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EMA sends its results on Roche investigation of pharmacovigilance non-compliance to the European Commission.
The European Medicines Agency (EMA) has sent its findings from an inquiry into pharmacovigilance non-compliance by Roche Registration to the European Commission. The commission began an infringement procedure against Roche is October 2012 to investigate if the company had failed to comply with pharmacovigilance obligations. A 2012 inspection by the United Kingdom Medicines and Healthcare Products Regulatory Agency had discovered shortcomings in Roche’s pharmacovigilance processes, according to EMA.
EMA’s report summarizes the agency’s findings on the allegations. The European Commission will decide on further action after review the report.