Press Release: European Medicines Agency gives final recommendations for 12 centrally authorised medicines manufactured at Ben Venue Laboratories

Continuing its review on the shortcomings in quality assurance identified at Ben Venue Laboratories, Ohio, USA, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), in February 2012, confirmed its initial advice and gave final recommendations for 12 out of 14 centrally authorised medicines manufactured at this site (Angiox, Busilvex, Vidaza, Vistide, Velcade, Ecalta diluent, Soliris, Cayston, Luminity, Mepact, Torisel and Vibativ).

On 13 January 2012, the UK’s medicines regulatory agency (MHRA) on behalf of the European regulatory network issued a restricted Good Manufacturing Practice Certificate to Ben Venue in order to stop the EU supply of non-essential medicines from Ben Venue, while allowing the continued supply of essential medicines.

The review of the two other centrally authorised medicines manufactured at this site, Caelyx and Ceplene, is still ongoing and is expected to be concluded in March 2012.

EMA: Press Release: EMA/CHMP/119670/2012 (16.2.12): European Medicines Agency gives final recommendations for 12 centrally authorised medicines manufactured at Ben Venue Laboratories http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/02/WC500122877.pdf

ESO: Background information: European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories http://www.europeansources.info/record/press-release-european-medicines-agency-gives-interim-recommendations-to-deal-with-shortcomings-in-quality-assurance-at-ben-venue-laboratories/

EMA: Press Release: EMA/CHMP/185096/2012 (16.3.12): European Medicines Agency recommends transfer of manufacturing sites for Caelyx and Ceplene http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/03/news_detail_001470.jsp&mid=WC0b01ac058004d5c1

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