On September 30, the Government of the Russian Federation sent a bill “On amendments to Part Two of the Tax Code of the Russian Federation” to the State Duma. The Russian authorities intend to increase the amount of state duty paid when registering medicines, medical products and biomedical cellular products.
“The draft law provides for an increase in the amount of the state fee paid when the federal authorized authority performs operations related to the registration of medicines and medical devices due to the fact that the costs of these legally significant actions have increased,” the explanatory note to the document stated.
It is proposed to increase state duties as follows:
– for confirmation of state registration of a medicinal product, from 145,000 to 172,000 rubles;
– for conducting an ethical examination, examination of documents of a medicinal product for obtaining permission to conduct a clinical trial: from 110,000 to 135,000 rubles;
– for the examination of documents submitted to determine the possibility of considering a medicinal product during state registration as orphan: from 25,000 to 420,000;
– for conducting an ethical examination, examination of documents of a medicinal product for obtaining permission to conduct a post-registration clinical trial: from 60,000 to 135,000 rubles;