FEDERAL LAW OF THE RUSSIAN FEDERATION

of December 27, 2019 No. 462-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 12, 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. 48, Art. 6165; 2014, No. 43, Art. 5797; No. 52, Art. 7540; 2015, No. 29, Art. 4367; No. 51, Art. 7245; 2016, No. 27, Art. 4194; 2017, No. 31, Art. 4827; 2018, No. 1, Art. 9; No. 24, Art. 3407; No. 49, Art. 7521; 2019, No. 31, Art. 4456) following changes:

1) in part 5 of Article 18:

a) the paragraph one of Item 1 to add with words ", except for information on the pharmaceutical substances included in the state register of medicines according to article 34 of this Federal Law";

b) add with Item 1.1 of the following content:

"1. 1) concerning the pharmaceutical substances which are part of medicine and included in the state register of medicines according to article 34 of this Federal Law - the copy of the document containing the following information:

a) name of pharmaceutical substance, its structure, general properties;

b) name and address of the producer;

c) analysis results of series of pharmaceutical substance;

d) expiration date;";

"Item 2 of part 1" shall be replaced with words 2) in Item 3 of part 8 of Article 34 of the word "part 2";

3) regarding the 4th Article 45 of the word "included in the state register of medicines" shall be replaced with words "data about which contain in the state register of medicines";

Shall be replaced with words 4) regarding the 2nd Article 47 of the word "to be included in the state register of medicines" "contain in the state register of medicines";

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