WKB lawyers have knowledge and experience in all aspects of pharmaceutical law. Our law firm represents both domestic and foreign researchers, manufacturers and distributors of medicinal and veterinary products, as well as medical equipment in commercial matters in proceedings before the public administration authorities including (Polish GIF-Main Pharmaceutical Inspectorate), disputes before regulatory authorities and courts.
In particular, we assist and represent clients in:
- Drafting tailor-made agreements covering distribution, outsourcing, clinical trials, marketing as well as licensing and consulting matters;
- All aspect of the process on obtaining licenses and permits for manufacturing and import of medicinal and veterinary products;
- Conducting legal and regulatory issues including clinical trials, through all their stages;
- Practices regarding sponsoring of health professionals such as doctors, chemists, telemarketers, etc;
- Formation and implementation relating to promotion of pharmaceuticals as well as medicinal and veterinary products;
- Advertising, distributing and placing medicinal products on the refundable drugs list;
- All aspects of intellectual property rights in medicinal and veterinary products, including the conduct of IP audits;
- All processes aimed at ensuring compliance with the data protection and privacy laws;
- commercial disputes and product liability;
- Legal assistance concerning conformity of Polish regulations with the Community law, and interpretation of the Community directives and regulations in the context of Polish regulations.
