eCTD/baseline submission

Appeared: 2019.02.19 10:37, Last modified: 2019.02.19 10:37

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/


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