regulation
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4415340796