As from 1 January 2018, it is obliged to submit the common technical document (CTD) electronically for variations of human medicines, registered via the Mutual Recognition Procedure (MRP) or Decentralised procedure (DCP).

This eCTD format is mandatory for the submission of new marketing authorization applications as well as for submissions regarding on-going regulatory activities, such as follow-up submissions for variations, periodic safety update reports, notifications, responses and renewals. It also includes active substance master file submissions used in European procedures and responses or supplementary information in ongoing MRPs.

More information can be found on the EMA eSubmission website.

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