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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 15, 2019 No. 774

About approval of Rules of forming of the list of alcohol-containing medical products, to activities for production, production and (or) turnover of which operation of the Federal law "About State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-containing Products and about Restriction of Consumption (Drinking) of Alcoholic Products" does not extend

(as amended of the Order of the Government of the Russian Federation of 31.12.2020 No. 2433)

According to item 4 of article 1 of the Federal law "About State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-containing Products and about Restriction of Consumption (Drinking) of Alcoholic Products" Government of the Russian Federation decides:

1. Approve the enclosed Rules of forming of the list of alcohol-containing medical products, to activities for production, production and (or) turnover of which operation of the Federal law "About State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-containing Products and about Restriction of Consumption (Drinking) of Alcoholic Products" does not extend.

2. To the Federal Service on supervision in the field of health care to approve regulations on the commission of Roszdravnadzor for forming of the list of alcohol-containing medical products, to activities for production, production and (or) turnover of which operation of the Federal law "About State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-containing Products and about Restriction of Consumption (Drinking) of Alcoholic Products", and structure of said commission does not extend.

3. To the Ministry of Health of the Russian Federation to introduce no later than November 26, 2019 in the Government of the Russian Federation in accordance with the established procedure the draft of the act of the Government of the Russian Federation of approval of the list of alcohol-containing medical products, to activities for production, production and (or) turnover of which operation of the Federal law "About State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-containing Products and about Restriction of Consumption (Drinking) of Alcoholic Products" does not extend.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of June 15, 2019 No. 774

Rules of forming of the list of alcohol-containing medical products, to activities for production, production and (or) turnover of which operation of the Federal law "About State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-containing Products and about Restriction of Consumption (Drinking) of Alcoholic Products" does not extend

1. These rules determine procedure for forming of the list of alcohol-containing medical products, to activities for production, production and (or) turnover of which operation of the Federal law "About State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-containing Products and about Restriction of Consumption (Drinking) of Alcoholic Products" does not extend (further - the list).

2. Forming of the list is performed by the formed Federal Service on supervision in the field of health care by the commission on forming of the list (further - the commission).

3. Organizational technical supply of activities of the commission is performed by the Federal Service on supervision in the field of health care.

4. The commissions are included 1 representative in position not below the deputy director of department of the Ministry of Health of the Russian Federation, on 1 representative in position not below the deputy director of department of the Ministry of Finance of the Russian Federation, the Ministry of Economic Development of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, on 3 representatives in position not below the deputy head of department from Federal Service for Alcohol Market Regulation, the Federal Service on supervision in the field of health care, the Federal Customs Service, Federal Antimonopoly Service, on 1 representative from the All-Russian merging of employers "Russian Union of Industrialists and Entrepreneurs", the All-Russian public organization of small and medium entrepreneurship "SUPPORT of RUSSIA", the All-Russian public organization "Business Russia", and also with the right of advisory vote the invited experts (non-staff specialists) of the Ministry of Health of the Russian Federation, representatives of the federal state educational organizations of the higher medical education, the state medical, scientific organizations, professional communities of doctors.

Requirements to representatives of the commission are determined independently by the federal executive bodies and the organizations specified in this Item.

5. Forming of the list and modification of it is performed according to names of medical products with indication of option of execution (model), number of the registration certificate on medical product and the producer (manufacturer) of medical product.

6. The alcohol-containing medical products in liquid form of release containing pharmaceutical substance of ethyl alcohol (ethanol) (further - medical product), registered in the Russian Federation in accordance with the established procedure and included in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products on condition of compliance to one or several of the following criteria are subject to inclusion in the list:

a) amount of consumer pack (packaging) of medical product (irrespective of volume fraction of content in it pharmaceutical substance of ethyl alcohol (ethanol) does not allow to use it as substitute (substitute) of alcoholic products;

b) retail price of medical product when comparing in comparable amounts on consumer pack (packaging) and content of ethyl alcohol for 20 and more percent above the retail price on alcoholic products with a strength over 28 percent established according to the paragraph the second article 5 of the Federal law "About State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-containing Products and about Restriction of Consumption (Drinking) of Alcoholic Products";

c) the functional purpose (application to destination) medical product established by the producer (manufacturer) in operational documentation (the instruction for application) is not connected with the use of medical product in human body or does not allow to use it as substitute (substitute) of alcoholic products;

d) physical and chemical and organoleptic characteristics of medical product exclude possibility of its use as substitute (substitute) of alcoholic products (intake).

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