Pharmaceutical manufacturers with a high degree of production localization will be supported in Russia

Dmitry Medvedev signed the Resolution No. 572 of May 12, 2018, aimed at supporting pharmaceutical manufacturers, all stages of whose production, including the synthesis of pharmaceutical substances, are carried out in Russia and other states of the Eurasian Economic Union. This Resolution established the granting of preferences in government procurement for such pharmaceutical manufacturers.

The Government Resolution No. 1289 of November 30, 2015 provides for restrictions on the admission in the implementation of the government procurement of foreign pharmaceutical products included in the list of necessary and essential pharmaceutical products. It is established that the state customer must reject all applications containing proposals for the supply of medicines originating from foreign countries (except the States of the Eurasian Economic Union – the EAEU), provided that at least two applications have been submitted for participation in the determination of the supplier, which contain proposals for the supply of medicines and Russia or another state of the EAEU is the country of origin of which It was established that the state customer must reject all applications containing proposals for the supply of drugs originating from foreign countries (except for the states of the Eurasian Economic Union - EAEU), provided that at least two applications are submitted for participation in the supplier definition about the supply of medicine drugs, the country of origin of which is Russia or another EEU state.

The Resolution No. 1289 was supplemented with new norms by the signed resolution. It has been established that if, after the indicated rejection of foreign drugs, among the considered applications there is at least one with a proposal for the supply of drugs, all stages of production of which, including the synthesis of the active substance molecule in the manufacture of pharmaceutical substances, are carried out in Russia or another state EEU, the preferential conditions for admission to government procurement will be applied to such drugs.

To confirm the compliance of a medicinal product and a pharmaceutical substance with the established requirements, the procurement participant in its application declares the manufacturer's compliance with the requirements of good manufacturing practices and provides a document issued by the Russian Ministry of Industry and Trade on the production of a medicinal product in Russia or another EEU state.

This Resolution applies only to the government procurement. Its effect does not extend to the area of commercial drug supplies.

The purpose of the made decisions is to support pharmaceutical manufacturers with a high degree of localization of production in Russia and other EAEU countries.