ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of December 25, 2025 No. 2143

About modification of the Order of the Government of the Russian Federation of July 6, 2012 No. 686

The government of the Russian Federation decides:

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; 2021, No. 1, Art. 99; 2022, No. 12, Art. 1853; No. 48, Art. 8508; 2023, No. 15, Art. 2686; 2024, No. 5, Art. 704).

Approved by the Order of the Government of the Russian Federation of December 25, 2025 No. 2143

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

1. To add the subitem "an" of Item 7 with the paragraph of the following content:

"data on dosage forms and (or) types of pharmaceutical substances which the producer of medicines intends to make;".

2. Item 14 (to state 1) in the following edition:

"14(1). The term of provision of the license for production of medicines for medical application the licensing body cannot exceed 27 working days.

The term of provision of the license for production of medicines for veterinary application by the licensing body cannot exceed 30 working days.

The licensing body has the right to extend the term of provision of service for 10 working days if the license applicant declares more than 3 addresses of places of implementation of the licensed type of activity.

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