eCTD/VNeeS will be mandatory for national applications

In February 2017 an updated version of the eSubmission-Roadmap was published, setting implementation dates for mandatory use of eCTD/VNeeS format in purely national new applications (01.07.2018) respectively for purely national variation and renewal applications (01.01.2019).

BASG recommends submitting at least module 3 as baseline submission separately before variation or renewal applications (according to Harmonised Technical Guidance for eCTD Submissions in the EU).

Please note:

Mandatory submission in eCTD from
01.01.2018: for all variations and renewals in EU procedures
01.07.2018: for all new applications in purely national procedures
01.01.2019:  for all variation and renewal applications in purely national procedures

Mandatory submission in VNeeS from
01.07.2018: for all new applications in purely national procedures
01.01.2019: for all variation and renewal applications in purely national procedures

More information is available at https://www.basg.gv.at/en/eservices/ectdvnees/.