eCTD submission

eSubmission Gateway mandatory for all eCTD submission through the Centralized Procedure

The European Medicines Agency (EMA) reminds marketing authorization holders that from 1 March 2014 the use of the eSubmission Gateway or web client has become mandatory for all electronic Common Technical Document (eCTD) submissions through the centralized procedure

After this date, the Agency will no longer accept submissions saved onto CD or DVD. This changes apply to all types of procedures, including active substance master file (ASMF) submissions

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002018.jsp&mid=WC0b01ac058004d5c1

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