ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of April 3, 2023 No. 534

About modification of appendix No. 2 to the Regulations on licensing of production of medicines

The government of the Russian Federation decides:

1. Approve the enclosed changes which are made to appendix No. 2 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; 2022, No. 12, Art. 1853).

2. This resolution becomes effective since March 1, 2024.

Approved by the Order of the Government of the Russian Federation of April 3, 2023 No. 534

Changes which are made to appendix No. 2 to the Regulations on licensing of production of medicines

1. Add with Item 1 (1) the following content:

"1(1). The organization and implementation of licensed control are implemented with use of the state information system "The Prototype Cloudy Solution on Automation of Control (Supervising) Activities" (further - information system). The data containing in the register of licenses in the automatic mode are represented to information system for the purpose of ensuring automation of licensed control. Information exchange of information system and information systems of the licensing body is performed with use of single system of interdepartmental electronic interaction or by means of program technical means of information systems.".

2. State Item 5 in the following edition:

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