Support of current activities of pharmaceutical and medical device companies

  • Assessment of the legal risks associated with current business activities
  • Legal audit of current documents and contracts
  • Elaboration of recommendations for risk minimization
  • Drafting of the necessary documents
  • Legal advice on implementation of exclusive rights.

Also we advise on the following legal issues:

  • clinical trials of medicines, and clinical trials of medical products;
  • registration of medicines;
  • registration of medical products;
  • production, manufacturing, storage, transportation, import into Ukraine and export from Ukraine, retail and storage of medicines and medical products;
  • registration of the prices for vital and essential medicines;
  • certification of compliance of medicines and medical products;
  • licences for the production of medicines, pharmaceutical and medical activities, and the manufacture and maintenance of medical equipment;
  • advertising and promotion; interaction with medical and pharmaceutical professionals;
  • participation in public procurement and appeals against unlawful acts of state customers and preferences being granted, and risks connected with optimising the above activities;
  • protection of personal data (including auditing whether the organisational and technical aspects of protective measures within a company are sufficient);
  • antimonopoly regulation of the industry;
  • taxation (including clinical research and tests, discounts, bonuses, the import of samples of medicines and medical products, and the application of tax benefits in the pharmaceutical industry);
  • foreign trade regulation of the turnover of medicines and medical products;
  • the granting of benefits and preferences when production is localised and contracts for private-public partnerships are entered into;
  • the transfer and organisation of production in Ukraine (legal support for construction, licensing, equipment and materials being imported, and support for production, sales and marketing).