ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
AND THE FEDERAL SERVICE OF THE RUSSIAN FEDERATION ON SUPERVISION IN THE FIELD OF HEALTH CARE

of April 25, 2019 No. 3239

About approval of Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in acceptance and accounting of notifications on the beginning of implementation of activities in the field of the address of medical products (except for carrying out clinical testing of medical products, their production, installation, adjustment, application, operation, including maintenance, and also repair)

According to orders of the Government of the Russian Federation of July 16, 2009 No. 584 "About notifying procedure for the beginning of implementation of separate types of business activity" (The Russian Federation Code, 2009, No. 30, Art. 3823; 2010, No. 16, Art. 1928; No. 44, Art. 5692; 2012, No. 1, Art. 171; No. 37, Art. 5002; 2013, No. 5, Art. 386; No. 8, Art. 826; No. 26, Art. 3338; No. 31, Art. 4214; No. 33, Art. 4391; 2014, No. 51, Art. 7466; 2016, No. 14, Art. 2001; 2017, No. 11, Art. 1577; No. 40, Art. 5848; No. 52, Art. 8121; 2018, No. 28, Art. 4215; No. 36, Art. 5647; No. 47, the Art. 7275) and 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" (The Russian Federation Code, 2011, No. 22, Art. 3169; No. 35, Art. 5092; 2012, No. 28, Art. 3908; No. 36, Art. 4903; No. 50, Art. 7070; No. 52, Art. 7507; 2014, No. 5, Art. 506; 2017, No. 44, Art. 6523; 2018, No. 6, Art. 880; No. 25, Art. 3696; No. 36, Art. 5623; 46, of the Art. 7050) I order to No.:

Approve the enclosed Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in acceptance and accounting of notifications on the beginning of implementation of activities in the field of the address of medical products (except for carrying out clinical testing of medical products, their production, installation, adjustment, application, operation, including maintenance, and also repair).

Approved by the Order of the Federal Service of the Russian Federation on supervision in the field of health care of April 25, 2019, No. 3239

Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in acceptance and accounting of notifications on the beginning of implementation of activities in the field of the address of medical products (except for carrying out clinical testing of medical products, their production, installation, adjustment, application, operation, including maintenance, and also repair)

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in acceptance and accounting of notifications on the beginning of implementation of activities in the field of the address of medical products (except for carrying out clinical testing of medical products, their production, installation, adjustment, application, operation, including maintenance, and also repair) (further respectively - Administrative regulations, the state service) establish terms and the sequence of ministerial procedures (actions) of officials of the Federal Service for supervision in the field of health care (further - Roszdravnadzor) and its territorial authorities (further - territorial authority) by provision of the state service, and also order of interaction between structural divisions of Roszdravnadzor (territorial authorities), their officials, interactions of Roszdravnadzor (territorial authorities) with applicants by provision of the state service.

Circle of applicants

2. Applicants on receipt of the state service (further - applicants) are the legal entities and individual entrepreneurs assuming to perform the following types of activity in the field of the address of medical products: technical testing, toxicological researches, production, import to the territory of the Russian Federation, export from the territory of the Russian Federation, storage, transportation, realization, utilization, destruction of medical products.

Requirements to procedure for informing on provision of the state service

3. Informing on procedure for provision of the state service is performed:

on the official site of Roszdravnadzor (territorial authority) on the Internet (further - the official site of Roszdravnadzor (territorial authority), Internet network);

on the official site in the federal state information system "Single Portal of the State and Municipal Services" (further - the Single portal);

in the federal state information system "Federal Register of the State Services (Functions)" (further - the federal register);

at information stands in reception on work with addresses of citizens or the information terminal (are established in the place, convenient for citizens);

on phone numbers for reference.

4. Reference information concerning provision of the state service is placed:

on the official site of Roszdravnadzor (territorial authority);

on the Single portal;

in the federal register;

at information stands or the information terminal (are established in the place, convenient for citizens).

5. Reference information is provided by officials of Roszdravnadzor (territorial authority) by phone, on personal acceptance of the applicant or in writing the mailing, or the electronic message to the address specified by the applicant.

Reference information includes data on the location, the working schedule, telephone numbers for enquiries, number of phone informant, addresses of the official site, e-mail and (or) form of feedback with Roszdravnadzor (territorial authority).

6. On the official site of Roszdravnadzor (territorial authority), information stands or the information terminal (are established in the place, convenient for citizens), on the Single portal the following information is placed:

procedure for receipt of information by applicants concerning provision of the state service;

the list of the regulatory legal acts of the Russian Federation regulating provision of the state service;

text of Administrative regulations;

the notification form used by service provision.

7. Information on the Single portal and the official site of Roszdravnadzor (territorial authority) on procedure and terms of provision of the state service based on the data containing in the federal register is provided to the applicant on a grant basis.

