Draft

Federal Law
On Amendments and Modifications to the Federal Law "On Medicines," the RF Criminal Code and the RSFSR Code On Administrative Law Violations

Article 1. Introduce into the Federal Law "On Medicines" (RF Collective Legislative Acts, 1998, No. 26, Article 3006, 2000, No. 2, Article 126) the following amendments:

Chapter I:
Add the following paragraph to Article 4:
"Counterfeit medicines are pharmaceutical products which are accompanied by false information about the ingredients and/or manufacturer."

Chapter IV:
Add the following paragraph to Article 13:
"4. The production of counterfeit medicines shall be prohibited."
Renumber paragraph 4 as paragraph 5.

Add the following paragraph to Article 17:
"4. The manufacture of counterfeit medicines shall be prohibited."
Renumber paragraph 4 as paragraph 5.

Chapter VI:
Compose Paragraph 9, Article 20 as follows:
"It shall be prohibited to import to the territory of the Russian Federation counterfeit medicines. Upon discovery of such medicines, the customs authorities of the Russian Federation shall confiscate them and subsequently destroy them in accordance with the procedure to be determined by the federal executive agency in the heath care area."

Chapter VII:

Compose Paragraph 1, Article 31 as follows:
"1. The sale of defective medicines, counterfeit medicines and medicines with expired dates of consumption is prohibited."

Compose Paragraph 2, Article 31 as follows:
"2. Defective medicines, counterfeit medicines and medicines with expired dates of consumption are subject to destruction."

"3. The procedure for destruction of defective medicines, counterfeit medicines and medicines with expired dates of consumption is to be developed in accordance with safety precautions pertaining to people, animals, and the environment, and is enacted by the federal executive agency in the heath care area."

Chapter XI:

Add the following paragraph to Article 44:
"4. The advertising of counterfeit medicines shall be prohibited."
Renumber paragraphs 2-9 as paragraphs 3-10 respectively.

Compose Chapter XIII as follows:

"Chapter XIII. Responsibility for Production and Circulation of Counterfeit Medicines
Article 46. Persons engaged in the production, manufacture, packaging, labeling, storage, transportation, purchase with the purpose of distribution, or distribution of counterfeit medicines bear responsibility as prescribed by the laws of the Russian Federation."

Renumber Chapter XIII as Chapter XIV, and Article 46 and 47 as 47 and 48 respectively.

Article 2. Add the following Article 238.1 to the RF Criminal Code (the Collected Legislative Acts of the Russian Federation, 1996, No. 25, Article 2954; 1998, No. 22, Article 2332; No. 26, Article 3012; 1999, No. 7, Article 873; 2001 No. 26, Article 2587):

"Article 238.1. Production, manufacture, packaging, labeling, storage, transportation, purchase with the purpose of distribution, or distribution of counterfeit medicines.

1. The production, manufacture, packaging, labeling, storage, transportation, purchase with the purpose of distribution, or distribution of counterfeit medicines conducted on a large scale are subject to a penalty which ranges from 500 to 1,000 minimum salaries or other income of the person convicted for a period of five months to one year, or imprisonment for up to three years.
   
2. The same acts if they are committed:
   a) by a group with a prior collusion or an organized group;
   b) repeatedly;
   c) by a person using his official status;
   d) on an extremely large scale,
   carry a penalty of imprisonment for a term of five to ten years, with or without confiscation of property.

Notes.

In terms of this Article 'large scale' is defined as counterfeit medicines with a value which exceeds 200 minimum salaries as determined by the laws of the Russian Federation at the time of the crime is committed; "extremely large scale" is defined as value in excess of 500 minimum salaries."

Article 3. Introduce the following amendments and modifications to the RSFSR Code On Administrative Law Violations (Rossiyskaya Gazeta, 2001, December 31):

"Article 14.26. Production, manufacture, packaging, labeling, storage, transportation, purchase with the intent to distribute, or distribution of counterfeit medicines

The production, manufacture, packaging, labeling, storage, transportation, purchase with the intent to distribute, or distribution of counterfeit medicines with a value of not more than 200 minimum salaries as determined by the Russian Federation legislature at the moment of infringement carries a fine, which ranges from 100 to 200 minimum salaries, with the confiscation of the discovered counterfeit medicines.

Article 4. This Federal Law will be effective from the date of its official publication."

President of the Russian Federation

V.V. Putin

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