The cost of registration of drugs in Russia

The cost of registration of drugs is determined for the applicant by Article 333.32.1. Tax code of the Russian Federation.

The Tax Code of the Russian Federation. Part 2. Section VIII. Chapter 25.3. (In the amended version of Federal Law No. 480-FZ of December 29, 2014)

Article 333.32.1. The amount of the state fee for the commission of actions by the authorized federal executive body when implementing state registration of drugs.

For the commission by the authorized federal executive body of actions related to the implementation of the state registration of drugs in accordance with the Federal Law "On the circulation of medicinal products", the state fee is paid in the following amounts (depending on the types of actions carried out):

1. for carrying out ethical expert appraisal, examination of medicinal product documents for obtaining permission to conduct clinical research of drug for medical use- 110 000 rubles;
2. for conducting an expert appraisal of the documents submitted for determining the possibility of considering a medicine during state registration as an orphaned drug - 25,000 rubles;
3. for conducting expertise of drug documents for obtaining permission to conduct an international multicenter clinical study of a medicine for medical use- 210,000 rubles;
4. for carrying out ethical expertise examination, examination of medicinal product documents for obtaining permission to conduct a post-patient clinical study of a drug for medical use - 60,000 rubles;
5. for conducting the expertise examination of the quality of the drug and examining the relationship of the expected benefit to the possible risk of using the medicine when it is registered with the state - 325,000 rubles;
6. for conducting expert appraisal of the quality of the drug and examining the relationship of the expected benefit to the possible risk of the use of a medicinal product permitted for medical use in the Russian Federation for more than twenty years, with the state registration of the medicinal product - 45,000 rubles;
7. for carrying out the expert examination of the quality of the drug and examining the relationship of the expected benefit to the possible risk of the use of the medicinal product for medical use in respect of which international multicenter clinical studies have been conducted, some of which have been carried out in the Russian Federation, with the state registration of the drug - 325,000 rubles;
8. for carrying out the expertise of the quality of the drug and examining the relationship of the expected benefit to the possible risk of using the medicinal product for veterinary use in the event of its state registration - 215,000 rubles;
9. for issuing permission to conduct a clinical trial of a drug for medical use - 5,000 rubles;
10. for issuing permission for an international multicenter clinical study of a medicinal product for medical use - 5,000 rubles;
11. for issuing a permit to conduct a post-patient clinical study of a medicine for medical use- 5,000 rubles;
12. for issuing a registration certificate of a drug - 10 000 rubles;
13. for the confirmation of the state registration of a drug for medical use - 145,000 rubles;
14. for the confirmation of the state registration of a drug for veterinary use - 70 000 rubles;
15. for making changes to the documents contained in the registration dossier for a registered medicine for medical use, requiring examination of a drug in terms of expertise examination of the quality of the medicinal product and (or) expert appraisal of the ratio of the expected benefit to the possible risk of using the drug - 75 000 rubles;
16. for making changes in the documents contained in the registration dossier for a registered drug for medical use, which do not require the expert examination of a medicine -  5,000 rubles;
17. for the inclusion in the state register of medicinal products of an active pharmaceutical ingredient produced for sale - 145,000 rubles;
18. for making changes in the documents for a pharmaceutical substance produced for sale and included in the state register of drugs requiring expert examination of medicinal products - 75,000 rubles;
19. for making changes in documents for an active pharmaceutical ingredient produced for sale and included in the state register of drugs that do not require expert examination of medicines - 5,000 rubles;
20. for making changes in the documents contained in the registration dossier for a registered drug for veterinary use requiring expert examination of a medicine - 70,000 rubles;
21. for making changes in the documents contained in the registration dossier for the registered drug for veterinary use, which do not require expert appraisal of a drug - 2 600 rubles;
22. for issuing a duplicate registration certificate of a drug - 2 000 rubles.