ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of November 25, 2022 No. 2141

About modification of the Regulations on licensing of production of medicines

The government of the Russian Federation decides:

1. Approve the enclosed changes which are made to the Regulations on licensing of production of medicines approved by the order of the Government of the Russian Federation of July 6, 2012 No. 686 "About approval of the Regulations on licensing of production of medicines" (The Russian Federation Code, 2012, No. 29, Art. 4116; 2020, No. 49, Art. 7954; 2021, No. 1, Art. 99; 2022, No. 12, Art. 1853).

2. This resolution becomes effective since January 1, 2023.

3. The paragraph third item 4 of the changes approved by this resolution is effective till March 1, 2023.

Approved by the Order of the Government of the Russian Federation of November 25, 2022 No. 2141

Changes which are made to Regulations on licensing of production of medicines

1. State Item 7 in the following edition:

"7. For receipt of the license the license applicant directs to the licensing body the application for provision of the license with appendix:

a) the data provided by part 1 of article 13 of the Federal law "About Licensing of Separate Types of Activity" including:

the data confirming availability at the license applicant on the property right or on other legal cause necessary for implementation of activities for production of medicines of rooms, buildings, constructions and (or) other objects in the place of implementation of the licensed type of activity, technical means, the equipment and technical documentation conforming to the established requirements;

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