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.
Regulations as regards the pharmacovigilance of medical products for human use are being amended by Regulation (EU) No 1235/2010 and Directive 2010/84/EU of the European Parliament and of the European Council which will enter into force respectively on 2 July and 21 July 2012.
Fimea accepts defective product notifications and adverse drug reaction reports. Marketing authorisation holders must report any serious adverse drug reactions occurring in Finland only to Fimea, not directly to the European Medicines Agency (EMA).
Please see the contact details in the event of defective product notifications.