The government extended the simplified procedure for registration and importation of medicines in the Russian Federation until 2025

The government has extended simplified procedures for registering and importing medicines until the end of 2024, Prime Minister Mikhail Mishustin said. According to him, many logistics chains were disrupted due to “external restrictions.” In this regard, it was decided to simplify the procedures so that drug manufacturers could bring them to the domestic market faster.

“First of all, we are talking about the registration of analogues of products already presented in Russia, as well as obtaining permits for the import of original drugs, the inscriptions on which are made in foreign languages, of course, if the labels with translation into Russian are on the packages when they are sold,”— said Mr. Mishustin at the meeting (quote from TASS).

As a result, the period for state registration and examination of the quality of medicines was reduced by 30 days. Medicines that can be registered in a simplified manner are determined by a special interdepartmental commission. It includes representatives of the Ministry of Health, Roszdravnadzor, the Ministry of Industry and Trade, the Ministry of Finance, the Federal Antimonopoly Service, and the Federal Customs Service. According to its decision, newly registered foreign drugs can also be sold in foreign packaging with a label in Russian, clarified in the government.

A simplified drug registration procedure was introduced in April 2022. As part of the amendments adopted against the backdrop of a serious shortage of medicines, foreign manufacturers and distributors were allowed to import drugs in Russia in foreign packaging. Experts said that this, in fact, legalizes the parallel import of medicines, including generics.

Laura Keffer


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