ORDER number 23N

MINISTRY OF HEALTH
OF THE RUSSIAN FEDERATION
(MINISTRY OF HEALTH OF RUSSIA)

ORDER number 23N

January 25, 2019

Moscow

About approval of
Administrative Regulations of the Ministry of Health
of the Russian Federation for the provision of public services
on registration of medicines intended
for circulation in the general market of medicines
in the framework of the Eurasian Economic Union, in accordance
with the Rules of registration and examination of medicines
for medical use, approved by decision of
Council of the Eurasian Economic Commission on November 3, 2016 № 78

    In accordance with the Resolution of the Government of the Russian Federation dated May 16, 2011 No. 373 “On the development and approval of administrative regulations for the implementation of state control (supervision) and administrative regulations for the provision of public services” (collected legislation of the Russian Federation, 2011, No. 22, Art. 3169; No. 35, Article 5092; 2012, No. 28, Article 3908; No. 36, Article 4903; No. 50, Article 7070; No. 52, Article 7507; 2014, No. 5, Article 506; 2017, No. 44 , Article 6523; 2018, No. 6, Article 880; No. 25, Article 3696; No. 36, Article 5623; No. 46, Article 7050) I order: To approve the attached Administrative Regulations of the Ministry of Health of the Russian Federation for the provision of state services for registration of medicines intended for circulation on the general market of medicines within the Eurasian Economic Union, in accordance with the Rules for registration and examination of medicines for medical use, approved by the decision of the Council of the Eurasian Economic Commission of November 3, 2016 No. 78

Minister   V.I. Skvortzova

APPROVED
by order of the Ministry of Health
of the Russian Federation
dated January 25, 2019 No. 23N

About approval of
Administrative Regulations of the Ministry of Health
of the Russian Federation for the provision of public services
on registration of medicines intended
for circulation in the general market of medicines
in the framework of the Eurasian Economic Union, in accordance
with the Rules of registration and examination of medicines
for medical use, approved by decision of
Council of the Eurasian Economic Commission on November 3, 2016 № 78.

I. General provisions

The subject of regulation of the Administrative Regulations

1. Administrative regulations of the Ministry of Health of the Russian Federation for the provision of state services for registration of medicines intended for circulation on the general market of medicines within the Eurasian Economic Union, in accordance with the Rules for registration and examination of medicines for medical use, approved by the decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016 (hereinafter referred to as the Regulations) establishes the terms and sequence of administration procedures, actions of the Ministry of Health of Russia, carried out in the framework of the provision of public services, and also establishes the procedure for interaction between the structural units of the Ministry of Health of Russia, its officials, and the interaction of the Ministry of Health of the Russian Federation with the applicants, other state authorities, and authorized bodies of the member states of the Eurasian Economic Union , institutions and organizations in the provision of public services.

This regulation does not apply to medicinal products specified in subclause “a” of clause 3 of the Rules for Registration and Examination of Medicinal Products for Medical Use, approved by the decision of the Council of the Eurasian Economic Commission No. 78 of November 3, 2016 (hereinafter referred to as the Registration Rules).

Circle of applicants

    2. An applicant for the provision of a state service (hereinafter referred to as the applicant) is the legal entity mentioned in paragraph 15th of clause 19 of the Registration Rules which has right to apply for registration, confirmation of registration (re-registration), changes in the registration dossier of drugs, other procedures related to registration, and responsible for the accuracy of the information contained in the documents submitted by it and the data of the registration dossier or provided for in paragraph fourteenth  of clause 19 of the Rules of registration or a legal entity in whose name the registration certificate of a medicinal product was issued and which is responsible for the safety, efficacy and quality of medicines.

Requirements for the procedure of informing on the provision of public services

    3. Informing about the procedure for providing public services is carried out by the Ministry of Health of Russia:

    1) by posting information, including the schedule for receiving applicants and telephone numbers for information on the official website of the Russian Ministry of Health on the Internet information and telecommunications network (hereinafter referred to as the Internet): www.rosminzdrav.ru (hereinafter referred to as the official website of the Ministry of Health of Russia);
    2) in the Federal State Information System “Unified Portal of State and Municipal Services (Functions)”: www.gosuslugi.ru (hereinafter referred to as the Unified Portal);
    3) on information stands in the reception room of the Ministry of Health of Russia;
    4) by phone numbers for references;
    5) in the media.

    4. Other federal executive bodies involved in the provision of public services:

    1) The Federal Tax Service (FTS of Russia);
    2) Federal Treasury (Russian Treasury);
    3) the Ministry of Industry and Trade of the Russian Federation (the Ministry of Industry and Trade of Russia);
    4) Federal Service for Supervision of Health in the Russian Federation (Roszdravnadzor).

    5. The following information and documents are posted on the official website and information stands of the Ministry of Health of Russia:

    1) these regulations and the list of regulatory legal acts of the Russian Federation governing the provision of public services;
    2) the schedule of admission of applicants and telephone numbers for references (consultations);
    3) bank details for paying the state fee;
    4) samples of applications and documents submitted for receiving the state service;
    5) the procedure for obtaining advice;
    6) the procedure for appealing decisions, actions or omissions of officials providing the public service;
    7) information about the electronic address of the Single portal.

    6. Informing is carried out orally or in writing at the personal request of the applicant, via telephone or e-mail.
Information submitted by applicants must be complete, reliable, understandable, descriptive, readable and operational.

II. State Service Standard

Name of state service

    7. The state service on registration of drugss intended for circulation on the general market of drugs within the Eurasian Economic Union, in accordance with the Rules for registration and examination of medicines for medical use, approved by the decision of the Council of the Eurasian Economic Commission of November 3, 2016 No. 78.

Name of the federal executive body providing public service

    8. The state service is provided by the Ministry of Health of Russia.
    9. When providing public services, the Ministry of Health of Russia interacts with:
    1) FTS of Russia;
    2) the Treasury of Russia;
    3) Ministry of Industry and Trade of Russia;
    4) Roszdravnadzor;
    5) authorized bodies (expert organizations) of the Member States of the Union;
    6) the Eurasian Economic Commission (hereinafter - the Commission);
    7) the expert committee on medicinal products for medical use at the Eurasian Economic Commission (hereinafter - the expert committee);
    8) other units, committees and working groups with the Commission.
    10. It is forbidden to require the applicant to take actions, including approvals, necessary for obtaining a public service and related to applying to other state bodies and organizations, except for obtaining services included in the list of services that are necessary and mandatory for the provision of public services, approved by the Government of the Russian Federation.

Description of the result of the provision of public services

    11. The results of the provision of public services are:
    1) issuance (direction) of a registration certificate of a medicinal product in the form given in Appendix 17 to the Registration Rules, approved general characteristics of the medicinal product (hereinafter referred to as SmPC), instructions for medical use (package leaflet), Normative Document on quality, packaging mockups, expert assessment report, an agreed risk management plan for the use of the drug (hereinafter - ERP) (if necessary) in accordance with the type of application for the provision of public services and, the conclusion of the Union on a plasma master file with an expert report attached (if necessary), the Union's conclusion on a master file of a vaccine agent with an expert report attached (if necessary);
    2) issuing (sending) a notification of the refusal on registration of a medicinal product with an indication of the reasons for making such a decision;
    3) issuing (sending) a notification of approval of making changes to the registration dossier of the registered drug, approved SmPC, package leaflet, Normative document, packaging mock-ups, expert assessment report, agreed by the ERP (in case changes are made to these variations);
    4) issuance of a notice of refusal to make changes to the registration dossier of a registered medicinal product with an indication of the grounds for making such a decision;
    5) issuing (sending) notification (approval) of making re-registration of the medicinal product;
    6) issuance of a notice of refusal to re-register the medicinal product, indicating the grounds for making such a decision;
    7) issuing (sending) a notification about bringing the registration dossier of a medicinal product in compliance with the requirements of the EAEU;
    8) issuance of a notice of refusal to bring the registration dossier of a medicinal product in accordance with the requirements of the EAEUn, indicating the grounds for making such a decision;
    9) issuing a decision on cancellation of the registration certificate of a medicinal product and exclusion of a medicinal product from the Unified Register of Registered Medicines of the Eurasian Economic Union (hereinafter referred to as the Unified Register of the EAEU), indicating the grounds for such a decision;
    10) issuance of a duplicate of the registration certificate of the medicinal product, prepared in accordance with Appendix No. 17 to the Registration Rules;
    11) issuance of a notice of refusal to issue a duplicate of the registration certificate of the medicinal product, indicating the grounds for making such a decision;
    12) placement of information in the Unified Register of the EAEU.

Terms of state service

    12. The term of registration and examination of the drug should not
exceed in the case of a decentralized procedure - 210 calendar days; in the case of the mutual recognition procedure - 210 calendar days (registration in the reference state), registration in the recognition state – 100 calendar days from the date of submission of the application for registration of the medicinal product specified in clause 19 of the Regulations to the date of placement of information in the unified register of the Union and issuance of the registration certificate.
    13. The term for amending the documents contained in the registration dossier of a registered medicinal product is 90 calendar days from the date of receipt of the documents specified in clause 23 or 24 of the Regulations.
    14. The deadline for making a decision to revoke a registration certificate of a medicinal product and exclude a medicinal product from the Unified Register of the EAEU is 5 working days from the day of occurrence of one of the grounds specified in paragraph 160 of the Registration Rules.
    15. The term of re-registration of the medicinal product is 120 calendar days from the date of the submission of the application for re-registration;
    16. The term for bringing the registration dossier of a medicinal product in
Compliance with the requirements of the EAEU - 100 calendar days from the date of the submission of the relevant application.
    17. The deadline for issuing a notice of refusal to register a drug is 10 business days from the date of such a decision.

The list of regulatory legal acts regulating relations arising from the provision of public services

18. The list of regulatory legal acts regulating relations arising in connection with the provision of public services is posted on the official website of the Ministry of Health of Russia, the information system “The State Register of Medicinal Products” and the Unified Register of the EAEU.

An exhaustive list of documents
required in accordance with regulatory legal acts
for the provision of public services and services that
are needed and required to provide
public service to be provided by
the applicant, the methods for obtaining them by the applicant, including
in electronic form, the order of their submission

 19. In order to register the medicinal product, the applicant submits to the Ministry of Health of Russia (as the authorized body of the reference state) the following documents, data and materials:

   1) application on paper and (or) in the form of an electronic document in accordance with Appendix No. 2 to the Registration Rules;
    2) the registration dossier in accordance with annexes No. 1-5 to the Rules for registration on electronic media. Additionally, module 1 of the registration dossier is submitted on paper if necessary (except for the ERP, the master file of the production site (s) and the master file for pharmacovigilance);
    3) samples of drugs (submitted to the federal state budgetary institution of the Ministry of Health of Russia created to ensure the fulfillment of the powers of the Ministry of Health of Russia to issue permits for conducting clinical trials of drugs and (or) on state registration of drugs (hereinafter – expert institution).
    Standard samples of active substances and related impurities, specific reagents and other materials necessary for testing samples of drugs specified in subparagraph 3 of this paragraph shall be submitted in consultation with the expert institution.
    Samples of drugs, specific reagents and other materials are presented in quantities agreed with the expert institution and necessary to conduct no more than a triple analysis in accordance with the requirements of the specification of the finished drug or other specifications included in the registration dossier, in a period agreed upon by the Ministry of Health of Russia not included in the general term of examination and registration of the drug.

    20. The applicant shall submit to the Ministry of Health of Russia (as the authorized body of the state of recognition) the following documents:

    1) application on paper and (or) in the form of an electronic document in accordance with Appendix No. 2 to the Registration Rules;
    2) module 1 of the registration dossier on paper and (or) in the form of an electronic document.

    21. In order to re-register the medicinal product the applicant submits to the Ministry of Health of Russia (as the authorized body of the reference state) the following documents:

    1) application on paper and (or) in the form of an electronic document in accordance with Appendix No. 2 to the Registration Rules;
    2) modules 1 and 2 of the registration dossier, prepared in accordance with Annexes No. 1-5 to the Registration Rules, on electronic media.

    22. In order to re-register the medicinal product the applicant submits to the Ministry of Health of Russia (as the authorized body of the state of recognition):

    1) application on paper and (or) in the form of an electronic document in accordance with Appendix No. 2 to the Registration Rules;
    2) module 1 of the registration dossier on electronic media.

    23. In order to make changes to the registration dossier the applicant presents the registered medicinal product to the Ministry of Health of Russia (as the authorized body of the reference state):

    1) application (notification) on paper and (or) in the form of an electronic document in accordance with Appendix No. 2 to the Registration Rules;
    2) dossier to make changes to the registration dossier of a registered medicinal product (hereinafter referred to as an amendment dossier) (notification) containing the elements listed in Appendix IV to Appendix No. 19 to the Registration Rules in the format described in Appendix No. 20 to the Registration Rules;
    3) a list of dates for submission of applications (notifications) about changes in the registration dossier of a medicinal product in the recognition states and documents confirming payment of the fee for making changes to the registration dossier of a medicinal drug (and its expertise if necessary) in cases and procedures established by the legislation of the recognition states, with indication of classification numbers of changes in accordance with Annex V to Annex No. 19 to the Registration Rules;
    4) samples of drugs, standard samples of active substances and related impurities, specific reagents and other materials necessary for laboratory tests (if necessary and in consultation with an expert institution when making significant changes of type II, affecting the production and quality control defined in Annex No. 19 to the Registration Rules).

    24. In order to make changes to the registration dossier of a registered drug, the applicant submits to the Ministry of Health of Russia (as the authorized body of the state of recognition) a statement (notification) on paper and (or) in the form of an electronic document in accordance with Appendix No. 2 to the Registration Rules.

    25. In order to bring the registration dossier of a medicinal product in compliance with the requirements of the EAEU, the applicant submits to the Ministry of Health of Russia the following documents:

    1) application on paper and (or) in the form of an electronic document in accordance with Appendix No. 2 to the Registration Rules;
    2) modules 1-3 of the registration dossier of the medicinal product in electronic form in accordance with Annexes 1-5 to the Registration Rules and module 1 of the registration dossier of the medicinal product on paper if necessary;
    3) modules 1-5 of the registration dossier in accordance with Annexes No. 1-5 to the Registration Rules in the event of further registration under the procedure established by Chapter V of the Registration Rules in the Member States of the Union in which such a drug was not registered before the Agreement entered on or before December 31, 2020. All available data of preclinical and clinical studies performed prior to the entry into force of the Agreement, in this case, are presented in accordance with Appendix No. 1 to the EAEU Registration Rules in modules 4-5 of the registration dossier of a medicinal product in the form of relevant reports without compulsory bringing them in compliance with the requirements of the Eurasian Economic Union for the preparation of reports on preclinical and clinical studies of the medicinal product provided by the Good Laboratory Practice Rules of the Eurasian Economic Union, the Good Clinical Practice Rules of the Eurasian Economic Union , as well as the rules of the study of bioequivalence of medicinal drug in the Eurasian Economic Union;
    4) written confirmation in free form that the documents and data contained in the submitted updated registration dossier in the format of the general technical document in accordance with Annexes No. 1-5 to the EAEU Registration Rules are identical in content to the registration dossier of the registered drug and do not contain changes to the registration dossier affecting the quality, efficacy, safety, or risk-benefit relationship of a drug.

    26. In order to cancel a registration certificate of a medicinal product and exclude a medicinal product from the Unified Register of the EAEU, the holder of the registration certificate of the medicinal product or its representative shall submit to the Ministry of Health of Russia a statement on the cancellation of the registration of the medicinal product, indicating the reasons for such action and indicating the need to take any additional measures or responses.

