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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 29, 2021 No. 1050

About approval of the Regulations on federal state control (supervision) of safety of donor blood and its components

According to Item 2 of article 19 of the Federal law "About Donorship of Blood and Its Components" and the Federal law "About the State Control (Supervision) and Municipal Control in the Russian Federation" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on federal state control (supervision) of safety of donor blood and its components.

2. Determine that the conducting planned inspections included in the plan for 2021 check on federal state control (supervision) of safety of donor blood and its components which start date comes after June 30, 2021 is subject to carrying out within federal state control (supervision) of safety of donor blood and its components according to this resolution.

3. Realization of the powers provided by this resolution is performed within the number of employees of Federal Medical Biological Agency, and also budgetary appropriations provided to Federal Medical Biological Agency on management and management in the sphere of the established functions established by the Government of the limiting Russian Federation.

4. Declare invalid the order of the Government of the Russian Federation of March 10, 2020 No. 255 "About approval of the Regulations on the state control of safety of donor blood and its components" (The Russian Federation Code, 2020, No. 11, the Art. 1557).

5. This resolution becomes effective since July 1, 2021.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of June 29, 2021 No. 1050

Regulations on federal state control (supervision) of safety of donor blood and its components

I. General provisions

1. This Provision establishes procedure for the organization and implementation of federal state control (supervision) of safety of donor blood and its components (further - the state control).

2. Subject of the state control are:

a) observance by the organizations performing activities in the sphere of the address of donor blood and (or) its components (further - subjects of the address of donor blood and (or) its components), mandatory requirements of the legislation of the Russian Federation on donorship of blood and its components (further - mandatory requirements), including:

the mandatory requirements of safety of donor blood and its components in case of their procurement, storage, transportation and clinical use established by rules of procurement, storage, transportation and clinical use of donor blood and its components, requirements to implementation of voluntary conveyance of donor blood and (or) its components, providing with donor blood and (or) its components in other purposes except clinical use, the requirement to maintaining the single database on implementation of the actions connected with safety of donor blood and its components, development, the organization and promotion of donorship of blood and its components;

requirements to maintaining the forms of medical documentation connected with donorship of blood and (or) its components, forms of the statistical recording and reporting under procurement, storage, transportation of donor blood and (or) its components;

requirements to the organization of activities of subjects of the address of donor blood and (or) its components on procurement, storage, transportation of donor blood and (or) its components, including regular standard rates and the standard of equipment of the medical organizations, their structural divisions, and also requirements to the organization of security system;

requirements to procedure for passing by donors of physical examination, immunization of donors for procurement of immunospecific plasma, to submission of information on reactions and about the complications which arose at recipients in connection with transfusion (transfusion) of donor blood and (or) its components;

requirements to observance of the standard rate of inventory of donor blood and (or) its components, and also procedure for its forming and expenditure;

b) execution of the decisions made by results of control (supervising) actions.

3. The state control is exercised by Federal Medical Biological Agency (its territorial authorities).

4. The state control is exercised on the basis of risk management of damnification (damage) determining the choice of preventive actions and control (supervising) actions, their content (including amount of the checked mandatory requirements), intensity and results.

5. The state control is exercised concerning the subjects of the address of donor blood and (or) its components performing procurement, storage, transportation and clinical use of donor blood and (or) its components.

6. The officials authorized on implementation of the state control (further - the official), are:

a) head of Federal Medical Biological Agency (his deputy);

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