ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of August 26, 2020 No. 1287

About modification of the Regulations on features of input of civil circulation of medicines for medical application

The government of the Russian Federation decides:

1. Approve the enclosed changes which are made to the Regulations on features of input in civil circulation of medicines for medical application approved by the order of the Government of the Russian Federation of June 30, 2020 No. 955 "About features of input in civil circulation of medicines for medical application" (The Russian Federation Code, 2020, No. 27, the Art. 4239).

2. This resolution becomes effective from the date of its official publication.

Approved by the Order of the Government of the Russian Federation of August 26, 2020 No. 1287

Changes which are made to Regulations on features of input in civil circulation of medicines for medical application

1. To state the subitem "e" of Item 6 in the following edition:

"e) the total quantity of units of medicine with indication of the units of measure declared for the purposes of import to the Russian Federation or introductions in civil circulation which is not exceeding quarterly amount of the medicine introduced into civil circulation for calendar year;".

2. In Item 7:

a) add the subitem "v" with words ", and in case of filing of application about issue of approval regarding the medicines made outside the territory of the Russian Federation, and in the absence of possibility of submission of the specified copies of agreements - copies of other documents (acts of the performed works) confirming the fact of purchase and installation of such equipment, and also development or completion of the software (in Russian)";

b) add the subitem "g" with words "(further - the actions plan)";

c) add with the subitem "d" of the following content:

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