FEDERAL LAW OF THE RUSSIAN FEDERATION

of July 29, 2017 No. 278-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 July 21, 2017

Approved by the Federation Council on July 25, 2017

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; 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; 2016, No. 1, Art. 20; No. 26, Art. 3871; No. 27, Art. 4193, 4194) following changes:

1) in Article 1:

a) in Item 3:

third to state the paragraph in the following edition:

"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), and also except for productions, production, purchase, deliveries, storage and (or) transportations of alcohol-containing medicines;";

the eleventh to state the paragraph in the following edition:

"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, production, purchase, deliveries, storage and (or) transportations of alcohol-containing medical products.";

b) add item 4 with paragraphs of the following content:

"The government of the Russian Federation in the procedure established by it proceeding from amount of consumer pack (packaging) and (or) cost and (or) functional purpose of alcohol-containing medical products establishes lists of these products, to activities for production, production and (or) turnover of which operation of this Federal Law does not extend.

The government of the Russian Federation in the procedure established by it proceeding from amount of consumer pack (packaging) and (or) cost and (or) functional purpose of alcohol-containing medicines establishes lists of these products, to activities for production, production and (or) turnover of which operation of this Federal Law does not extend.";

2) in Article 2:

a) in subitem 3.1 of the word "in the liquid state" shall be replaced with words "in liquid form of release";

b) state subitem 3.2 in the following edition:

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

3) in Article 5:

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

"the organization and carrying out federal state control (supervision) in the field of production and turnover of ethyl alcohol, alcoholic and alcohol-containing products;";

b) to declare the paragraph of the twenty eighth invalid;

4) in Item 1 of Article 6:

a) to state the paragraph of the sixth in the following edition:

"implementation of regional state control (supervision) in the field of retail sale of alcoholic and alcohol-containing products;";

b) add with the paragraph of the following content:

"approval of the list of settlements in which there is no access to the Internet, including the access point determined according to the Federal Law of July 7, 2003 No. 126-FZ "About communication" in coordination with the authorized Government of the Russian Federation federal executive body.";

Item 1 of Article 7 to add 5) with words ", alcohol-containing products";

6) in Article 8:

a) in Item 2:

word in paragraph one", pharmaceutical substance of ethyl alcohol (ethanol)," to exclude;

in the paragraph the eighteenth to exclude the words "for production of alcohol-containing medicines and alcohol-containing medical products";

in the paragraph the nineteenth to exclude the words "for production of alcohol-containing medicines and alcohol-containing medical products";

add with paragraphs of the following content:

"Reservoirs for acceptance of pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol at the organizations and the individual entrepreneurs using pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol for production of alcohol-containing medicines and (or) alcohol-containing medical products and also in production process of other medicines and (or) medical products, shall be equipped with automatic gages and accounting of concentration and amount of anhydrous alcohol in pharmaceutical substance of ethyl alcohol (ethanol) or in ethyl alcohol, amount of pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol.

Software and hardware of the organizations and individual entrepreneurs using pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol for production of alcohol-containing medicines and (or) alcohol-containing medical products and also in production process of other medicines and (or) 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) or in ethyl alcohol, amount of pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol, about amount of their purchase.

The equipment for accounting of volume of turnover and use of pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol for production of alcohol-containing medicines and (or) alcohol-containing medical products, and also in production process of other medicines and (or) medical products shall be equipped with technical means of fixing and information transfer about production volume and turnover of alcohol-containing products in Unified State Automated Information System.

Software and hardware of the organizations and individual entrepreneurs using pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol for production of alcohol-containing medicines and (or) alcohol-containing medical products and also in production process of other medicines and (or) medical products, shall provide acceptance and information transfer about amount of use of pharmaceutical substance of ethyl alcohol (ethanol) or ethyl alcohol, and also information on production volume and (or) turnover (except for retail sale) alcohol-containing medicines and alcohol-containing medical products received using technical means of fixing and information transfer about production volume and turnover of alcohol-containing products in Unified State Automated Information System.";

b) in Item 2.1:

state subitem 3 in the following edition:

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info