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 instructions 

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