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 February 11, 2019 No. 918

About approval of Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in issue of the conclusions (allowing documents) for import to the Russian Federation and export from the Russian Federation of samples of biological materials of the person (except for biological material of the person received when performing clinical trial of medicine for medical application, and biological material of the person received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial), haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos

According to the Federal Law of July 27, 2010 No. 210-FZ "About the organization of provision of the state and municipal services" (The 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, the Art. 4858), 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" (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 issue of the conclusions (allowing documents) for import to the Russian Federation and export from the Russian Federation of samples of biological materials of the person (except for biological material of the person received when performing clinical trial of medicine for medical application, and biological material of the person received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial), haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos.

Approved by the Order of the Federal Service of the Russian Federation on supervision in the field of health care of February 11, 2019, No. 918

Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in issue of the conclusions (allowing documents) for import to the Russian Federation and export from the Russian Federation of samples of biological materials of the person (except for biological material of the person received when performing clinical trial of medicine for medical application, and biological material of the person received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial), haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos

I. General provisions

Subject of regulation of Administrative regulations

1. Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in issue of the conclusions (allowing documents) for import to the Russian Federation and export from the Russian Federation of samples of biological materials of the person (except for biological material of the person received when performing clinical trial of medicine for medical application, and biological material of the person received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial), haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos (further respectively - Administrative regulations, the state service), establishes terms and the sequence of ministerial procedures (actions) of the Federal Service for supervision in the field of health care (further - Roszdravnadzor), order of interaction between structural divisions of Roszdravnadzor, his officials, and also interactions of Roszdravnadzor with applicants, other public authorities and local government bodies, the organizations by provision of the state service.

2. The state service is provided concerning samples of biological materials of the person (except for biological material of the person received when performing clinical trial of medicine for medical application, and biological material of the person received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial), haematopoietic stem cells, marrow, donor lymphocytes for the purpose of the performing unrelated transplantation, gametes and embryos included in Section 2.21 of the Inventory concerning which the allowing procedure for import to customs area of the Eurasian Economic Union and (or) export from customs area of the Eurasian Economic Union (The decision of Board of the Eurasian economic commission of April 21, 2015 No. 30) (The Official site of the Eurasian Economic Union of http://www.eaeunion.org/, 22.04 is established. 2015, 17.06. 2015, 02.09. 2015, 07.10. 2015, 18.11. 2015, 18.05. 2016, 03.06. 2016, 15.06. 2016, 31.08.2016, 28.09.2016, 01.01. 2017, 17.01. 2017, 03.07. 2017, 08.08. 2017, 05.09. 2017, 16.11. 2017, 15.12. 2017, 27.04.2018, 18.06. 2018, 19.10. 2018) (further - the List).

3. The state service is provided when importing to the Russian Federation from the third countries on customs area of the Eurasian Economic Union and export from the Russian Federation to the third countries from customs area of the Eurasian Economic Union of samples of biological materials of the person (except for biological material of the person received when performing clinical trial of medicine for medical application, and biological material of the person received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial), haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos.

Circle of applicants

4. Applicants on provision of the state service (further - applicants) are:

1) legal entities;

2) the physical persons registered as individual entrepreneurs;

3) physical persons (regarding import, export of samples of the biological materials of the person intended for private use).

Requirements to procedure for informing on provision of the state service

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

on the official site of Roszdravnadzor on the Internet (further - the official site of Roszdravnadzor, 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 federal state information system "The federal register of the state services (functions) (further - the federal register);

at information stands in reception on work with addresses of citizens;

on phone numbers for reference.

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

on the official site of Roszdravnadzor;

on the Single portal;

in the federal register;

at information stands.

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

7. 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.

8. On the official site of Roszdravnadzor and 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 forms of statements (notifications, messages) used by service provision.

9. Information on the Single portal and the official site of Roszdravnadzor 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

10. The state service in issue of the conclusion (the allowing document) for import to the Russian Federation and export from the Russian Federation of samples of biological materials of the person (except for biological material of the person received when performing clinical trial of medicine for medical application, and biological material of the person received when performing clinical trial of biomedical cellular product for its studying for the purpose of this clinical trial), haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos (further - the conclusion (the allowing document).

