Posted by Michael Wonder on 04 Jul 2016
Infringement procedure against Roche – EMA update
4 July 2016 - The EMA has concluded its second inquiry within the framework of its infringement procedure against Roche.
The infringement procedure was started by EMA on 23 October 2012 at the request of the European Commission in the framework of Commission Regulation 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 authorised products.
This followed a pharmacovigilance inspection carried out in 2012 by the United Kingdom Medicines and Healthcare Products Regulatory Agency, which identified serious shortcomings of the pharmacovigilance processes of the marketing authorisation holder.
The initial EMA investigation report was finalised on 14 April 2014 and forwarded, in accordance with Article 10 of the Penalties Regulation, to Roche, the Member States and the European Commission.
