State Duties

  • 1. Documentation expertize for receiving a permit to perform clinical studies of a human medicinal product and Ethics Committee expert examination, while applying for the State Registration of a human medicinal product - 75000 rubles.
  • 2. Quality control expertize of a human medicinal product and risk-benefit ratio examination of a human medicinal product administration, while applying for the State Registration of a human medicinal product - 225000 rubles.
  • 3. Quality control expertize of a human medicinal product and risk-benefit ratio examination of a human medicinal product administration, while applying for the State Registration of a human medicinal product permitted for medical use in the territory of Russian Federation for more than 20 years - 30000 rubles.
  • 4. Quality control expertize of a human medicinal product and risk-benefit ratio examination of a human medicinal product administration, while applying for the State Registration of a human medicinal product in case the International multi-institutional clinical studies of this human medicinal product have been performed and a part of them was performed in the territory of Russian Federation - 225000 rubles.
  • 5. Quality control expertize of a veterinary medicinal product and risk-benefit ratio examination of a veterinary medicinal product administration, while applying for the State Registration of a veterinary medicinal product - 150000 rubles.
  • 6. Confirmation of the State Registration of a human medicinal product -100000 rubles.
  • 7. Confirmation   of   the   State   Registration   of   a   veterinary   medicinal   product - 50000 rubles.
  • 8. Making  amendments   to  the Information  Leaflet  for a human  medicinal  product - 50000 rubles.
  • 9. Making amendments  to   the   Package Leaflet for   a   veterinary medicinal   product - 50000 rubles.
  • 10. Making amendments to the composition of a human medicinal product - 100000 rubles.
  • 11. Including a pharmaceutical substance (API), which is not used in the manufacture of medicinal products to State Register of Medicinal Remedies of RF - 100000 rubles.
  • 12. Issuing a permit for performing International multi-institutional clinical studies of a human medicinal product - 200000 rubles.
  • 13. Issuing a permit for performing post approval clinical studies of a human medicinal product - 50000 rubles.

  * The size of State Duties is set by the corresponding authorized federal body of the executive branch - Ministry of Health and Social Development of the Russian Federation (Minzdravsocrazvitiya Rossii), which is responsible for the State Registration of medicinal products in RF, subject to Federal Act of RF № 61-FA "Of Drug Circulation" d/d April 12, 2010