The name of the body providing the state service

11. The state service is provided by Roszdravnadzor.

12. 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" (The 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, the Art. 390) (further - the order of the Government of the Russian Federation of May 6, 2011 No. 352).

Description of result of provision of the state service

13. Results of provision of the state service are:

1) issue (direction) to the applicant of the conclusion (allowing document);

2) issue (direction) to the applicant of the notification on refusal in issue of the conclusion (the allowing document) with indication of causes of failure.

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

14. The term of provision of the state service and issue (direction) of the documents which are result of provision of the state service constitutes 5 working days from the date of registration in Roszdravnadzor of the documents which arrived from the applicant.

The regulatory legal acts regulating provision of the state service

15. The list of the regulatory legal acts regulating provision of the state service is posted on the official site of Roszdravnadzor, 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

16. For provision of the state service the applicant represents (sends) the following documents <1> to Roszdravnadzor:

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<1> Item 16 of the Regulations on import to customs area of the Eurasian Economic Union and export from customs area of the Eurasian Economic Union of bodies and tissues of the person, blood and its components, samples of biological materials of the person (The decision of Board of the Eurasian economic commission of April 21, 2015 No. 30) (The Official site of the Eurasian Economic Union of http://www.eaeunion.org/, 22.04. 2015, 17.06. 2015, 02.09. 2015, 07.10. 2015, 18.11. 2015, 18.05. 2016, 03.06. 2016, 15.06. 2016, 31.08.2016, 28.09.2016, 01.01. 2017, 17.01. 2017, 03.07. 2017, 08.08. 2017, 05.09. 2017, 16.11. 2017, 15.12. 2017, 27.04.2018, 18.06. 2018, 19.10. 2018).

1) the statement for issue of the conclusion (the allowing document) constituted in any form;

2) the draft of the conclusion (the allowing document) which is drawn up according to methodical instructions for filling of single form of the conclusion (the allowing document) for import, export and transit of the separate goods included in the single inventory to which measures of non-tariff regulation in trade with the third countries approved by the Decision of Board of the Eurasian economic commission of May 16, 2012 No. 45 are applied;

3) the copy of the agreement (contract), and in case of lack of the agreement (contract) - the copy of other document confirming intentions of the parties;

4) the copy of the license for implementation of the licensed type of activity or data on availability of the license for implementation of the licensed type of activity (if it is stipulated by the legislation state member) if such type of activity is connected with circulation of goods concerning which licensing on customs area of the Union is introduced;

5) the informed consent of the patient or his legal representatives on movement of samples of biological materials of the person, except as specified movements of such samples for carrying out external control of quality of researches, including for carrying out referens-researches.

17. For receipt of the conclusion (the allowing document) by physical person when moving samples of biological materials of the person in goods quality for private use, are represented the following documents (go) to Roszdravnadzor:

1) the statement for issue of the conclusion (the allowing document) constituted in any form;

2) the draft of the conclusion (the allowing document) provided by the subitem 2 of Item 16 of Administrative regulations;

3) copy of the identity document of the applicant;

4) the informed consent of the patient or his legal representatives on movement of samples of biological materials of the person.

18. The statement for issue of the conclusion (the allowing document), the documents attached to it are submitted by the applicant directly or go to Roszdravnadzor the registered mail with the assurance of receipt.

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 service 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.

Data on availability of the license for implementation of the medical activities (except for the specified activities performed by the medical organizations and other organizations entering private health care system, in the territory of the innovative center "Skolkovo") performed in the territory of the Russian Federation are at the disposal of Roszdravnadzor.

20. Roszdravnadzor has no right 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" (The Russian Federation Code, 2010, No. 31, of 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, the Art. 4858) (further - the Federal Law of July 27, 2010 No. 210-FZ);

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, except as specified, stipulated in Item 4 parts 1 of article 7 of the Federal Law of July 27, 2010 to No. 210-FZ.

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 of provision of the state service are not provided.

23. The bases for refusal in provision of the state service are:

a) non-presentation of the documents provided by Items 16 and 17 of Administrative regulations;

b) availability of incomplete or false information in the documents submitted for receipt of the conclusion (the allowing document).

