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Fax: +370 5 263 92 65

News title
With EU support a new Twinning project in the area of medicines and medical devices is launched

The formal opening ceremony organised on 9 March 2017 by the Delegation of the European Union to the Republic of Moldova, the Medicines and Medical Devices Agency of the Republic of Moldova, the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the Republic of Poland marked the official start of the EU-funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” which will strive to improve the quality of the medicines, medical devices and pharmaceutical activity in the Republic of Moldova.

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.

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.