EMA concludes inquiry into Roche infringement procedure

The European Medicines Agency says it has concluded its inquiry into alleged non-compliance with pharmacovigilance obligations of Roche Registration Ltd, a unit of Swiss drug major Roche (ROG: SIX), and sent its report on this to the European Commission for the next steps.

Without revealing the outcome of its review, the EMA notes that the inquiry is part of the infringement procedure against Roche. It was started by the Agency in October 2012 at the request of the European Commission in the framework of Commission Regulation (EC) No 658/2007, the so-called Penalties Regulation. The aim of the inquiry was to investigate allegations that the company had failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicines.

This followed a pharmacovigilance inspection carried out in 2012 by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), which identified serious shortcomings in Roche’s pharmacovigilance processes.