    27. In order to obtain a duplicate of the registration certificate, the applicant submits to the Ministry of Health of Russia an application for issuing a duplicate of the registration certificate of the medicinal product.

    28. Application and documents stipulated by clauses 19-27 of the Regulations for submission:
    on paper - submitted by the applicant to the Ministry of Health of Russia directly or sent by registered mail with delivery receipt and investment inventory;
    in the form of an electronic document - are presented using public information and telecommunication networks, including the Internet, and through the Union's Single Portal.
    The Ministry of Health does not have the right to require the applicant to indicate information in the application, as well as to submit documents that are not provided for in paragraphs 19-27 of the Regulations or the Registration Rules.

An exhaustive list of documents required
to provide public services that
are at the disposal of government bodies,
local government and other bodies involved
in the provision of state or municipal services,
and which the applicant is entitled to provide, as well as ways
of their receipt by applicants, including in electronic
form, order of their submission

    29. In order to provide the state service, the following information is required at the disposal of state bodies:

    1) FTS of Russia - information about the applicant, contained in the Unified State Register of Legal Entities;
    2) Treasury of Russia - information about the payment of state duty for the provision of public services. The Ministry of Health of the Russian Federation independently verifies that the applicant pays a relying duty through the state information system on state and municipal payments;
    3) authorized bodies (expert organizations) of the Member States of the EAEU confirming the approval of the expert report on the assessment of the expert institution or confirming the approval by the Ministry of Health of the expert report on the assessment of the reference state;
    4) Roszdravnadzor:

    a) information about the results of pharmaceutical inspections of subjects of circulation of medicinal products for medical use for compliance with the Rules of Good Laboratory Practice of the Eurasian Economic Union in the field of circulation of medicines;
    b) information about the results of pharmaceutical inspections of subjects of circulation of medicinal products for medical use in accordance with the Rules of Good Clinical Practice of the Eurasian Economic Union;
    c) information on the results of pharmaceutical inspections of subjects of circulation of medicinal products for medical use in accordance with the Rules of Good Practice of Pharmacovigilance of the Eurasian Economic Union;

    5) The Ministry of Industry and Trade of Russia - information on the results of the pharmaceutical inspection of subjects of medicinal product circulation for compliance with the Rules of Good Manufacturing Practice of the EAEU;

    30. It is forbidden to demand from the applicant:

    1) submission of documents and information or the implementation of actions, the submission or implementation of which is not provided for by the regulatory legal acts regulating relations arising in connection with the provision of public services;
    2) submission of documents and information that, in accordance with the regulatory legal acts of the Russian Federation, regulatory legal acts of the constituent entities of the Russian Federation and municipal legal acts, are at the disposal of state bodies that provide public services, other state bodies, local self-government bodies and (or) bodies and local governments of organizations involved in the provision of state or municipal services, with the exception of the following documents.

An exhaustive list of reasons for refusal
in accepting documents required for submission
to receive state service

    31. There are no grounds for refusing to accept documents required for the provision of a state service.

Exhaustive list of reasons for suspension
or refusal to provide public services

    32. The basis for the suspension of the provision of public services are:

    1) a request from the Ministry of Health of Russia for the submission of missing additional information, necessary explanations or clarifications of documents and data contained in the registration dossier in accordance with clauses 55, 61, 95, 101, 139, 144, 164, 169, 191, 211, 238 and (or) 264 Registration Rules;
    2) the requests of the states of recognition in accordance with the Registration Rules, when the Ministry of Health of Russia acts as an authorized body of the reference state;
    3) the applicant’s submission of a supplemented notice of a minor change of type IB in accordance with clauses 184 or 231 of the Regulations;
    4) settlement of disagreements between the Member States of the Union regarding the recognition of the expert assessment report, the SmPC projects, package leaflet, packaging mock-ups and ERPs (if necessary) in the expert committee on the basis of clauses 71, 109, 204 or 270 of the Regulations;
    5) the applicant's request in accordance with clauses 71, 109, 204 or 270 of the Regulations.

    33. In accordance with paragraph 64 of the Registration Rules, the Ministry of Health of Russia refuses to register a drug in the following cases:

    a) the ratio of the expected benefits to the possible risks associated with the use of the drug is not favorable;
    6) the effectiveness of the medicinal product is not confirmed by the information provided by the applicant;
    c) the quality of the medicinal product is not confirmed;
    d) the proposed methods and methods of quality control are not reproducible;
    e) the applicant has submitted false information;
    f) according to the results of the appointed inspection during the period of registration of the medicinal product, compliance with the appropriate pharmaceutical practices of the EAEU was not confirmed.

The list of services that are necessary and mandatory for
the provision of public services, including information about the document
(documents) issued by organizations participating in
provision of public services

    34. Services required for the provision of public services are not provided.

The procedure, amount and grounds for charging a state duty or other fee,
charged for the provision of public services.

    35. The payment of state duty for the provision of public services is carried out in the amounts established by paragraph 2 of Article 333.32.113 of the Tax Code of the Russian Federation, prior to the submission of a relevant application to the Ministry of Health of Russia, including using the Unified Portal for details filled in by the body (organization).

The procedure, amount and grounds for charging for the provision of services,
which are necessary and mandatory for the provision of
public services, including information
about the method of calculating the size of such a fee

    36. The fee for the provision of services that are necessary and mandatory for the provision of public services is not charged due to the lack of such services.

The maximum waiting time in the queue when submitting a request
on the provision of public services and upon receipt
result of service provision

    37. The maximum waiting time in the queue in the case of the applicant's direct application to the Ministry of Health of Russia for the submission of documents necessary for the provision of the state service is 15 minutes.

    38. The maximum waiting time in the queue in the case of the applicant's direct application to the Ministry of Health of Russia for obtaining documents resulting from the provision of the state service is 15 minutes.

Term and order of registration of the request of the applicant
on the provision of public services and services,
provided by the organization involved in providing
government services, including in electronic form

    39. Documents received from applicants to the Ministry of Health of Russia, including in the form of an electronic document, are subject to mandatory registration within 1 business day from the day following the day they are received.

    39. Documents received from applicants to the Ministry of Health of Russia, including in the form of an electronic document, are subject to mandatory registration within 1 business day from the day following the day they are received.

    40. Acceptance and registration of documents specified in clause 39 of the Regulations is carried out by the Department of Case Management and Personnel of the Ministry of Health of Russia responsible for the implementation of the administrative procedure for receiving and registering documents when providing a public service, according to an inventory, a copy of which is marked of documents on the day of admission is handed over to the applicant or sent to him by registered mail with notification of receipt or in the form of an electronic document signed by electronic signatures.

Requirements for the premises in which the public service is provided, to the waiting room, places for filling in requests for the provision of public services, information stands with samples of their filling and a list of documents required for the provision of each state service, placement and processing of visual, textual and multimedia information about the procedure for providing such a service, including the provision of accessibility for persons with disabilities to these facilities in accordance with the legislation of the Russian Federation ii about social protection of persons with disabilities

    41. The premises intended for the provision of public services are provided with the necessary equipment, stationery, office furniture, air conditioning, wardrobe, telephone, computer with the ability to print and access the Internet, as well as access to documents and information in electronic form or paper carrier.

    42. Visual, textual and multimedia information about the procedure for providing a public service is posted on an information stand or information terminal installed in a convenient place for people, as well as on the Single Portal, on the website of the Ministry of Health of Russia containing the information specified in the Regulations.

    The presentation of visual, textual and multimedia information on the procedure for the provision of a public service must comply with the optimal visual and auditory perception of such information by the representatives of the applicant.

    43. Entry and movement around the premises where state services are provided should not create difficulties for people with disabilities.
    In accordance with the legislation of the Russian Federation on the social protection of persons with disabilities, they are provided with:
    conditions for unhindered access to the building and the premises in which the public service is provided, as well as for the unimpeded use of transport, communications and information;
    the possibility of independent movement in the territory in which buildings and premises are located in which the state service is provided, as well as entering and exiting such objects, boarding and disembarking the vehicle, including using special means;
    accompaniment of people with persistent impairment of visual function and self-movement;
    proper placement of equipment and information carriers necessary to ensure the unhindered access of persons with disabilities to the buildings and premises in which the public service is provided, taking into account the limitations of their vital activities;
    duplication of sound and visual information necessary for people with disabilities, as well as inscriptions, signs and other textual and graphic information with signs in braille boldface;
    the admission of a sign language interpreter and a sign interpreter;
    The admission of the guide dog to the buildings and premises in which the public service is provided;
    assisting people with disabilities to overcome barriers that prevent them from receiving government services on a par with others.
    If it is impossible to fully adapt buildings and premises to the needs of persons with disabilities, the Ministry of Health of Russia, in accordance with Article 15 of the Federal Law of November 24, 1995 No. 181-ФЗ “On Social Protection of Disabled Persons in the Russian Federation”, is obliged to take measures to ensure that persons with disabilities have access to the place of service or, when possible, provide it at the place of residence of the disabled person or in remote mode.

Indicators of the availability and quality of public services, including the number of interactions with the applicant officials the provision of public services and their duration, the possibility receiving state services in a multifunctional center
the provision of state and municipal services, the possibility of either
the impossibility of obtaining public services in any territorial
subdivision of the public service providing body applicant (extraterritorial principle), the possibility of obtaining information about
state services, including the use of information and communication technology
Indicators of the availability and quality of public services, including
the number of interactions with the applicant officials the provision of public services and their duration, the possibility receiving state services in a multifunctional center the provision of state and municipal services, the possibility of either the impossibility of obtaining public services in any territorial
subdivision of the public service providing body applicant (extraterritorial principle), the possibility of obtaining information about state services, including the use of information and communication technology

    44. Indicators of the availability of public services are:

    location in the area of access to major highways;
    availability of complete and understandable information about the places, procedure and terms for the provision of public services in a publicly accessible place in the building of the Ministry of Health of Russia, in public information and telecommunication networks (including on the official website of the Ministry of Health of Russia);
    the possibility of obtaining information on the progress of the provision of state services, including the use of information and communication technologies;
the presence of the necessary and sufficient number of civil servants, as well as the premises in which documents are received from applicants, the issuance of documents provided for by these regulations in order to meet the deadlines for the provision of public services established by the Union Registration Rules and Regulations.

Indicators of the quality of the provision of public services are:

    meeting the deadlines for the provision of public services; Compliance with the applicants' right to receive relevant and reliable information on the procedure for the provision of public services;
    the number of interactions of the applicant with officials in the direct provision of public services and theirduration;
    lack of complaints about actions (inaction) of officials licensing authority.
    The interaction of the applicant with state civil servants of the Ministry of Health of Russia is carried out at the personal request of the applicant:
    for submission of documents required for the provision of public services;
    to obtain the result of the provision of public services.

The duration of the applicant's interaction with civil servants of the Ministry of Health of Russia in the provision of public services should be no more than:

    15 minutes - when receiving documents related to the provision public service;
    10 minutes - when issuing documents related to the provision public service;
    10 minutes - when informing about the provision of public services by phone.

Other requirements, including considering features
the provision of public services in multi-functional
centers providing state and municipal
services and features of the provision of state
electronic services

    45. The possibility of obtaining public services in the multifunctional center of state and municipal services, as well as on the extraterritorial basis is not provided.
    Other requirements and features of the provision of public services in the form of an electronic document are missing.

 

III. The composition, sequence and timing of the administrative procedures, the requirements for the order of their implementation, including the features of the administrative procedures in electronic form

List of administrative procedures

46. When providing public services, the following administrative procedures are carried out:

1) registration of the medicinal product by the Ministry of Health of Russia as the authorized body of the reference state. The procedure includes the following steps:

a) receiving and registering an application and registration documents for a medicinal product;
b) deciding on the start of the registration procedure;
c) sending to the applicant a request for the submission of missing additional information, necessary explanations or clarifications of documents and data contained in the registration dossier, based on the results of an assessment of the completeness, fullness and correctness of the paperwork contained in the registration dossier;
d) issuing a task to conduct an examination of the medicinal product;
e) initiation of the need for unscheduled or planned pharmaceutical inspection on the grounds provided for by the Registration Rules;
f) following the results of the expert examination of the request for the submission of missing additional information, necessary explanations or clarifications of documents and data contained in the registration dossier;
g) sending to the applicant a request from the state of recognition in the form provided for in Annex No. 18 to the Registration Rules;
h) sending to the applicant a decision on registration of the medicinal product or refusal to register the medicinal product;

2) approval (refusal) by the Ministry of Health of Russia as the authorized body of the state for the recognition of the expert report on the assessment of the reference state for the purpose of registering a drug.

The procedure includes the following steps:

a) receiving and registering an application for registration of a drug and accompanying documents;
b) making a decision on the start of the registration procedure for a medicinal product;
c) issuing a task for consideration of an expert report on the evaluation of a medicinal product prepared by the reference state;
d) upon the results of the examination, sending to the applicant a request for the submission of missing additional information, necessary explanations or clarifications of documents and data contained in the registration dossier;
e) sending the decision on registration or refusal to register the drug to the applicant;

3) re-registration of the drug (renewal of drug registration)by the Ministry of Health of Russia as the authorized body of the reference state.

The procedure includes the following steps:

a) receiving and registering the application for re-registration of the medicinal product and accompanying documents;
b) making a decision on the beginning of the procedure for re-registration of the medicinal product;
c) sending to the applicant a request for the submission of missing additional information, necessary explanations or clarifications of documents and data contained in the re-registration dossier of the medicinal product, based on the results of the assessment of the completeness, completeness and correctness of the documents contained in the re-registration dossier of the medicinal product;
d) issuing a task to conduct an examination of the medicinal product;
e) initiation of the need for unscheduled or planned pharmaceutical inspection on the grounds provided for by the Registration Rules;
f) following an examination of the request for an applicant submission of missing additional information, necessary explanations or clarifications of documents and data contained in the dossier for re-registration of the medicinal product;
g) sending to the applicant a request from the state of recognition in the form provided for in Annex No. 18 to the Registration Rules;
h) sending to the applicant a decision on re-registration or refusal to re-register the medicinal product;

4) approval (refusal) by the Ministry of Health of Russia as the authorized body of the state for the recognition of the expert report on the assessment of the reference state for the purpose of re-registering the medicinal product.

The procedure includes the following steps:

a) receiving and registering the application for re-registration of the medicinal product and accompanying documents;
b) making a decision on the beginning of the procedure for re-registration of the drug;
c) issuance of a task for consideration of an expert report on the evaluation of a medicinal product prepared by the reference state;
d) upon the results of the examination, sending to the applicant a request for the submission of missing additional information, necessary explanations or clarifications of documents and data contained in the re-registration dossier;
f) sending the decision on re-registration or refusal of re-registration to the applicant;

5) the Ministry of Health of Russia as the authorized body of the reference state to bring the registration dossier of the drug into compliance with the requirements of the EAEU.

The procedure includes the following steps:

a) receiving and registering an application for bringing the registration dossier of a medicinal product and accompanying documents into compliance;
b) making a decision on the commencement of the procedure for bringing the registration dossier of a medicinal product into compliance
c) sending to the applicant a request for the submission of missing additional information, necessary explanations or clarifications of documents and data contained in the dossier for alignment with the requirements of the Union, the registration dossier, based on the results of the assessment of the completeness, completeness and correctness of the documents contained in conformity;
d) issuing a task to conduct an examination of the medicinal product;
e) initiation of the need for unscheduled or planned pharmaceutical inspection on the grounds provided for by the Registration Rules;
e) sending to the applicant, based on the results of the examination, a request for the submission of missing additional information, necessary explanations or clarifications, documents and data contained in the file for alignment with the requirements of the Union;
g) sending to the applicant a decision on bringing into conformity or refusing to bring in compliance with the requirements of the Union;

6) making by the Ministry of Health of Russia as an authorized body of the reference state changes to the registration dossier of a medicinal product registered in more than one Member State of the EAEU.

