H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

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/


Last updated: 2019.02.19 10:37