The Tax Code of the Russian Federation and to Certain Legislative Acts of the Russian Federation, 41-FZ, 5 April 2010

Article 33332.1. The rates of the state fee for the execution of actions by an authorized federal executive body in the performance of state registration of medicinal products

For the execution of actions by an authorized federal executive body in the performance of state registration of medicinal products in accordance with the Federal Law on Circulation of Medicines, the state fee shall be paid at the following rates (depending on the type of actions executed):

1) for conducting a review of documents to procure permissions to conduct clinical trials of a medicinal product for medical use, and review by ethics committees upon application for state registration of a medicinal product: 75,000 roubles;

2) for conducting an expertise of quality of a medicine and an assessment of the ratio between anticipated benefits and possible risk of use of the medicinal product for medical use as part of state registration thereof: 225,000 roubles;

3) for conducting an expertise of quality of a medicine and an assessment of the ratio between anticipated benefits and possible risk of use of the medicinal product for medical use in the territory of the Russian Federation and marketed for more than twenty years, as part of state registration of the medicinal product: 30,000 roubles;

4) for conducting an expertise of quality of a medicine and an assessment of the ratio between anticipated benefits and possible risk of use of the medicinal product for medical use as has passed international multi-centre clinical trials, with some of them completed in the territory of the Russian Federation, as part of state registration of the medicinal product: 225,000 roubles;

5) for conducting an expertise of quality of a medicine and an assessment of the ratio between anticipated benefits and possible risk of use of the medicinal product for veterinary use as part of state registration thereof: 150,000 roubles;

6) for confirming state registration of a medicinal product for medical use: 100,000 roubles;

7) for confirming state registration of a medicinal product for veterinary use: 50,000 roubles;

8) for introducing changes into the Package Leaflet for a medicinal product for medical use: 50,000 roubles;

9) for introducing changes into the Package Leaflet for a medicinal product for veterinary use: 50,000 roubles;

10) for introducing changes into the composition of a medicinal product for medical use: 100,000 roubles;

11) for inclusion of a pharmaceutical excipient not used in the manufacture of medicinal products into the state register of medicines: 100,000 roubles;

12) for issuing a permission for conducting an international multi-centre clinical trial of a medicinal product for medical use: 200,000 roubles;

13) for issuing a permission for conducting a post-registration clinical trial of a medicinal product for medical use: 50,000 roubles.