The procedure includes the following steps:

a) receiving and registering an application for making changes in the registration dossier of a registered drugand accompanying documents;
b) making a decision on the start of the procedure for amending the registration dossier of a registered medicinal product;
c) sending to the applicant a request for the submission of missing additional information, necessary explanations or clarifications of documents and data contained in the change file, based on the results of an assessment of the completeness, completeness and correctness of the paperwork contained in the change file for the medicinal product;
d) issuing a task to conduct an examination of the medicinal product;
e) initiation of the need for unscheduled or planned pharmaceutical inspection on the grounds provided for by the Registration Rules;
f) sending to the applicant, based on the results of the examination, a request for the submission of missing additional information, necessary explanations or clarifications of documents and data contained in the dossier for changing the medicinal product;
g) sending to the applicant a request of the state of recognition in the form provided for in Annex No. 18 to the Registration Rules of the EAEU;
h) sending to the applicant a decision on making changes in the registration dossier of a registered medicinal product or on refusing to make changes in the registration dossier of a registered medicinal product;

7) making by the Ministry of Health of Russia as an authorized body of the reference state changes to the registration dossier of a medicinal product registered only in the reference state.

The procedure includes the following steps:

a) receiving and registering an application for making changes in the registration dossier of a registered drug and accompanying documents;
b) making a decision on the start of the procedure for amending the registration dossier of a registered drug;
c) sending to the applicant a request for the submission of missing additional information, necessary explanations or clarifications of documents and data contained in the change file, based on the results of an assessment of the completeness, completeness and correctness of the paperwork contained in the change file for the medicinal product;
d) issuing a task to conduct an examination of the medicinal product;
e) initiation of the need for unscheduled or planned pharmaceutical inspection on the grounds provided for by the Registration Rules;
f) sending to the applicant, based on the results of the examination, a request for the submission of missing additional information, necessary explanations or clarifications of the documents and data contained in the file for the change;
g) sending to the applicant a decision on amending the registration dossier of a registered medicinal product or refusing to make changes in the registration dossier of a registered medicinal product;

8) approval (refusal) of the Ministry of Health of Russia as authorized body of the state of recognition of changes in a registration dossier of a medicinal product registered in more than one Member State of the EAEU.

The procedure includes the following steps:

a) receiving and registering an application for making changes in the registration dossier of a registered drug and accompanying documents;
b) deciding on the start of the procedure for amending registration dossier of the registered drug;
c) issuance of a task for consideration of an expert report on the evaluation of a medicinal product prepared by the reference state;
d) sending, according to the results of the examination, a request for the submission of missing additional information, necessary explanations or clarifications of the documents and data contained in the file for the change;
e) sending the applicant a decision on making changes in the registration dossier of a registered medicinal product or on refusing to make changes in the registration dossier of a registered medicinal product;

9) cancellation of the registration certificate;

10) issuance of a duplicate registration certificate of the medicinal product;

11) correction of admitted misprints and errors in the documents issued as a result of the provision of the state service.

47. The heads of the structural units of the Ministry of Health of Russia, who carry out the provision of public services in accordance with these regulations, organize documentary records of the implementation of each stage of the administrative procedures referred to in these regulations.

Registration of the drug by the Ministry of Health of Russia
as the authorized body of the reference state

    48. The administrative procedure “Registration of a drug by the Ministry of Health of Russia as a reference state” is carried out in connection with the submission to the Ministry of Health of Russia of an application for registration of a drug and the documents referred to in paragraph 19 of the Regulations using the Unified Portal.

    49. The documents specified in clause 48 of the Regulations are adopted by the Ministry of Health of Russia in accordance with Clauses 39 and 40 of the Regulations.

    50. The Ministry of Health of Russia assigns a unique registration number to the application, which is formed using the integrated system, and informs the applicant on the day of admission.

    51. The head of the structural unit of the Ministry of Health of Russia (his deputy), who is responsible for the provision of the state service, within one working day from the date of receipt of the documents referred to in paragraph 48 of the Regulations, appoints the executive officer (hereinafter the executive officer) from among the employees of the register drugs.
    The last name, first name and patronymic (if available) of the responsible executor and his telephone number should be communicated to the applicant by his written or oral request.
    On the day of the appointment, the responsible executor shall provide the expert institution with access to the registration dossier of the medicinal product using the appropriate means of electronic communication.

    52. The responsible executive, within 5 working days from the day the applicant submits the application for drug registration, provides the authorized bodies (expert organizations) of the recognition state with access to the registration dossier of the medicinal product using the tools of the integrated system.

    53. Within 14 working days from the date of receipt of the documents referred to in paragraph 48 of the Regulations, the expert institution and the executive officer validate the registration dossier, including by comparing such information with information provided in the order of inter-agency information interaction.

    54. The formation and submission of interdepartmental requests to the bodies involved in the provision of public services are carried out by the responsible executor in accordance with Article 7.2 of Law No. 210-FZ within the framework of the administrative procedure related to the receipt and registration of the application for registration of a medicinal product and the accompanying documents decision on the start of the registration procedure for a medicinal product within 14 working days from the date of receipt of the documents referred to in paragraph 49 of the Regulations, responsible executive in order to obtain information necessary for the provision of public services.

    Submission of information necessary for the provision of public services is carried out, among other things, in electronic form using a single system of inter-agency electronic interaction and regional systems of inter-departmental electronic interaction connected to it.

    55. In case of non-compliance of the application with the requirements established by Appendix No. 2 to the Registration Rules, identification of insufficient information, need for clarification or checking of documents and data contained in the registration dossier, the Russian Ministry of Health within 10 working days from the date of receipt of such registration application and accompanying documents notifies the applicant of the need to eliminate the violations found and (or) the presentation of missing documents within a period not exceeding 90 calendar days from the date of placement the appropriate notification in the information system of Ministry of Health of Russia, by sending a notice to the applicant personally against a receipt or notification by registered mail with return receipt or transmission in electronic form via telecommunication channels or in e-document form signed by electronic signature.

    The deadline, calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ends with the applicant submitting such documents and data to the Russian Ministry of Health, is not taken into account in order to calculate the time frame for the examination and registration of the drug.

    56. The Russian Ministry of Health rejects an application for registration of a drug if documents and data of the registration dossier fails to be submitted within 90 days according to the comments of the Ministry of Health of Russia and (or) failure to pay the fee for registration and examination of the drug in cases and procedures established by the legislation of the Russian Federation, and informs the applicant and the authorized bodies (expert organizations) of the states of recognition through an integrated system within a period not exceeding 4 working days from the date of adoption solutions.

    57. Within 10 working days from the date of submission of the application for registration and the registration dossier complying with the requirements of the Union Registration Rules, the Ministry of Health of Russia decides to begin the examination and registration of the medicinal product.

    58. The Ministry of Health of Russia places the application for drug registration and registration dossier on the official website of the Russian Ministry of Health, which are available only to authorized bodies (expert organizations) of the recognition countries, and submits to the Commission information on the identification number of the application for registration of the drug using the EAEU's integrated information system .

    Authorized bodies (expert organizations) of the recognition states are entitled to familiarize themselves with the progress of expert work at the Ministry of Health of Russia, including the correspondence of the applicant and the Ministry of Health of Russia on the elimination of comments and documents submitted by the applicant during the examination and registration of the drug.

    59. Within 4 working days from the date of the decision to start the examination and registration of the medicinal product, the Ministry of Health of Russia issues to the expert institution a task for the expertise of the medicinal product.

    60. After receiving a valid registration dossier, the expert institution shall, within 90 calendar days from the date of commencement of the examination, send to the authorized bodies (expert organizations) of the states of recognition copies of expert reports with the wording of comments and inquiries to the applicant on the form in accordance with Annexes No. 6-9 and (or) 22 to the Registration Rules and the preliminary evaluation report in the form provided for in Appendix No. 11 to the Registration Rules. In preparing these expert reports, the expert institution is guided by the instructions contained in Appendices 13-15 and 23 of the Registration Rules.

    According to the results of the examination or at the request of any authorized body (any expert organization) of the state of recognition, the expert institution has the right to offer, and the Ministry of Health of Russia has the right to agree on the establishment of additional requirements for the medicinal product in accordance with the provisions of paragraphs 116-118 of the Registration Rules. The established requirements are entered into the expert opinion and are subject to approval by the states of recognition, like any other provisions of the expert assessment report.

    61. During the registration and examination of the drug, the Ministry of Health of Russia has the right to send the applicant a written and (or) electronic request for the submission of missing additional information, necessary explanations or clarifications regarding the submitted documents and the registration dossier data (including the proposal to amend the SmPC, package leaflet, drug packaging mock-ups or other documents of the registration dossier).

    62. In the case of requests sent to the applicant, the authorized body (expert organization) of the state of recognition no later than 30 calendar days from the date of receipt of the preliminary assessment report of the expert institution sends requests to the expert institution, which within 5 working days from the date of receipt of the last request from State of recognition forms a single request and sends it to the applicant.

    The interaction between the authorized bodies (expert organizations) when sending requests to the applicant is carried out in electronic form in the form provided by Appendix No. 18 to the Registration Rules, using the tools of the integrated system.

    The request can be sent to the applicant personally against a receipt, sent by mail by registered mail with the receipt of receipt or sent in electronic form via telecommunication channels or in the form of an electronic document signed with an electronic signature. After the first request, subsequent requests are allowed only in case of additional questions about the data submitted by the applicant in response to the previous request.

    63. The applicant is obliged to provide a response to the request within a period not exceeding 90 calendar days from the date of receipt of the request. On the basis of the applicant’s relevant application, the time limit for responding to a request may be extended by the Ministry of Health of the Russian Federation for valid reasons. The general deadline for responding to requests should not exceed 180 calendar days.

    64. In the event that the documents and data requested by the Russian Ministry of Health are not submitted within the established time limit, the examination and registration of the medicinal product is terminated. The decision of the Ministry of Health of Russia notifies the applicant and the authorized bodies (expert organizations) of the state of recognition within 14 working days from the date of the adoption of such a decision in writing and (or) electronic form.

    65. The deadline, calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ended with the applicant submitting such documents and data to the Russian Ministry of Health, is not taken into account in order to calculate the time period for examination and registration of the medicinal product.

    66. The Russian Ministry of Health initiates an inspection by the pharmaceutical inspectorate of Russia for compliance with the rules of good pharmaceutical practices provided for in clause 29 of the Regulations if facts are found during the registration procedure that cast doubt on the accuracy of the information submitted by the applicant in the registration dossier regarding:

    1) preclinical studies or clinical studies;
    2) the production of a medicinal product or its components, including the production of an active substance;
    3) pharmacovigilance systems.

    Such inspections may also be initiated in the cases specified in clauses 31, 33, 35-39 of the Registration Rules. In the event of the discovery of facts of unreliability of data, appropriate procedural measures are taken in accordance with the legislation of the Russian Federation and EAEU law.

    Examination of the drug in the case of initiating a pharmaceutical inspection is not suspended. At the same time, the preparation of an expert assessment report is completed by an expert institution after it receives the inspection results. An unscheduled pharmaceutical inspection with the direction of the inspection report should be carried out on time for registration of the drug, but not more than 180 calendar days from the date of the decision of the Russian Ministry of Health to initiate the inspection.

    The applicant organizes visits to the production site, test center, research center, the location of the master file of the applicant's pharmacovigilance system or the premises of organizations recruited by the applicant to perform any actions within production, quality control, development, research or pharmacovigilance, within 30 calendar days from day of receipt of information about the need for inspection or indicates a specific date of the visit, but no more than 90 calendar days from the date of receipt at kazannogo information.

    67. The expert institution and the Ministry of Health of the Russian Federation shall consider the applicant's responses, including responses to requests from authorized bodies (expert organizations) of the recognition states, within 30 calendar days from the date of receipt of the answer.

    68. Within a period not exceeding 155 calendar days from the date of submission of the application for registration, the Ministry of Health of Russia sends to the recognition states and the applicant a draft final expert assessment report on the form in accordance with Appendix No. 16 to the Registration Rules, along with the applicant's responses to requests, projects of SmPC, package leaflet, packaging mock-ups, Normative document, and, if necessary, the SUR project. The Ministry of Health of Russia places on its official website an expert assessment report, which is available only to authorized bodies (expert organizations) of the recognition states.

    If the expert institution has prepared a negative project of the final expert assessment report and the Ministry of Health of Russia decided to refuse registration on the basis of clause 114 of the Registration Rules, the examination and registration of the medicinal product is terminated. The decision of the Ministry of Health of Russia notifies the applicant within 14 working days from the date of the adoption of such a decision in written and (or) electronic form with the attachment of the final expert assessment report.

    If the expert institution has prepared a positive project of the final expert assessment report, its review is conducted by authorized bodies (expert organizations) of the recognition states.

    69. According to the results of consideration in accordance with clause 60 of the Rules of draft final expert assessment report and in the absence of comments from the authorized bodies (expert organizations) of the recognition states or after their withdrawal in accordance with paragraph 61 or 71 of the Regulations, the expert institution together with the authorized bodies (expert organizations) of the recognition states complete the procedure for the examination of the medicinal drug in within 10 working days (the 175th calendar day from the day the application for registration was submitted).

    70. In the case of comments from the authorized bodies (expert organizations) of the states of recognition of the draft final expert assessment report, the draft of the SmPC, package leaflet, packaging mock-ups or the draft of Normative document, the expert institution consults with the authorized bodies (expert organizations ) of the state of recognition in electronic form within 10 working days in the form in accordance with Appendix No. 18 to the Registration Rules (the 165th calendar day from the date of filing the application for registration).

    71. In case of unresolved disagreements in the framework of mutual consultations and receipt by the Ministry of Health of Russia of the conclusion of the authorized bodies of the states of recognition of the impossibility of recognizing the expert assessment report prepared by the expert institution, the expert committee does not exceed 60 calendar days from the date of sending the authorized bodies of the states of the conclusion about the impossibility of recognizing a positive expert assessment report prepared by an expert institution, conducts the settlement procedure of disputes in accordance with the rules of registration.

    If the disagreements between the expert institution and the competent authorities of the recognition states regarding the recognition of the expert assessment report are resolved, the Ministry of Health of Russia completes the examination and proceeds to the procedure for issuing final documents in accordance with clause 69 of the Regulations.

    If the disagreements between the Ministry of Health of Russia and the authorized bodies of the state of recognition regarding recognition of the expert assessment report are not resolved, the Ministry of Health of Russia completes the examination and proceeds to the procedure for issuing final documents in accordance with paragraphs 69, 72 and 73. At the request of the applicant, the issuance of a registration certificate may be suspended until the disagreements of the authorized bodies of other states of recognition and the Ministry of Health of Russia are resolved. The specified period does not include the terms of examination and registration provided for by the Regulations.

    72. After making a decision on the possibility of registering a medicinal product in accordance with paragraph 69 and paragraph two of paragraph 71 of the Regulations of the Ministry of Health of Russia, within a period not exceeding 30 calendar days, issues to the applicant a registration certificate of the medicinal product in the form provided in Appendix 17 to the Registration Rules, approved SmPC, package leaflet, Normative document, packaging mock-ups, expert assessment report, as well as the agreed SUR if necessary. Within 10 working days from the date of adoption of the said decision, the applicant is obliged to translate the SmPC, package leaflet, packaging mockups into the languages of recognition states, if there is a relevant requirement in the legislation of the Member States.

