ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of December 31, 2019 No. 1954

About modification of the Order of the Government of the Russian Federation of December 14, 2018 No. 1556

The government of the Russian Federation decides:

Approve the enclosed changes which are made to 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).

Approved by the Order of the Government of the Russian Federation of December 31, 2019 No. 1954

Changes which are made to the Order of the Government of the Russian Federation of December 14, 2018 No. 1556

1. In word preamble "According to parts 5 - the 7th article 67 of the Federal law "About Drug Circulation" to exclude.

2. Add with Items 1 (1) - 1(7) following contents:

"1(1). Determine that the legal entities and individual entrepreneurs who are subjects of drug circulation according to the Provision approved by this resolution (further - subjects of drug circulation):

perform the registration in monitoring system of movement of medicines for medical application (further - monitoring system) from January 1, 2020 to February 29, 2020 (inclusive) or after February 29, 2020 within 7 calendar days from the date of origin at subjects of drug circulation of need of implementation of the activities connected with the address of medicines in the presence of the right to perform such activities;

no later than 21 calendar days from the date of registration in monitoring system provide readiness of the information systems for information exchange with monitoring system and send to the operator of monitoring system the request for passing of testing of information exchange with indication of producers of software and hardware of information systems;

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