The European Medicines Agency (EMA) has initiated an infringement procedure against Roche Registration, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicines.
The infringement procedure follows a pharmacovigilance inspection carried out in 2012 by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), which identified serious shortcomings of Roche's pharmacovigilance processes. The start of this procedure means that the Agency will further investigate the allegations against Roche within the legal framework of Regulation (EC) No 658/2007. It does not prejudge the outcome of the investigation.
The Agency will report the outcome of its investigation to the European Commission who may impose fines or periodic penalty payments under the regulation mentioned above if it finds that Roche has committed an infringement of its obligations.
The Agency has informed Roche, the European Commission and the Member States' national competent authorities that it has started an infringement procedure in this case. The Agency continues to assess the overall public health impact of the inspection.
The legal base for the Agency's opening of formal proceedings is Article 5 of Commission Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorizations granted under Regulation (EC) No 726/2004, the “penalties regulation.”