Privatsphäre-Einstellungen

Commission Penalty Regulation

New regulation on financial penalties for infringement of obligations for centrally authorised medicinal products

Dr. Jörg Schickert

Lovells LLP, Munich (Germany)

The European Commission adopted the “Regulation No. 658/2007 concerning financial penalties for the infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004”1) (the “Penalty Regulation”). The Penalty Regulation penalises the infringement of pre- and post-marketing obligations for centrally authorised medicinal products in the European Community. Whenever a marketing authorisation holder (MAH) violates specific regulatory obligations in relation to pharmaceuticals authorised under Regulation (EC) No. 726/2004, the European Commission will be entitled to impose significant financial fines.