    73. The Ministry of Health of Russia places, in accordance with the procedure for the formation and maintenance of a unified register of the EAEU, information on the registration of a medicinal product and its active ingredients in the unified register of the Union with the following approved documents:

1) SmPC;
2) leaflet;
3) packaging mock-ups;
4) Normative document;
5) the final expert assessment report, compiled in accordance with Appendix No. 16 to the Registration Rules, after exclusion of confidential data and data about experts;
6) summary of the agreed SUR (if necessary).

    74. The Russian Ministry of Health at the request of the applicant in a period not exceeding 5 working days from the date of receipt of such a request, provides authorized bodies (expert organizations) of the recognition state access to the registration dossier of the drug and the expert report on assessment through an integrated system using additional documents and information submitted by the applicant to the requests of the Ministry of Health of Russia.

Approval (refusal) of the Ministry of Health of Russia
as the authorized body of the state of recognition of the expert report of
reference state assessment for drug registration purposes

    75. The administrative procedure “Coordination (inconsistency) by the Ministry of Health of Russia of an expert report on the assessment of a reference state for the purpose of registering a drug” is carried out in connection with the submission to the Ministry of Health of Russia of the documents referred to in clause 20 of the Regulations.

    76. The documents referred to in clause 75 of the Regulations are adopted by the Ministry of Health of Russia in the manner established in accordance with clauses 39 and 40 of the Regulations.

    77. The applicant shall submit to the Ministry of Health of Russia the documents referred to in paragraph 75 of the Regulations, no later than 14 working days from the date of the submission of the application for drug registration to the reference state.

    78. The head of the structural unit of the Ministry of Health of Russia (his deputy), who is responsible for the provision of the state service, within one working day from the date of receipt of the documents specified in clause 75 of the Regulations, appoints the executive in charge.

    The last name, first name and (if available) patronymic of the responsible executor and his telephone number should be communicated to the applicant by his written or oral request and are available to him and the authorized body (expert organization) of the reference state and other recognition states for viewing on the official website of the Russian Ministry of Health.

    79. On the day of appointment, the responsible executor provides the expert institution with access to the registration dossier of the medicinal product using appropriate electronic communication tools and issues to the expert institution the task of reviewing the documents specified in paragraph 69 of the Registration Rules.

    80. The executive officer shall daily analyze the data of the relevant information systems of the Member States of the EAEU in order to provide access to the documents specified in paragraph 68 of the Registration Rules in the case of the procedure established by Chapter V of the Registration Rules, or documents specified in paragraph 94 of the Registration Rules, in case of procedures established by Chapter VI of the Registration Rules.

    81. The Ministry of Health of Russia, within 14 working days from the date of submission of the application, rejects the application for registration of a medicinal product according to the procedure established by Chapter V or VI of the Registration Rules, in case of non-compliance of the application with the requirements of the Registration Rules and (or) non-payment of the fee for registration and examination of the medicinal product in cases and the procedure stipulated by the legislation of the Russian Federation.

    82. Based on the conclusion of the expert institution and within a period not exceeding 50 calendar days from the date of access to the expert assessment report prepared by the reference state, the Ministry of Health of Russia sends, if necessary, a request to the applicant and to the authorized body (expert organization) of the reference state in the form given in Appendix 18 to the Registration Rules. The request may contain a proposal for the establishment of measures provided for in paragraphs 116-118 of the Registration Rules.

    In its request, drawn up in accordance with the first paragraph of this paragraph, the Ministry of Health of Russia has the right to raise the question of initiating the appropriate inspection provided for by the Registration Rules.

    The applicant sends a response to the request to the Ministry of Health of Russia in a period not exceeding 90 calendar days. The term of the applicant's response to the request is not included in the general term of the examination and registration of the medicinal product. The Ministry of Health of Russia, within 5 working days from the date of receipt of the applicant's response, provides the authorized body (expert organization) of the reference state access to it through the integrated information system of the EAEU.

    If the requested documents and information are not submitted within the established time, the examination and registration of the medicinal product is terminated. Within 10 working days from the date of termination, the applicant shall be notified of the decision taken.

    83. For a period not exceeding 50 calendar days from the date of submission to the Ministry of Health of Russia of an application for registration of a drug in the absence of requests to the applicant, or for a period not exceeding 20 calendar days from the date of receipt of the applicant's response to the request, the Ministry of Health of Russia using the integrated information of the Union’s system sends to the authorized body (expert organization) of the reference state a conclusion on the possibility or impossibility of recognizing the expert assessment report prepared by the reference state.

    84. If it is impossible to recognize the expert assessment report prepared by the expert organization of the reference state, the Ministry of Health of Russia sends to the authorized body (expert organization) of the reference state, other recognition states participating in the drug registration procedure, the applicant and the expert committee conclude that it is impossible to recognize such an expert assessment report, indicating one or more of the following reasons:

    a) the "benefit - risk" relationship in connection with the use of the drug is unfavorable;
    b) the applicant has not proven the effectiveness of the drug;
    c) the quality of the medicinal product is not confirmed;
    d) the applicant has submitted false information;
    e) according to the results of the appointed inspection, during the period of registration of the medicinal product, a discrepancy has been revealed to the appropriate pharmaceutical practices of the EAEU, which is critical.

    85. If upon completion of the dispute resolution procedure in the expert committee of the Ministry of Health of Russia decides that the data presented in the expert assessment report do not allow to conclude that the applicant has confirmed the quality, effectiveness and (or) favorable “benefit-risk” relationship drug, the Ministry of Health of Russia refuses to register a drug. The decision of the Ministry of Health of Russia notifies the applicant within 14 working days from the date of such a decision in written and (or) electronic form indicating the reasons for refusing registration and providing detailed reasons for such a decision.

    86. In case of recognition by the Ministry of Health of Russia of the expert assessment report prepared by the reference state, the Ministry of Health of Russia takes a decision on the registration of the drug and no later than 10 working days:

    a) issues to the applicant a registration certificate of the medicinal product in the form given in Appendix No. 17 to the Registration Rules;
    b) coordinates the regulatory document on quality issued by the reference state;
    c) places information about the medicinal product and its active ingredients in the unified register of the Union with the application of the approved SmPC, package leaflet, packaging mock-ups, approved SUR (if necessary) in accordance with the procedure for the formation and maintenance of a single registry of the Eurasian Union.

    87. The registration certificate of the medicinal product is issued by the Ministry of Health of Russia with a validity period established by the reference state.

Re-registration (renewal of registration) of the drug by the Ministry of Health of Russia as the authorized body of the reference state

    88. The administrative procedure “Re-registration of a medicinal product by the Ministry of Health of Russia as a reference state” is carried out in connection with the submission to the Ministry of Health of Russia of an application for renewal of registration of a medicinal drug (hereinafter the application for re-registration) and documents specified in clause 21 of the Regulations.

    89. The documents referred to in paragraph 88 of the Regulations are accepted by the Ministry of Health of Russia in the manner prescribed by paragraphs 39 and 40 of the Regulations.
    The Ministry of Health of Russia assigns a unique number to the application for re-registration, which is formed using an integrated system, and informs the applicant on the day of admission.

    90. The head of the structural unit of the Ministry of Health of Russia (his deputy), who is responsible for the provision of the state service, within one working day from the date of receipt of the documents referred to in paragraph 88 of the Regulations, appoints the executive officer.

    The last name, first name and patronymic (if available) of the responsible executor and his telephone number should be communicated to the applicant by his written or oral request.

    91. The responsible officer on the day of appointment provides the expert institution with access to the dossier for the renewal of registration of the registered medicinal product using appropriate electronic communication tools.

    92. The responsible executive, within 5 working days from the day the applicant submits an application for re-registration, grants the authorized bodies (expert organizations) of the state recognition of access to the file on re-registration of the medicinal product using the tools of the integrated system.

    93. Within 14 working days from the date of receipt of the documents specified in clause 88 of the Regulations, the expert institution and the responsible executor will validate the re-registration dossier, including by comparing such information with information provided as an inter-agency information interaction.

    94. The formation and submission of interdepartmental requests to the bodies involved in the provision of public services is carried out by the responsible executor in accordance with article 7.2 of Law No. 210-FZ within the framework of the administrative procedure related to receiving and registering the re-registration application and accompanying documents, deciding the procedure of re-registration of the medicinal product, within 14 working days from the date of receipt of the documents specified in paragraph 88 of the Regulations, to the responsible filler in order to obtain information necessary for the provision of public services.

    Submission of information necessary for the provision of public services is carried out, among other things, in electronic form using a single system of inter-agency electronic interaction and regional systems of inter-departmental electronic interaction connected to it.

    95. In case of non-compliance of the application with the requirements set forth in Appendix No. 2 to the Registration Rules, detection of insufficient information, need for clarification or verification of documents and data contained in the registration renewal dossier, the Ministry of Health of Russia within 10 working days from the date of receipt of such applications for renewal of registration and accompanying documents notifies the applicant of the need to eliminate the violations found and (or) the presentation of missing documents in a period not exceeding 90 calendar days from the date of another notice in the information system of the Ministry of Health of Russia by sending the notice to the applicant personally against a receipt, or sending a notice by registered mail with acknowledgment of receipt, or sending it in electronic form via telecommunication channels or in the form of an electronic document signed with an electronic signature.

    The deadline, calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ends with the applicant submitting such documents and data to the Russian Ministry of Health, is not taken into account in order to calculate the period for examination and renewal of registration of the drug.

    96. The Ministry of Health of Russia rejects the application for renewal of registration of the registered drug in case of non-submission of documents and data on the comments of the Ministry of Health of Russia and (or) non-payment of the fee for re-registration and examination of the drug in 90-day period in cases and in the manner established by the legislation of the Russian Federation this is the applicant and the authorized bodies (expert organizations) of the recognition states through an integrated system within 4 business days from the date of the decision.

    97. Within 5 working days from the date of submission of the application for renewal of registration and registration renewal dossier complying with the requirements of the Union Registration Rules, the Russian Ministry of Health decides on the commencement of the examination and registration renewal procedure of the medicinal product.

    98. The Ministry of Health of Russia places a registration renewal application and re-registration dossier on the official website of the Russian Ministry of Health that is accessible only to authorized bodies (expert organizations) of the recognition states, and submits to the Commission information on the identification number of the application for registration renewal of the registered medicinal product using the integrated information system of the EAEU.

    Authorized bodies (expert organizations) of the recognition states are entitled to familiarize themselves with the progress of expert work in the Ministry of Health of Russia, including the correspondence of the applicant and the Ministry of Health of Russia on the elimination of comments and documents submitted by the applicant during the examination and renewal of registration of the registered medicinal product.

    99. Within 4 working days from the date of the decision to start the examination and registration renewal process of the drug, the Ministry of Health of Russia issues to the expert institution a task for the examination of the drug.

    100. After receiving a valid registration renewal dossier, the expert institution shall, within 50 calendar days from the date of commencement of the examination, send to the authorized bodies (expert organizations) of the states of recognition copies of expert reports with the wording of comments and inquiries to the applicant on the form in accordance with annexes No. 6-8 and (or) 22 to the Registration Rules and the preliminary evaluation report in the form provided for in Appendix No. 11 to the Registration Rules. In preparing these expert reports, the expert institution is guided by the instructions contained in Appendices 13-15 and 23 of the Registration Rules.

    According to the results of the examination or at the request of any authorized body (any expert organization) of the state of recognition, the expert institution has the right to offer, and the Ministry of Health of Russia has the right to agree on the establishment of additional requirements for the medicinal product in accordance with the provisions of paragraphs 116-118 of the Registration Rules. Installed requirements are included in the expert opinion and are subject to approval by the recognition states.

    In the event that facts are discovered during the examination that cast doubt on the accuracy of the information provided, the Ministry of Health of Russia acts in accordance with clause 66 of the Regulations.

    101. During the registration renewal process and examination of the drug, the Ministry of Health of Russia has the right to send the applicant a written and (or) electronic request for missing additional information, necessary explanations or clarifications regarding the submitted documents and data on registration renewal dossier (including the proposal to make changes SmPC, package insert, drug packaging mock-ups or other documents for re-registration).

    102. In the case of requests sent to the applicant, the authorized body (expert organization) of the state of recognition no later than 20 calendar days from the date of receipt of the preliminary assessment report of the expert institution sends requests to the expert institution, which within 5 working days from the date of receipt of the last request from State of recognition forms a single request and sends it to the applicant.

    The interaction between the authorized bodies (expert organizations) when sending requests to the applicant is carried out in electronic form in the form given in Appendix 18 to the Registration Rules, using the tools of the integrated system.

The request can be sent to the applicant personally against a receipt, sent by mail by registered mail with the receipt of receipt or sent in electronic form via telecommunication channels or in the form of an electronic document signed with an electronic signature. After the first request, subsequent requests are allowed in case of additional questions on the data submitted by the applicant in response to the previous request.

    The applicant is obliged to provide an answer to the request within a period not exceeding 90 calendar days from the date of receipt of the request. On the basis of the applicant’s application, the period for responding to a request may be extended by the Ministry of Health of the Russian Federation for valid reasons. The general deadline for responding to requests should not exceed 180 calendar days.

    103. In the event that the documents and data requested by the Russian Ministry of Health are not submitted within the prescribed period, the examination and renewal of registration of the registered medicinal product is terminated. The decision of the Ministry of Health of Russia notifies the applicant and the authorized bodies (expert organizations) of the state of recognition within 14 working days from the date of the adoption of such a decision in writing and (or) electronic form.

    104. The period calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ended with the applicant submitting such documents and data to the Ministry of Health of Russia is not taken into account in order to calculate the time period for examination and re-registration of the drug.

    105. The expert institution and the Ministry of Health of the Russian Federation review the applicant's responses, including responses to requests from authorized bodies (expert organizations) of the recognition states, within 20 calendar days from the date of receipt of the response.

    106. Within a period not exceeding 90 calendar days from the date of the submission of the application for drug registration renewal, the Ministry of Health of Russia sends to the recognition states and the applicant a draft final expert assessment report on the form in accordance with Appendix 16 to the Registration Rules, along with the applicant’s responses to inquiries, also, if necessary, SmPC projects, package leaflet, packaging mock-ups, Normative document, SUR, if any of the specified documents were changed. The Ministry of Health of Russia places on its official website an expert assessment report, which is available only to authorized bodies (expert organizations) of the recognition states.

    If the expert institution has prepared a negative draft of the final expert assessment report and the Ministry of Health of Russia has decided not to renew drug registration on the basis of clause 146 of the Registration Rules, the examination and drug registration renewal process are terminated. The decision of the Ministry of Health of Russia notifies the applicant within 14 working days from the date of the adoption of such a decision in written and (or) electronic form with the attachment of the final expert assessment report.

    If an expert institution has prepared a positive draft final expert assessment report, it will be reviewed by authorized bodies (expert organizations) of the recognition states.

    107. According to the results of consideration in accordance with clause 100 of the Regulations of the draft final expert assessment report in the absence of comments from the authorized bodies (expert organizations) of the recognition states or after their removal in accordance with clause 101 or 109 of the Regulations, the expert institution together with the authorized bodies (expert organizations) of the state of recognition complete the procedure for the examination of a medicinal product within 10 working days (the 115th calendar day from the day the application is submitted about re-registration).

    108. In the case of comments from the authorized bodies (expert organizations) of the states to the draft final expert assessment report, the draft of the SmPC, package leaflet, packaging mock-ups, SUR or Normative document, the expert institution consults with the authorized authorities (expert organizations) of the states recognition in electronic form within 10 working days in accordance with the form given in Appendix 18 to the Registration Rules (95th calendar day from the date of submission of the application for registration renewal of the drug).

