The European Commission has requested that the European Medicines Agency (EMA) should investigate the company Roche Registration Ltd. for allegedly failing to comply with Pharmacovigilance requirements in relation to its 19 centrally- authorised medicines. EMA stated that it has started an infringement procedure against the company.
On the basis of the infringement procedures, a pharmacovigilance inspection was carried out by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The inspection found serious shortcomings on Roche’s pharmacovigilance process.
Once the conclusions of the Commission’s investigation are delivered, and if it concludes that Roche has committed an infringement of its obligations, the Swiss pharma company will face a single fine or periodic penalty payments - as established under Regulation (EC) No 658/2007.
For more information:
EPHA related articles
EPHA position on pharmacovigilance
EPHA Briefing: Proposed Directive on Pharmacovigilance
Pharmacovigilance - legislative update
Pharmacovigilance: Transitional arrangements published & EMA consultation on good pharmacovigilance practice