The Ministry of Industry and Trade has amended the draft document on the “second one out” rule

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The Ministry of Industry and Trade of Russia has updated the draft government decree on the introduction of the “second one out” rule in public drugs procurement, PhV reports.

The updated rule, which will be in force from September 2024, will apply to the entire list of strategically important medicines, as Deputy Head of the Ministry of Industry and Trade Vasily Osmakov announced. If the list of strategically important medicines is updated, then the rule will come into force for newly included drugs two years after the amendment.

The publication reports that the project is currently undergoing a conciliation procedure.

The “second one out” mechanism gives an absolute advantage in public bidding procedure to manufacturers that effect full-cycle production of their drugs in the Russian Federation, including the substance synthesis stage. The customer has to reject all other applications if at least one application with such a domestically produced drug is submitted during public procurement.