EMA updates on infringement procedure against Roche

4 July 2016

The European Medicines Agency today said it has concluded its second inquiry within the framework of its infringement procedure against Swiss pharma giant Roche (ROG: SIX).

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.

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

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