eCTD submission

eSubmission Gateway or web client mandatory for all eCTD submission through the Centralized Procedure from 1 March, 2014

The European Medicines Agency (EMA) reminds marketing authorisation 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 centralised 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

Author

KnetAdmin

Book a Demo