ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of April 20, 2019 No. 472

About accounting treatment and declaring of production volume, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol), and also production, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products and about modification of the Order of the Government of the Russian Federation of June 19, 2006 No. 380

The government of the Russian Federation decides:

1. Approve enclosed:

Rules of accounting of production volume, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol), and also production, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products;

Rules of submission of declarations on production volume, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol), and also production, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products;

changes which are made to the order of the Government of the Russian Federation of June 19, 2006 No. 380 "About accounting of production volume, turnover and (or) use of ethyl alcohol, alcoholic and alcohol-containing products, and also accounting of use of production capacities, amount of the collected grapes and grapes used for production of wine-making products" (The Russian Federation Code, 2006, No. 26, Art. 2845; 2009, No. 4, Art. 505; 2010, No. 12, Art. 1335; 2012, No. 17, Art. 1996; 2014, No. 12, Art. 1298; 2015, No. 50, Art. 7167; 2016, No. 22, Art. 3210; 2018, No. 3, Art. 531; 2019, No. 1, Art. 14).

2. Determine that:

reliability of accounting of production volume of pharmaceutical substance of alcohol of ethyl (ethanol) is determined taking into account the losses arising in case of production of the specified products within rates of natural loss, and the error of measurements allowed by automatic gages and accounting of concentration and amount of waterless alcohol in pharmaceutical substance of alcohol of ethyl (ethanol), amount of pharmaceutical substance of alcohol of ethyl (ethanol);

reliability of accounting of production volume of alcohol-containing medicines and (or) alcohol-containing medical products is determined taking into account the losses arising in case of production of the specified products within rates of natural loss;

reliability of accounting of volume of turnover and use of pharmaceutical substance of alcohol of ethyl (ethanol), and also turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products is determined taking into account the losses arising in case of turnover and use of the specified products within rates of natural loss.

3. To the Ministry of Finance of the Russian Federation:

in 3-month time to approve rates of natural loss in case of production, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol), and also in case of production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products;

in 4-month time to approve evaluation procedure of reliability of accounting of production volume, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol) for production of alcohol-containing medicines and (or) alcohol-containing medical products, in production process of other medicines and (or) medical products, and also productions, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products.

4. Recognize invalid paragraphs two and third orders of the Government of the Russian Federation of December 29, 2017 as No. 1694 "About accounting treatment and declaring of production volume, delivery and (or) use for own needs of pharmaceutical substance of alcohol of ethyl (ethanol) and introduction of amendments to some acts of the Government of the Russian Federation" (The Russian Federation Code, 2018, No. 3, the Art. 531).

Approved by the Order of the Government of the Russian Federation of April 20, 2019 No. 472

Rules of accounting of production volume, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol), and also production, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products

1. These rules establish accounting treatment for production volume, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol), and also production, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products.

2. These rules do not extend to accounting of production volume, production and (or) turnover of the alcohol-containing medicines and (or) alcohol-containing medical products included in the lists of the specified products established by the Government of the Russian Federation according to paragraphs second and third 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".

3. Accounting of production volume, delivery and (or) use for own needs of pharmaceutical substance of alcohol of ethyl (ethanol) perform the organizations performing production of pharmaceutical substance of alcohol of ethyl (ethanol).

Accounting of volume of turnover and use of pharmaceutical substance of alcohol of ethyl (ethanol) is performed by the organizations and the individual entrepreneurs performing turnover of pharmaceutical substance of alcohol of ethyl (ethanol).

Accounting of production volume, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products is performed by the organizations and the individual entrepreneurs performing production, production and (or) turnover of alcohol-containing medicines and (or) alcohol-containing medical products in the amount exceeding 200 decalitres a year.

4. When accounting production volume, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol) unit of measure is the decalitre of waterless alcohol at temperature of this products of +20 °C.

When accounting production volume, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products unit of measure is the decalitre.

Accounting is performed to within thousand shares of decalitre.

5. Accounting of production volume, delivery and (or) use for own needs of pharmaceutical substance of alcohol of ethyl (ethanol) by the organizations performing production of pharmaceutical substance of alcohol of ethyl (ethanol) is conducted using automatic gages and accounting of concentration and amount of waterless alcohol in pharmaceutical substance of alcohol ethyl (ethanol), amount of pharmaceutical substance of alcohol of ethyl (ethanol) (further - automatic means) and technical means of fixing and information transfer about production volume and turnover of ethyl alcohol, alcoholic and alcohol-containing products in Unified State Automated Information System of accounting of production volume and turnover of ethyl alcohol, alcoholic and alcohol-containing products (further - technical means).

6. Accounting of volume of turnover (except as specified, the these rules provided by Items 7 and 8) pharmaceutical substance of alcohol of ethyl (ethanol) the organizations and the individual entrepreneurs performing turnover of pharmaceutical substance of alcohol of ethyl (ethanol) is conducted using technical means.

