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FEDERAL LAW OF THE RUSSIAN FEDERATION

of June 6, 2019 No. 134-FZ

About introduction of amendments to the Federal law "About Drug Circulation" regarding state regulation of the prices of the medicines included in the list of vital and essential drugs

Accepted by the State Duma on May 23, 2019

Approved by the Federation Council on May 29, 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; 2012, No. 26, Art. 3446; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 52, Art. 7540; 2015, No. 10, Art. 1404; No. 29, Art. 4367; 2016, No. 27, Art. 4283; 2018, No. 1, Art. 9; No. 49, Art. 7521) following changes:

Shall be replaced with words 1) in Item 9 of Article 5 of the word of "the marginal medicines of selling prices established by producers on vital and essential drugs" "marginal selling prices of producers on the medicines included in the list of vital and essential drugs";

2) in Article 60:

a) in Item 2 of the word of "establishment by producers of marginal medicines of selling prices" shall be replaced with words "marginal calculation of selling prices of producers";

b) in Item 3 of the word of "the marginal medicines of selling prices established by producers" shall be replaced with words "marginal selling prices of producers";

Article 61 to state 3) in the following edition:

"Article 61. State registration and marginal re-registration of selling prices of producers on the medicines included in the list of vital and essential drugs

1. Marginal selling price of the producer on the medicine included in the list of vital and essential drugs is subject to state registration according to the procedure, established by the Government of the Russian Federation, based on the application of the holder or the owner of the registration certificate of the medicine (authorized by it persons) submitted in authorized federal executive body.

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