of December 7, 2021 No. 2220
About modification of the Regulations on federal state control (supervision) of the address of medical products
The government of the Russian Federation decides:
1. Approve the enclosed changes which are made to the Regulations on federal state control (supervision) of the address of medical products approved by the order of the Government of the Russian Federation of June 30, 2021 No. 1066 "About federal state control (supervision) of the address of medical products" (The Russian Federation Code, 2021, No. 27, the Art. 5442).
2. This resolution becomes effective since March 1, 2022.
Russian Prime Minister
M. Mishustin
Approved by the Order of the Government of the Russian Federation of December 7, 2021 No. 2220
After the Section "The Decisions Made by results of Control (Supervising) Actions" to add with the Section of the following content:
"Key indicator of the state control of the address of medical products
126(1). Key indicator of the state control of the address of medical products (further - key indicator) is the number of persons who died as a result of approach of unfavorable events in case of application of medical products for accounting year on 1000000 people.
Value of key indicator is calculated based on messages which are sent within accounting year to the Federal Service on supervision in the field of health care by subjects of the address of medical products according to article 96 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" and Rules of carrying out monitoring of safety, quality and efficiency of medical products approved by the Decision of Board of the Eurasian economic commission of December 22, 2015 No. 174.
Target value of key indicator:
for 2022 - no more 0,7;
for 2023 - no more 0,65;
for 2024 - no more 0,6;
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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