Press Release: Regulatory information – EMA announces next steps for the maintenance of information on authorised medicines by marketing-authorisation holders

Author (Corporate)
Series Title
Series Details 31.01.14
Publication Date 31/01/2014
Content Type

The European Medicines Agency (EMA) released on the 31 January 2014 guidance to support marketing-authorisation holders updating the information on authorised medicines that they have submitted to the Agency in accordance with Article 57(2) of the 2010 pharmacovigilance legislation.
Source Link http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/01/news_detail_002014.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Legal Notice, 31.01.14: Legal Notice on the Implementation of Article 57(2) of Regulation (EC) No. 726/2004: Electronic Submission of Information on Medicinal Products for Human Use by Marketing Authorisation Holders to the European Medicines Agency http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500108212.pdf
EMA: Detailed-guidance documents http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000336.jsp&mid=WC0b01ac058079126c
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