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EU Financial Penalties For Centrally Approved Medicinal Products in Europe - How to Prepare? by Peter W.L. Bogaert
Covington & Burling LLP - Brussels Office
Genevieve Michaux
Covington & Burling LLP - Brussels Office
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September 19, 2012
Previously published on September 17, 2012
Commission Regulation No. 658/2007 (the “Penalties Regulation”), as recently amended by Commission Regulation No. 488/2012, 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.
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