Pharmacovigilance Division
- Ensure the safety monitoring of medicinal products and the evaluation of risk minimisation measures;
- Maintain, update and analyse data and information on adverse reactions to medicinal products;
- Evaluate periodic safety update reports submitted by the marketing authorisation holder; participate in the Period safety update report single assessment (PSUSA) for active substances delegated by the Pharmacovigilance Risk Assessment Committee (PRAC);
- Evaluate pharmacovigilance data in the procedures of medicine authorisation, renewal and variation;
- plan and carry out routine, recurrent and emergency inspections to monitor and evaluate the compliance of the marketing authorisation holder with good pharmacovigilance practice;
- Prepare the Agency's information on pharmacovigilance issues for communication with doctors, pharmacists and the public.
