The Decree of the Government of the Russian Federation No. 337 dated 22 April 2016 amended the Decree of the Government No. 102, dated 5 February 2015 by clarifying the procedure for applying the restrictions on admission of certain types of medical devices originating from foreign states to participation in procurements for state and municipal needs (hereinafter – procurements).
Under the amended Decree No. 102, in the course of procurement of certain medical devices manufactured outside Russia, the customer shall reject all applications (final bids) with offers to supply medical devices manufactured in foreign states (other than the member-states of the Eurasian Economic Union (EAEU)), provided that at least two applications have been submitted meeting the requirements of the procurement notice and (or) tender documentation (final bids), which simultaneously:
- contain offers to supply one or several types of medical devices included in the List and manufactured in any of the EAEU member-states;
- do not contain offers to supply the same medical device from the same manufacturer or manufacturers of the same group of persons, as defined in Article 9 of the Federal Law 'On Protection of Competition'.
The amendments also provide that:
- if an application (final bid) containing an offer to supply certain medical devices included in the list and manufactured in foreign states (save for the EAEU member-states) (the List) is not be rejected the access conditions shall apply for the purposes of procurement of goods manufactured in a foreign state or a group of foreign states, established by the Ministry of economic development of the Russian Federation;
- medical devices included into the List and medical devices not included therein may not be a subject of the came contract (same lot);
- if at the conclusion of a contract the applications containing offers to supply certain medical devices included in the list (save for the EAEU member-states) were rejected in accordance with the restrictions, in the course of the contract performance the replacement of a medical device with a medical device originating not from the EAEU member-state as well as the replacement of the medical device manufacturer shall be not allowed.
The list of certain medical devices originating from foreign states, which are subject to the access restrictions for procurement purposes, remained unchanged, however, was supplemented with the codes in accordance with the All-Russian Classification of Products by Economic Activities (OKPD2) OK 034-2014.
The restrictions on access to participate in procurement of foreign medical devices (save for those originating from the EAEU member-states) were introduced by the Government of the Russian Federation within the powers in accordance with the Federal Law 'On the Contractual System for Procurement of Goods, Works and Services for State and Municipal Needs' for the purposes of protection of the internal Russian market and support of Russian manufacturers.
The amendments introduced by the Decree No. 337 became effective on 4 May 2016.
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