Pharmaceutical law

Our advice covers problems associated with medicinal products, dietary supplements, foods for special nutritional purposes and medical devices, including:

• developing marketing structures, including international structures (particularly pricing and reimbursement rules),
• drawing up distribution and marketing agreements, obtaining the required manufacturing and marketing licences,
• dvising during wholesale distribution and retail sales carried out for pharmacies,
• withdrawing medicinal products from the market,
• support with mergers and acquisitions between entities operating on the pharmaceutical and food markets,
• drawing up internal procedures to regulate marketing activity and minimise legal risks arising from the company’s day-to-day operations and contacts between the company’s employees and healthcare workers,
• day-to-day co-operation in assessing advertising and promotional communiqués and proper marking of medicinal products, medical devices, dietary supplements and foods for special nutritional purposes, also in tax matters,
• support in proceedings to have products listed as reimbursable and in setting official prices,
• running training sessions on legal regulations for medical representatives and regional management, and for marketing department staff and management of pharmaceutical companies,
• advising sector organisations, especially on the legislative process,
• support in organising and day-to-day running of clinical trials, including drafting agreements, applications and correspondence with supervisory authorities,
• professional support and representation in disputes with public authorities supervising the pharmaceutical sector, e.g. Main Pharmaceutical Inspector, Main Sanitary Inspector, local sanitary inspection authorities, voivodship pharmaceutical inspectors and the National Health Fund.