FEDERAL LAW OF THE RUSSIAN FEDERATION

of July 3, 2016 No. 261-FZ

About introduction of amendments to 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 separate legal acts of the Russian Federation

Accepted by the State Duma on June 24, 2016

Approved by the Federation Council on June 29, 2016

Article 1

Bring in the Federal Law of November 22, 1995 No. 171-FZ "About state regulation of production and turnover of ethyl alcohol, alcoholic and alcohol-containing products and about restriction of consumption (drinking) of alcoholic products" (in editions of the Federal Law of January 7, 1999 No. 18-FZ) (The Russian Federation Code, 1995, No. 48, Art. 4553; 1999, No. 2, Art. 245; 2001, No. 53, Art. 5022; 2002, No. 30, Art. 3026, 3033; 2004, No. 45, Art. 4377; 2005, No. 30, Art. 3113; 2006, No. 1, Art. 20; No. 31, Art. 3433; No. 43, Art. 4412; 2007, No. 1, Art. 11; No. 31, Art. 3994; No. 49, Art. 6063; 2008, No. 30, Art. 3616; 2009, No. 1, Art. 21; No. 52, Art. 6450; 2010, No. 15, Art. 1737; No. 31, Art. 4196; 2011, No. 1, Art. 42; No. 27, Art. 3880; No. 30, Art. 4566, 4601; 2012, No. 26, Art. 3446; No. 27, Art. 3589; No. 31, Art. 4322; No. 53, Art. 7584, 7611; 2013, No. 30, Art. 4065; No. 44, Art. 5635; 2015, No. 1, Art. 43, 44, 47; No. 14, Art. 2022; No. 27, Art. 3973) following changes:

1) in Item 3 of Article 1:

"the address of the alcohol-containing medicines registered by authorized federal executive body and included in the state register of medicines, except for in productions, turnover and (or) use for own needs of pharmaceutical substance of ethyl alcohol (ethanol);";

b) the fifth to declare the paragraph invalid;

c) add with the paragraph of the following content:

"the address of the alcohol-containing medical products registered by authorized federal executive body and included in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products, except for productions of alcohol-containing medical products in the liquid state with content of pharmaceutical substance of ethyl alcohol (ethanol);";

2) in Article 2:

a) in subitem 1 of the word "ethyl alcohol under pharmacopoeian Articles" shall be replaced with words "pharmaceutical substance of ethyl alcohol (ethanol)";

b) state subitem 2.1 in the following edition:

"2. 1) pharmaceutical substance of ethyl alcohol (ethanol) - the pharmaceutical substance determined according to the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" and containing ethyl alcohol;";

c) state subitem 3 in the following edition:

"3) alcohol-containing products - food or non-food products, alcohol-containing medicines, alcohol-containing medical products with content of ethyl alcohol of more 0,5 of percent of amount of finished goods;";

d) add with subitems 3.1 and 3.2 of the following content:

"3. 1) alcohol-containing medicines - the medicines for medical and veterinary application in the liquid state determined according to the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" and containing pharmaceutical substance of ethyl alcohol (ethanol);

3. 2) alcohol-containing medical products - the medical products in the liquid state containing pharmaceutical substance of ethyl alcohol (ethanol);";

e) in subitem 15 the word "needs;" shall be replaced with words "needs. Are not recognized production of alcoholic products of action for production of alcoholic products by mixing of the purchased alcoholic products containing in consumer packaging and marked according to article 12 of this Federal Law, with other food products or using other engineering procedures (insisting, fermentation and others) concerning such alcoholic products, made by the organization performing retail sale of alcoholic products when rendering services of public catering in places of rendering such services;";

3) in Article 5:

a) the fifth to state the paragraph in the following edition:

"the organization and carrying out the state control (supervision) in the field of production and turnover of ethyl alcohol, alcoholic and alcohol-containing products, and also the state supervision of use of the capital processing equipment for production of ethyl alcohol which is subject to state registration;";

b) ceased to be valid according to the Federal Law of the Russian Federation of 29.07.2017 No. 278-FZ

The paragraph the twelfth Item 1 of Article 6 to declare 4) invalid;

5) in Article 8:

a) in Item 2:

word in paragraph one of "ethyl alcohol under pharmacopoeian Articles" shall be replaced with words ", pharmaceutical substance of ethyl alcohol (ethanol), alcohol-containing medicines and (or) alcohol-containing medical products";

word in paragraph eight "in paragraphs one and the second" shall be replaced with words "in paragraphs one, the second and eighteenth";

add with paragraphs of the following content:

"The capital processing equipment of the organizations performing production of pharmaceutical substance of ethyl alcohol (ethanol) for production of alcohol-containing medicines and alcohol-containing medical products shall be equipped with automatic gages and accounting of concentration and amount of anhydrous alcohol in pharmaceutical substance of ethyl alcohol (ethanol), amount of pharmaceutical substance of ethyl alcohol (ethanol) and to be sealed up (are sealed) by the federal executive body authorized on control (supervision) in the field of production of turnover of ethyl alcohol, alcoholic and alcohol-containing products.

Software and hardware of the organizations performing production of pharmaceutical substance of ethyl alcohol (ethanol) for production of alcohol-containing medicines and alcohol-containing medical products shall provide acceptance and information transfer, received with use of automatic gages and accounting of concentration and amount of anhydrous alcohol in pharmaceutical substance of ethyl alcohol (ethanol), amount of pharmaceutical substance of ethyl alcohol (ethanol), about amount of its production, delivery and (or) use for own needs.";

b) in Item 2.1:

in subitem 3 of the word "with population less than three thousand people" to exclude, "the law of the subject of the Russian Federation" shall be replaced with words words "The government of the Russian Federation, including on representation of public authorities of subjects of the Russian Federation";

state subitem 7 in the following edition:

"7) productions and (or) turnover of alcohol-containing medicines and (or) alcohol-containing medical products;";

c) in Item 5:

the paragraph one after words" (the main withdrawal of spirit production)," to add with the words "except for productions of pharmaceutical substance of ethyl alcohol (ethanol)";

paragraph two after words" (the main withdrawal of spirit production)," to add with the words "except for productions of pharmaceutical substance of ethyl alcohol (ethanol)";

third after words" (the main withdrawal of spirit production)" to add the paragraph with the words "except for productions of pharmaceutical substance of ethyl alcohol (ethanol)";

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