Russian Prime Minister Dmitry Medvedev signed the Decree No. 572 of May 12, 2018, aimed at supporting the manufacturers of medicinal products that perform all stages of production, including the synthesis of pharmaceutical substances, on the territory of Russia and other member states of the Eurasian Economic Union (EAEU). Such medicines will be given preferences in public procurement.
The Decree of the Government of the Russian Federation No. 1289 of November 30, 2015, restricts access of foreign medicinal products to public procurement of medicines included in the list of vital and essential drugs. The Decree stipulates that the state customer must reject all bids for supply of medicinal products originating from foreign countries (except for the EAEU member states), if there are at least two bids for supply of medicinal products originating from Russia or other EAEU member state submitted for participation in supplier selection procedure.
The new document introduces several amendments to the Decree No. 1289. It establishes that if, after such rejection of foreign medicinal products, there remains at least one bid for supply of medicinal products, for which all stages of production, including the synthesis of active substance molecules in the manufacturing of pharmaceutical substances, are performed on the territory of Russia or other EAEU member states, such medicinal products will be subject to preferential terms of access to public procurement.
To confirm the compliance of medicinal product and pharmaceutical substance to established requirements, the bidder should state in its bid the compliance of manufacturer with the requirements of good manufacturing practices and submit a document issued by the Ministry of Industry and Trade of Russia regarding manufacturing of medicinal product on the territory of Russia or other EAEU member state.