    109. In case of unresolved disagreements in the framework of mutual consultations and receipt by the Ministry of Health of Russia of the conclusion of the authorized bodies of the states of recognition of the impossibility of recognizing the expert assessment report prepared by the expert institution, the expert committee does not exceed 60 calendar days from the day the authorized bodies of the states acknowledge the conclusion about the impossibility of recognizing a positive expert assessment report prepared by an expert institution, conducts the settlement procedure disagreements in accordance with the Registration Rules.

    If the disagreements between the expert institution and the authorized authorities of the recognition states regarding the recognition of the expert assessment report are resolved, the Russian Ministry of Health completes the examination and proceeds to the procedure for issuing final documents in accordance with clause 107 of the Regulations.

    If disagreements between the Ministry of Health of Russia and the authorized bodies of the state of recognition regarding recognition of the expert assessment report are not resolved, the Ministry of Health of Russia completes the examination and proceeds to the procedure for issuing final documents in accordance with clauses 107, 110 and 111 of the Regulations. At the request of the applicant, the issuance of a registration certificate may be suspended until the disagreements of the authorized bodies of other states of recognition and the Ministry of Health of Russia are resolved. The specified period is not included in the terms of examination and registration provided for by these regulations.

    110. After making a decision on the possibility of registering renewal of a medicinal product in accordance with clause 107 and paragraph 2 of clause 109 of the Regulations of the Ministry of Health of Russia, within a period not exceeding 5 calendar days, issues to the applicant a registration certificate of the medicinal drug in the form in accordance with Appendix No. 17 to the Registration Rules, and, if provided for, approved by the SmPC, a leaflet, Normative document, packaging mock-ups, expert assessment report and SUR. Within 10 working days, the applicant is obliged to translate the SmPC, package leaflet, packaging mockups into the languages of recognition states, if there is a relevant requirement in the legislation of the Member States.

    111. The Ministry of Health of Russia updates, in accordance with the procedure for the formation and maintenance of a unified EAEU registry, information on the registration of a medicinal product and its active ingredients in the unified register of the EAEU with the application, if applicable, of the following approved documents:

1) SmPC;
2) leaflet;
3) packaging mock-ups;
4) Normative document;
5) the final expert assessment report, compiled in accordance with Annex No. 16 to the Registration Rules, after exclusion of confidential data and expert data
6) summary of SUR.

    112. An expert institution in the framework of the examination conducted in
in accordance with clause 100 of the Regulations, carries out an analysis of the fulfillment by the holder of the registration certificate of the conditions established during registration in accordance with Chapter VII of the Registration Rules. When new data on the safety and efficacy of a drug is detected, the Ministry of Health of Russia has the right to make changes to the conditions of registration and (or) put forward new conditions in accordance with Chapter VII of the Registration Rules.

    113. An expert institution in the framework of the examination conducted in
in accordance with clause 100 of the Regulations, verifies that the holder of a registration certificate certifies obligations to maintain information on a medicinal product up to date in the light of current scientific knowledge, taking into account the conclusions on the results of assessments and recommendations of the authorized body (expert organization) in accordance with the Requirements of the drug and the general characteristics of the medicinal product for medical use, approved by Council Decision Eurasian Economic Commission on November 3, 2016 number 88

    114. If the expert institution has established within the framework of the examination, carried out in accordance with clause 100 of the Regulations, that the obligations specified in clause 112 of the Regulations are not fulfilled for objective reasons and changes are required in the registration dossier of the medicinal product, after the decision of the Ministry of Health of Russia to renew registration of the drug, then SmPC, leaflet and (or ) SURs (as appropriate) should be updated by the holder initiating a registration certificate of the relevant procedure for making changes to registration dossier within a period not exceeding 180 calendar days from the date of the request sent by the Ministry of Health of Russia on the need to make changes to the registration dossier.

    115. The Ministry of Health of Russia has the right to agree on making changes to the registration dossier of a type I drug in accordance with the classification given in Appendix No. 19 to the Registration Rules as part of re-registering a drug, in order to avoid additional filing an application for making type I changes to the registration dossier.

    116. On the basis of pharmacovigilance data and taking into account the circumstances specified in paragraphs 114 and 115 of the Registration Rules, during registration renewal of a medicine, the Ministry of Health of Russia has the right to once decide to issue a registration certificate with a validity period of 5 years with the need for additional registration renewal the expiration of the specified period.

    117. In the case of registration renewal of a medicinal product registered under the conditions in accordance with Chapter VII of the Registration Rules, the term of the next renewal of a registration procedure shall be determined in accordance with the degree of fulfillment of the conditions and in accordance with the provisions of paragraphs 116-118 of the Registration Rules.

    If additional requirements are established as part of re-registration with regard to the medicinal product under consideration, in accordance with the provisions of paragraphs 116-118 of the Registration Rules, the expert institution and the Ministry of Health of Russia shall act in accordance with paragraph 2 of paragraph 60 of the Regulations.

    118. The grounds for the Ministry of Health of Russia to refuse to renew registration of the medicinal product are:

    a) the persistence of the following serious health risks associated with the use of the drug at the time of re-registration:

    1) a proven unfavorable "benefit - risk" relationship or a revealed lack of therapeutic efficacy, provided that the conditions of use of the drug described in the approved SmPC are observed;
    2) the facts established according to pharmacovigilance evidence of an unfavorable “benefit-risk” relationship, including a significant excess of the frequency of reproducing certain undesirable reactions compared with the data indicated in the approved SmPC;
    3) the discrepancy between the qualitative and quantitative composition of the medicinal product and the registered composition or the repeated inconsistency of the quality of the medicinal product during its circulation in the Union market with the quality described in the registration dossier;
    4) unreliable or non-updated data of the registration dossier accompanying the application for re-registration;

    b) the holder of the registration certificate doesn’t remove the comments or fails to provide an answer within the allotted time to the questions raised during the examination of the medicinal product;
    c) the holder’s failure to comply with the pharmacovigilance obligations established in accordance with the rules of good pharmacovigilance practices of the Union, or obligations under the registration procedure on conditions.

Approval (refusal) of the Ministry of Health of Russia
as the authorized body of the state of recognition of expert
Reference State Assessment Report for registration renewal of a
medicinal product

    119. The administrative procedure “Approval (refusal) by the Ministry of Health of Russia of an expert report on the assessment of a reference state for the purpose of re-registration of a medicinal product” is carried out in connection with the submission to the Ministry of Health of Russia of the documents according to the paragraph 22 of the Regulations.

    120. The documents referred to clause 119 of the Regulations are accepted by the Ministry of Health of Russia in the manner established by clauses 39 and 40 of the Regulations.

    121. The applicant shall submit to the Ministry of Health of Russia the documents according to clause 119 of the Regulations, no later than 14 working days from the date of submission of the application for registration renewal to the reference state.

    122. The head of the structural unit of the Ministry of Health of Russia (his deputy), who is responsible for the provision of the state service, within one working day from the date of receipt of the documents specified in clause 120 of the Regulations, appoints the responsible executor.

    The surname, name and patronymic (if available) of the responsible executor and his telephone number must be communicated to the applicant by his written or oral request. The data of the responsible executive must be available to the applicant, the authorized body (expert organization) of the reference state and other recognition states for viewing on the official website of the Russian Ministry of Health.

    123. On the day of appointment, the responsible executor provides the expert institution with access to the dossier for registration renewal of the medicinal product using the appropriate electronic communication means and issues to the expert institution the task of examining the documents specified in paragraph 122 of the Registration Rules.

    124. The executive officer shall daily analyze the data of the respective information systems of the Member States of the EAEU in order to place in them the documents indicated in paragraph 106 of the Registration Rules.

    125. Based on the conclusion of the expert institution and within a period not exceeding 20 calendar days from the date of access to the expert report on the assessment of the reference state, the Ministry of Health of Russia sends, if necessary and on the basis of the evaluation conducted by the expert institution, a request to the applicant and authorized body (expert organization) of the reference state in the form given in Appendix 18 to the Registration Rules. The request may contain a proposal to establish the measures provided for in paragraphs 116-118 of the Registration Rules.

    In its request, drawn up in accordance with the first paragraph of this paragraph, the Ministry of Health of Russia has the right to raise the question of initiating the appropriate inspection provided for by the Registration Rules.

    126. Within a period not exceeding 20 calendar days from the date of receipt of the final expert report on the assessment of the reference state, the Ministry of Health of Russia using the tools of the integrated system sends to the authorized body (expert organization) of the reference state a conclusion on the possibility or impossibility of recognizing the expert report assessing the reference state.

    127. If it is impossible to recognize the expert assessment report prepared by the expert organization of the reference state, the Ministry of Health of Russia sends to the authorized body (expert organization) of the reference state, other recognition states participating in the re-registration procedure of the medicinal product, the applicant and the expert committee on the impossibility of recognizing such expert evaluation report with a justification of the decision made within the period specified in paragraph 125 of the Regulations.

    128. If, upon completion of the dispute settlement procedure, the expert committee of the Ministry of Health of Russia decides that the data presented in the expert assessment report do not allow us to conclude that the applicant confirmed the preservation of a favorable attitude “Benefit versus risk” of the drug, the Ministry of Health of Russia refuses to re-register the drug. The decision of the Ministry of Health of Russia notifies the applicant within 14 working days from the date of such a decision in written and (or) electronic form indicating the reasons for refusing renewal of registration and providing detailed reasons for such a decision.

    129. In case of recognition by the Ministry of Health of Russia of an expert assessment report prepared by the reference state, the Ministry of Health of Russia takes a decision on re-registering the drug and no later than 5 working days:

a) issues to the applicant a registration certificate of the medicinal product in the form given in Appendix No. 17 to the Registration Rules;
b) update the necessary information about the medicinal product and its active ingredients in the unified register of the EAEU with the application, if applicable, approved by the SmPC, package leaflet, packaging mock-ups, SUR (if necessary) in accordance with the procedure for the formation and maintenance of a single registry of the EAEU.

    130. The grounds for the refusal of the Ministry of Health of Russia to recognize the expert report on the assessment of the reference state are:

    a) the persistence of the following serious health risks associated with the use of the drug at the time of re-registration:

    1) a proven unfavorable "benefit - risk" ratio or a revealed lack of therapeutic efficacy, provided that the conditions of use of the drug described in the approved SmPC are observed;
    2) the facts established according to pharmacovigilance evidence of an unfavorable “benefit-risk” ratio, including a significant excess of the frequency of reproducing certain undesirable reactions compared with the data indicated in the approved SmPC;
    3) the discrepancy between the qualitative and quantitative composition of the medicinal product and the registered composition or the repeated inconsistency of the quality of the medicinal product during its circulation in the EAEU market with the quality described in the registration dossier;
    4) unreliable or non-updated data of the registration dossier accompanying the application for renewal of registration;

    b) the holder of the registration certificate doesn’t respond to the comments or fails to provide an answer within the allotted time to the questions raised during the examination of the medicinal product;
    c) the holder’s failure to comply with the pharmacovigilance obligations established in accordance with the rules of good pharmacovigilance practices of the EAEU, or obligations under the registration procedure on conditions.

Bringing documents of the registration dossier of the drug
in compliance with the requirements of the EAEU by the Ministry of Health of Russia as the authorized body of the reference state

    131. The administrative procedure “Compliance with the requirements of the Union” is carried out in connection with the submission to the Ministry of Health of Russia of an application for complience with the requirements of the EAEU (hereinafter - the application for alignment) and the documents referred to in paragraph 25 of the Regulations, using the Single Portal .

    132. The documents referred to in Clause 131 of the Regulations are adopted by the Ministry of Health of Russia in the manner prescribed by Clauses 39 and 40 of the Regulations.

    133. The Ministry of Health of Russia assigns a unique number to the application for harmonization, which is formed using the integrated system, and informs the applicant on the day of admission.

    134. The head of the structural unit of the Ministry of Health of Russia (his deputy), who is responsible for the provision of the state service, within one working day from the date of receipt of the documents specified in clause 131 of the Regulations, appoints the executive in charge.
    The last name, first name and patronymic (if available) of the responsible executor and his telephone number should be communicated to the applicant by his written or oral request.
    The responsible officer on the day of the appointment provides the expert institution with access to the dossier for compliance with the use of appropriate means of electronic communication.

    135. The responsible executive, within 5 working days from the day the applicant submits the registration application, provides the authorized bodies (expert organizations) of the state with access to the file for alignment with the use of the integrated system.
    136. The applicant is entitled, when it is brought into conformity with the requirements of the EAEU, at the same time making changes to the registration dossier of a registered medicinal product. In this case, the procedure for making such changes and the assessment of the dossier for compliance with the acts included in the EAEU law is carried out in accordance with Annexes No. 19 and 20 to the Registration Rules.
    137. Within 14 working days from the date of receipt of the documents specified in clause 131 of the Regulations, the expert institution and the responsible executor will carry out the validation of the dossier for compliance, including by comparing such information with information provided as an inter-agency information interaction.
    138. Formation and submission, if necessary, of interdepartmental requests to the bodies involved in the provision of public services, is carried out in accordance with Article 7.2 of Law No. 210-FZ in the framework of the administrative procedure related to the reception and registration of an application for alignment and accompanying documents, adoption decisions on the commencement of the procedure “Compliance with the requirements of the EAEU”, within 10 working days from the date of receipt of the documents referred to in Clause 131 of the Regulations, to the to the executive in order to obtain information necessary for the provision of the state service.

    Submission of information necessary for the provision of public services is carried out, among other things, in electronic form using a single system of inter-agency electronic interaction and regional systems of inter-departmental electronic interaction connected to it.

    139. In case of non-compliance of the application with the requirements set forth in Appendix No. 2 to the Registration Rules, identification of insufficient information, need for clarification or clarification of documents and data contained in the alignment dossier, the Ministry of Health of Russia within 14 business days from the date of receipt of such applications and documents the dossier for bringing in conformity notifies the applicant about the need to eliminate the revealed violations and (or) the presentation of missing documents within a period not exceeding 90 calendar days from the day of placement of the relevant notice in the information system of the Ministry of Health of Russia, by sending the notice to the applicant personally against a receipt, or sending a notice by registered mail with a receipt receipt, or sending it in electronic form via telecommunication channels or in the form of an electronic document signed with an electronic signature.

    The deadline, calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ended with the applicant submitting such documents and data to the Russian Ministry of Health, is not taken into account in order to calculate the time period for the examination and bring it into conformity with the requirements of the EAEU.

    140. The Ministry of Health of Russia rejects the application for compliance in case of non-submission of documents and data on the 90-day deadline for harmonization with the requirements of the EAEU on the observations of the Ministry of Health of Russia and (or) non-payment of the fee for alignment with the requirements of the EAEU and expertise of the medicinal product in cases and in accordance with the procedure established by the legislation of the Russian Federation, and informs the applicant about this through an integrated system within 4 working days from the date of the decision.

    141. Within 5 calendar days from the date of submission of the application for compliance and the dossier for harmonization with the requirements of the EAEU that meet the requirements of the Registration Rules, the Ministry of Health of Russia decides to begin the examination of the drug and harmonize with the requirements of the EAEU.

    142. Within 4 working days from the date of the decision to start the examination and registration of the medicinal product, the Ministry of Health of Russia issues to the expert institution a task for the expertise of the medicinal product.

    143. The expert institution - after receiving a valid dossier to be brought into compliance with the requirements - prepares expert reports within 50 calendar days from the date of commencement of the examination with the wording of comments and requests to the applicant on the form in accordance with annexes No. 6-8 and (or) 22 Registration Rules and Preliminary Evaluation Report in the form provided for in Appendix No. 11 to the Registration Rules. In preparing these expert reports, the expert institution is guided by the instructions contained in Appendices 13-15 and 23 of the Registration Rules.

