Decree No 744 of August 2, 2016, signed by Dmitry Medvedev, established criteria that assign medicinal drugs and medical devices to industrial products without Russian analogues.
According to the document, as of January 1, 2017 medicinal drugs, sera and vaccines will be considered to be manufactured in Russia if they were authorized according to the Russian legislation, with technological operations performed at the EEU territory, corresponding to a complex of stages of technological process of production of a finished pharmaceutical form, packaging and quality control at release. Pharmaceutical substances will be considered manufactured in Russia, if information about these is present in the State List of Drugs, and if certain technological operations are performed in the EEU for these drugs.
The explanatory note to the document informs, that until recently the requirements to industrial products specified in statement No 719 did not apply to the drugs and medical devices as to referral to the category of products manufactured in Russia.
Approval of criteria stated in Decree No 744 should help decrease the cost of foreign components used for production of medical devices as of January 1, 2019 by 10-40%.