II. Standard of provision of the state service

Name of the state service

8. The state service in acceptance and accounting of notifications on the beginning of implementation of activities in the field of the address of medical products (except for carrying out clinical testing of medical products, their production, installation, adjustment, application, operation, including maintenance, and also repair) (further - the notification).

The name of the body providing the state service

9. The state service is provided by Roszdravnadzor and its territorial authorities.

10. It is forbidden to demand from the applicant of implementation of actions the, including approvals necessary for receipt of the state service and connected with the appeal to other state bodies and the organizations, except for receipts of the services included in the list of services which are necessary and obligatory for provision of the state services, No. 352 approved by the order of the Government of the Russian Federation of May 6, 2011 "About approval of the list of services which are federal executive bodies, State Atomic Energy Corporation "Rosatom" of the state services, necessary and obligatory for provision, and are provided by the organizations participating in provision of the state services, and determination of the amount of payment for their rendering" <1>.

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<1> Russian Federation Code, 2011, No. 20, Art. 2829; 2012, No. 14, Art. 1655; No. 36, Art. 4922; 2013, No. 33, Art. 4382; No. 49, Art. 6421; No. 52, Art. 7207; 2014, No. 21, Art. 2712; 2015, No. 50, Art. 7165; Art. 7189; 2016, No. 31, Art. 5031; No. 37, Art. 5495; 2017, No. 8, Art. 1257; No. 28, Art. 4138; No. 32, Art. 5090; No. 40, Art. 5843; No. 42, Art. 6154; 2018, No. 16, Art. 2371; No. 27, Art. 4084, No. 40, Art. 6129; 2019, No. 5, Art. 390.

Description of result of provision of the state service

11. Results of provision of the state service are:

1) acceptance (registration) by Roszdravnadzor (territorial authority) of notifications on entering of data into the Register of notifications on implementation of activities in the field of the address of medical products (further - the Register) or refusal in acceptance (registration) of notifications;

2) accounting of notifications by Roszdravnadzor (territorial authority) by entering of data into the Register;

3) introduction of changes by Roszdravnadzor (territorial authority) (refusal in modification) in the Register.

The term of provision of the state service, including taking into account need of the appeal to the organizations participating in provision of the state service, the term of suspension of provision of the state service if the possibility of suspension is stipulated by the legislation the Russian Federation, the term of issue (direction) of the documents which are result of provision of the state service

12. Registration of the notification by Roszdravnadzor (territorial authority) is performed in day of its receipt.

Roszdravnadzor (territorial authority) enters the data specified in Item 12 of Rules of submission of notifications on the beginning of implementation of separate types of business activity and accounting of the specified notifications approved by the order of the Government of the Russian Federation of July 16, 2009 No. 584 <2> (further - Rules), in the Register in day of receipt of the notification.

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<2> Russian Federation Code, 2009, No. 30, Art. 3823; 2010, No. 16, Art. 1928; No. 44, Art. 5692; 2012, No. 1, Art. 171; No. 37, Art. 5002; 2013, No. 5, Art. 386; No. 8, Art. 826; No. 26, Art. 3338; No. 31, Art. 4214; No. 33, Art. 4391; 2014, No. 51, Art. 7466; 2016, No. 14, Art. 2001; 2017, No. 11, Art. 1577; No. 40, Art. 5848; No. 52, Art. 8121; 2018, No. 28, Art. 4215; No. 36, Art. 5647; No. 47, Art. 7275.

Placement of the data containing in the Register on the official site of Roszdravnadzor and its territorial authorities is performed within 10 days from the date of registration of the notification.

13. When obtaining from the applicant of information on change of its location and (or) the place of the actual implementation of its activities, change of the residence of the individual entrepreneur and (or) the place of the actual implementation of activities, reorganization of the legal entity <3>, Roszdravnadzor (territorial authority) enters data in the Register within 5 working days from the date of receipt of the relevant documents in Roszdravnadzor.

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<3> Item 10 Governed.

14. The term of issue (direction) to the applicant of the second copy of the notification or motivated refusal in its registration is performed in day of registration of the notification.

15. The term of issue (direction) to the applicant of information on modification of the data containing in the Register or refusal about modification of the data containing in the Register constitutes 5 working days from receipt date of the statement.

The regulatory legal acts regulating provision of the state service

16. The list of the regulatory legal acts regulating provision of the state service is posted on the official site of Roszdravnadzor (territorial authority), in the federal register and on the Single portal.

The exhaustive list of the documents necessary according to regulatory legal acts for provision of the state service and services which are necessary and obligatory for provision of the state service, subject to representation by the applicant, methods of their obtaining by the applicant, including electronically, procedure for their representation

17. For provision of the state service the applicant represents to Roszdravnadzor (territorial authority) prior to the actual performance of works (rendering the services) specified in Item 87 of appendix No. 1 to Rules, the notification in duplicate in the form provided by appendix No. 2 to Rules.

