10 Small Submissions
No more than 10 Documents per submission
Country: European Union
Health Authority: European Medicines Agency (EMA)
eCTD, Accepted Since: 01-06-2005
eCTD Version: Module 1 Specification v3.0.4, M2-M5 - v3.2.2
MA, Clinical Trial Application (CTA), Originals, Variations, Renewals, ASMF, CEP, PSUR with Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP)
USA, Health Canada, Switzerland, South Africa, Australia, EAEU, Jordan, Thailand, GCC, ASEAN