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.
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.
Cookies are small text files which are used to simplify and improve operation of our website and enhance user experience. Without your consent, we are only allowed to store in your device cookies strictly necessary for use of our website. Use of any other type of cookies requires your permission. Our website uses different types of cookies. Some cookies are also used by our partners – providers of services at our website. By clicking on “Accept all” button you grant us your consent to store cookies in your device as stated below and process data gathered through such cookies as set out in our Cookie Notice . By clicking on “Reject all” button you reject storing cookies on your device with the exception of strictly necessary cookies. In the "Settings" you can customize, i.e. give or refuse consent also in relation to individual types of cookies.
They enable the basic functionality of the website that cannot function without them.
Type and function
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.
Strictly necessary cookie - Stores a unique identifier for a given session on the website
Strictly necessary cookie - Stores a unique identifier for the selected language of the website
Strictly necessary cookie - The cookie stores a visitor's consent settings for the collection of analytical data about his/her movement on the website.
Strictly necessary cookie - The cookie stores a visitor's consent settings for the data collection for marketing purposes.
Strictly necessary cookie - Stores information whether the cookie bar has been confirmed in the past.
They track website traffic and by collecting anonymous statistics allow the operator to better understand its users and thus constantly improve the website.
Type and function
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.
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.
Analytical cookie – Registers a unique identifier that is used to generate statistical data about how a visitor uses the website.
Analytical cookie – Used for web analysis by HotJar, identifies the visitor during the session
Analytical cookie – stores a unique identifier of the website visitor
Analytical cookie – Applies when Google Analytics are embedded via Google Tag Manager. It has the same function as _gat.