    According to the results of the examination, the expert institution has the right to offer, and the Ministry of Health of Russia has the right to agree on the establishment of additional requirements in relation to the medicinal product in accordance with the provisions of paragraphs 116-118 of the Registration Rules. Installed requirements are made in the expert opinion.

    In the event that facts are discovered during the examination that cast doubt on the accuracy of the information provided, the Ministry of Health of Russia acts in accordance with clause 66 of the Regulations.

    144. During procedure of compliance with the requirements of the EAEU and the examination of the medicinal product, the Ministry of Health of Russia has the right to send the applicant a written and (or) electronic request for additional information, necessary requests or clarifications regarding the submitted documents and data on the compliance ( including proposals for amending the SmPC, package leaflet, drug packaging mock-ups, or other documents for compliance with the requirements of the Union).

    The request can be sent to the applicant personally against a receipt, sent by mail by registered mail with the receipt of receipt or sent in electronic form via telecommunication channels or in the form of an electronic document signed with an electronic signature. After the first request, subsequent requests are allowed only in case of additional questions about the data submitted by the applicant in response to the previous request.

    145. The applicant is obliged to provide a response to the request within a period not exceeding 90 calendar days from the date of receipt of the request. On the basis of the applicant’s application, the period for responding to a request may be extended by the Ministry of Health of the Russian Federation for valid reasons. The general deadline for responding to requests should not exceed 180 calendar days.

    146. In the event that the documents and data requested by the Ministry of Health of Russia are not submitted within the prescribed period, the examination and harmonization with the requirements of the EAEU cease. The decision of the Ministry of Health of Russia notifies the applicant within 14 working days from the date of such a decision in writing and (or) electronic form.

    147. The period calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ended with the applicant submitting such documents and data to the Ministry of Health of Russia is not taken into account in order to calculate the period for conducting an examination of the medicinal product and bringing it in line with the requirements of the EAEU.

    148. An expert institution and the Ministry of Health of the Russian Federation shall consider the applicant's responses within a period of not more than 20 calendar days from the date of receipt of the answer.

    149. According to the results of the examination of the medicinal product, taking into account the consideration mentioned in paragraph 148 of the Regulations, and subject to the preparation of a positive expert assessment report and a positive decision on the compliance of the registration dossier of the medicinal product to the requirements of the Union, the Ministry of Health of Russia:

    a) issues to the applicant a registration certificate of the medicinal product in the form provided in Appendix 17 to the Registration Rules, approved SmPC, a leaflet, a Normative document on quality control, packaging mock-ups of the medicinal product agreed by the SUR (if necessary);
    b) places, in accordance with the procedure for the formation and maintenance of a unified register of the EAEU, information on the registration of a medicinal product and its active ingredients in the unified register of the EAEU with the following approved documents:

    1) SmPC;
    2) leaflet;
    3) packaging mock-ups;
    4) Normative document;
    5) the final expert assessment report, compiled in accordance with Appendix No. 16 to the Registration Rules, after exclusion of confidential data and data about experts;
    6) summary of the agreed SUR (if necessary).

The Russian Ministry of Health issues the applicant with an indefinite registration certificate if the drug has been registered in 3 Member States of the Union for 5 years or more.

    The Russian Ministry of Health issues a registration certificate to the applicant with a validity of 5 years and the need to re-register upon their expiry if the drug was registered in 3 or less of the Member States of the Union for less than 5 years.

    Based on the results of the compliance with the requirements of the EAEU, the applicant is entitled to initiate the procedure for the recognition of the expert assessment report in the Member States of the EAEU, in which the medicinal product was registered according to national procedures. In this case, the Ministry of Health of Russia performs the appropriate actions described in paragraphs 69-71 and 74 of the Regulations.

    150. The Ministry of Health of Russia refuses to bring it into conformity with the requirements of the EAEU, if the results of the examination of a medicinal product have established that its quality is not confirmed, or - in accordance with paragraph 179 of the Registration Rules - an unfavorable “risk-benefit” ratio has been identified. In order to eliminate the conflict between paragraphs 178 and 179 of the Registration Rules regarding the possibility of assessing the “benefit-risk” relationship when adjusting and evaluating the feasibility of establishing additional measures specified in the second paragraph of paragraph 143 of the Rules, it is necessary, in particular, to be guided by the provisions of the Preamble of the Agreement:

    a) the desire to improve the health of the population by ensuring market access of high-quality, safe and effective medicines;
    b) interest in providing guarantees of safety, efficacy and quality of medicines for human life and health, environmental protection, animal and plant life and health, and prevention of actions that mislead consumers.

Introduction by the Ministry of Health of Russia as an authorized body of the reference state of changes to the registration dossier of a medicinal product registered in more than one Member State of the EAEU

    151. To ensure continuous evaluation of the “benefit-risk” ratio of a registered drug, the Ministry of Health of Russia (including at the request of an expert institution) has the right to send to the holder of the registration certificate a request for data confirming that the benefit-risk ratio of a registered drug remains favorable and (or) that the holder of the registration certificate fulfills the obligations stipulated in clauses 147-150 of the Registration Rules. The holder of the registration certificate is required to provide the Ministry of Health of Russia with the necessary documents and data as soon as possible, but no later than 30 calendar days from the date of receipt of the corresponding request.

The Ministry of Health of Russia (including at the request of an expert institution) has the right to send to the holder of the registration certificate a request for a copy of the pharmacovigilance system master file. The holder of the registration certificate is obliged to submit a corresponding copy within 10 working days from the date of receipt of this request.

    152. Amendments to the registration dossier of the registered medicinal product is carried out in accordance with the classification of changes made in the registration dossier of the registered drug, and the rules for their introduction are given in Appendices No. 19 and 20 of the Registration Rules.

    Examination of changes in the registration dossier of drugs is carried out in accordance with Annex No. 20 to the Registration Rules.

    An expert report (conclusion) on the assessment of changes made to the registration dossier of a medicinal product is drawn up based on the results of such examination in accordance with Appendix No. 21 to the Registration Rules.

    153. Before submitting an application for a change, the classification of which is not in Appendix No. 19 to the Registration Rules, the holder of the registration certificate has the right to send a request to the Ministry of Health of Russia to receive recommendations on the classification of such a change.

    The Ministry of Health of Russia, within 45 calendar days from the date of receipt of the request specified in the first paragraph of this paragraph, sends the recommendation to the applicant, the rest of the Member States and the expert committee in electronic and (or) paper form. This period may be extended by another 45 calendar days if the Ministry of Health of Russia considers it necessary to consult with an expert committee.

    154. When making changes to the registration dossier regarding changes to the SmPC and (or) leaflet, the Ministry of Health of Russia approves and issues to the holder of the registration certificate a new SmPC and (or) leaflet.

    155. When notifying about several changes or submitting several applications for making amendments with respect to each change in accordance with chapter II or sub-clause 4.1.1 of Annex No. 19, the applicant submits to the Ministry of Health of Russia (as an authorized body of the reference state) separate notification or application file changes in the registration dossier of a registered medicinal product, except as specified in the Registration Rules.

    156. If the changes affect the information and data of the registration certificate, the Ministry of Health of Russia, in the event of a positive decision, issues to the applicant a new registration certificate with the same number for the residual period of registration of the drug.

    157. In paragraphs 158-204 of the Regulations, the Ministry of Health of Russia acts as an authorized body of the reference state. Applicant means registration certificate holder intending to make corresponding change to the registered registration dossier of the drug product.

    158. The administrative procedure “The introduction of the Ministry of Health of Russia as of the reference state of changes to the registration dossier of medicinal products registered in more than one member state of the EAEU ”is carried out in connection with the submission to the Ministry of Health of the Russian Federation of a statement (notification) of amendments to the registration dossier of a registered medicinal product (hereinafter - the application for amendment) and the documents specified in paragraph 23 of the Regulations using the Single Portal.

    159. The documents referred to in paragraph 158 of the Regulations are accepted Ministry of Health of Russia in the manner prescribed by paragraph 40 of the Regulations.

    The Ministry of Health of Russia assigns to the application (notification) of changes a unique number formed using the integrated information system of the EAEU, and informs the applicant on the day of admission.

    160. The head of the structural unit of the Ministry of Health of Russia (his deputy), who is responsible for the provision of the state service, within one working day from the date of receipt of the documents referred to in paragraph 158 of the Regulations, appoints the executive officer.

    The last name, first name and (if available) patronymic of the responsible executor and his telephone number should be communicated to the applicant upon his written or oral request.

    The responsible officer on the day of appointment provides the expert institution with access to the change dossier using appropriate electronic communication tools.

    161. The responsible executive shall, within 5 working days from the day the applicant submits an application for amendments, grant the authorized bodies (expert organizations) of the states of recognition access to the file on the change using the tools of the integrated system.

    162. Within 5 working days from the date of receipt of the documents specified in clause 158 of the Regulations, the expert institution and the executive officer validate the change dossier, including by comparing such information with information provided in the order of interdepartmental information interaction.

    163. Formation and submission of interdepartmental requests to the bodies involved in the provision of public services are carried out by the responsible executor in accordance with Article 7.2 of Law No. 210-FZ within the framework of the administrative procedure related to the reception and registration of the application (notification) on amendments and accompanying documents deciding on the start of the procedure for making changes to the registration dossier of a registered medicinal product within 5 working days from the date of receipt documents specified in clause 158 of the Regulations to the responsible executor in order to obtain information necessary for the provision of the state service.

    Submission of information necessary for the provision of public services is carried out, among other things, in electronic form using a single system of inter-agency electronic interaction and regional systems of inter-departmental electronic interaction connected to it.

    164. In case of non-compliance of the application (notification) with the requirements established by Appendix No. 2 to the Registration Rules, detection of insufficient information, need for clarification or justification of documents and data contained in the change file, the Ministry of Health of Russia within 5 business days from the date of receipt of such statements the introduction of changes and accompanying documents notifies the applicant of the need to eliminate the violations found and (or) the presentation of missing documents within a period not exceeding 90 calendar days from the date of placing the relevant notice in the information system of Ministry of Health of Russia, by sending a notice to the applicant personally against a receipt or notification by registered mail with return receipt or transmission in electronic form via telecommunication channels or in e-document form signed by electronic signature.

    The deadline, calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and finished with the applicant submitting such documents and data to the Russian Ministry of Health, is not taken into account in order to calculate the period for conducting the examination and making changes to the registered drug file.

    165. The Ministry of Health of Russia rejects an application (notification) for making changes in the case of non-submission of documents and data for a change of 90 days on the comments of the Ministry of Health of Russia and (or) failure to pay the fee for making changes and examination of the drug in the cases and procedure established by law Of the Russian Federation, and informs the applicant and the authorized bodies (expert organizations) of the recognition states through an integrated system about this within no more than 4 working days from the date of the decision.

    166. Within 5 working days from the date of the submission of the application for amendments and the change file that comply with the requirements of the EAEU Registration Rules, the Ministry of Health of Russia decides to begin the examination and amend the registration dossier of the registered drug.

    167. The Ministry of Health of Russia places a request for amendments and the dossier documents for the change on the official website of the Ministry of Health of Russia, which are available only to authorized bodies (expert organizations) of the recognition states, and submits to the Commission information on the identification number of the application for changes using the integrated information system of the EAEU.

    Authorized bodies (expert organizations) of the recognition states are entitled to familiarize themselves with the progress of expert work in the Ministry of Health of Russia, including the correspondence of the applicant and the Ministry of Health of Russia regarding the elimination of comments and the documents submitted by the applicant in the process of examination and introduction of changes in the registration dossier of the registered drug.

    168. On the day the decision is made to start the examination and to amend the registration dossier of the registered drug, the Ministry of Health of Russia issues to the expert institution a task for the examination of the drug.

    169. At the time of making changes to the registration dossier and examination of the medicinal product, the Ministry of Health of Russia has the right to send the applicant a written and (or) electronic request for missing additional information, necessary explanations or clarifications regarding the submitted documents and data on the change (including proposals for amendments to the SmPC, package leaflet, packaging models of the drug or other documents of the registration dossier).

    The request can be sent to the applicant personally against a receipt, sent by mail by registered mail with the receipt of receipt or sent in electronic form via telecommunication channels or in the form of an electronic document signed with an electronic signature. After the first request, subsequent requests are allowed in case of additional questions on the data submitted by the applicant in response to the previous request.

    In the event that facts are discovered during the examination that cast doubt on the accuracy of the information provided, the Ministry of Health of Russia acts in accordance with clause 66 of the Regulations.

    170. The applicant is obliged to provide a response to the request within a period not exceeding 90 calendar days from the date of receipt of the request.

    171. In the event that the documents and data requested by the Russian Ministry of Health are not submitted within the prescribed period, the examination and introduction of changes to the registration dossier of the registered medicinal product is terminated. The decision of the Ministry of Health of Russia notifies the applicant and the authorized bodies (expert organizations) of the state of recognition within 14 working days from the date of the adoption of such a decision in writing and (or) electronic form.

    172. The deadline, calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ended with the applicant submitting such documents and data to the Russian Ministry of Health, is not taken into account in order to calculate the time period for conducting an examination and making changes to the registered drug.

    173. Depending on the type of changes introduced by Annex No. 19 to the Registration Rules, the Ministry of Health of Russia and the expert institution carry out the actions provided for in paragraphs 174-178 or 179-187 of the Regulations.

    174. The expert institution conducts an examination in accordance with paragraph 2.1.2 of Annex No. 20 to the Registration Rules.

    175. Not later than the 25th calendar day from the date of receipt of the valid change dossier, the expert institution shall submit the opinion drawn up in accordance with the third paragraph of clause 152 of the Regulations to the Ministry of Health of Russia.

    176. Within 30 calendar days from the date of granting access to the change file, the Ministry of Health of Russia accepts the opinion provided for in clause 175 of the Regulations, and:

    a) notifies the applicant and the relevant authorities of the state of recognition of acceptance or rejection of the change;
    b) in case of rejection of the change, notifies the applicant and the relevant authorities of the state of recognition of the grounds for his decision;

    177. If a change is adopted, the Ministry of Health of Russia notifies the applicant and the relevant state authorities of changes in the decision making conditions for registration of a medicinal product, including SmPC, and any conditions, obligations or restrictions affecting the registration of a medicinal product or changes in labeling or package leaflet affected by change in SmPC, and acts in accordance with paragraph 178 of the Regulations.

    178. The Ministry of Health of Russia makes changes to the registration dossier, places information about making changes in the EAEU single register with the attachment of relevant documents and issues such relevant documents to the applicant on the conditions and terms specified in clause 2.1.2 of Annex 20 to the Registration Rules.

    179. If, according to the results of validation provided for by clause 162 of the Regulations, the change is not recognized as not meeting the criteria for an insignificant IB type change, provided for by Annex V of Appendix No. 19 to the Registration Rules, or it is not classified as an insignificant IB type change in accordance with Clause 1.5 of Appendix No. 19 to the Registration Rules and the Ministry of Health of Russia believes that such a change could have a significant impact on the quality, safety or efficacy of the drug, he promptly notified is it interested Member States of the Union and the applicant.

    180. If within 10 working days the interested Member States of the Union do not express disagreement, the applicant receives confirmation of the need to revise the application and supplement it in accordance with the requirements for significant type II changes. After receiving a valid revised application, the procedure for examining type II change, described in clauses 189, 204 of the Rules, begins.

    If the interested member states of the EAEU do not agree with the conclusion of the Ministry of Health of Russia, he is obliged to take a final decision regarding the classification of the proposed statement, taking into account the comments received from the interested states.

