Press Release: New pharmacovigilance legislation comes into operation

Author (Corporate)
Series Title
Series Details EMA/441425/2012 (2.7.12)
Publication Date 02/07/2012
Content Type

The European Medicines Agency (EMA) welcomed the start of new European Union legislation on pharmacovigilance, which entered into force on 1 July 2012. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines.

The new pharmacovigilance legislation is comprised of Directive 2010/84/EU and Regulation (EU) No 1235/2010.

Source Link Link to Main Source http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/07/news_detail_001553.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/441425/2012 (2.7.12): New pharmacovigilance legislation comes into operation http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2012/07/WC500129311.pdf
EMA: Press Release: EMA/487397/2012 (19.7.12): European Medicines Agency holds first meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/07/news_detail_001570.jsp&mid=WC0b01ac058004d5c1
EMA: News, 19.7.12: European Medicines Agency publishes video explaining new pharmacovigilance legislation http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/07/news_detail_001571.jsp&mid=WC0b01ac058004d5c1

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