General information


Analytical Expertise Center Pharmacovigilance sector's main activity is systematic monitoring of adverse drug reactions and risk-benefit balance to ensure the safe use of the medicines, gathering information, registering, evaluating, archiving, establishing contacts between the parties and taking the necessary measures to minimize the damage caused by drugs. Activities for this purpose are as follows:
  • Tracing, recording, evaluating, archiving adverse drug reactions, transmitting information to the Uppsala Monitoring Center of the World Health Organization;
  • By examining the official websites of World Health Centers, minimizing the risk by monitoring the warnings on pharmaceutical safety, investigating security-related applications by registering owners, taking advantage of the risk-benefit balance assessment based on these data applying appropriate measures for medicinal products which has already registered or is going to registration procedures in our country;
  • Taking the necessary measures, by investigating Risk Management Plans (RMP) and Periodic Safety Update Reports (PSUR);
  • Preparation of a list of medicines under additional monitoring;
  • Delivery of information to healthcare professionals;
  • Establishment of pharmacovigilance control system;
  • Taking the necessary measures to promote the spontaneous data transmission by healthcare professionals for the best application of pharmacovigilance system;
  • Organization of pharmacovigilance training and courses.