Pharmaceutical and medical law

Due to extensive experience in conducting marketing activities and advertising, our law firm offers services with respect to restrictions on promotion and advertising of medical products and dietary supplements.
We provide legal opinions concerning advertisements and other marketing activities in order to respect compliance provisions within the Food and Nutrition Safety Act as well as within EU legal acts. Knowing the market, its needs and restrictions we find the best solutions for our clients.

Advertising and promotion of medical products:

• advising on advertising campaigns targeted for the public, physicians and pharmacists;

• estimation of advertisements’ compliance with the provisions of laws and regulations in force, the principles of competition and EU law. In particular we estimate whether the advertisement may be taken as misleading;

• clients’ representation in proceedings before the Main Pharmaceutical Inspector, administrative courts and in disputes with competitors before civil courts.

Advertising and promotion of dietary supplements:

• estimation of advertisements’ compliance with the provisions of laws and regulations in force (Food and Nutrition Safety Act), the principles of competition and EU law (substantive analysis, risk evaluation);

• client representation in proceedings before administrative bodies, including the State District Sanitary Inspector, the State Provincial Sanitary Inspector and the Chief Sanitary Inspector;

• preparation of applications and explanatory letters in proceedings before administrative bodies;
  preparation of appeals against decisions issued by administrative bodies;

• clients’ representation in proceedings before administrative courts (Regional Administrative Courts, the Supreme Administrative Court) and the civil courts.

Our law firm conducts ongoing monitoring of changes in Polish and European Union law regarding advertising and promotion of medical products and dietary supplements. We provide assistance in obtaining the necessary permits for placing medical products and dietary supplements on the market.

• advice on medicinal products, dietary supplements, nutritional products of special purposes and medical products including in particular

• representing clients before administrative bodies and institutions within the pharmaceutical sector (Main Pharmaceutical Inspector, Chief Sanitary Inspector, local authorities, institutions of self-regulation)

• consultation and comprehensive support in obtaining permits for production and placing on the market, as well as on the withdrawal of medical products from the market

Compliance in the area of labeling medical products and dietary supplements

• medicinal products and dietary supplements labeling accuracy evaluation  (including trade mark protection issues)

Tax Advisory

• Tax advisory regarding pharmaceutical industry

Contacts:

Mail: kancelaria@kalwas.pl