7. Accounting of purchasing amount and use of pharmaceutical substance of alcohol of ethyl (ethanol) for production of alcohol-containing medicines and (or) alcohol-containing medical products by the organizations and the individual entrepreneurs performing production of alcohol-containing medicines and (or) alcohol-containing medical products and also for production of other medicines and (or) medical products (except as specified, stipulated in Item 8 these rules), is conducted using automatic means and technical means.

8. Accounting of purchasing amount and use of pharmaceutical substance of alcohol of ethyl (ethanol) by the pharmaceutical organizations, veterinary pharmaceutical organizations, the individual entrepreneurs having the license for pharmaceutical activities, the medical organizations conducting procurement of pharmaceutical substance of alcohol of ethyl (ethanol) for the purpose of its use as raw materials or auxiliary material in case of production of alcohol-containing medicines and (or) alcohol-containing medical products and also in the course of production of other medicines and (or) medical products:

a) in the amount exceeding 200 decalitres a year - it is conducted using automatic means and technical means;

b) in the amount equal or not exceeding 200 decalitres a year, - without application of automatic means and technical means.

9. Accounting of production volume, production and (or) turnover (except for retail sale and cases, stipulated in Item 10 these rules) alcohol-containing medicines and (or) alcohol-containing medical products the organizations and the individual entrepreneurs performing production and supply of alcohol-containing medicines and (or) alcohol-containing medical products in the amount exceeding 200 decalitres a year is conducted using technical means.

10. Accounting of production volume, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products in the amount exceeding 200 decalitres a year, the pharmaceutical organizations, the veterinary pharmaceutical organizations, the individual entrepreneurs having the license for pharmaceutical activities, the medical organizations conducting procurement of pharmaceutical substance of alcohol of ethyl (ethanol) in volume of no more than 200 decalitres a year for the purpose of its use as raw materials or auxiliary material in case of production and production of alcohol-containing medicines and (or) alcohol-containing medical products in the course of production of other medicines and (or) medical products and also accounting of volume of turnover (except for retail sale) the purchased alcohol-containing medicines and (or) alcohol-containing medical products are conducted by the organizations and individual entrepreneurs without use of technical means.

11. Automatic means shall meet the requirements to the automatic gages and accounting of concentration and amount of waterless alcohol in finished goods, amount of finished goods approved by the order of the Government of the Russian Federation of June 28, 2006 No. 396 "About requirements to automatic gages and accounting of concentration and amount of waterless alcohol in finished goods, amount of finished goods".

12. Technical means shall conform to the requirements established to the technical means of fixing and information transfer about production volume and turnover of ethyl alcohol, alcoholic and alcohol-containing products in Unified State Automated Information System of accounting of production volume and turnover of ethyl alcohol, alcoholic and alcohol-containing products approved by the order of the Government of the Russian Federation of July 9, 2016 No. 650 "About requirements to technical means of fixing and information transfer about production volume and turnover of ethyl alcohol, alcoholic and alcohol-containing products in Unified State Automated Information System of accounting of production volume and turnover of ethyl alcohol, alcoholic and alcohol-containing products".

13. For accounting of production volume, purchase, delivery and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol) for production of alcohol-containing medicines and (or) alcohol-containing medical products, and also in production process of other medicines and (or) medical products the following indicators are used:

a) amount of pharmaceutical substance of alcohol of ethyl (ethanol);

b) amount of waterless (100 percent) alcohol in pharmaceutical substance of alcohol ethyl (ethanol);

c) concentration of waterless alcohol in pharmaceutical substance of alcohol ethyl (ethanol).

14. Measure values, these rules specified in Item 13, in case of production, delivery and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol) for production of alcohol-containing medicines and (or) alcohol-containing medical products, and also in production process of other medicines and (or) medical products are determined using automatic means after the end of the last technology transaction connected with production of pharmaceutical substance of alcohol of ethyl (ethanol) before its transfer on storage or for use.

Measure values, these rules specified in Item 13, when purchasing pharmaceutical substance of alcohol of ethyl (ethanol) for production of alcohol-containing medicines and (or) alcohol-containing medical products, and also for its use in production process of other medicines and (or) medical products are determined using automatic funds before its transfer for storage or for use.

Measure values, these rules specified in Item 13, when purchasing pharmaceutical substance of alcohol of ethyl (ethanol) for production of alcohol-containing medicines and (or) alcohol-containing medical products, and also for its use in production process, production of other medicines and (or) medical products are determined based on indicators of automatic means of the supplier (consignor) of pharmaceutical substance of alcohol of ethyl (ethanol).

15. Measure values, these rules specified in Item 13, shall not deviate the measure values specified in source accounting documents, more than the amount calculated according to evaluation procedure of reliability of accounting of production volume, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol) for production of alcohol-containing medicines and (or) alcohol-containing medical products in production process of other medicines and (or) medical products and also production, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products, the established Ministry of Finance of the Russian Federation.

