State duties for registration of medicines and medical devices will increase from January 2022

Russian President Vladimir Putin signed a law on increasing state duties on the registration of drugs and medical devices. In addition, the same regulatory legal act extended value added tax (VAT) benefits for medical products with Russian registration certificates for the period from January 1, 2022.
In the new version of the Tax Code of the Russian Federation, the state duty for an examination for conducting a clinical examination of a medicinal product will be 135 thousand rubles, for a post-registration examination it will grow from 60 thousand to 135 thousand rubles. Prices for the inclusion of a drug in the State Register of Medicines will increase from 145 thousand rubles in the current edition to 253 thousand rubles.

The state duty for issuing a registration certificate for a medical device will increase from 7 to 11 thousand rubles, for an examination of the quality, efficiency and safety of class 1 – from 45 to 72 thousand rubles, class 2a – from 65 to 104 thousand rubles, class 2b – from 85 to 136 thousand rubles, class 3 – from 115 to 184 thousand rubles. The fee for making changes to the dossier will increase from 1.5 to 2.5 thousand rubles, the rates for re-examination – from 20-50 thousand rubles, depending on the risk class, to 32-104 thousand rubles.

The size of the state duty for granting permission to use unregistered medical devices for in vitro diagnostics will amount to 9.5 thousand rubles, for an examination of the quality, safety and effectiveness of such medical devices – 65.8 thousand rubles, a repeated examination will cost 54.5 thousand rubles.

The fee for the examination of the quality of biomedical cell products (BMCP) upon registration will be 580 thousand rubles, the examination of the effectiveness and the ratio of the expected benefit to the possible risk of using BMCP – 220 thousand rubles, and in the case of international multicenter clinical trials with respect to the registered product – 415 thousand rubles …

The increase in state fees is caused by „an increase in the cost of carrying out these legally significant actions.“ According to the conclusion of the Government of the Russian Federation, adjusting the size of the state duty for the registration of medicines and medical devices will allow in 2022-2024 to allocate an additional 3 billion rubles to the budget annually.

In addition, the same law extended the effect of VAT exemptions on medical devices registered under Russian rules for the period after December 31, 2021. Amendments to Art. 149 and Art. 164 of the Tax Code of the Russian Federation were introduced in the second reading in the State Duma, and then approved along with the bill in the third reading and in the Federation Council.

In the previous version of the Tax Code, the possibility of obtaining a zero rate and benefits extended to medical devices that had the EAEU registration certificate, or products validated according to Russian rules, but until December 31, 2021. In the new edition, the phrase “until December 31, 2021” is excluded, the validity of the rule in relation to Russian registration certificates is not limited in time.