EMA starts infringement procedure against Roche

Published: 24-Oct-2012
Regulatory

For alleged non-compliance with pharmacovigilance obligations


The European Medicines Agency (EMA) has launched an ‘infringement procedure’ into Roche’s alleged failure to comply with pharmacovigilance obligations in relation to its 19 centrally authorised medicines.

The probe follows an inspection carried out in May by the UK Medicines and Healthcare products Regulatory Agency (MHRA) at Roche’s plant in Welwyn, Hertfordshire, ‘which identified serious shortcomings of Roche’s pharmacovigilance processes,’ EMA said.

The Agency will further investigate the allegations against Roche within the legal framework of Regulation (EC) No 658/2007 and report on the outcome to the European Commission, which ‘may impose fines or periodic penalty payments under the above Regulation if it finds that Roche has committed an infringement of its obligations’.

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