ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of December 2, 2020 No. 1986

About modification of the Regulations on licensing of production of medicines

The government of the Russian Federation decides:

1. Bring in 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, the Art. 4116), the following changes:

a) the paragraph one of Item 8 to state in the following edition:

"8. In case of intention to perform activities for production of medicines for the address which is not provided by the license the licensee in the statement for renewal of the license in addition to the data specified in Items 1 and 3 of part 1 of Article 13 and part 4.1 of article 18 of the Federal law "About Licensing of Separate Types of Activity" specifies:";

b) in paragraph one of Item 9 of the word "not specified in the license" shall be replaced with words "not provided by the license";

c) state Items 11 and 12 in the following edition:

"11. The licensing body places in the federal state information system "Single Portal of the State and Municipal Services (Functions)" in accordance with the established procedure data on the course of adoption of the decision on provision of the license by it (about refusal in provision of the license), renewal of the license (about refusal in renewal of the license), suspension, renewal, cancellation of the license, data on cancellation of the license, and also data on date of provision of the license and registration license number.

12. Access to the public information containing in registers of licenses is provided with the licensing body by means of its placement on the Internet, including in the form of open data. The data on licenses containing in the register of licenses receive the status of open data when entering record into this register which is kept in electronic form.";

d) in Item 14:

words "the duplicate and the copy of the license" shall be replaced with words "statements from the register of licenses";

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