Основни положения и принципи на правната уредба в областта на фармацията
Basic Provisions and Principles of the Legal Framework in the Field of Pharmacy

Author(s): Lilia Monova-Asenova
Subject(s): Social Sciences, Law, Constitution, Jurisprudence, Sociology, Health and medicine and law, EU-Legislation, Administrative Law
Published by: Университет за национално и световно стопанство (УНСС)
Keywords: regulation; pharmacy; legal principles; regulatory authorities; administrative and criminal liability; public health protection
Summary/Abstract: The legal framework governing relations in the field of pharmacy is based on fundamental legal principles. The article analyses key principles such as proportionality, non-discrimination, precaution, and the benefit-risk ratio, which determine the content and structure of regulatory practices and mechanisms in the pharmaceutical sector. Commonly accepted principles for public health protection, safety, and access to medicines and treatment, which are embedded in the Bulgarian Constitution, are reflected in areas such as pharmaceutical product registration, intellectual property rights, manufacturing standards, wholesale and retail drug trading authorizations, and pharmacovigilance. The article also highlights the interaction between national and international regulatory authorities in the pharmaceutical sector and the harmonization within the legal frameworks of EU member states. Additionally, the role of administrative and criminal liability in maintaining compliance and ensuring public health is examined. Through a review of applicable legal principles and key provisions, the article identifies challenges within the regulatory framework and offers recommendations for its improvement.

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