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Medical and Pharmaceutical Law

As one of the relatively small number of law firms in the Slovak market, we are specialised utterly in medical law and pharmaceutical law, or medicines law. Educated also in pharmacy and experienced through practical work in the pharmaceutical branch, the English-speaking team of specialists is able to provide legal services to all entities operating in the health care sector, ranging from individual health professionals (medical practitioners, pharmacists), health care facilities (outpatient departments, clinics, hospitals), to businesses operating in this sector (manufacturers and distributors). In the context of medical law and pharmaceutical law, we concentrate primarily on providing legal services for companies operating in the pharmaceutical and healthcare sectors holding an authorisation for manufacture or or wholesale distribution of medicinal products, holding authorisation for providing pharmaceutical care, or authorised to market, manufacture and distribute medical devices as part of their business activities, based not only in Slovakia but also abroad – mainly in Germany, Denmark and the Czech Republic. In particular, we provide the clients with monitoring of the Slovak and European legislation in the field of medical and pharmaceutical law, analysis of changes in legislation and its practical application (especially the Act no. 362/2011 Coll. on Medicinal Products and Medical Devices and on Amendments and Supplements to Certain Acts; the Act no. 578/2004 Coll. on Healthcare Providers, Healthcare Professionals, Healthcare Professional Organisations and on the Amendment and Supplements to Certain Acts, the Decree of the Ministry of Health of the Slovak Republic no. 128/2014 on the Requirements for Good Manufacturing Practice and the Requirements for Good Distribution Practice, the 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 for communication with the relevant Slovak state authorities within health care sector (e.g. the State Institute for Drug Control and the Ministry of Health), preparation of various submissions to these public authorities (applications, authorisations), legal representation in administrative proceedings with public authorities (statements, appeals), as well as with relevant foreign authorities and bodies (EMA – European Medicines Agency, BfArM – Das Bundesinstitut für Arzneimittel und Medizinprodukte), legal advice and the preparation of applications for authorisations for the production of medicinal products for human use, the wholesale distribution of medicinal products for human use, and applications for handling in narcotic and psychotropic substances, drafting legal opinions in the area of regulation of trading and handling of medicinal products in the European Union, legal advice on legislative regulation of fees and charges for health care providers, legal advice and representation of companies in tax-related proceedings concerning withholding tax before the Financial Directorate of the Slovak Republic, as well as in subsequent judicial proceedings (for more information see the Tax and Financial Law section), legal advice on providing monetary and non-monetary benefits to healthcare providers and 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, employment law, administrative law or public procurement law in relation to their business activities (directly or through cooperating law firms abroad).

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