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Efficacy and Safety Division

  • Evaluate the preclinical and clinical data on the efficacy and safety of medicinal products contained in the dossiers submitted in support of marketing authorisation and renewal of marketing authorisation in accordance with the requirements of the legislation;
  • Determine the classification of a medicinal product in accordance with the requirements of the legislation;
  • Prepare information for communication to doctors, pharmacists and the general public on the efficacy and safety of medicines.