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Pharmaceutical law

Pharmaceutical law

Wholesale and retail trade in medical products, drawing up distribution agreements, changes within the scope of distribution, and consulting within the scope of applications. read more
Medical devices

Medical devices

Classification of products as medical devices. read more
Food

Food

Classification of products as dietary supplements or as other foods. read more
Reimbursement

Reimbursement

Applying for official prices to be established and registration of product into reimbursement lists. read more
Cosmetics

Cosmetics

Classification of products as cosmetic, notification duties, labelling and advertising. read more
Pro bono activities

Pro bono activities

Free of charge legal professional advice within the scope of right to health and access to medical care. read more
Other markets

Other markets

We offer legal advisory related to placing food stuff. read more
Other

Other

Electronic provision of services, comparative advertising, providing opinions on drafts of legal acts. read more

Pharmaceutical law

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.