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 Link to Main Source 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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