    If the Ministry of Health of Russia considers that the proposed change can be considered as an insignificant change of type IB, it notifies the applicant of the result of validation.

    181. The expert institution conducts an examination in accordance with paragraph 2.2.2 of Annex No. 20 to the Registration Rules.

    182. Not later than the 25th calendar day from the date of receipt of the valid change dossier, the expert institution shall transmit the opinion drawn up in accordance with the third paragraph of clause 152 of the Regulations to the Ministry of Health of Russia.

    183. Within 30 calendar days from the date of acknowledgment of receipt of a valid notice, the Ministry of Health of the Russian Federation notifies the applicant of the results of the procedure.

    If the Ministry of Health of Russia has not sent its conclusion regarding the notification to the applicant within 30 calendar days from the date of receipt of the notification, the notification shall be accepted by all relevant authorities. In this case, the subparagraph "c" of paragraph 186 and paragraph 187 of the Regulations apply.

    184. In case of a negative conclusion, the applicant is entitled to resubmit the amended dossier to the Ministry of Health of Russia within 30 calendar days from the date of its receipt.
    If the applicant does not submit an amended notification in accordance with the conclusion or request of the Ministry of Health of Russia, the notification shall be deemed rejected by all relevant authorities.

    185. In the case of a supplemented notice:

    a) the Ministry of Health of Russia acts in accordance with clause 162 of the Regulations with regard to additionally submitted documents and data;
    b) the Ministry of Health of Russia and the expert institution review the newly submitted documents and data in a period not exceeding 30 calendar days from the date of receipt of such notification with the adoption of the conclusion.

    186. According to the results of the review and within the time specified in clause 185 of the Regulations, the Ministry of Health of Russia:

    a) notifies the applicant and the relevant authorities of the state of recognition of acceptance or rejection of the change;
    b) in case of rejection of the change, notifies the applicant and the relevant authorities of the state of recognition of the grounds for his decision;
    c) if accepted, notifies the applicant and the relevant authorities of the state of recognition of changes in the conditions for making a decision on registration of a medicinal product, including SmPC and any conditions, obligations or restrictions affecting the registration of a medicinal product or changes in labeling or package leaflet, due to a change in SmPC in connection with the amendment, and acts in accordance with paragraph 187 of the Regulations.

    187. The Ministry of Health of Russia makes changes to the registration dossier, places information about changes in the Union’s single register with the attachment of relevant documents and issues such relevant documents to the applicant on the conditions and terms specified in clause 2.2.2 of Annex 20 to the Registration Rules.

    188. Paragraphs 189-204 set out the procedure for making changes on significant changes of type II.

    189. The expert institution and the responsible executor shall carry out the validation specified in clause 162 of the Regulations within 14 days. According to the results of validation, the Ministry of Health of Russia acts in accordance with clauses 163-172 of the Regulations. The expert institution conducts an examination in accordance with paragraph 2.3.2 of Annex No. 20 to the Registration Rules.

    190. Within 45 calendar days from the date of receipt of a valid application for making changes, the expert institution is obliged to complete the examination of the medicinal product and prepare a draft expert evaluation report, subject to the provisions provided for in paragraph 60 of the Regulations.

    191. According to the results of the examination and during the period mentioned in paragraph 189 of the Regulations, the Ministry of Health of Russia has the right to send the applicant a written and (or) electronic request for the submission of missing additional information, necessary explanations or clarifications regarding the submitted documents and the data of the change ( including proposals for changes to the SmPC, package leaflet, drug packaging mock-ups, or other documents for change).

    192. The Ministry of Health of Russia forwards the request to the applicant and a copy of the request to the appropriate authorities of the states of recognition in the form established by Appendices 6-8 to the Registration Rules.

    193. The applicant is obliged to provide a response to the request within a period not exceeding 90 calendar days from the date of receipt of the request.

    194. In the event that the documents and data requested by the Russian Ministry of Health are not submitted within the prescribed period, the examination and introduction of changes to the registration dossier of the registered medicinal product is terminated. The decision of the Ministry of Health of Russia notifies the applicant and the authorized bodies (expert organizations) of the state of recognition within 10 working days from the date of the adoption of such a decision in writing and (or) electronic form.

    195. The period calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ended with the applicant submitting such documents and data to the Ministry of Health of Russia is not taken into account in order to calculate the period for conducting the examination and making changes to the registered drug.

    196. The expert institution and the Ministry of Health of the Russian Federation shall consider the answers of the applicant within 15 calendar days from the day the answer is received.

    197. According to the results of consideration, the Ministry of Health of Russia is obliged during the period specified in clause 196 of the Regulations:

a) prepare a draft decision on a change request;
    b) send a draft expert opinion, finalized on the basis of the review referred to in paragraph 196 of the Regulations, and a draft decision on the application for amending the relevant authorities of the state of recognition before the expiration of the 60-day period from the date of receiving the valid application in paper and (or) electronic form .

    According to the results of the examination, the expert institution has the right to offer, and the Ministry of Health of Russia has the right to agree on the establishment of additional requirements in relation to the medicinal product in accordance with the provisions of paragraphs 116-118 of the Registration Rules. The established requirements are entered into the expert opinion and are subject to approval by the states of recognition, like any other provisions of the expert assessment report.

    198. The Ministry of Health of Russia has the right to reduce the total 60-day period, taking into account the urgency of the issue, or extend it to 90 calendar days for changes in modifying the approved indications for use or including new indications for use, or a group of changes in accordance with paragraph 4 of paragraph 3.4. .2 of appendix No. 19 to the Registration Rules.

    199. If, following the results of consideration in accordance with clauses 196 or 197 of the Regulations, the Ministry of Health of Russia has decided to reject the application for amendment, it shall notify the applicant and the relevant authorities of the recognition of his decision and the grounds for its adoption.

    200. In the case of a positive decision and the direction of the relevant documents to the recognition states in accordance with clause 197 of the Regulations, the Ministry of Health of Russia acts in accordance with clause 201 or 202 of the Regulations.

    201. If 30 calendar days after the date of notification of recognition by the states in accordance with clause 197 of the Regulations and in the absence of a notification from the states of recognition of the request sent to the applicant in accordance with clause 2.3.6 of Annex 19 to the Registration Rules of the Ministry of Health of Russia:

    a) receives notification of recognition by the state of recognition of the draft expert report or
    b) does not receive any notification from the recognition states, it decides on the adoption of the amendment and acts in accordance with subparagraph “c” of paragraph 186 and paragraph 203 of the Regulations.

    202. If the Ministry of Health of Russia after 20 calendar days from the date of notification of the recognition states in accordance with clause 197 of the Regulations receives from the state of recognition (or the states of recognition) notification of the request to the applicant, then after no more than 120 calendar days from the date of notification of the recognition states with clause 197 of the Regulations, it acts in accordance with clause 201 of the Regulations of the Ministry of Health of Russia:

    a) receives notification of recognition by the state of recognition of the draft expert report or
    b) does not receive any notification from the recognition states,

it decides on the adoption of the amendment and acts in accordance with subparagraph “c” of paragraph 186 and paragraph 203 of the Regulations.

    203. The Ministry of Health of Russia makes changes to the registration dossier, places information about changes in the Union’s single register with the attachment of relevant documents and issues such relevant documents to the applicant on the conditions and terms specified in paragraph 2.3.3 of Appendix 20 to the Registration Rules.

    204. If, after the deadlines specified in clause 201 or 202 of the Regulations, the Ministry of Health receives a notice of non-recognition of the draft expert report from at least one state of recognition, the Ministry of Health acts in accordance with section 2.5 of Appendix No. 19 to the Registration Rules. Based on the recommendation of the expert committee, the Ministry of Health of Russia acts in accordance with clause 199 or 203 of the Regulations, as appropriate.

Introduction by the Ministry of Health of Russia as the authorized body of the reference state variations to the registration dossier of the drug, registered only in the reference state

 

    205. In paragraphs 206-248 of the Regulations, the Ministry of Health of Russia is guided by the provisions provided for in paragraphs 151-156 of the Regulations. The applicant is the holder of a registration certificate who plans to make a corresponding change in the registration dossier of a registered drug.

    206. The administrative procedure “Introduction by the Ministry of Health of Russia as a reference state changes to the registration dossier of drugs registered only in the reference state” is carried out in connection with the submission to the Ministry of Health of Russia of an application (notification) on amendments and documents specified in clause 23 of the Regulations (for except for the information specified in subparagraph 3) using the Single Portal.

    207. The documents referred to in clause 206 of the Regulations are adopted by the Ministry of Health of Russia in the manner prescribed by clause 40 of the Regulations.
    The Ministry of Health of Russia assigns to the application (notification) of changes a unique number formed using the integrated information system of the EAEU, and informs the applicant on the day of admission.

    208. The head of the structural unit of the Ministry of Health of Russia (his deputy), who is responsible for the provision of the state service, within one working day from the date of receipt of the documents referred to in paragraph 206 of the Regulations, appoints the executive officer.

    The surname, name, patronymic (if available) of the responsible executor and his telephone number must be communicated to the applicant by his written or oral request.

    The responsible officer on the day of appointment provides the expert institution with access to the change dossier using appropriate electronic communication tools.

    209. Within 5 working days from the date of receipt of the documents specified in clause 206 of the Regulations, the expert institution and the executive officer validate the dossier for variations, including by comparing such information with information provided as an inter-agency information interaction.

    210. Formation and submission of interdepartmental requests to the bodies involved in the provision of public services are carried out by the responsible executor in accordance with Article 7.2 of Law No. 210-FZ within the framework of the administrative procedure related to the reception and registration of the application (notification) on amendments and accompanying documents deciding on the start of the procedure for making changes to the registration dossier of a registered medicinal product within 5 working days from the date of receipt of documents specified in clause 206 of the Regulations to the responsible executor in order to obtain information necessary for the provision of the state service.

    Submission of information necessary for the provision of public services is carried out, among other things, in electronic form using a single system of inter-agency electronic interaction and regional systems of inter-departmental electronic interaction connected to it.

    211. In case of non-compliance of the application (notification) with the requirements established by Appendix No. 2 to the Registration Rules, detection of insufficient information, need for clarification or justification of documents and data contained in the variation dossier, the Ministry of Health of Russia within 5 business days from the date of receipt of such declarations the introduction of changes and accompanying documents notifies the applicant of the need to eliminate the violations found and (or) the presentation of missing documents within a period not exceeding 90 calendar days from the date of placing the relevant notice in the information system of Ministry of Health of Russia, by sending a notice to the applicant personally against a receipt or notification by registered mail with return receipt or transmission in electronic form via telecommunication channels or in e-document form signed by electronic signature.

    The deadline, calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ends with the applicant submitting such documents and data to the Russian Ministry of Health, is not taken into account in order to calculate the period for conducting the examination and making changes to the registered drug file.

    212. The Ministry of Health of Russia rejects an application (notification) for making changes in the case of non-submission of documents and data for a change of 90 days on the comments of the Ministry of Health of Russia and (or) failure to pay the fee for making changes and examination of the drug in the cases and manner prescribed by law Of the Russian Federation, and informs the applicant and the authorized bodies (expert organizations) of the recognition states through an integrated system about this within no more than 4 working days from the date of the decision.

    213. Within 5 working days from the date of the submission of the application for amendments and the change file that meet the requirements of the EAEU Registration Rules, the Ministry of Health of Russia decides to start the examination and amends the registration dossier of the registered drug.

    214. The Ministry of Health of Russia places a request for amendments and the dossier documents for the change on the official website of the Ministry of Health of Russia submits to the Commission information on the identification number of the application for changes using the integrated information system of the EAEU.

    215. On the day of the decision to begin the examination and to amend the registration dossier of the registered drug, the Ministry of Health of Russia issues an expert institution assignment for the examination of the drug.

    216. When making changes to the registration dossier and examination of the medicinal product, the Ministry of Health of Russia has the right to send the applicant a written and (or) electronic request for missing additional information, necessary explanations or clarifications regarding the submitted documents and data on the change (including proposals for amendments to the SmPC, package leaflet, packaging mock-ups of the drug or other documents of the registration dossier).

    The request can be sent to the applicant personally against a receipt, sent by mail by registered mail with the receipt of receipt or sent in electronic form via telecommunication channels or in the form of an electronic document signed with an electronic signature. After the first request, subsequent requests are allowed only in case of additional questions about the data submitted by the applicant in response to the previous request.

    In the event that facts are discovered during the examination that cast doubt on the accuracy of the information provided, the Ministry of Health of Russia acts in accordance with clause 66 of the Regulations.

    217. The applicant is obliged to provide a response to the request within a period not exceeding 90 calendar days from the date of receipt of the request.

    218. In the event that the documents and data requested by the Russian Ministry of Health are not submitted within the prescribed period, the examination and introduction of changes to the registration dossier of the registered medicinal product is terminated. The decision of the Ministry of Health of Russia notifies the applicant within 14 working days from the date of such a decision in writing and (or) electronic form.

    219. The deadline calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ended with the applicant submitting such documents and data to the Ministry of Health of Russia is not taken into account in order to calculate the period for conducting the examination and making changes to the registration dossier of the registered drug.

    220. Depending on the type of the changes provided for in Appendix No. 19 to the Registration Rules, the Ministry of Health of Russia and the expert institution carry out the actions provided for by clauses 221-225 of the Regulations or clauses 226-234 of the Regulations.

    221. The expert institution conducts an examination in accordance with clause 2.1.2 of Annex No. 20 to the Registration Rules.

    222. Not later than the 25th calendar day from the date of receipt of the valid change dossier, the expert institution shall transmit the opinion drawn up in accordance with the third paragraph of clause 152 of the Regulations to the Ministry of Health of Russia.

    223. Within 30 calendar days from the date of receipt of a valid change dossier, the Ministry of Health of Russia accepts the opinion referred to in clause 222 and:

    a) notify the applicant of the acceptance or rejection of the change;
    b) in the event of a change being rejected, notify the applicant of the reasons for its decision.

    224. If a change is adopted, the Ministry of Health of Russia notifies the applicant of a change in the conditions for making a decision on registration of a drug, including SmPC, and any conditions, obligations or restrictions affecting the registration of a drug or a change in labeling or leaflet due to a change in SmPC and acts in accordance with paragraph 225 of the Regulations.

    225. The Ministry of Health of Russia makes changes to the registration dossier, places information about changes in the Union’s single register with the attachment of relevant documents and issues such relevant documents to the applicant on the conditions and terms specified in paragraph 2.1.3 of Appendix 20 to the Registration Rules.

    226. If, according to the results of validation provided for in clause 209 of the Regulations, the change is not recognized as meeting the criteria for an insignificant IB type change established by Annex V of Appendix No. 19 to the Registration Rules, or it is not classified as an insignificant IB type change in accordance with Clause 1.5 of Appendix No. 19 to the Registration Rules and the Ministry of Health of Russia believes that such a change may have a significant impact on the quality, safety or efficacy of the drug, he immediately notifies the applicant of the need to review the application and supplement it in accordance with the requirements for significant changes of type II. After receiving a valid revised application, the procedure for examining type II change, described in paragraphs 235-248 of the Rules, begins.

    227. If the Ministry of Health of Russia considers that the proposed change can be considered as an insignificant change of type IB, it notifies the applicant of the result of validation.

    228. The expert institution conducts an examination in accordance with paragraph 2.2.3 of Annex No. 20 to the Registration Rules.

    229. No later than the 25th calendar day from the date of receipt of a valid change dossier, the expert institution transmits the opinion drawn up in accordance with the third paragraph of clause 152 of the Regulations to the Ministry of Health of Russia.

