Russias Ministry of Health Announced Duty for Examination of Drugs Registration Application

23 September 2019

GMP News

The state duty for the examination of documents submitted to determine the possibility of state registration of a medicinal product for medical use with the establishment of post-registration measures was proposed to be established by the Russian Ministry of Health. The document is published on the regulation.gov.ru portal.

Previously, the agency developed a draft law “On Amendments to the Federal Law“ On the Circulation of Medicines ”regarding the implementation of state registration of medicines for medical use with the establishment of post-registration measures.”

For its implementation, it is necessary to amend paragraph 1 of Article 333.32.1 of the second part of the Tax Code of the Russian Federation, which provide for the establishment of a state fee paid to the authorized body for the examination of documents submitted to determine the possibility of state registration of a medicine for medical use with the establishment of post-registration measures.

The state duty is proposed to be set at 25 thousand rubles. It is established on the basis of the current size of state duties paid for similar types of work during state registration of medicines in accordance with the federal law “On the circulation of medicines”.

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