Roche Faces Potential Fine In EU Safety Probe

Law360, New York (October 23, 2012, 10:00 PM EDT) -- The European Medicines Agency started an investigation into Roche Holding AG on Tuesday to determine whether it failed to comply with safety reporting requirements for 19 of its medications, a probe that could culminate in a hefty fine against the company.

At the request of the European Commission, the agency launched an infringement procedure against Roche Registration Ltd. under a 2007 EC regulation. An inspection by a U.K. health agency revealed that Roche did not evaluate reams of U.S. case reports to determine whether any suspected...
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