Article 2

BIO S COSMETICS LIMITED

www.bio-s-cosmetics.pro

№ 1355640

FEDERAL LAW

No. 532-FZ of 31 December 2014 https://www.rg.ru/2015/01/12/medicamenty-dok.html

“On the application of changes into certain laws of the Russian Federation concerning counteraction against selling falsified, counterfeit, poor-quality and unregistered medicines, medical devices and falsified biologically active additives ”

Adopted by the State Duma on 19 December 2014

Approved by the Council of the Federation on 25 December 2014

Article 1.

Introduce the following changes into the Criminal Code of the Russian Federation (Compendium of Legislation of the Russian Federation, 1996, N 25, article 2954; 1998, N 26, article 3012; 1999, N 12, article 1407; N 28, article 3490, 3491; 2001, N 11, article 1002; N 47, article 4405; 2003, N 27, article 2712; N 50, article 4848; 2004, N 30, article 3091; 2005, N 1, article 13; 2006, N 2, article 176; N 31, article 3452; 2007, N 21, article 2456; N 31, article 4008; N 45, article 5429; 2008, N 15, article 1444; N 52, article 6235; 2009, N 31, article 3921; N 52, article 6453; 2010, N 19, article 2289; N 21, article 2525; N 49, article 6412; 2011, N 11, article 1495; N 19, article 2714; N 30, article 4598; N 50, article 7362; 2012, N 10, article 1162, 1166; N 24, article 3071; N 30, article 4172; N 47, article 6401; N 53, article 7633, 7637; 2013, N 26, article 3207; N 27, article 3442, 3477; N 30, article 4078; N 44, article 5641; N 48, article 6165; N 51, article 6685, 6696; N 52, article 6945, 6946; 2014, N 19, article 2310; N 23, article 2927; N 26, article 3385; N 30, article 4278):

1) in paragraph “a” of part one of article 104¹ " numbers " 235¹, 238¹ shall be supplemented after numbers " 234,, ", numbers " 327²" shall be supplemented after numbers " 307-309, ";

2) article 235¹ shall be supplemented by the following content:

“Article 235¹. Illegal production of medicine and medical goods

1. The production of medicine or medical goods without a special permission (license) if this permission (license) is obligatory

-provides a penalty of imprisonment for a period of three to five years with a fine of five thousand to two million rubles or in the amount of the salary or another income of the convict for a period of six months to two years or without it.

2. The same actions committed by:

а) an organized group of people;

б) of a large amount,

- provide a penalty of imprisonment for a period of three to eight years with a fine of one million to three million rubles or in the amount of the salary or another income of the convict for a period one year to three years or without it.

Note. A large amount in this article is regarded the cost of medicine or medical goods exceeding one hundred thousand rubles.

3) article 238¹ shall be supplemented by the following content:

" Article 238¹. Circulation of falsified, low-quality, unregistered medicine and medical goods and realization of falsified biologically active additives.

The production, realization or import to the territory of the Russian Federation of falsified medicines, realization and import to the territory of the Russian Federation of poor-quality medicines, illegal production, realization or import to the territory of the Russian Federation for realization unregistered medicines, production, realization or import to the territory of the Russian Federation falsified biologically active additives containing pharmaceutical substances that were not declared in the process of state registration, conducted on a large scale;

- provides a penalty of compulsory labor for a period from three to five years with the revocation of the right to take up certain posts or to indulge in certain kinds of activities for a period from three years or without it, or of imprisonment for the period from three to five years with a fine in the amount from five hundred to two million rubles or in the amount of the salary or another income of the convict for a period from six months to two years or without it with the revocation of the right to take up certain posts or to indulge in certain kinds of activities for a period from three years or without it.

1. The same actions if they are:

а) committed by a group an organized group of people;

b) resulted in infliction of grievous bodily harm or individual’s death

provide a penalty of imprisonment for a period of five to eight years with a fine of one million to three million rubles or in the amount of the salary or another income of the convict for a period from one year to three years or without it with the revocation of the right to take up certain posts or to indulge in certain kinds of activities for a period from five years or without it.

1. The actions described in part one and part two of the following article, resulting in the death of two or more individuals,

-provide a penalty of imprisonment for a period of from eight to twelve years with a fine from two million to five million rubles or in the amount of the salary or another income of the convict for a period from two years to five years or without it with the revocation of the right to take up certain posts or to indulge in certain kinds of activities for a period from ten years or without it.

Note 1. This article does not apply to the cases of illegal sale and import to the territory of the Russian Federation of drugs, psychotropic substances or their precursors, drastic or poisonous substances, as well as the illegal production of drugs, psychotropic substances or their precursors.

Note 2. A large scale in this article is considered to be the cost of medicines or biologically active additives on a sum exceeding one hundred rubles. ";

4) article 327² shall be supplemented by the following content:

" Article 327². Falsification of documents for medicines or the package of medicines

1. Production of deliberately falsified documents for medicines for the purpose of sale or usage (registration certificate, the certificate or declaration of compliance, instructions on the usage of the medicine or the normative, technical and operational documentation on the producer of a medical device),

-provides a penalty of a fine from five hundred thousand to one million rubles or in the amount of the salary or another income of the convict for a period from one year to two years or compulsory labor for a period up to three years, or imprisonment for the same period of time.

1. Production or usage of deliberately falsified primary package and/or secondary (consumer) package of a medicine for the purpose of sale or application.

-provides a penalty of a fine from five hundred thousand to one million rubles or in the amount of the salary or another income of the convict for a period from one year to two years or compulsory labor for a period up to three years, or imprisonment for the same period of time.

3. Commitment of the actions described in part one and part two of this article, organized by a group of people

-provides a penalty of imprisonment for a period of from five to ten years with the revocation of the right to take up certain posts or to indulge in certain kinds of activities for a period up to three years.”.

Article 2

Introduce the following changes to the Federal law of January 2, 2000 N 29-ФЗ “On the quality and safety of food products” (Compendium of Legislation of the Russian Federation, 2000, N 2, article 150; 2003, N 27, article 2700; 2004, N 35, article 3607; 2006, N 14, article 1458; 2007, N 1, article 29; 2011, N 1, article 6; N 30, article 4590, 4596):

1) change the content of paragraph sixteen of article 1 as following:

“falsified food products (including biologically active additives), materials and goods – food products (including biologically active additives), materials and goods, that were deliberately changed (falsified) and (or) have hidden effects and qualities, the information about which was initially not full and misleading; ”;

2) part 2 of article 13 shall be supplemented by a paragraph with the following content:

“While organizing and applying the activities for state control in the field of ensuring the quality and safety of food products, materials and goods it is not obligatory to preliminarily inform a legal person or an individual entrepreneur that produce food products, and (or) sell food products, and (or) provide services of catering about the start of an unplanned field check.”.