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The Ministry of Industry and Trade proposed to postpone the introduction of the "second extra" rules to January 2026

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In Russia, the issue of postponing the entry into force of the "second superfluous" mechanism from September 1, 2025 to January 1, 2026 is being considered. This was reported to Izvestia on August 6 by the press service of the Ministry of Industry and Trade.

It is specified that from September 1, 2025, if the competition for the state purchase of medicines receives applications from manufacturers who produce the drug in Russia on a full cycle, then all foreign analogues will be automatically rejected.

"This mechanism is a continuation of the vector aimed at the localization of medicines, previously laid down by the "third superfluous" mechanism (it has been in operation since 2015 as part of the Decree of the Government of the Russian Federation dated 11/30/2015 No. 1289). In particular, thanks to the "third extra", there was a steady growth in the share of locally produced medicines among the auction participants, as well as a decrease in the cost of medicines," the ministry said.

The ministry stressed that within the list of vital and essential medicines (VED) there are strategically important products that should be produced in Russia. This is necessary to ensure independence from international supply chains, especially during crises such as COVID-19. The main goal is to prioritize medicines for the domestic industry, ensuring a full production cycle.

However, now the agency, together with the Russian Ministry of Finance, is working on the issue of postponing the entry into force of such a provision to January 1, 2026.

"The postponement of the deadline is due to the need for a "seamless" transition to the "second superfluous to SZLS" mechanism (strategically important medicines. — Ed.)": so that all interested manufacturers have time to register in the traceability system and enter all the necessary data into it, as well as in view of the adoption of the law, which introduced the term "strategically important medicines" into the current legislation and which is supposed to update the list of SZLS," they said.

In addition, together with the Ministry of Health, the Ministry of Finance, and the Federal Antimonopoly Service, measures are being considered to introduce into legislation measures that include combinations of existing supports, including the "second extra" mechanism and price preferences for medicines from the list of medicines manufactured in the Eurasian Economic Union (EAEU).

On April 28, Russian Prime Minister Mikhail Mishustin announced that the share of domestic vital medicines should grow to 90%. He stressed that in order to provide high-quality medical care, it is necessary to have effective medicines manufactured in Russia.

All important news is on the Izvestia channel in the MAX messenger.

Переведено сервисом «Яндекс Переводчик»

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