Pharmacovigilance

Marketing authorisation holders are responsible for monitoring the safety of medical products that have received marketing authorisation and for commencing appropriate actions if changes are identified in the benefit-risk balance of such a medical product. Regulatory agencies and marketing authorisation holders in the pharmaceutical industry take steps to ensure adequate pharmacovigilance through, among other things, monitoring adverse reactions and by risk management procedures. Fimea oversees and carries out pharmacovigilance nationally and as part of the EU’s agency network.

Please see the contact details in the event of defective product notifications.