eCTD/baseline submission
From 01/01/2019 all submissions (human) in CP, DCP, MRP and NP have to be submitted in eCTD structure.
Baselines are recommended but not required. The applicant decides whether to submit a baseline or not.
( HMA eSubmission Roadmap Annex 2. )
For more information:
http://esubmission.ema.europa.eu/
