eCTD submission

EU-EMA is transitioning to a compulsory usage of the eAFs

New versions of the electronic Application Forms (eAF v. 01.19.0.1) are now available. The version v. 01.19.0.1 of the eAFs can be used from 30 November 2015 and will replace the current version of eAF v. 01.18 after a transitional period on 11 January 2016.

Versions 01.18 and 01.19 will continue being accepted until 11 January 2016. Previous versions of the forms (v 01.18 and v 01.19 before the hotfix) will no longer be accepted after this date.

The use of the eAFs will become mandatory for all European procedures covered by the eAFs including Mutual Recognition, Decentralised Procedure and the national applications from 1 January 2016.

http://esubmission.ema.europa.eu/index.htm

Author

KnetAdmin

Book a Demo