FEDERAL LAW OF THE RUSSIAN FEDERATION

of March 8, 2015 No. 34-FZ

About introduction of amendments to article 61 of the Federal law "About Drug Circulation"

Accepted by the State Duma on February 20, 2015

Approved by the Federation Council on February 25, 2015

Article 1

Bring in article 61 of 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; 2014, No. 52, Art. 7540) following changes:

The name to state 1) in the following edition:

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

To state 2) to part 1 and 2 in the following edition:

"1. The selling prices established by producers of marginal medicines on the medicines included in the list of vital and essential drugs are subject to state registration according to the procedure, established by the Government of the Russian Federation.

2. Based on the application of the producer of the medicines included in the list of vital and essential drugs submitted till October 1 every year, the registered marginal selling price on medicine can be re-registered once in the calendar year according to the procedure established by the Government of the Russian Federation.";

3) parts 2.1 and 2.2 to recognize invalid;

Part 3 to state 4) in the following edition:

"3. Marginal calculation of the selling prices specified in parts 1 and 2 of this Article in case of their state registration or re-registration is performed according to the technique approved by the Government of the Russian Federation and considering, in particular:

1) respect for balance of consumer interests of the medicines included in the list of vital and essential drugs, and producers of the medicines included in the list of vital and essential drugs;

2) the actual selling price on medicines in the Russian Federation, the price of import of medicines to the Russian Federation, and also the prices of the similar medicines which are in circulation in the Russian Federation;

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