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

24. 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

25. 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

26. 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

27. The maximum term of expectation in queue when giving request about provision of the state service and 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

28. The statement and documents which arrived from the applicant in Roszdravnadzor for receipt of the state service within 1 working day from the date of their receipt are registered the officials of Roszdravnadzor responsible for acceptance and document registration.

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

29. The room in which the state service is provided, the waiting room, the place for filling of requests about provision of the state service shall be 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 the following documents (data) in electronic form or on paper:

to copies of the regulatory legal acts regulating activities for provision of the state service;

to the text of Administrative regulations.

30. Visual, text and multimedia information on procedure for provision of the state service, including with models of filling and the list of the documents necessary 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.

Execution of visual, text and multimedia information on procedure for provision of the state service shall correspond to optimum visual and acoustical perception of this information by visitors.

31. The entrance and movement on rooms in which are performed receiving and delivery of the documents necessary for provision of the state service shall not create difficulties for persons with limited opportunities.

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

conditions for easy access to object (the building, the room) in which the state service, and also conditions 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 services, and also entrance to such objects and exit from them, landing in the vehicle and disembarkation from it, including with use of wheelchair are 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 services, and to services taking into account restrictions of their life activity are 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 services are provided;

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

In case of impossibility to completely adapt object taking into account needs of disabled people the owner of object 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" <2> shall take measures for ensuring access of disabled people to the place of provision of service, or provide its provision at the place of residence of the disabled person or in the remote mode.

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<2> 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

33. Indicators of availability and quality 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) of officials of Roszdravnadzor;

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 by provision of the state service;

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

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

34. Electronically with use of the Single portal accomplishment of the following actions is provided to the applicant:

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

pre-judicial (extrajudicial) appeal of decisions and actions (failure to act) of Roszdravnadzor, official of Roszdravnadzor.

35. In the course of provision of the state service the applicant interacts with officials of Roszdravnadzor 2 times:

1) in case of submission of documents for receipt of the conclusion (the allowing document);

2) in case of receipt of the conclusion (the allowing document) or notifications on refusal in issue of the conclusion (the allowing document);

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

36. The possibility of receipt of the state service in territorial authorities of Roszdravnadzor (the exterritorial principle) is not provided.

37. 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

38. Opportunity is electronically provided to the applicant:

receipts of information on procedure and terms of provision of the state service;

on pre-judicial (extrajudicial) appeal of decisions and actions (failure to act) of Roszdravnadzor, the official of Roszdravnadzor.

III. Structure, sequence and terms of accomplishment of ministerial procedures (actions), requirements to procedure for their accomplishment, including feature of accomplishment of ministerial procedures (actions) electronically

Exhaustive list of ministerial procedures (actions)

39. By provision of the state service the following ministerial procedures (actions) are performed:

1) acceptance, registration of a statement and documents necessary for provision of the state service;

2) consideration of the documents on provision of the state service which arrived from the applicant and decision making about issue (direction) of the conclusion (the allowing document) or about refusal in issue (direction) of the conclusion (the allowing document);

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

40. Implementation of ministerial procedures electronically, including with use of the Single portal, is not provided.

41. The ministerial procedures (actions) performed in the multipurpose centers of provision of the state and municipal services no.

Acceptance, registration of a statement and documents necessary for provision of the state service

42. The basis for ministerial procedure is receipt in Roszdravnadzor of the statement for issue of the conclusion (the allowing document) and the documents provided by Items 16 or 17 of Administrative regulations.

43. The statement and documents necessary for provision of the state service and provided to Roszdravnadzor (including electronically), are registered in Administration of Roszdravnadzor.

44. The statement and documents submitted to Roszdravnadzor for the purpose of provision of the state service go to the department performing issue of the conclusions (allowing documents).

45. Control of accounting of the arrived documents is daily exercised by the head of department of Roszdravnadzor performing issue of the conclusions (allowing documents) (further - the head of department).

46. Decision acceptance criterion on ministerial procedure is availability of the statement and the documents necessary for provision of the state service.

47. Registration of a statement and the documents necessary for provision of the state service is result of ministerial procedure.

Consideration of the documents on provision of the state service which arrived from the applicant and decision making about issue (direction) of the conclusion (the allowing document) or about refusal in issue (direction) of the conclusion (the allowing document)

48. The basis for ministerial procedure is registration arrived the statement and the documents necessary for provision of the state service.

