FEDERAL LAW OF THE RUSSIAN FEDERATION

of December 27, 2019 No. 475-FZ

About introduction of amendments to the Federal law "About Drug Circulation" and the Federal Law "About introduction of amendments to the Federal law "About Drug Circulation"

Accepted by the State Duma on December 18, 2019

Approved by the Federation Council on December 23, 2019

Article 1

Bring in the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; No. 42, Art. 5293; No. 49, Art. 6409; 2011, No. 50, Art. 7351; 2012, No. 26, Art. 3446; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 11, Art. 1098; No. 43, Art. 5797; No. 52, Art. 7540; 2015, No. 29, Art. 4367; 2017, No. 31, Art. 4791; 2018, No. 1, Art. 9; No. 24, Art. 3407; No. 49, Art. 7521; No. 53, Art. 8437; 2019, No. 23, Art. 2917; No. 31, Art. 4456) following changes:

1) in Article 4:

a) add with Item 10.1 of the following content:

"10. 1) original medicine - medicine with new active ingredient which is registered by the first in the Russian Federation or in foreign states based on results of preclinical researches of medicines and clinical trials of the medicines confirming its quality, efficiency and safety;";

b) state Item 11 in the following edition:

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