18. In case of changes, stipulated in Item 10 Rules, the applicant represents (sends) to Roszdravnadzor (territorial authority) in any form the statement for modification of the Register with application of copies of the documents confirming the fact of availability of corresponding changes.

The exhaustive list of the documents necessary according to regulatory legal acts for provision of the state service which are at the disposal of the state bodies, local government bodies and other bodies participating in provision of the state or municipal services and which the applicant has the right to provide, and also methods of their obtaining by applicants, including electronically, procedure for their representation

19. For provision of the state service submission of the documents which are at the disposal of state bodies, local government bodies and other bodies is not required.

20. By provision of the state service it is forbidden to demand from the applicant:

1) submissions of documents and information or implementation of actions, representation or implementation of which it is not provided by the regulatory legal acts governing the relations arising in connection with provision of the state service;

2) submissions of documents and information which according to regulatory legal acts of the Russian Federation, regulatory legal acts of subjects of the Russian Federation and municipal legal acts are at the disposal of the state bodies providing the state service, other state bodies, local government bodies and (or) subordinated to state bodies and local government bodies of the organizations, participating in provision of the state or municipal services, except for documents, specified in part 6 of article 7 of the Federal Law of July 27, 2010 to No. 210-FZ "About the organization of provision of the state and municipal services" <4>;

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<4> Russian Federation Code, 2010, No. 31, Art. 4179; 2011, No. 15, Art. 2038; No. 27, Art. 3873, Art. 3880; No. 29, Art. 4291; No. 30, Art. 4587; No. 49, Art. 7061; 2012, No. 31, Art. 4322; 2013, No. 14, Art. 1651; No. 27, Art. 3477, Art. 3480; No. 30, Art. 4084; No. 51, Art. 6679; No. 52, Art. 6952, Art. 6961, Art. 7009; 2014, No. 26, Art. 3366; No. 30, Art. 4264; No. 49, Art. 6928; 2015, No. 1, Art. 67, Art. 72; No. 10, Art. 1393; No. 29, Art. 4342, Art. 4376; 2016, No. 7, Art. 916; No. 27, Art. 4293, Art. 4294; 2017, No. 1, Art. 12; No. 31, Art. 4785; No. 50, Art. 7555; 2018, No. 1, Art. 63; No. 9, Art. 1283; No. 17, Art. 2427; No. 18, Art. 2557; No. 24, Art. 3413; No. 27, Art. 3954; No. 30, Art. 4539; No. 31, Art. 4858; 2019, No. 14, Art. 1461.

3) submissions of documents and information, absence and (or) unauthenticity of which were not specified in case of initial refusal in documents acceptance, necessary for provision of the state service, or in provision of the state service, except as specified, stipulated in Item 4 parts 1 of article 7 of the Federal Law of July 27, 2010 to No. 210-FZ "About the organization of provision of the state and municipal services".

The exhaustive list of the bases for refusal in documents acceptance, necessary for provision of the state service

21. The bases for refusal in documents acceptance, necessary for provision of the state service, are not provided.

The exhaustive list of the bases for suspension or refusal in provision of the state service

22. The bases for suspension or refusal in provision of the state service are absent.

The list of services which are necessary and obligatory for provision of the state service, including data on the document (documents) issued (issued) by the organizations participating in provision of the state service

23. Services which are necessary and obligatory for provision of the state service including data on the document (documents) issued (issued) by the organizations participating in provision of the state service are not provided.

Procedure, the size and the bases of collection of the state fee or other payment levied for provision of the state service

24. For provision of the state service the state fee or other payment are not levied.

Procedure, the size and the bases of collection of payment for provision of services which are necessary and obligatory for provision of the state service, including information on method of calculation of such payment

25. Collection of payment for provision of services which are necessary and obligatory for provision of the state service, is not provided.

The maximum term of expectation in queue when giving request about provision of the state service and in case of receipt of result of provision of the state service

26. The maximum term of expectation in queue in case of submission of the documents by the applicant necessary for provision of the state service, and (or) in case of receipt of result of the state service constitutes 15 minutes.

The term and order of registration of request of the applicant about provision of the state service, including electronically

27. The notification and documents which arrived from the applicant in Roszdravnadzor (territorial authority) (including in electronic form) for receipt of the state service, is registered in day of their receipt.