16. For accounting of production volume or turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products the following indicators are used:

a) amount of alcohol-containing medicines and (or) alcohol-containing medical products;

b) amount of waterless (100 percent) alcohol in alcohol-containing medicines and (or) alcohol-containing medical products;

c) concentration of waterless alcohol in alcohol-containing medicines and (or) alcohol-containing medical products.

17. Measure values, these rules specified in Item 16, are determined based on indicators of source accounting documents of the organizations and individual entrepreneurs performing production or turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products.

18. Measure values, these rules specified in Items 13 and 16, are fixed by the organizations and the individual entrepreneurs performing accounting of purchasing amount and use of pharmaceutical substance of alcohol of ethyl (ethanol) for production of alcohol-containing medicines and (or) alcohol-containing medical products in production process of other medicines and (or) medical products, and also accounting of production volume, production and (or) turnover of alcohol-containing medicines and (or) alcohol-containing medical products without use of technical means, in register of purchasing amount and use of pharmaceutical substance of alcohol of ethyl (ethanol), and also production volume, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products.

Data on variations of the measure values fixed in case of assessment of reliability of accounting of production volume, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol) for production of alcohol-containing medicines and (or) alcohol-containing medical products in production process of other medicines and (or) medical products, and also production volume, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products, are introduced in the magazine specified in paragraph one of this Item.

The form of the magazine specified in paragraph one of this Item, and procedure for its filling are established by the Ministry of Finance of the Russian Federation.

Approved by the Order of the Government of the Russian Federation of April 20, 2019 No. 472

Rules of submission of declarations on production volume, turnover and (or) use of pharmaceutical substance of alcohol of ethyl (ethanol), and also production, production and (or) turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products

1. These rules establish procedure for representation and form of declarations:

a) about production volume, turnover and (or) use for own needs of pharmaceutical substance of alcohol of ethyl (ethanol);

b) about the scope of supply of pharmaceutical substance of alcohol of ethyl (ethanol);

c) about purchasing amount of pharmaceutical substance of alcohol of ethyl (ethanol);

d) about volume of turnover of pharmaceutical substance of alcohol of ethyl (ethanol);

e) about production volume, production and turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products;

e) about purchasing amount of alcohol-containing medicines and (or) alcohol-containing medical products;

g) about the scope of supply of alcohol-containing medicines and (or) alcohol-containing medical products;

h) about volume of turnover of alcohol-containing medicines and (or) alcohol-containing medical products.

2. The declarations specified in Item 1 of these rules (further - declarations), represent:

a) the organizations performing production of pharmaceutical substance of alcohol of ethyl (ethanol);

b) the organizations and the individual entrepreneurs performing turnover of pharmaceutical substance of alcohol of ethyl (ethanol);

c) the organizations and the individual entrepreneurs performing production, production and (or) turnover of alcohol-containing medicines and (or) alcohol-containing medical products in the amount exceeding 200 decalitres a year.

3. The organizations performing production of pharmaceutical substance of alcohol of ethyl (ethanol) represent declarations on production volume, turnover and (or) use for own needs of pharmaceutical substance of alcohol of ethyl (ethanol) in form according to appendix No. 1.

4. The organizations performing production of pharmaceutical substance of alcohol of ethyl (ethanol), and the faces performing supply of pharmaceutical substance of alcohol of ethyl (ethanol) represent declarations on the scope of supply of pharmaceutical substance of alcohol of ethyl (ethanol) in form according to appendix No. 2.

5. Persons conducting procurement of pharmaceutical substance of alcohol of ethyl (ethanol) represent declarations on purchasing amount of pharmaceutical substance of alcohol of ethyl (ethanol) in form according to appendix No. 3.

6. Persons performing turnover of pharmaceutical substance of alcohol of ethyl (ethanol) represent declarations on volume of turnover of pharmaceutical substance of alcohol of ethyl (ethanol) in form according to appendix No. 4.

7. Persons performing production, production and turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products, represent declarations on production volume, production and turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products in form according to appendix No. 5.

8. Persons conducting procurement of alcohol-containing medicines and (or) alcohol-containing medical products represent declarations on purchasing amount of alcohol-containing medicines and (or) alcohol-containing medical products in form according to appendix No. 6.

9. Persons performing supply of alcohol-containing medicines and (or) alcohol-containing medical products represent declarations on the scope of supply of alcohol-containing medicines and (or) alcohol-containing medical products in form according to appendix No. 7.

10. Persons performing turnover (except for retail sale) alcohol-containing medicines and (or) alcohol-containing medical products, represent declarations on volume of turnover of alcohol-containing medicines and (or) alcohol-containing medical products in form according to appendix No. 8.

11. Declarations are represented quarterly, no later than the 20th following reporting quarter.

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