ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of November 29, 2022 No. 2164

About modification of the Regulations on licensing of pharmaceutical activities

The government of the Russian Federation decides:

1. Approve the enclosed changes which are made to the Regulations on licensing of pharmaceutical activities approved by the order of the Government of the Russian Federation of March 31, 2022 No. 547 "About approval of the Regulations on licensing of pharmaceutical activities" (The Russian Federation Code, 2022, No. 15, the Art. 2469).

2. This resolution becomes effective since March 1, 2023 and 6 and 8 changes approved by this resolution which become effective since September 1, 2023 are effective till September 1, 2028, except for Items 3, of 4,.

Approved by the Order of the Government of the Russian Federation of November 29, 2022 No. 2164

Changes which are made to Regulations on licensing of pharmaceutical activities

1. To add the subitem "k" of item 4 after the paragraph of third with the paragraph of the following content:

"for implementation of pharmaceutical activities in the field of drug circulation for medical application regarding production of radio pharmaceutical medicines - the higher or secondary pharmaceutical or medical education and additional professional education in the field of radiochemistry, radiation safety taking into account the features established by the legislation of the Russian Federation in the field of ensuring radiation safety.".

2. In Item 6:

a) in the subitem "z":

state paragraph two in the following edition:

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