On December 2, 2015 the Russian Government published its
Resolution No. 1289 on Restrictions and Conditions for Admission of
Medicines on the List of Vital and Essential Medicines Originating
in Foreign States for the Purposes of Procurement for State and
Municipal Needs of November 30, 2015 (hereinafter "Resolution
1289"). The restrictions on state procurement of
foreign-manufactured vital and essential medicines (hereinafter
"Essential Medicines") are similar to the restrictions on
procurement of foreign medical devices that were established in
According to Resolution 1289, during procurement the state
customer shall reject all offers to supply Essential Medicines
originating in foreign states (except for member states of the
Eurasian Economic Union (hereinafter "EAEU member
states"), if at least two bids meeting the requirements of the
notice and/or procurement documentation are submitted and, at the
contain offers to supply Essential Medicines originating from a
EAEU member state;
do not contain offers to supply Essential Medicines from the
same manufacturer or manufacturers in the same group.
For these purposes, a medicine's country of origin is
determined according to the procedure set forth in the Agreement on
the Rules for Determining the Country of Origin of Goods in the CIS
of November 20, 2009 and in accordance with the criteria for
determining the country of origin established by those
When entering into and performing a contract for the supply of
Essential Medicines in observance of the restrictions contemplated
by Resolution 1289, it is not permitted to substitute a drug from a
specific manufacturer or its country of origin indicated in the
The restrictions established by Resolution 1289 do not
until December 31, 2016 in procurement of Essential Medicines
originating from foreign states (except for EAEU member states) for
which only primary and secondary packaging, or secondary packaging
of medicines is done on the territories of EAEU member states
with release quality control;
if the customer has published a notice of Essential Medicines
procurement or sent out invitations to participate in closed
identification of a supplier before Resolution 1289 comes into
in procurement of medicines by customers operating in a foreign
state, in order to support their activities in that territory.
The current List of Essential Medicines was enshrined in
Government Order No. 2782-r on Approval of the List of Vital and
Essential Medicines for Medical Use for 2015 of December 30, 2014.
The Russian Ministry of Health has already prepared the draft of an
expanded List of Essential Medicines for 2016.1
Official sources note that the Resolution was adopted to develop
domestic pharmaceutical manufacturing. Minister of Industry and
Trade of Russia Denis Manturov says that of the medicines affected
by the Resolution, 282 have two or more Russian
According to the general rule, Resolution 1289 enters into force
seven days after its official publication, in other words, as of
December 10, 2015.
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