EMA: European Medicines Agency publishes updated set of mandatory Article 57(2) requirements for marketing authorization holders - Mandatory data set to be submitted by 2 July 2012

The European Medicines Agency has published an updated set of mandatory requirements for marketing authorisation holders to comply with Article 57(2), one of the key measures of the new pharmacovigilance legislation. The Agency has considerably reduced the number of data fields initially required in the format published on 2 July 2011, thus significantly reducing the administrative burden and helping marketing authorisation holders to meet their legal deadline of 2 July 2012.

The Agency will continue to support marketing authorisation holders on the data submission process through online and face-to-face training and a dedicated helpdesk. An online data entry tool (EVWEB) hosted by the Agency to facilitate data submission by small and medium-sized enterprises was also released into production today.

To find more information please use the below mentioned EMA weblink

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/03/news_detail_001459.jsp&mid=WC0b01ac058004d5c1&jsenabled=true