Requirements to rooms in which the state service, to the waiting room, places for filling of requests about provision of the state service is provided, to information stands with models of their filling and the list of the documents necessary for provision of each state service, to placement and execution of visual, text and multimedia information on procedure for provision of such service, including to ensuring availability to disabled people of the specified objects in accordance with the legislation of the Russian Federation about social protection of disabled people

28. The rooms intended for provision of the state service are provided with the equipments, office supplies, office furniture, the air conditioning system, access to clothes, phone, the computer, necessary for provision of the state service, with possibility of seal and access to the network "Internet", and also access to documents (data) in electronic form or on paper.

29. Visual, text and multimedia information on procedure for provision of the state service is placed at the information stand or the information terminal (are established in the place, convenient for citizens), and also on the Single portal, on the official site of Roszdravnadzor (territorial authority).

30. The entrance and movement on rooms in which provision of the state service is performed shall not create difficulties for persons with limited opportunities.

31. In accordance with the legislation of the Russian Federation about social protection of disabled people are provided to them:

conditions of easy access to object (the building, the room) in which the state service, and also for free use of transport, means of communication and information is provided;

possibility of independent movement on the territory in which objects are located (buildings, rooms), in which the state service, and also entrance to such objects and exit from them, landing in the vehicle and disembarkation from it, including with use of wheelchair is provided;

escort of the disabled people having permanent disorders of function of sight and independent movement;

proper placement of the equipment and the data carriers necessary for providing easy access of disabled people to objects (buildings, rooms) in which the state service, taking into account restrictions of their life activity is provided;

duplication of sound and visual information, necessary for disabled people, and also texts, signs and other text and graphical information the signs executed by relief and dot font of Braille;

admission of the signer and tiflosurdoperevodchik;

the admission of seeing eye dog on objects (buildings, rooms) in which the state service is provided;

rendering to disabled people the help in overcoming the barriers preventing receipt of the state service by them on an equal basis with other persons.

In case of impossibility to completely adapt object taking into account needs of disabled people Roszdravnadzor according to article 15 of the Federal Law of November 24, 1995 No. 181-FZ "About social protection of disabled people in the Russian Federation" <5> shall take measures for ensuring access of disabled people to the place of provision of service or when it is possible, to provide its provision at the place of residence of the disabled person or in the remote mode.

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<5> Russian Federation Code, 1995, No. 48, Art. 4563; 2014, No. 49, Art. 6928; 2018, No. 1, Art. 61.

Indicators of availability and quality of the state service, including the number of interactions of the applicant with officials by provision of the state service and their duration, possibility of receipt of information on the course of provision of the state service, including with use of information and communication technologies, opportunity or impossibility of receipt of the state service in the multipurpose center of provision of the state and municipal services (including in full), in any territorial subdivision of the body providing the state service at the choice of the applicant (the exterritorial principle), by means of request about provision of several state and (or) municipal services in the multipurpose centers of provision of the state and municipal services, the stipulated in Article 15.1 Federal Laws of July 27, 2010 No. 210-FZ "About the organization of provision of the state and municipal services"

32. Indicators of availability and quality of provision of the state service are:

1) open access for applicants and other persons to information on procedure and terms of provision of the state service, procedure for appeal of actions (failure to act) for officials of Roszdravnadzor (territorial authority);

2) observance of the standard of provision of the state service;

3) lack of claims of applicants to actions (failure to act) of officials of Roszdravnadzor (territorial authority) by provision of the state service;

4) completeness and relevance of information on procedure for provision of the state service;

5) provision of possibility of filing of application about the provision of the state service and other documents (containing in them the data) necessary for provision of the state service, in electronic form;

6) provision of possibility of receipt of information on the course of provision of the state service, including with use of information and communication technologies;

7) possibility of the choice by the applicant of form of the request for provision of the state service (personally, in electronic form with use of the Single portal);

8) the number of interactions of the applicant (his representative) with officials of Roszdravnadzor (territorial authority) by provision of the state service and their duration.

Opportunity to estimate availability and quality of the state service on the Single portal and on the official site of Roszdravnadzor is provided to applicants.

33. By provision of the state service electronically through the Single portal or the official site of Roszdravnadzor (territorial authority) accomplishment of the following actions is provided to the applicant:

1) receipt of information on procedure and terms of provision of the state service;

2) forming of request about provision of the state service;

3) acceptance and registration in Roszdravnadzor (territorial authority) of the notification, statement for modification of the Register and other documents necessary for provision of the state service;

4) receipt of result of provision of the state service;

5) receipt of data on the course of accomplishment of request about provision of the state service;

6) implementation of quality evaluation of provision of the state service;

7) pre-judicial (extrajudicial) appeal of decisions and actions of Roszdravnadzor (territorial authority), official or federal government civil servant of Roszdravnadzor (territorial authority).

34. The applicant has possibility of receipt of the state service in Roszdravnadzor or any territorial authority of Roszdravnadzor providing the state service for the choice (the exterritorial principle).

