The European Union regulatory network incident management plan for medicines for human use

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Publication Date 2012
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The European Medicines Agency (EMA) published the European Union regulatory network incident management plan for medicines for human use in August 2012.

This plan, which has been in operation since September 2009, explains how the European Medicines Agency (EMA), the European Commission and medicines regulatory authorities in the EU Member States work together to ensure that the most appropriate actions are taken across the EU whenever incidents (new events or information) arise concerning human medicines. It covers medicines authorised centrally, nationally and through the decentralised and mutual-recognition procedures.

Source Link http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/07/WC500130379.pdf
Related Links
EMA: News, 13.8.12: European Medicines Agency explains EU incident management plan for human medicines http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/07/news_detail_001582.jsp&mid=WC0b01ac058004d5c1

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