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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

According to Item 2 of article 19 of the Federal law "About Donorship of Blood and Its Components" Government of the Russian Federation decides:

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

2. Add the list of types of federal state control (supervision) to which the risk - the oriented approach approved by the order of the Government of the Russian Federation of August 17, 2016 No. 806 "About application risk - the oriented approach is applied under the organization of separate types of the state control (supervision) and introduction of amendments to some acts of the Government of the Russian Federation" (The Russian Federation Code, 2016, No. 35, Art. 5326; 2017, No. 9, Art. 1361; No. 11, Art. 1563; No. 15, Art. 2197; 2018, No. 9, Art. 1403; 2019, No. 10, Art. 962; No. 14, Art. 1515), Item 26 of the following content:

"26. State control of safety of donor blood and its components".

3. To Federal Medical Biological Agency to approve till January 1, 2021 forms of checking sheets (lists of the control questions) which are subject to use when implementing the state control of safety of donor blood and its components.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of March 10, 2020 No. 255

Regulations on the state control of safety of donor blood and its components

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

2. The state control is exercised using risk - the oriented approach and with attraction in need of experts or the expert organizations.

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

4. Officials of state control body, representatives on implementation of the state control, are:

a) head of Federal Medical Biological Agency and its deputies;

b) heads of structural divisions of Federal Medical Biological Agency, their deputies, other government civil servants whose official regulations provide powers on implementation of the state control;

c) head of territorial authority of Federal Medical Biological Agency and its deputies;

d) heads of structural divisions of territorial authority of Federal Medical Biological Agency, their deputies, other government civil servants whose official regulations provide powers on implementation of the state control.

5. Subject of the state control is observance by the organizations performing activities for procurement, storage, transportation and clinical use of donor blood and (or) its components (further respectively - object of the state control, legal entities), requirements of rules of procurement, storage, transportation and clinical use of donor blood and its components (further - mandatory requirements).

6. The state control is exercised by means of conducting scheduled and unscheduled documentary and (or) exit inspections, the organization and holding actions for prevention of violations of mandatory requirements, actions for control performed without interaction with legal entities, according to the procedure, provided by the Federal Law "About Protection of the Rights of Legal Entities and Individual Entrepreneurs when Implementing the State Control (Supervision) and Municipal Control".

7. Terms and the sequence of ministerial procedures under the organization of the state control are established by the administrative regulations of implementation of the state control developed and approved according to the order of the Government of the Russian Federation of May 16, 2011 No. 373 "About development and approval of administrative regulations of implementation of the state control (supervision) and administrative regulations of provision of the state services".

8. Officials of state control body when conducting planned inspection of all legal entities shall use checking sheets (lists of control questions).

Checking sheets (lists of control questions) contain the questions mentioning all mandatory requirements imposed to legal entities.

The subject of scheduled inspection of legal entities is limited to the list of the questions included in checking sheets (lists of control questions).

9. Within implementation of the state control the following events are held:

a) consideration of the documents and materials characterizing activities of legal entities for observance of mandatory requirements;

b) survey of the rooms used by legal entities when implementing procurement, storage, transportation and clinical use of donor blood and its components;

c) control over the implementation of the instruction which is earlier issued to the legal entity about elimination of the revealed violations of mandatory requirements;

d) holding actions for control without interaction with legal entities and registration of results of such actions;

e) conducting the examinations and investigations directed to establishment of cause and effect relationship between the revealed violation of mandatory requirements and the fact of damnification of life and to health of citizens.

10. Observation of observance of mandatory requirements by means of information analysis about activities or actions of legal entities which is represented them (including by means of use of 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) in state control body according to the Federal Law "About Donorship of Blood and Its Components" and other regulatory legal acts of the Russian Federation accepted according to it or can be received (including within interdepartmental information exchange) state control body without assignment on the legal entity of obligations belongs to actions for control when which carrying out interaction of state control body with legal entities is not required, not provided by the Federal Laws and other regulatory legal acts of the Russian Federation accepted according to them.

11. When implementing the state control the officials specified in item 4 of this provision have the right:

a) request in accordance with the established procedure in public authorities, local government bodies and the organizations subordinated to them, and also at legal entities is information and documents necessary for implementation of the state control;

b) freely in case of presentation of the official ID and copy of the order (order) of the head (deputy manager) of state control body on purpose of check to get access to the territory occupied by legal entities, to the buildings used by them, structures, constructions, rooms, to the medical products and materials used by them, and also to conduct necessary researches, testing, measurements, investigations, examinations and other actions for implementation of the state control;

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