35. Within submission of the notification and (or) the statement for provision (receipt of result) of the state service single interaction of the official of Roszdravnadzor (territorial authority) responsible for interaction with applicants is supposed.

Duration of interaction of the applicant with the official of Roszdravnadzor by provision of the state service does not exceed 15 minutes.

36. The possibility of receipt of the state service in the multipurpose center of provision of the state and municipal services is not provided.

Other requirements including considering features of provision of the state service in the exterritorial principle (if the state service is provided on the exterritorial principle) and features of provision of the state service electronically

37. For possibility of giving of request electronically through the Single portal or the official site of Roszdravnadzor (territorial authority) the applicant shall be registered in system of the Single portal.

In case of the direction of the documents specified in Items 17 and 18 of Administrative regulations electronically the strengthened qualified digital signature of the applicant according to the Federal Law of April 6, 2011 No. 63-FZ "About the digital signature" <6> and the order of the Government of the Russian Federation of June 25, 2012 No. 634 "About types of the digital signature which use is allowed in case of the request for receipt of the state and municipal services" <7> is used.

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<6> Russian Federation Code, 2011, No. 15, Art. 2036; No. 27, Art. 3880; 2012, No. 29, Art. 3988; 2013, No. 14, Art. 1668; No. 27, Art. 3463, Art. 3477; 2014, No. 11, Art. 1098; No. 26, Art. 3390; 2016, No. 1, Art. 65; No. 26, Art. 3889.

<7> Russian Federation Code, 2012, No. 27, Art. 3744; 2013, No. 45, Art. 5807; 2018, No. 36, Art. 5623.

III. Structure, the sequence and terms of accomplishment of ministerial procedures (actions), requirements to procedure for their accomplishment, including feature of accomplishment of ministerial procedures (actions) electronically, and also features of accomplishment of ministerial procedures (actions) in the multipurpose centers of provision of the state and municipal services

38. Provision of the state service includes the following ministerial procedures:

1) obtaining and registration of notifications by Roszdravnadzor (territorial authority) from applicants;

2) accounting of notifications by Roszdravnadzor (territorial authority) by entering of data into the Register;

3) receipt by Roszdravnadzor (territorial authority) of statements for modification of the Register with application of copies of the documents confirming the fact of modification, and entering of corresponding changes into the Register;

4) procedure of ministerial procedures electronically, including with use of the Single portal;

5) procedure for correction of the made typographical errors and error messages in given as a result of provision of the state service documents.

39. The ministerial procedures performed in the multipurpose centers of provision of the state and municipal services no.

Obtaining and registration of notifications by Roszdravnadzor (territorial authority) from applicants

40. The basis for ministerial procedure is receipt in Roszdravnadzor (territorial authority) of the notification in duplicate constituted in the form provided by appendix No. 2 to Rules and the containing data on intention of the applicant to perform the works (to render service) specified in Item 87 of appendix No. 1 to Rules.

41. In case of submission of the notification it is direct in Roszdravnadzor (territorial authority), day of registration of the notification is considered day of its giving.

In case of the direction of the notification by mail day of sending the mailing is considered day of its giving.

42. The notification provided to Roszdravnadzor (territorial authority), including electronically is registered in Administration of Roszdravnadzor (territorial authority) with indication of the date of receipt and assignment of the entering number to the document.

43. The head of department, performing provision of the state service, designates from number of persons employed of department the official responsible for provision of the state service (further in the text - the executive in charge).

The surname, name and middle name (the last in the presence) the executive in charge, its position and phone number are told the applicant according to its written or oral address.

44. In case of receipt of the notification by the executive in charge are checked notification form and content for compliance to the requirements established by Rules.

45. The executive in charge in day of receipt of the notification registers him by putting down of mark with indication of date of its obtaining and registration number in the Register.

One copy of the notification remains in Roszdravnadzor, and the second is handed (goes) in day of registration to the applicant.

46. In case of submission of the notification which is drawn up with violation of Item 17 of Administrative regulations, to the applicant the motivated refusal in registration of the notification signed by the deputy manager of Roszdravnadzor (territorial authority) in day of receipt of the notification goes.

47. Decision acceptance criterion on ministerial procedure is availability or lack of the bases for refusal in registration of the notification.

48. Results of ministerial procedure are delivery (direction) to the applicant of the registered notification or motivated refusal in registration of the notification.

Accounting of notifications by Roszdravnadzor (territorial authority) by entering of data into the Register

49. The basis for ministerial procedure is registration in Roszdravnadzor (territorial authority) of the notification by the executive in charge.

