FEDERAL LAW OF THE RUSSIAN FEDERATION

of December 29, 2014 No. 480-FZ

About modification of Article 333.32.1 of part two of the Tax Code of the Russian Federation

Accepted by the State Duma on December 23, 2014

Approved by the Federation Council on December 25, 2014

Article 1

Bring in Article 333.32.1 of part two of the Tax Code of the Russian Federation (The Russian Federation Code, 2000, No. 32, Art. 3340; 2004, No. 45, Art. 4377; 2010, No. 15, Art. 1737; 2014, No. 30, Art. 4222; to No. 43, the Art. 5796) change, having stated it in the following edition:

"Article 333.32.1. The amount of the state tax for making of actions by authorized federal executive body when implementing state registration of medicines

For making by authorized federal executive body of the actions connected with implementation of state registration of medicines according to the Federal Law "About Drug Circulation", the state fee is paid in the following sizes (depending on types of the performed actions):

1) for conducting ethical examination, examination of documents of medicine for receipt of permission to performing clinical trial of medicine for medical application - 110 000 rubles;

2) for conducting examination of the documents submitted for determination of opportunity to consider medicine for medical application in case of state registration as orphan medicine - 25 000 rubles;

3) for conducting examination of documents of medicine for receipt of permission to performing the international multicenter clinical trial of medicine for medical application - 210 000 rubles;

4) for conducting ethical examination, examination of documents of medicine for receipt of permission to performing post-registration clinical trial of medicine for medical application - 60 000 rubles;

5) for conducting examination of quality of medicine and examination of the attitude of the expected advantage towards possible risk of use of medicine for medical application in case of its state registration - 325 000 rubles;

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