Press Release: Regulatory information – eSubmission Gateway or web client mandatory for all eCTD submissions through the centralised procedure from 1 March 2014

Author (Corporate)
Series Title
Series Details 07.02.14
Publication Date 07/02/2014
Content Type

The European Medicines Agency (EMA) reminded marketing authorisation holders in February 2014 that from 1 March 2014 the use of the eSubmission Gateway or web clientExternal link icon will become mandatory for all electronic Common Technical Document (eCTD) submissions through the centralised procedure. After this date, the Agency will no longer accept submissions saved onto CD or DVD. This will apply to all types of procedures, including active substance master file (ASMF) submissions.

Source Link Link to Main Source http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002018.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: eSubmission http://esubmission.ema.europa.eu/

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