50. The executive in charge enters data in the Register in day of receipt of the notification by means of introduction of the following data:

1) complete and reduced, including corporate (in the presence), the name of the legal entity, its form of business, surname, name, middle name (in the presence) the individual entrepreneur;

2) postal addresses of the location of the legal entity, including its branches and representations, places of the actual implementation of the declared type (types) of activities, places of the actual implementation of the declared type (types) of activities of the individual entrepreneur;

3) primary state registration number of the legal entity or primary state registration number of record about state registration of the individual entrepreneur;

4) identification taxpayer number, date of statement of the legal entity or individual entrepreneur on accounting in tax authority;

5) type of activity, work types (services) which are carried out as a part of activities about which beginning it is reported in the notification;

6) receipt date of the notification and its registration number.

51. The register in electronic form is posted on the official site of Roszdravnadzor which data are open and public, including on the websites of territorial authorities.

52. Entering of data into the Register is performed in time, according to Item 12 of Administrative regulations.

53. Decision acceptance criterion on ministerial procedure is receipt and registration of the notification.

54. Entering of data into the Register, and also placement of the data containing in the Register on the official site of Roszdravnadzor (territorial authority) is result of ministerial procedure.

Receipt by Roszdravnadzor (territorial authority) of statements for modification of the Register with application of copies of the documents confirming the fact of modification, and entering of corresponding changes into the Register

55. The basis for ministerial procedure is receipt in Roszdravnadzor (territorial authority) of the statement in any form of modification of the Register with application of copies of the documents confirming the fact of introduction of the following changes:

1) change of the location of the legal entity and (or) place of the actual implementation of activities;

2) change of the residence of the individual entrepreneur and (or) place of the actual implementation of activities;

3) reorganization of the legal entity.

56. The statement for modification of the Register and the enclosed documents are registered in day of their receipt in Administration of Roszdravnadzor (territorial authority).

57. The executive in charge appointed the head of department enters the corresponding data in the Register.

58. In case of the submission of the statement and the enclosed documents which are not corresponding to Item 18 of Administrative regulations, to the applicant the motivated refusal in modification of the Register goes.

59. Decision acceptance criterion on ministerial procedure is availability or lack of the bases for refusal in modification of the Register.

60. Placement of data on changes in the Register on the official site of Roszdravnadzor (territorial authority) or the direction (delivery) to the applicant of motivated refusal in modification of the Register is result of ministerial procedure.

Procedure of ministerial procedures electronically, including with use of the Single portal

61. Forming of request about provision of the state service (further - request) is performed by means of filling of electronic request form on the Single portal or on the official site of Roszdravnadzor (territorial authority) without the need for additional giving of request in any other form.

On the Single portal and models of filling of electronic request form are posted on the official site of Roszdravnadzor (territorial authority).

If on the Single portal the possibility of filling of electronic request form is not provided to the applicant, then for forming of request on the Single portal automatic transition to filling of electronic form of the specified request on the official site of Roszdravnadzor (territorial authority) is provided.

Formatno-logichesky check of the created request is performed by Roszdravnadzor (territorial authority) after filling with the applicant of each of fields of electronic request form. In case of identification of incorrectly filled field of electronic request form the applicant is notified on nature of the revealed mistake and procedure for its elimination by means of the information message directly electronically of request.

62. When forming by the applicant of request it is provided:

1) possibility of copying and preserving request and other documents necessary for service provision;

2) possibility of seal on paper copies of electronic request form;

3) preserving the values which are earlier entered into electronic request form at any time at the request of the user, including in case of errors of input and return for repeated input of values to electronic request form;

4) filling of fields of electronic request form prior to input of data by the applicant with use of the data placed in the federal state information system "Single System of Identification and Authentication in the Infrastructure Providing Information and Technological Interaction of the Information Systems Used for Provision of the State and Municipal Services Electronically" (further - single system of identification and authentication), and the data published on the Single portal, on the official site of Roszdravnadzor (territorial authority) in the part concerning the data which are absent in single system of identification and authentication;

5) opportunity to return on any of stages of filling of electronic request form without loss of earlier entered information;

6) possibility of access for the applicant on the Single portal, the official site of Roszdravnadzor (territorial authority) to the requests which are earlier sent by it within at least one year, and also partially created requests - within at least 3 months.

The created and signed request, other documents necessary for provision of the state service go to Roszdravnadzor (territorial authority) by means of the Single portal or the official site of Roszdravnadzor.

63. The applicant has possibility of receipt of information on the course of provision of the state service.

Information on the course of provision of the state service goes to the applicant Roszdravnadzor (territorial authority) to the e-mail address or with use of means of the Single portal, the official site of Roszdravnadzor (territorial authority) at the choice of the applicant.

64. By provision of the state service electronically to the applicant goes:

1) notification on acceptance and registration of request;

2) notification on the beginning of the procedure of provision of the state service;

3) the notification on opportunity to receive result of provision of the state service;

4) the notification on motivated refusal in service provision.

