Denisa Fuchsová

Senior Associate
Awards and media
Practice Areas
Industry Sectors

Denisa Fuchsová specialises in pharmaceutical and health law, contract law, and public law regulation. Denisa provides legal support to clients in the areas of medicinal products, medical devices, cosmetics and the provision of healthcare services, including issues related to clinical trials and testing, marketing of products, compliance with regulatory requirements, pricing and reimbursement regulation, inspections and administrative proceedings, and commercial relations.

Prior to joining our law firm in 2019, Denisa worked at the State Institute for Drug Control and at the Government Office. Denisa also supplemented her legal education with a year of management studies at Lund University in Sweden accredited by the Association of MBAs (AMBA).

Membership in professional associations

Czech Bar Association

Czech, English
  • Masaryk University, Faculty of Law, Brno (2013), Mgr. (Master of Laws)
  • Lunds Universitet, School of Economics and Management, Sweden (2019), MSc (Master of Science)
  • comprehensive legal advice to leading multinational manufacturers and distributors of medicinal products and medical devices
  • drafting and negotiating commercial and other contracts - manufacturing, distribution, logistics, provision of services, provision of grants, NDAs, provision of bonuses, data purchasing
  • representing a manufacturer before the State Institute for Drug Control in product recall proceedings and in borderline product proceedings
  • advising in proceedings to change the maximum price and the amount and conditions of reimbursement of a medicinal product
  • advising on the vigilance of medical devices
  • advising on regulatory requirements for the advertising of medicinal products and medical devices
  • regulatory advice to radiopharmaceuticals manufacturers
  • representing a health service provider in administrative proceedings for the imposition of a fine
  • advising on the transfer of the activities of a health service provider
  • advising a health service provider on telemedicine issues
  • risk-sharing agreements with health insurers
  • regulatory advice related to cosmetic product claims
As in previous years, the beginning of summer at HAVEL & PARTNERS is associated with a wave of internal promotions, which is record-breaking this year. Jiří Kunášek becomes a new equity partner with effect from 1 July, Veronika Bočanová and Ivan Houfek are promoted to the position of partner. Additional 25 attorneys are moving to […]
Authors: František Neuwirth, Denisa Fuchsová In December 2022 and January 2023, new legislation on medical devices and in vitro diagnostic medical devices (jointly “medical devices”) came into force: We provide an overview of the most important changes in this post. AMENDMENT TO THE Act on Advertising Regulation Amendment to Act No. 40/1995 Sb. on Advertising […]
Authors: Václav Audes, Kateřina Slavíková, Denisa Fuchsová In late 2021, the European Parliament adopted Regulation (EU) 2021/2282 of the European Parliament and of the Council on health technology assessment (the “Regulation”), which had been under discussion for several years. The European Union hopes that the adoption of the Regulation will establish a joint instrument that […]
Authors: Václav Audes, František Neuwirth, Denisa Fuchsová In the Czech Republic, persons who undergo Covid-19 vaccination have been given the opportunity to claim financial compensation from the state if the vaccination (or, more precisely, the medicinal product containing a vaccine) causes harm. The Czech Parliament adopted Act No. 569/2020 Sb., on the Distribution of Medicinal […]
Authors: Václav Audes, František Neuwirth, Denisa Fuchsová On 17 April 2020, in response to the extraordinary circumstances triggered by the pandemic outbreak of COVID-19 caused by the SARS-CoV-2 virus, the European Parliament approved an amendment to Regulation (EU) 2017/745 on medical devices (MDR). The key aim of the proposed amendment is, in particular, to ensure the availability of […]


Fill in your e-mail and get regular news from the world of law and business.

Contact Us

Copyright © 2024 HAVEL & PARTNERS s.r.o., advokátní kancelář