Pharmaceutical law

Pharmaceutical and medical law are on of the most vital and consistently developed areas of our practice.
We represent research units of both Polish and foreign manufacturers, distributors, parallel importers of medicinal and veterinary products and medical devices in all their areas of business activity, including proceedings before medical inspection bodies, regulatory authorities but also administrative and common courts. Our firm renders comprehensive service to a leading company introducing generics to the market.
We have developed our practical experience through the analysis of cases of clinical trials, potential problems connected with the admittance of medicinal products to trade, the manufacturing process or their advertising but also matters connected with unfair competition in the pharmaceutical market, intellectual property rights, legal liability for the product and even matters closely related to penal responsibility for the infringement of pharmaceutical law.
Our lawyers frequently asked to actively participate in conferences and trainings share their knowledge and experience and thus have the opportunity to confront with current problems within the sector. Our team members publish articles in professional magazines, explore their knowledge during doctoral studies, trainings and academic seminars, keep improving their professional skills and are always ready to face new challenges resulting form the market dynamics.
We do know that in your business practice the legal service has to be of the top quality, supported by years of in-depth experience and thorough knowledge, and we shall certainly deliver it to you.


Our service includes:

  • drafting opinions and verifying marketing activities and strategies in the regulated market
  • analyzing the procedures of admittance of medicinal products to trade, technology transfer and the know-how
  • advising on issues concerning Competition Law within domestic and European regulations, particularly within the protection against product forgery and unfair advertising
  • preparation and giving opinions on license agreements, cooperation agreements, insurance agreements, agreements concerning clinical trails and any other type connected with the sector
  • counseling on parallel import mechanisms
  • analyzing the issues of liability of persons managing the companies of the healthcare law as well as entities responsible for harm caused by medicinal product or device
  • legal advice on authorization and notification of medicinal products within the domestic and European regulations
  • representation and counseling in proceedings aiming at admittance a medicinal product to trade, licence for parallel import and notification for parallel distribution, obtaining permissions for the manufacture and import of medicinal products, permissions for the wholesale activity and other activities within the pharmaceutical law as well as proceeding regarding the reimbursement of medicinal products


Our recent work:

  • legal counsel connected with the infringement of the principle of the distribution of medicinal products

The firm is currently involved in the representation of a number of entities of retail and wholesale distribution, in penal and administrative proceedings, initiated in connection with the activities of pharmaceutical inspection authorities that verify the processes of resale of the medicinal products form pharmacies to pharmaceutical wholesalers. We advise entities whose practices have been questioned on how to optimize  the risk and organise the entity properly.

  • we protect our Clients against consumers’ claims resulting from damages caused by medicinal device

The firm represents one of the leading Polish manufacturers of medicinal products in a compensation proceeding on injury caused by damaging the implanted medicinal product.

The firm represents the biggest in Poland group of patients affected by a drug which was later withdrawn form the world’s markets.

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Responsible partner

Przemysław Maciak

przemyslaw.maciak@smmlegal.pl