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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

According to part 5 of article 95 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" Government of the Russian Federation decides:

1. Approve enclosed:

Regulations on federal state control (supervision) of the address of medical products;

list of invalid acts of the Government of the Russian Federation.

2. Determine that the scheduled inspections included in the annual plan of conducting planned inspections of legal entities and individual entrepreneurs for 2021 and unscheduled inspections which start date comes after June 30, 2021 are carried out by the Federal Service on supervision in health sector according to the Provision approved by this resolution.

3. 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 30, 2021 No. 1066

Regulations on federal state control (supervision) of the address of medical products

General provisions

1. This Provision establishes procedure for the organization and implementation of federal state control (supervision) of the address of medical products (further - the state control).

2. Subject of the state control are:

a) observance of mandatory requirements to the address of medical products, including:

requirements to technical testing, toxicological researches, clinical testing, production, production, import to the territory of the Russian Federation, confirmation of conformity, storage, transportation, realization, installation, adjustment, application, operation, including maintenance, repair, utilization and destruction;

quality requirements, safety and efficiency of the medical products which are in circulation in the territory of the Russian Federation;

b) observance of licensed requirements to activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment;

c) observance of requirements to provision by subjects of the address of medical products of information on medical products according to the Federal Law "About Bases of Protection of Public Health in the Russian Federation";

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

3. The state control is exercised by the Federal Service on supervision in health sector and its territorial authorities (further - state control body).

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

a) head (deputy manager);

b) officials whose job responsibilities according to official regulations or the job description include implementation of powers on implementation of the state control, including holding preventive actions and control (supervising) actions.

5. The officials authorized on decision making about holding control (supervising) actions are the head (deputy manager) of state control body.

6. Provisions of the Federal Law "About the State Control (Supervision) and Municipal Control in the Russian Federation" are applied to the relations connected with implementation of the state control.

7. The rights and obligations of inspectors are stipulated in Clause 29 Federal Laws "About the State Control (Supervision) and Municipal Control in the Russian Federation".

Objects of the state control

8. The state control body exercises the state control of the following objects (further - objects of the state control):

a) activities of legal entities and individual entrepreneurs (further - controlled persons) in the sphere of the address of medical products;

b) results of activities of controlled persons;

c) buildings, rooms, constructions and the equipment to which the mandatory requirements used when implementing activities in the sphere of the address of medical products are imposed (further - production facilities).

9. Accounting of objects of the state control is performed by means of collection, processing, the analysis and accounting of information on objects of the state control provided to state control body according to regulatory legal acts of the Russian Federation, information obtained within interdepartmental interaction, and also public information without interaction with controlled persons.

Risk management of damnification (damage) to the values protected by the law when implementing the state control

10. The state control is exercised on the basis of risk management of damnification (damage).

11. The Federal Service on supervision in health sector when implementing the state control refers objects of the state control to one of the following categories of risk of damnification (damage) (further - categories of risk):

a) significant risk;

b) average risk;

c) moderate risk;

d) low risk.

12. Reference of objects of the state control to certain category of risk is performed based on criteria of reference of objects of activities of the legal entities and individual entrepreneurs performing activities in the sphere of the address of the medical products established according to appendix.

The Federal Service on supervision in health sector performs review of the category of risk appropriated earlier to object of the state control within 5 working days from the date of receipt of data on compliance of object of the state control to criteria of risk of other category of risk or about change of criteria of risk according to criteria of reference of objects of the state control to the categories of risk provided by appendix to this Provision.

Accounting of risks of damnification (damage) to the values protected by the law when holding control (supervising) actions

13. Types of planned control (supervising) actions concerning objects of the state control depending on the appropriated category of risk and frequency of their carrying out:

a) for category of significant risk one of the specified control (supervising) actions:

inspection visit - once in 4 years;

exit check - once in 4 years;

test purchase - once in 4 years;

selective control - once in 4 years;

b) for category of average risk one of the specified control (supervising) actions:

inspection visit - once in 6 years;

exit check - once in 6 years;

test purchase - once in 6 years;

selective control - once in 6 years;

c) for category of moderate risk one of the specified control (supervising) actions:

inspection visit - once in 6 years;

exit check - once in 6 years;

test purchase - once in 6 years;

selective control - once in 6 years.

14. Concerning the objects of the state control referred to category of low risk, planned control (supervising) events are not held.

Prevention of risks of damnification (damage) to the values protected by the law

15. The state control body annually approves the program of prevention of risks of damnification (damage) to the values protected by the law which is posted on its official site on the Internet (further - Internet network).

16. The state control body can hold the following preventive events:

a) informing;

b) generalization of law-enforcement practice;

c) announcement of caution;

d) consultation;

e) preventive visit.

17. The annual report on results of generalization of law-enforcement practice prepares no later than February 25 of the year following after year of generalization of law-enforcement practice.

18. The report on law-enforcement practice affirms the order of the head of the Federal Service on supervision as health sector and is posted on its official site in Internet network in time, not exceeding 5 working days from the date of approval of the report.

Announcement of caution

19. In case of availability at state control body of data on the preparing violations of mandatory requirements or signs of violations of mandatory requirements and (or) in case of lack of the confirmed data that violation of mandatory requirements did harm (damage) to the values protected by the law or created threat of damnification (damage) to the values protected by the law, the state control body announces to controlled person caution inadmissibility of violation of mandatory requirements (further - caution) and suggests to take measures for ensuring compliance with mandatory requirements.

20. Controlled person has the right within 15 days from the date of receipt of caution to give to state control body objection concerning caution.

21. In objection concerning caution by controlled person are specified:

a) name of the legal entity, surname, name, middle name (in the presence) individual entrepreneur;

b) identification taxpayer number of the legal entity, individual entrepreneur;

c) date and number of the caution directed to the address of controlled person;

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