| Author (Corporate) | European Medicines Agency |
|---|---|
| Series Title | Press Release |
| Series Details | EMA/666493/2012 (23.10.12) |
| Publication Date | 23/10/2012 |
| Content Type | News |
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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. |
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| Source Link | http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/10/news_detail_001641.jsp&mid=WC0b01ac058004d5c1 |
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| Subject Categories | Business and Industry, Health |
| Countries / Regions | Europe |
