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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of August 30, 2019 No. 1118

About modification of the Regulations on monitoring system of movement of medicines for medical application

The government of the Russian Federation decides:

Approve the enclosed changes which are made to the Regulations on monitoring system of movement of medicines for medical application approved by the order of the Government of the Russian Federation of December 14, 2018 No. 1556 "About approval of the Regulations on monitoring system of movement of medicines for medical application" (The Russian Federation Code, 2018, No. 53, the Art. 8641).

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of August 30, 2019 No. 1118

Changes which are made to Regulations on monitoring system of movement of medicines for medical application

1. In Item 2:

a) in paragraph eleven of the word "means of identification of group packaging of medicines" to exclude;

b) in the paragraph the twelfth to replace the word "value" with the word "appointment";

c) after the paragraph of the thirteenth to add with the paragraph of the following content:

"marking code" - the unique sequence of symbols consisting of serial global identification number of trade item and code of check, created for the purposes of identification of primary package (concerning medicines for medical application for which the secondary package is not provided) and secondary (consumer) package of medicines for medical application;";

d) in the paragraph the fourteenth shall be replaced with words the words "consisting of key of check and the digital signature" "consisting of the identifier (individual sequence number) of key of check and code value of check";

e) in the paragraph the fifteenth ambassador of the words "authentic data" to add with words "(including data on the means of identification and (or) material carriers containing means of identification applied on them)";

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