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Medical and pharmaceutical law

As one of the relatively few law firms on the Slovak market, we specialize exclusively in medical law and pharmaceutical law. Our English-speaking team of specialists, with education in the field of pharmacy and practical work experience in pharmacy, provides legal services to all entities operating in the healthcare sector, from individual healthcare professionals (doctors, pharmacists), healthcare facilities (clinics, polyclinics, hospitals) to commercial companies operating in this field (manufacturing and distribution companies). Within the framework of medical and pharmaceutical law, we focus primarily on providing legal services to commercial companies operating in the field of pharmacy and healthcare that hold licenses for the manufacture of medicines or wholesale distribution of medicines, holders of licenses to provide pharmacy care, or which are authorized within the scope of their business activities to market, manufacture, or distribute medical devices, with headquarters not only in the Slovak Republic but also abroad, particularly in Germany, Denmark, and the Czech Republic. For these clients, we mainly provide monitoring of Slovak and European legislation in medical and pharmaceutical law, analysis of changes in legislation and their practical application (in particular Act No. 362/2011 Coll. Act on Medicinal Products and Medical Devices and on Amendments to Certain Acts, Act No. 578/2004 Coll. Act on Healthcare Providers, Healthcare Professionals, Professional Organizations in Healthcare and on Amendments to Certain Acts, Decree of the Ministry of Health of the Slovak Republic No. 128/2014 on requirements for good manufacturing practice and requirements for good wholesale practice, Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use and other regulations), legal advice on communication with the relevant Slovak state authorities in the field of healthcare (e.g. the State Institute for Drug Control or the Ministry of Health), preparation of various submissions to these state authorities (applications, permits), legal representation in administrative proceedings with state authorities (statements, appeals), as well as with relevant foreign authorities (EMA - European Medicines Agency, BfArM - Das Bundesinstitut für Arzneimittel und Medizinprodukte), legal advice and preparation of applications for licenses to manufacture human medicines, for the wholesale distribution of human medicines, and applications for the handling of narcotic and psychotropic substances, drafting of legal opinions in the area of regulation of trade and handling of medicines within the European Union, legal advice on legislative regulations in the area of payments and fees for healthcare providers, legal advice and representation of commercial companies in tax proceedings concerning withholding tax before the Financial Directorate of the Slovak Republic, as well as in subsequent court proceedings (for more information, see the section on tax and financial law), legal advice on the provision of monetary and non-monetary benefits to healthcare providers or their employees or business partners, legal advice on the marketing, manufacture, or distribution of medical devices, comprehensive legal advice on the operation of these companies in the areas of commercial law, labor law, administrative law, or public procurement law related to their business (directly or through cooperating law firms abroad).

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