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

News title
For Marketing Authorisation Holders

Please be informed that from the 1st of May, 2016, State Medicines Control Agency (SMCA) switches to 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. More information about national requirements for e-dossier’s submission could be found here.

Regarding medicinal products for which „sunset clause“ may already be applied

The State Medicines Control Agency on the ground of market monitoring data has compiled the list of medicinal products authorized in the Republic of Lithuania which more than for three years had not been supplied to the Lithuanian market.

Electronic application forms (eAF)
From the 1st of January 2016 the use of electronic application forms (eAF) for MRP/DCP and national procedures (initial MA‘s, renewals, variations) will be mandatory within electronic submissions.  The currently used application forms in Word format published by the European Commission and SMCA will no longer be available and only the latest version of the electronic application form will be used for all EU procedures, including CP, MRP/DCP and national procedures. These are the first steps towards the Single Submission Portal used with an integrated eAF which will be implemented by 2018 with the goal of streamlining life cycle management of submissions. The details of the implementation plan are available from the European Medicines Agency (EMA) website European Medicines Agency homepage. --->
For Marketing Authorisation Holders

The State Medicine Controle Agency kindly informs that applicants can initiate worksharing procedure between Baltic States (Lithuania, Latvia, Estonia) in order to change the invented name of medicinal products and to harmonize clinical infomation.