The State Duma supported the increase in state fees for the registration of medicines and medical devices
The State Duma of the Russian Federation approved in the first reading amendments to the Tax Code (TC), suggesting an increase in state duties on procedures for registration and examination of drugs and medical devices, as well as setting state duties for the registration of biomedical cell products (BMCP) and issuance of permits for the use of unregistered medical devices for diagnostics in vitro.
The government of the Russian Federation submitted to the State Duma a bill providing for an increase in state duties at the end of September 2021.
As follows from the document, in the new edition of the Tax Code, the state duty for examination for conducting a clinical examination of a drug will be 135 thousand rubles, for a post-registration CT 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 the issuance of a registration certificate for a medical device will increase from 7 thousand to 11 thousand rubles, for the examination of the quality, efficiency and safety of class 1 – from 45 thousand to 72 thousand rubles, class 2a – from 65 thousand to 104 thousand rubles, class 2b – from 85 up to 136 thousand rubles, class 3 – from 115 to 184 thousand rubles. The fee for making changes to the dossier will grow from 1.5 thousand rubles to 2.5 thousand, and the rates for re-examination will rise 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 BMCP at registration will be 580 thousand rubles, for 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 was 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.