Mironov invited Mishustin to postpone the increase in fees for drug registration to 2024
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Sergei Mironov, chairman of the Just Russia – For Truth party, sent an official letter to Prime Minister Mikhail Mishustin. In it, the politician asked to postpone the increase in the registration fee for medicines and changes in the registration dossier to January 1, 2024, follows from the published statement. on the official site parties. According to Mr. Mironov, the postponement is needed in order to reduce the costs of pharmaceutical companies against the backdrop of import substitution.
“The duties have been increased for items included in the defective lists of drugs (not available in pharmacies.— “b”) planned for import substitution by the domestic pharmaceutical industry. Due to supply restrictions and the forced replacement of components, consumables and auxiliary materials for the production of drugs, market participants need to make changes to the registration dossier for the drug every time any data on the drug is changed,” Sergey Mironov concluded.
According to Mr. Mironov, these measures are forcing manufacturers of domestic medicines to spend additional amounts of money to comply with these rules.
In November 2021, Russian President Vladimir Putin signed a law to increase state duties for the registration of medicines and medical devices. So, according to him, the fee for the examination of documents for medicines against oral diseases increased almost 17 times – from 25 thousand to 420 thousand rubles. The fee for the examination required to conduct a clinical trial of a medicinal product has increased from 110,000 to 135,000 rubles.
Earlier it was reported that the government has simplified the registration of certain drugs in Russia to avoid shortages and supply disruptions, reducing the registration period to 30 days. This provision is valid until the end of 2023. Interruptions in the supply of medicines arose due to logistical difficulties.
More details – in the publication “Kommersant” “Medicines will not keep you waiting”.
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