First annual report on EudraVigilance for the European Parliament, the Council and the Commission

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Publication Date 2013
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The European Medicines Agency (EMA), in July 2013, published the first annual report on EudraVigilance for the European Parliament, the Council and the Commission, which covers the period from 1 January to 31 December 2012.

It is the third time the Agency has issued an annual report on the EudraVigilance database. However, it is the first time that this report has been published under a provision of the new pharmacovigilance legislation, for submission to the European Parliament, the Council and the European Commission.

The EudraVigilance database is a web-based information system designed to collect, manage and analyse reports of suspected side effects to medicinal products.

Source Link http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146607.pdf
Related Links
EMA: News, 26.07.13: 2012 annual report on EudraVigilance published http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/07/news_detail_001853.jsp&mid=WC0b01ac058004d5c1

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