Pharmaceutical law

Our highly specialized lawyers advise on pharmaceutical law matters and on reimbursement of medicinal products. For over 15 years we have been providing comprehensive legal services to both domestic and international pharmaceutical companies.

Our services include:

  • Obtaining the marketing authorization for medicinal products (including orphan drugs), post-registration variations, manufacturing and import of medicinal products, wholesale and retail trade in medicinal products.

  • Reimbursement strategies for medicinal products and legal support in reimbursement proceedings before the Minister of Health.

  • Principles of advertising and promoting medicinal products, including legal verification of advertising materials and promotional campaigns as well as establishing the rules of cooperation with advertising and marketing agencies.

  • Intellectual property protection of medicinal products.

  • Parallel import – both in the regulatory area and intellectual property protection, including disputes over parallel import of medicinal products non-compliant with the BMS conditions.

  • Legal verification of contracts specific to the pharmaceutical sector, including international transactions.

  • Clinical trials and other research projects.

  • Contacts with regulatory authorities and supervisory authorities (Minister of Health, President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Chief Pharmaceutical Inspector, Provincial Pharmaceutical Inspectors).