Pharmaceutical Law

KZR&P provides legal services to companies on the pharmaceutical market, related to all the legal aspects of trading, manufacture and distribution of medicinal products. We prepare legal opinions concerning Polish and European pharmaceutical law, conduct litigation, advise our clients in administrative proceedings and draft agreements related to all aspects of the business of our Clients on the pharmaceutical market.

In particular we offer:

• assistance with procedures for market authorization of pharmaceutical products (national and central registration, MRP, parallel import, decentralized procedures);
• assistance with registration of generic drugs and active substances with well established use;
• assistance with compliance issues as regards manufacturing procedures;
• assistance with various administrative aspects of clinical trials and compliance with GCP requirements;
• advice on and drafting of distribution agreements;
• advice on unfair competition in the pharmaceutical sector and infringement on personal rights of pharmaceutical companies;
• advice on permitted advertising and promotional activities of pharmaceutical products;
• assistance with monitoring of quality, safety and effectiveness of pharmaceutical products (pharmacovigilance);
• advice on protection of personal data by pharmaceutical companies; and
• advice on protection of industrial property in the pharmaceutical sector.