65. The applicant has the right to receive result of provision of the state service in electronic form or on paper.

Procedure for correction of the made typographical errors and error messages in given as a result of provision of the state service documents

66. If Roszdravnadzor (territorial authority) made mistakes and (or) typographical errors in the notification sent to the applicant and (or) in the Register, the applicant has the right to direct the application for need of correction of the made typographical errors and (or) mistakes with statement of essence made typographical errors and (or) mistakes and application of a copy of the document containing typographical errors and (or) mistakes.

67. The executive in charge appointed the head of department within 1 working day from the date of receipt of the corresponding statement performs the data specified in the statement.

68. In case of identification of the made typographical errors and (or) mistakes the executive in charge performs according to the procedure for clerical work established in Roszdravnadzor (territorial authority) correction of such typographical errors and (or) mistakes in time, not exceeding 3 working days from the date of receipt in Roszdravnadzor (territorial authority) of the corresponding statement.

69. Decision acceptance criterion on ministerial procedure is availability or lack of such typographical errors and (or) mistakes in the notifications sent to the applicant and (or) the Register.

70. Correction of the made typographical errors and (or) mistakes in the notification sent to the applicant and (or) in the Register is result of ministerial procedure.

IV. Forms of control of provision of the state service

Procedure of the current control of observance and execution by responsible officials of provisions of Administrative regulations and other regulatory legal acts establishing requirements to provision of the state service and also adoption of decisions by them

71. The current control of respect for the sequence of the actions determined by ministerial procedures by provision of the state service is performed by the head and officials of Roszdravnadzor (territorial authority) responsible for the organization of work on provision of the state service, by conducting checks of observance and execution by executives in charge of provisions of Administrative regulations, other regulatory legal acts of the Russian Federation, and also when carrying out internal audit of effectiveness of provision of the state service (further - check).

72. Checks of completeness and quality of provision of the state service include conducting checks, identification and elimination of violations of the rights of applicants, consideration, decision making and preparation of answers to the addresses of applicants containing claims to actions (failure to act) and decisions of the officials of Roszdravnadzor (territorial authority) responsible for provision of the state service.

Procedure and frequency of implementation of scheduled and unscheduled inspections of completeness and quality of provision of the state service, including procedure and forms of control of completeness and quality of provision of the state service

73. Carrying out scheduled and unscheduled inspections is performed for the purpose of identification of violations of procedure for provision of the state service, including timeliness and completeness of consideration of addresses of applicants, justification and legality of adoption of decisions on them.

74. Scheduled inspections of completeness and quality of provision of the state service are carried out by authorized officers of Roszdravnadzor (territorial authority) at least 1 time a year.

75. The annual plan of checks is established by the head of Roszdravnadzor (territorial authority).

76. Unscheduled inspections of completeness and quality of provision of the state service are carried out by the structural division of Roszdravnadzor (territorial authority) performing acceptance and accounting of notifications with participation of authorized officers of divisions of Roszdravnadzor (territorial authority) for the specific address (claim) of citizens or legal entities on decisions or the actions (failure to act) of officials of Roszdravnadzor (territorial authority) taken or performed during provision of the state service.

77. Results of check are drawn up in the form of the act and signed by authorized officers of Roszdravnadzor (territorial authority).

Responsibility of officials of Roszdravnadzor (territorial authority) for the decisions and actions (failure to act) taken (performed) by them during provision of the state service

78. The personal responsibility of officials of Roszdravnadzor (territorial authority) for provision of the state service is enshrined in their official regulations according to requirements of the legislation of the Russian Federation.

79. The contractor responsible for provision of the state service bears the personal responsibility for:

1) consideration of the documents provided by the applicant;

2) adherence to deadlines and procedure for acceptance and accounting of notifications;

3) observance of procedure, including terms of provision of the state service;

4) reliability of the data entered in the Register.

The provisions characterizing requirements to procedure and forms of control of provision of the state service including from citizens, their associations and the organizations

80. Citizens, their associations and the organization can control provision of the state service by receipt of information by phone, e-mail, on the official site of Roszdravnadzor (territorial authority) and through the Single portal, and also by means of receipt of answers to written addresses.

81. Control of provision of the state service from authorized officers of Roszdravnadzor (territorial authority) shall be permanent, comprehensive and objective.

82. For control of provision of the state service citizens, their associations and the organizations have the right to send to Roszdravnadzor and its territorial authorities individual and collective addresses with offers, recommendations about quality excellence and procedure for provision of the state service, and also the statement and the claim with the message on violation by the officials of Roszdravnadzor (territorial authority) responsible for the organization of work on provision of the state service, requirements of these Administrative regulations, legal and legal acts.

