Denisa Fuchsová

Associate

Email:
denisa.fuchsova@havelpartners.cz

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

Languages
Czech, English

Education

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

Publications and newsletters

Legislative changes in the field of medical devices
Authors: František Neuwirth, Denisa Fuchsová In December 2022 and January 2023, new legislation … read more »

New Health Technology Assessment Regulation – a step forward in promoting innovative health technologies in the EU?
Authors: Václav Audes, Kateřina Slavíková, Denisa Fuchsová In late 2021, the European Parliament… read more »

Czech Republic to compensate for harm suffered as a result of Covid-19 vaccination
Authors: Václav Audes, František Neuwirth, Denisa Fuchsová In the Czech Republic, persons who un… read more »

Effective date of the European Regulation on Medical Devices to be deferred
Authors: Václav Audes, František Neuwirth, Denisa Fuchsová On 17 April 202… read more »