Company code 191351864
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Phone: +370 5 263 92 64
Fax: +370 5 263 92 65

News title
Cardiovascular system medicines – the most consumed in all Baltic States

The most consumed medicines in the Baltic States from 2013 to 2015 were medicines used to treat cardiovascular system diseases similar as during the period from 2010 to 2012, shows the new book “Baltic Statistics on Medicines 2013–2015”. The consumption of these medicines more than threefold exceeded the consumption of the second most used groups of medicines in each of the Baltic States (the group of alimentary tract and metabolism medicines in Latvia and Estonia and the nervous system medicines in Lithuania).

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. --->