Article 60. State Regulation of Prices for Medicinal Products for Medical Use

The state regulation of prices for medicinal products for medical use shall be exercised as follows:

1) approval of the list of vital and essential medicinal products that are included into such list under international nonproprietary or chemical names and which meet the following criteria:

a) administration of the particular medicinal product for diagnostics, prevention and treatment of diseases including those prevailing in the morbidity structure of the Russian Federation;
b) the advantage of the specific medicinal product compared to other medicinal products for a particular disease, syndrome or clinical case;
c) therapeutic equivalence of the specific medicinal product to medicinal products having the similar mechanism of pharmacologic action;

2) approval of the methodology for determination of the manufacturers’ maximum ex-works prices for the medicinal products included in the list of vital and essential medicinal products;

3) state registration of the manufacturers’ maximum ex-works prices for the medicinal products included in the list of vital and essential medicinal products;

4) maintaining of the state register of the manufacturers’ maximum ex-works prices for the medicinal products included in the list of vital and essential medicinal products;

5) approval of the methodology for determination by executive authorities of the Russian Federation constituent entities of maximum wholesale and maximum retail mark-ups to the actual ex-works prices of manufacturers of medicinal products for the medicinal products included in the list of vital and essential medicinal products;

6) determination of maximum wholesale and maximum retail mark-ups to the actual ex-works prices of manufacturers of medicinal products for the medicinal products included in the list of vital and essential medicinal products;

7) approval of the procedure for giving mandatory instructions to the executive authorities of the Russian Federation constituent entities to bring their decisions on determination of maximum wholesale and maximum retail mark-ups to the actual ex-works prices of manufacturers of medicinal products for the medicinal products included in the list of vital and essential medicinal products into compliance with the legislation of the Russian Federation in the order established by the Government of the Russian Federation, if such decisions were taken in violation of the legislation of the Russian Federation;

8) addressing executive authorities of the Russian Federation constituent entities by an authorized federal executive body with mandatory instructions to bring the decisions on determination of maximum wholesale and maximum retail mark-ups to the actual ex-works prices for the medicinal products included in the list of vital and essential medicinal products taken in violation of the laws of the Russian Federation into compliance with the legislation of the Russian Federation;

9) exercise of state control over application of the prices for medicinal products in the order prescribed by the Government of the Russian Federation; (as amended by Federal Law of October 11, 2010, No. 271-FZ)

10) application of sanctions for violation of the pricing procedure for the vital and essential medicinal products as provided for by the legislation of the Russian Federation.