ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 10, 2023 No. 961

About modification of the Regulations on federal state control (supervision) in the field of drug circulation

The government of the Russian Federation decides:

Approve the enclosed changes which are made to the Regulations on federal state control (supervision) in the field of drug circulation approved by the order of the Government of the Russian Federation of June 29, 2021 No. 1049 "About federal state control (supervision) in the field of drug circulation" (The Russian Federation Code, 2021, No. 27, the Art. 5427).

Approved by the Order of the Government of the Russian Federation of June 10, 2023 No. 961

Changes which are made to Regulations on federal state control (supervision) in the field of drug circulation

1. Subitems "a" - "" of Item 13 to replace with the text of the following content:

"a) high risk;

b) significant risk;

c) average risk;

d) moderate risk;

e) low risk.".

2. To add Item 16 after paragraph one with paragraphs of the following content:

"for category of high risk one of the specified control (supervising) actions:

inspection visit - once in 2 years;

exit check - once in 2 years;

documentary check - once in 2 years;".

3. In Item 36:

a) state the subitem "an" in the following edition:

"a) the objects of the state control referred to categories of high and considerable it is risk;";

b) in the subitem "b" of the word "renewed licenses" shall be replaced with words "the licenses which entered changes in register".

4. In appendix No. 1 to the specified Provision:

a) add Item 2 with words ", and in monitoring system of movement of medicines for medical application";

b) subitems "a" - "" of item 4 to replace with the text of the following content:

"a) high risk - if the hazard rate (K) constitutes over 49 points;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info