Press Release: European Medicines Agency starts infringement procedure to investigate Roche’s alleged non-compliance with pharmacovigilance obligations

Author (Corporate)
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Series Details EMA/666493/2012 (23.10.12)
Publication Date 23/10/2012
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The European Medicines Agency (EMA), announced on 23 October 2012, that it had started an infringement procedure against Roche Registration Ltd, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorised medicines.

The initiation of the infringement procedure followed a pharmacovigilance inspection carried out in 2012 by the UK Medicines and Healthcare products Regulatory Agency (MHRA), which identified serious shortcomings of Roche’s pharmacovigilance processes.

Source Link Link to Main Source http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/10/news_detail_001641.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/666493/2012 (23.10.12) http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2012/10/WC500134176.pdf
EMA: Press Release: EMA/652837/2013 (19.11.13): European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/11/news_detail_001962.jsp&mid=WC0b01ac058004d5c1

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