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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of March 20, 2020 No. 311

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, Art. 8641; 2019, No. 37, Art. 5162).

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of March 20, 2020 No. 311

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

1. In Item 2:

a) state paragraph two in the following edition:

"aggregation" - process of consolidation of medicines at any stage of the address of medicines the subject of drug circulation in tertiary (transport) packaging of medicines with drawing the corresponding code of identification of tertiary (transport) packaging of medicines and with preserving information in monitoring system on interrelation of means of identification or codes of identification of each medicine enclosed in such packaging with code of identification of tertiary (transport) packaging of medicines;";

b) paragraphs the tenth and eleventh to recognize invalid;

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

"identification code" - the serial global identification number of trade item representing the unique identifier of secondary (consumer) package of medicine (in case of its absence - primary package of medicine) created by way of addition to global identification number of trade item of individual serial number of trade item;

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