Pharmaceutical law

We specialize in comprehensive legal advice, offering support to companies in the pharmaceutical industry. Our services include advising on the wholesale and retail trade of medicinal products, as well as drafting and reviewing contracts, including distribution agreements.

We provide advisory on:

• wholesale and retail trade medical products, including particularly drawing up or providing opinions on distribution agreements, preparation of modifications within the distribution system with a view to introducing a direct distribution model, consultancy of applications for authorization for wholesale trade or permission to run a public pharmacy;
• advertising of medicinal products, including providing opinions on marketing programmes and single advertisements, representation of clients in proceedings before the Main Pharmaceutical Inspector, preparing agreements with advertising agencies, preparing internal policies and guidelines on the rules of the marketing policy within company, running internal training courses for sales representatives, medical representatives and management executive officers;
• activities which are not classified as advertising g of medical products, in particular educational campaigns and sponsoring of radio and television;
• clinical trials, including the preparation of model clinical trials agreements (both tripartite: sponsor/investigator/site and bilateral: sponsor/investigator, sponsor/site), providing opinions on agreements, negotiating agreements with investigators and sites, preparing documentation related to personal data protection for clinical trials, support for sponsors or CROs during their discussions with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (“URPL”) and bioethics committees;
• parallel import, including evaluation of the activities compliant with Pharmaceutical Law and the jurisdiction of the European Court of Justice;
• manufacturing of medicinal products, including applying for or amending manufacturing authorisations;
• wholesaling activity in the scope of DPD, legal support in the event of inspections carried out by the Pharmaceutical Inspection;
• pharmacies activity in the context of their advertising and representation in the event of inspection carried out by Pharmaceutical Inspection;
• registration of medicinal products, including registration documentation, renewal or shortening of the term of marketing authorisations for medicinal products, issues related to data exclusivity protection.