49. The head of department in day of registration of the documents which arrived in Roszdravnadzor from the applicant appoints from number of persons employed of department of the contractor responsible for consideration of the documents submitted for receipt of the conclusion (the allowing document) (further - 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.

50. The executive in charge, no later than the next working day from the date of receipt of the statement for issue of the conclusion (the allowing document) and the documents provided by Items 16 or 17 of Administrative regulations carries out assessment of their completeness, reliability of the data provided to them.

51. In the absence of the bases for refusal in provision of the state service, stipulated in Item 23 Administrative regulations, the executive in charge within 1 working day performs preparation of the draft of the conclusion (the allowing document) and approves it with the head of department of Roszdravnadzor performing issue of the conclusions (allowing documents) (further - the head of department).

In the presence of the bases for refusal in provision of the state service, stipulated in Item 23 Administrative regulations, the executive in charge within 1 working day performs preparation of the draft of the notification on refusal in issue of the conclusion (the allowing document) with indication of causes of failure and approves with the head of department.

52. The conclusion (the allowing document), the notification on refusal in issue of the conclusion (the allowing document) are signed by the head of Roszdravnadzor (his deputy).

The conclusion (the allowing document), the notification on refusal in issue of the conclusion (the allowing document) are issued to the applicant (the authorized representative of the applicant) directly or go the registered mail with the assurance of receipt.

53. Decision acceptance criterion on ministerial procedure is availability or lack of the bases for refusal in issue of the conclusion (the allowing document).

54. Results of ministerial procedure are:

1) decision making about issue (direction) of the conclusion (the allowing document);

2) decision making about refusal in issue (direction) of the conclusion (the allowing document).

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

55. In case of identification by the applicant in the conclusion (the allowing document) of typographical errors and (or) mistakes the applicant submits the application for correction of such typographical errors and (or) mistakes in Roszdravnadzor.

56. 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.

57. In case of identification of the made typographical errors and (or) mistakes the executive in charge performs correction of such typographical errors and (or) mistakes in time, not exceeding 3 working days from the date of receipt in Roszdravnadzor of the corresponding statement.

58. Decision acceptance criterion on ministerial procedure is availability or lack of such typographical errors and (or) mistakes in the conclusion (the allowing document).

59. Correction of typographical errors and (or) mistakes in the issued documents 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

60. 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 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).

61. 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 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

62. 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.

63. Scheduled inspections of completeness and quality of provision of the state service are carried out by authorized officers of Roszdravnadzor in accordance with the established procedure, but at least 1 time a year.

64. The annual plan of checks is established by the head of Roszdravnadzor.

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

66. Results of check are drawn up in the form of the act and signed by authorized officers of Roszdravnadzor.

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

67. The personal responsibility of officials of Roszdravnadzor for provision of the state service is enshrined in their official regulations.

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

1) consideration of the documents submitted by the applicant;

2) adherence to deadlines and procedure for documents acceptance;

3) observance of procedure, including terms, provisions of the state service.

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

69. 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 and through the Single portal, and also by means of receipt of answers to written addresses.

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

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

71. To interested persons the possibility of the direction of the claim to decisions, actions or failure to act of Roszdravnadzor, the official of Roszdravnadzor according to article 11.2 of the Federal Law of July 27, 2010 is provided to No. 210-FZ 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" (The Russian Federation Code, 2012, No. 48, Art. 6706; 2013, No. 52, Art. 7218; 2015, No. 2, Art. 518; 2018, No. 49, Art. 7600).

72. 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 mistakes in required data;

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

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

74. 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)

75. Informing interested persons on procedure for submission of the claim is performed on the official site of Roszdravnadzor and 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 and also his officials

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

1) the Federal Law of July 27, 2010 No. 210-FZ;

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" (The Russian Federation Code, 2012, No. 35, Art. 4829; 2014, No. 50, Art. 7113; 2015, No. 47, Art. 6596; 2016, No. 51, Art. 7370; 2017, No. 44, Art. 6523; 2018, No. 25, Art. 3696).

77. The list of the regulatory legal acts regulating procedure for pre-judicial (extrajudicial) appeal of decisions and actions (bezdeystviye) of Roszdravnadzor and also his officials, is posted on the official site of Roszdravnadzor in Internet network, in the federal register and 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.

 

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