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The cost of drug registration in the Eurasian Economic Union (EAEU)

On March 7, 2017, the President of the Russian Federation signed amendments to the Tax Code of the Russian Federation, in accordance with which the amount of state duties for drug registration procedures under the rules of the Eurasian Economic Union (EAEU) is established.

In accordance with the amendments for the commission by the authorized federal executive body of actions related to 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 performed):

  • for conducting an expert appraisal of a drug for medical use with the state registration of the medicinal product - 325 000 rubles;
  • for the evaluation of the expert report on the assessment of the safety, efficacy and quality of the drug for medical use - 325,000 rubles;
  • for conducting examination of the drug with a well-studied medical application with the state registration of the drug - 45 000 rubles;
  • for the evaluation of the expert report on the assessment of the safety, efficacy and quality of the drug with well-studied medical use with the state registration of the drug - 45 000 rubles;
  • for the confirmation of the state registration of a drug for medical use - 145 000 rubles;
  • for making variations to the documents contained in the registration dossier of the drug registered for medical use, requiring expert examination of the drug - 75,000 rubles;
  • for making variation to the documents contained in the registration dossier of the drug registered for medical use, which do not require an expert apparisal of the drug, 5,000 rubles;
  • for bringing the registration dossier of the drug for medical use in accordance with the requirements of the Eurasian Economic Union - 75,000 rubles;
  • for issuing a registration certificate of a drug for medical use - 10 000 rubles;
  • for issuing a duplicate of the registration certificate of a drug for medical use - 2 000 rubles.

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