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On 9 December 2014 a law substantially amending Federal Law No. 61-FZ “On Circulation of Medicines” dated 12 April 2010 (the “Law”) was adopted, in its third reading, by the State Duma of the Russian Federation.
These new amendments made to the Law (the “Amendments”) are the most significant amendments since the Law first came into force in 2010. They not only have the purpose of clarifying the Law’s conceptual framework by eliminating some of its shortcomings and improving the rules for the registration, manufacture and quality control of medicines, but also, to some extent, they aim to harmonise Russian laws on the circulation of medicines with international standards.