eCTD format mandatory for MRP-procedures

date: 22/12/2017

From 1st of January 2018 the eCTD format will become mandatory for variations of human medicines via the Mutual Recognition Procedure (MRP).

According to the EU eSubmission Roadmap v.2.0, the eCTD format will be mandatory for all MRP submissions, human including variations, notifications, renewals, PSURs from the 1st of January 2018. This includes active substance master files (ASMF’s)-submissions used in European procedures and also responses and supplementary information in ongoing MRP-procedures.

 More information can be found on EMA eSubmission website.


Last updated on 22/12/2017