The Government Bill HE 200/2012, given on 20 December 2012 to amend the Medicines Act, was passed as such in the Finnish Parliament on 12 March 2013.

As a result of the amendments, which mainly concern pharmacovigilance, holders of marketing authorizations or registrations should (i) operate and maintain a pharmacovigilance database in order to monitor medicine safety and changes in risk-benefit ratios; (ii) permanently and continuously employ a person in charge of pharmacovigilance; (iii) deliver periodic electronic safety reports to the Finnish Medicines Agency (“Fimea”); and (iv) submit applications for marketing authorizations and renewals of registrations nine (9) months prior to expiration, which is three (3) months earlier than is currently required in the Act.

In conformity with the amendments, Fimea will establish and maintain a drug safety web portal and report all received information on severe adverse effects to the European Medicines Agency’s EudraVigilance database.