Pharmacovigilance
General information
Pharmacovigilance is a set of activities related to collecting, assessing and responding to adverse reactions to medicines
Adverse reactions to medicines reporting
Healthcare professionals and patients may report suspected adverse reaction to the Institute
Instructions for marketing authorisation holders
Duties of marketing authorisation holders are precisely defined by the legislation and instructionsÂ
Direct Healthcare Professional Communication
New information of importance for safe use of medicines are sent in the form of a Letter to healthcare professionals
Risk minimisation measures
Risk minimization measures are interventions and activities that are carried out to prevent or reduce the possibility of adverse reactions
List of serious adverse reactions
Serious adverse reaction to a medicine is any adverse reaction that can cause death, life endangerment and hospitalization
List of medicines under additional monitoring
 Institute publishes the List of medicines under additional monitoring
Annual reports
Institute collects, assesses and analyses adverse reactions to medicines reports