The EMA has concluded its second inquiry within the framework
of its infringement procedure against Roche. The infringement
procedure was started by EMA on October 23, 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 Roche failed to
comply with its pharmacovigilance obligations in relation to 19 of
its centrally authorized products, following a pharmacovigilance
inspection carried out in 2012 by the MHRA, which identified
serious shortcomings of the pharmacovigilance processes of the
marketing authorization holder.
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