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.

Více informací

Other Practice Areas

合规

知识产权

能源法和基础建设

收购、并购

破产及重组

投资和项目

Publications by PRK on the regulation of the pharmaceutical industry
(2022)

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

合伙人

Monika Maskova

高级合规顾问

Martin Frolik

Jan Augustin

Show All

References

We advised a major pharmaceutical company on the regulation of the pharmaceutical industry, including representing them before the State Institute for Drug Control in administrative procedures to determine maximum prices and dealing with issues related to pricing and reimbursement procedures.

We provided legal advice to a leading pharmaceutical company on the advertising of medicinal products, including helping them during proceedings related to an alleged breach of the industry code of ethics.

We advised a UK company providing clinical research services to the pharmaceutical and biotechnology industry, including reviewing their model contracts for clinical trials.

We advised a leading manufacturer of hearing aids on reimbursement issues.

We have advised various food manufacturers on product labelling.

Cookie name	Type and function	Source	Storage period
SERVERID	Strictly necessary cookie – Ensures that the user uses the same server during a particular visit/session. The cookie sets the infrastructure provider and represents a functional element.	Solidpixels	Session
CMS-(ID)-FE	Strictly necessary cookie - Stores a unique identifier for a given session on the website	Solidpixels	Session
CMS-(ID)-FE-language	Strictly necessary cookie - Stores a unique identifier for the selected language of the website	Solidpixels	1 day
CMS-(ID)-FE-cookies_allow_ac	Strictly necessary cookie - The cookie stores a visitor's consent settings for the collection of analytical data about his/her movement on the website.	Solidpixels	5 years
CMS-(ID)-FE-cookies_allow_mc	Strictly necessary cookie - The cookie stores a visitor's consent settings for the data collection for marketing purposes.	Solidpixels	5 years
CMS-(ID)-FE-cookies_notification	Strictly necessary cookie - Stores information whether the cookie bar has been confirmed in the past.	Solidpixels	5 years

Cookie name	Type and function	Source	Storage period
_ga	Analytical cookie – The cookie is used to distinguish unique/individual users by assigning a randomly generated number as an identifier. It is included in every page request on your website and is used to calculate visitor data, campaign sessions for page analytics reporting.	Google	2 years
_gat	Analytical cookie – A _gat cookie is used to limit analytics requests in order to restrict the requests sent from your browser to Google services. Cookies have several limitations that can cause excessive reporting of the number of users.	Google	1 day
_gid	Analytical cookie – Registers a unique identifier that is used to generate statistical data about how a visitor uses the website.	Google	1 day
_hjlncludedInSample	Analytical cookie – Used for web analysis by HotJar, identifies the visitor during the session	HotJar	Session
_hjid	Analytical cookie – stores a unique identifier of the website visitor	Hot Jar	1 year
_dc_gtm_UA-*	Analytical cookie – Applies when Google Analytics are embedded via Google Tag Manager. It has the same function as _gat.	Google	Session

Cookie name	Type and function	Source	Storage period
_fbp	Marketing cookie – used to track visits across websites	Facebook	3 months
_gcl_au	Marketing cookie – determines advertising effectiveness on the websites visited by a user	Google Adsense	3 months
NID	Marketing cookie – stores a unique identifier that identifies a returning user and is used for advertising targeting	Google	6 months