PRACTICE AREA

Food, Drugs and Medical Devices

The Food, Drugs and Medical Devices practice at PRK helps leading pharmaceutical, biotechnology, medical device, food, cosmetics and tobacco firms navigate the complex national and EU regulatory landscape. We advise clients on developing, manufacturing, marketing, promoting and distributing their products.

We also offer support in the area of pricing and reimbursement of drugs, biologics, medical devices and other regulated products. Besides our deep knowledge of the relevant legislation, we maintain a commercial focus and an understanding of our clients' priorities in their day-to-day business operations. We are able to do this in part thanks to the fact that many of our legal experts have themselves spent time working in the industry.

Publications by PRK on the regulation of the pharmaceutical industry
(2021)


Read PRKs’ contribution to the Life Sciences 2021 Chambers Global
Practice Guides

(2021)


A strong legal team on your side

Miriam Galandova

合伙人


Miriam Galandova

Monika Maskova

合伙人


Monika Maskova

Martin Frolik

高级合规顾问


Martin Frolik

Elena Cervenova

Elena Cervenova

Jan Augustin

Jan Augustin

References

We provided comprehensive legal services to a leading manufacturer of tobacco products on their launch of a new category of tobacco product on the Czech and Slovak markets.

We provided legal advice relating to a transaction between two global pharmaceutical companies, involving the sale and purchase of business operations within the Czech Republic. Our support covered various aspects of Czech law, including corporate, regulatory, commercial and labour issues, with a strong emphasis on practical implementation.

We advised a major Czech pharmaceutical company on contractual documentation related to clinical trials, advertising medicinal products and other marketing activities, and on certain contractual obligations.

We advised a leading manufacturer of household detergents and other consumer chemicals on the transfer of an acquired portfolio of biocides, detergents and other products. We helped them with new registrations and notifications for individual products, including biocides, chemical substances, detergents, dangerous mixtures, medical devices, plant protection products and veterinary products.

We provided legal advisory services to a leading international food supplement distributor in connection with the transfer of its distribution activities in the Czech Republic. Our work included notifying the Agriculture and Food Inspection Authority of the start of the client's activities in the Czech Republic, providing information on re-labelling stockpiled products and notifying the Ministry of Health of a change of distributor for certain notified food supplements.