Company code 191351864
Žirmūnų str. 139A, Vilnius, Lithuania
Phone: +370 5 263 92 64
Fax: +370 5 263 92 65


Starting from the 1st of May, 2016, State Medicines Control Agency (SMCA) switches to e-submission (e-dossier) only. All applications for marketing authorization, renewal, all types of variations (under national, decentralized or mutual recognition procedures) need to be submitted only as e-dossier (eCTD or NeeS) via CESP (Common European Submission Portal) or written in CD/DVD with cover letter. 


National e-submission guidance


Usefull links:

Last Update: 2016-04-20 14:58:50