Last Monday, the Ministry of Health proposed extending the simplified procedure for making changes to the registration dossier for defective registered medications until December 31, 2024.
It became possible to make corrections to the registration file in a simplified form in March last year (Decree of the Government of the Russian Federation No. 440) after the introduction by foreign states of a number of economic restrictive measures against Russia.
The measures taken are aimed at preventing the shortage of medicines for medical purposes. In accordance with the document, the deficit or the risk of its occurrence is established by a specially organized interdepartmental commission, which includes representatives of various state executive authorities. The composition of the commission, as well as the criteria for defect and the risk of its occurrence, are approved by the Ministry of Health of the Russian Federation.
The established order allows you to make changes in an accelerated mode. So, depending on the corrections being introduced, the quality examination may not be carried out. At the same time, the time for consideration of the application has been reduced.
Also, until the end of December 2024, the regime for accelerated registration of drugs and the importation of drugs in foreign packaging has been extended.