Originally published as Covington E-Alert on September 17, 2012

Commission Regulation No. 658/20071 (the “Penalties Regulation”), as recently amended by Commission Regulation No. 488/2012,2 empowers the European Commission to impose financial penalties in relation to medicinal products approved through the centralised procedure. No financial penalties have yet been imposed, but the situation may change following the recent amendments, which added safety and paediatric obligations to the list of obligations that may be enforced by financial penalties.

This note briefly examines the Penalties Regulation and provides recommendations for preparing for investigations and avoiding financial penalties. A copy of the currently applicable version of the Regulation can be found here. The penalties regime applies to medicines for human use as well as veterinary medicines but this note primarily focuses on the former.

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