eCTD submission

XML delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client website

1 September 2015, companies should use the XML delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client website.

As of 1 September 2015, companies should use the XML delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client website. After this date, it will no longer be possible to submit PSUR submissions using the existing file-naming convention. The PSUR XML delivery file for EMA submission is introduced to harmonise the submission mechanism for all PSURs submitted to EMA and it will apply to all types of PSUR and PSUR supplementary information submissions.

http://www.ema.europa.eu/ema/index.jsp?cur=pages/news_and_events/news/2015/06/news_detail_002346.jsp&mid=WC0b01ac058004d5c1

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