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Lithuania and Poland will Support Moldova in Strengthening Regulation of Pharmaceutical Activities and Medical Devices

2016 05 05

Lithuania together with Poland as a junior partner won selection and will be implementing the European Union Twinning project “Strengthening of the Medicines and Medical Devices Agency of Moldova as regulatory agency in the field of medicines, medical devices and pharmaceutical activity”.

For a period of two years the team of Lithuanian experts from the Ministry of Health, State Medicines Control Agency, National Health Insurance Fund, in cooperation with colleagues from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Poland, will assist the Medicines and Medical Devices Agency of the Republic of Moldova in developing practical skills in regulation and supervision of the market for medicinal products and medical devices in line with the EU standards.

Director of the Lithuanian State Medicines Control Agency Mr. Gintautas Bacys will lead implementation of the EU Twinning project in cooperation with the Junior Project Leader Mr. Grzegorz Cessak, President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Poland. Chief Specialist of the Department of Pharmacy of the Lithuanian Ministry of Health Ms. Anželika Oraitė will be assigned as the Resident Twinning Advisor. The Central Project Management Agency (CPMA) will assure financial-administrative management of the Twinning activities. European Commission’s funding assigned for the project amounts to EUR 1,1 mln.

Close and effective cooperation between the Lithuanian State Medicines Control Agency and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Poland began in 2012. Two Agencies share experience in various training programs, inspectors participate in the Good Clinical Practices and Pharmacovigilance inspections, experts from both agencies form teams and participate in the medicines authorization procedures. The Agencies also organize