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

National requirements for submissions
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 requirements for e-submission could be found here
  • All documentation/information should be submitted only in Lithuanian or English.
With any new regulatory activity the proof of payment is mandatory.  All information about fees could be found here .

Last Update: 2016-05-20 10:20:11