V. Pre-judicial (extrajudicial) procedure for appeal of decisions and actions (failure to act) of Roszdravnadzor (territorial authority), and also their officials

Information for interested persons on their right to pre-judicial (extrajudicial) appeal of actions (failure to act) and (or) the decisions made (performed) during provision of the state service (further - the claim)

83. Interested persons have the right to appeal actions (failure to act) of officials of Roszdravnadzor (territorial authority) and the decisions made (performed) by them during provision of the state service in pre-judicial (extrajudicial) procedure.

84. To interested persons the possibility of the direction of the claim to decisions, actions (failure to act) of Roszdravnadzor (territorial authority), the official of Roszdravnadzor (territorial authority) according to article 11.2 of the Federal Law of July 27, 2010 is provided to No. 210-FZ "About the organization of provision of the state and municipal services" and according to the procedure, No. 1198 established by the order of the Government of the Russian Federation of November 20, 2012 "About the federal state information system providing process of pre-judicial (extrajudicial) appeal of the decisions and actions (failure to act) made by provision of the state and municipal services" <8>.

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<8> Russian Federation Code, 2012, No. 48, Art. 6706; 2013, No. 52, Art. 7218; 2015, No. 2, Art. 518; 2018, No. 49, Art. 7600.

85. Interested persons can address with the claim including in the following cases:

1) violation of term of registration of a statement;

2) violation of term of provision of the state service;

3) the requirement of representation by the applicant of the documents which are not provided by regulatory legal acts of the Russian Federation for provision of the state service;

4) refusal in documents acceptance which representation is provided by regulatory legal acts of the Russian Federation for provision of the state service;

5) refusal in provision of the state service if the bases of refusal are not provided by the Federal Laws and other regulatory legal acts of the Russian Federation accepted according to them;

6) the requirement of introduction by the applicant by provision of the state service of the payment which is not provided by regulatory legal acts of the Russian Federation;

7) refusal of officials in correction of the made typographical errors and (or) mistakes in required data (the notification sent to the applicant and (or) in the Register);

8) violation of term or procedure for issue of documents by results of provision of the state service;

9) suspension of provision of the state service if the bases of suspension are not provided by the Federal Laws and other regulatory legal acts of the Russian Federation accepted according to them.

Public authorities, the organizations and claims of person authorized for consideration to which the claim of the applicant in pre-judicial (extrajudicial) procedure can be sent

86. The claim to decisions, actions (failure to act) of the official of Roszdravnadzor (territorial authority) can be submitted addressed to the head of Roszdravnadzor (territorial authority).

87. The claim to decisions, actions (failure to act) of the head of territorial authority can be submitted to Roszdravnadzor.

88. The claim to decisions, actions (failure to act) of the head of Roszdravnadzor can be submitted to the Ministry of Health of the Russian Federation.

Methods of informing applicants on procedure for giving and consideration of the claim, including with use of the Single portal of the state and municipal services (functions)

89. Informing interested persons on procedure for submission of the claim is performed on the official site of Roszdravnadzor and its territorial authorities, on the Single portal.

The list of the regulatory legal acts regulating procedure for pre-judicial (extrajudicial) appeal of decisions and actions (failure to act) of Roszdravnadzor (territorial authority) and also his officials

90. The relations arising in connection with pre-judicial (extrajudicial) appeal of decisions and actions (failure to act) of Roszdravnadzor (territorial authority) and also officials of Roszdravnadzor (territorial authority), are regulated by the following regulatory legal acts:

1) the Federal Law of July 27, 2010 No. 210-FZ "About the organization of provision of the state and municipal services";

2) the order of the Government of the Russian Federation of August 16, 2012 No. 840 "About procedure for giving and consideration of claims to decisions and actions (failure to act) of federal executive bodies and their officials, federal government employees, officials of state non-budgetary funds of the Russian Federation, the state corporations given according to the Federal Laws authority on provision of the state services in the established field of activity and their officials, the organizations provided by part 1.1 of article 16 of the Federal law "About the Organization of Provision of the State and Municipal Services" and their workers, and also the multipurpose centers of provision of the state and municipal services and their workers" <9>.

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<9> Russian Federation Code, 2012, No. 35, Art. 4829; 2018, No. 25, Art. 3696.

91. The list of the regulatory legal acts regulating procedure for pre-judicial (extrajudicial) appeal of decisions and actions (failure to act) of Roszdravnadzor (territorial authority) and also officials, is posted on the official site of Roszdravnadzor and its territorial authorities, on the Single portal.

Information containing in the Section V of these Administrative regulations is subject to placement at the information stand or the information terminal (are established in the place, convenient for citizens), on the official site of Roszdravnadzor and its territorial authorities, on the Single portal.

Information specified in this Section is subject to placement on the Single portal.

Roszdravnadzor provides placement and updating of data in appropriate section of the federal register.

 

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