    230. Within 30 calendar days from the date of acknowledgment of receipt of a valid notification, the Ministry of Health of the Russian Federation notifies the applicant of the results of the procedure.

    If the Ministry of Health of Russia has not sent its conclusion regarding the notification to the applicant within 30 calendar days from the date of receipt of the notification, the notification shall be deemed accepted. In this case, subparagraph “c” of paragraph 233 and paragraph 234 of the Regulations apply.

    231. In the event of a negative conclusion, the applicant is entitled to resubmit the amended dossier to the Ministry of Health of Russia within 30 calendar days from the date of its receipt.
    If the applicant does not submit an amended notification in accordance with the opinion or request of the Ministry of Health of Russia, the notification shall be deemed rejected.

    232. In case of a submission of a supplemented notification, the Ministry of Health of Russia and the expert institution review the newly submitted documents and data within a period not exceeding 30 calendar days from the date of receipt of such notification with the adoption of an opinion.

    233. According to the results of the review and within the time specified in clause 232 of the Regulations, the Ministry of Health of the Russian Federation notifies the applicant of acceptance or rejection of the change:

    a) in the event of a change being rejected, notify the applicant of the reasons for its decision;
    b) if approved, notifies the applicant of a change in the conditions for making a decision on registration of a medicinal product, including SmPC and any conditions, obligations or restrictions affecting the registration of a medicinal product or a change in labeling or package leaflet due to a change in SmPC , and acts in accordance with paragraph 234 of the Rules.

    234. The Ministry of Health of Russia makes changes to the registration dossier, places information about changes in the Union’s single register with the attachment of relevant documents and issues such relevant documents to the applicant on the conditions and terms specified in clause 2.2.3 of Appendix No. 20 to the Registration Rules.

    235. In order to make changes on significant changes of type II, the expert institution and the responsible executor shall carry out the validation specified in paragraph 209 of the Regulations within 14 days.

    236. According to the results of validation, the Ministry of Health of Russia acts in accordance with clauses 210-219 of the Regulations. The expert institution conducts an examination in accordance with subparagraph 2.3.4 of Annex No. 20 to the Registration Rules.

    237. Within 45 calendar days from the date of receipt of a valid application for making changes, the expert institution is obliged to complete the examination of the medicinal product and prepare a draft expert assessment report, subject to the provisions provided for in paragraph 60 of the Regulations.

    238. According to the results of the examination and during the period stipulated by paragraphs 235–236 of the Regulations, the Ministry of Health of Russia has the right to send the applicant a written and (or) electronic request for the submission of missing additional information, necessary explanations or clarifications regarding the submitted documents and data (including proposals for amending the SmPC, package leaflet, packaging mock-ups for the medicinal product, or other documents for a change).

    239. The Ministry of Health of Russia sends a request to the applicant in the form established by Appendices 6-8 to the Registration Rules.

    240. The applicant is obliged to provide a response to the request within a period not exceeding 90 calendar days from the date of receipt of the request.

    241. In the event that the documents and data requested by the Russian Ministry of Health are not submitted within the prescribed period, the examination and introduction of changes to the registration dossier of the registered medicinal product is terminated. The decision of the Ministry of Health of Russia notifies the applicant within 10 working days from the date of such a decision in writing and (or) electronic form.

    242. The period calculated from the date the Ministry of Health sent the applicant a request for additional documents and data and ended with the applicant submitting such documents and data to the Ministry of Health of Russia is not taken into account in order to calculate the time period for conducting an examination and making changes to the registered drug file.

    243. The expert institution and the Ministry of Health of the Russian Federation shall consider the applicant's responses within 15 calendar days from the date of receipt of the answer.

    According to the results of the examination, the expert institution has the right to offer, and the Ministry of Health of Russia has the right to agree on the establishment of additional requirements in relation to the medicinal product in accordance with the provisions of paragraphs 116-118 of the Registration Rules. The established requirements are entered into the expert opinion and are subject to approval by the states of recognition, like any other provisions of the expert assessment report.

    244. According to the results of consideration, the Ministry of Health of Russia is obliged, within the period specified in clause 243 of the Regulations, to prepare a draft decision on the application for amendment.

    245. The Ministry of Health has the right to reduce the total 60-day period, taking into account the urgency of the issue, or extend it to 90 calendar days for changes in modifying the approved indications for use or including new indications for use, or a group of changes in accordance with paragraph 4 of paragraph 3.4. .2 of appendix No. 19 to the Registration Rules.

    246. If, based on the results of consideration in accordance with clauses 243 or 244 of the Regulations, the Ministry of Health of Russia has decided to reject the application for amendments, he shall notify the applicant of his decision and the grounds for its adoption.

    247. In the event of a positive decision, the Ministry of Health of Russia takes a decision on the adoption of the amendment and acts in accordance with subparagraph “c” of clause 233 and clause 248 of the Regulations.

    248. The Ministry of Health of Russia makes changes to the registration dossier, places information about making changes in the Union’s single register with the attachment of relevant documents and issues such documents to the applicant on the conditions and terms specified in paragraph 2.3.5 of Annex 20 to the Registration Rules.

Approval (refusal) by the Ministry of Health of Russia
as the authorized body of the state of recognition
of making changes to the registration dossier of the drug,
registered in more than one Member State of the EAEU

    249. The administrative procedure “Approval (refusal) by the Ministry of Health of Russia as the authorized body of the state of recognition of making changes to the registration dossier of the drug, registered in more than one Member State of the EAEU ,” is carried out in connection with the submission to the Ministry of Health of the documents referred to in paragraph 24 of the Regulations.

    250. The documents referred to in clause 249 of the Regulations are accepted by the Ministry of Health of Russia in the manner prescribed by clause 40 of the Regulations.

    251. The applicant submits to the Ministry of Health of Russia the documents specified in clause 249 of the Regulations, simultaneously with the submission of the application for amendment.

    252. The head of the structural unit of the Ministry of Health of Russia (his deputy), who is responsible for the provision of state services, within one working day from the date of receipt of the documents referred to in paragraph 249 of the Regulations, appoints the executive officer.

    253. The last name, first name and patronymic (if any) of the responsible executor and his telephone number must be communicated to the applicant upon his written or oral request. The data of the responsible executive must be available to the authorized body (expert organization) of the reference state and other recognition states for viewing on the official website of the Ministry of Health of Russia.

    254. On the day of appointment, the executive officer shall provide the expert institution with access to the change dossier using the appropriate electronic communication tools and assign the expert institution with the task of reviewing the documents referred to in paragraph 251 of the Regulations.

    255. Depending on the type of the changes provided for in Appendix No. 19 to the Registration Rules, the Ministry of Health of Russia carries out the actions provided for in paragraphs 256-257 of the Regulations.

    256. Within 30 calendar days from the date of granting access to the dossier for making amendments, the Ministry of Health of Russia, taking into account the evaluation by an expert institution of documents, access to which was granted in accordance with clause 254 of the Regulations, and based on the opinion of the authorized body (expert organization) of the reference state:

    a) notifies the applicant and the relevant authorities of the Member States of the acceptance or rejection of the change;
    b) if approved, notifies the applicant and the relevant authorities of the Member States of the change of conditions for making a decision on the registration of a medicinal product, including SmPC, and any conditions, obligations or restrictions affecting the registration of a medicinal product or changes in labeling or package leaflet due to changes in SmPC, in connection with the amendment, and operates in accordance with paragraph 257 of the Regulations.

    257. The Ministry of Health of Russia makes changes to the registration dossier, places information about changes in the Union’s single register with the attachment of relevant documents and issues such relevant documents to the applicant on the conditions and terms specified in clause 2.1.2 of Appendix 20 to the Registration Rules.

    258. In order to notify insignificant IB type changes, the Ministry of Health has the right, within 10 working days from the date of granting access to the change dossier, to express its opinion on the opinion of the reference state on the basis of the conclusion of the expert institution regarding the necessity of considering the insignificant IB type change as a significant change Type II.

    259. In the event that the authorized body (expert organization) decides on the reference state to classify the submitted amendment as Type II amendment, the Ministry of Health of the Russian Federation acts in accordance with Clauses 262-270 of the Regulations.

    260. Within 30 calendar days from the date of granting access to the change dossier (or a longer period in accordance with the examination procedure in the reference state), the Russian Ministry of Health, taking into account the assessment by the expert institution of the documents, access to which was granted in accordance with paragraph 253 of the Regulations, and on the basis of the conclusion of the authorized body (expert organization) of the reference state:

    a) notifies the applicant and the relevant authorities of the Member States of the acceptance or rejection of the change;
    b) if approved, notifies the applicant and the relevant authorities of the Member States of the change of conditions for making a decision on the registration of a medicinal product, including SmPC, and any conditions, obligations or restrictions affecting the registration of a medicinal product or changes in labeling or package leaflet due to changes in SmPC, and operates in accordance with paragraph 261 of the Regulations.

    261. The Ministry of Health of Russia makes changes to the registration dossier, places information about making changes in the Union’s common register with the attachment of relevant documents and issues such relevant documents to the applicant on the conditions and terms specified in clause 2.2.2 of Appendix 20 to the Registration Rules.

    262. In order to be notified of significant changes of type II, within 30 calendar days from the date of receipt of the draft expert assessment report and draft decision of the reference state specified in paragraph 2.3.4 of Appendix No. 20 to the Registration Rules, the Ministry of Health of Russia decides on the approval or refusal of the expert assessment report prepared by the expert organization of the reference state, and notifies the authorized body (expert organization) of the reference state accordingly.

    263. No later than 20 calendar days from the date of access to the documents specified in clause 262 of the Regulations, the Ministry of Health of Russia on the basis of an assessment of an expert institution and, if necessary, sends a request to the applicant and to the authorized body (expert organization) of the reference state in the form provided by Annex No. 18 to the Registration Rules. The request may contain a proposal to establish the measures provided for in paragraphs 116-118 of the Registration Rules.

    264. In its request, drawn up in accordance with clause 263 of the Regulations, the Ministry of Health of Russia has the right to raise the question of initiating an appropriate inspection provided for in the Registration Rules.

    265. The applicant sends a response to the request to the Ministry of Health of Russia within a period not exceeding 90 calendar days. The term of the applicant's response to the request is not included in the general term of the examination and changes in the registration dossier of the registered drug.

    266. In the event that the requested documents and information are not submitted within the prescribed period, the examination and introduction of changes to the registration dossier of the registered medicinal product is terminated.

    Within 10 working days from the date of the decision, the applicant shall be notified of the decision taken.

    267. If during the period specified in Article 262 of the Regulations, the Ministry of Health of Russia does not send an opinion on the acceptance or rejection of the documents mentioned in this paragraph, the decision of the Ministry of Health of Russia shall be accepted.

    268. If the documents referred to in paragraph 262 of the Regulations are recognized by all relevant authorities, the Ministry of Health of Russia:

    a) notifies the applicant and the relevant authorities of the Member States of the acceptance or rejection of the change;
    b) if approved, notifies the applicant and the relevant authorities of the Member States of the change of conditions for making a decision on the registration of a medicinal product, including SmPC, and any conditions, obligations or restrictions affecting the registration of a medicinal product or changes in labeling or package leaflet due to variations in SmPC, and operates in accordance with paragraph 269 of the Regulations.

    269. The Ministry of Health of Russia makes changes to the registration dossier, places information about making changes in the Union’s single register with the attachment of relevant documents and issues such relevant documents to the applicant on the conditions and terms specified in paragraph 2.3.3 of Appendix No. 20 to the Registration Rules.

    270. In the event that the Ministry of Health of Russia or any other authorized body (expert organization) of the state does not accept the positive conclusion of the reference state, the Ministry of Health of Russia acts in accordance with section 2.5 of Appendix No. 19 to the Registration Rules. In the case of a positive recommendation of the expert committee, the Ministry of Health of Russia acts in accordance with clause 269 of the Regulations, as appropriate.

Revocation (cancellation) of the registration certificate

    271. The administrative procedure “Revocation (Cancellation) of the Registration Certificate” is carried out on the basis provided for by sub-clause “a” of clause 160 of the Registration Rules.

    272. The applicant submits to the Ministry of Health of Russia applications for cancellation of the registration certificate of the medicinal product and documents explaining the reasons for making such a decision.

    273. During the next working day from the date of receipt of the application referred to in paragraph 272 of the Regulations to the Ministry of Health of Russia, the executive officer appointed by the head of the structural unit of the Ministry of Health of Russia (his deputy) responsible for the provision of public services considers the application and documents specified in paragraph 272 Regulations.

    274. Not later than 5 working days from the date of submission to the Ministry of Health of the documents referred to in paragraph 272 of the Regulations, the Ministry of Health of Russia decides to revoke the registration certificate and the measures provided for in paragraph 161 of the Registration Rules, or the decision to refuse to revoke the registration certificate to applicant written explanation indicating the reasons for such refusal.

    275. No later than the next business day from the date of the adoption of the decision referred to in paragraph 274, the executive officer shall enter the relevant information in the Unified Register of the Union.

 

Issuance of a Duplicate of Registration certificate of the drug

    276. The administrative procedure “Issuance of a Duplicate of Registration certificate of the drug” is carried out in connection with the receipt from the holder of the registration certificate to the Ministry of Health of Russia of an application for issuance of a duplicate of the registration certificate of the medicinal product using the Single Portal.

    The reason for submitting an application for a duplicate registration certificate of a medicinal product may be the identification of errors and misprints in it.

    277. Within 10 working days from the date of receipt of the application for the submission of a duplicate of the registration certificate of a medicinal product, the Ministry of Health of Russia draws up a duplicate of the registration certificate of the medicinal product on the registration certificate form marked “duplicate” and “the original registration certificate is invalid” certificate or sends it by registered mail with the receipt of receipt.

    278. Application for issuance of duplicate registration certificate
of the medicinal product is presented by the holder of the registration certificate to the Ministry of Health of Russia on paper directly or sent by registered mail with a receipt and investment list or in electronic form, signed with an electronic signature using public information and telecommunication networks, including portal.

    279. Application for issuance of duplicate registration certificate of the drug, as well as a copy of a duplicate registration certificate of the drug attached to the registration dossier on the drug.

 

Correction of typos and errors issued as a result
of providing state service documents

    280. The basis for the commencement of the administrative procedure is the appeal of the applicant, who has received a registered registration certificate, for the correction of misprints and errors in documents issued as a result of the provision of the state service.

    281. The term for passing an administrative procedure shall not exceed 10 calendar days from the date of registration of the application for correction of errata and errors in documents issued as a result of the provision of state services.

    282. The decision on the correction of misprints and errors in the documents issued as a result of the provision of the state service is taken if they reveal inconsistencies in the documents attached to the application.

    283. The result of the administrative procedure is the correction of misprints and errors in the documents issued as a result of the provision of the state service, or a reply sent to the applicant with information about the absence of misprints and errors in the documents issued as a result of the provision of the state services.

Formation and direction of interdepartmental request

    284. The basis for the implementation of the administrative procedure is the receipt of an application for the provision of a state service registered in the established manner without the documents specified in clause 29 of the Regulations, which are not submitted by the applicant on his own initiative.

    285. If there is a basis specified in clause 284 of the Regulations, an employee of the Ministry of Health of Russia, who is responsible for the preparation of documents, independently requests the necessary documents by sending an inter-agency request to the appropriate federal executive bodies.

    286. The Ministry of Health of Russia in the framework of the provision of state services interacts with the authorities specified in paragraph 29 of the Regulations.

    287. An inter-agency request is sent within a period not exceeding one working day following the day of receipt to the officer responsible for preparing the documents, the application and the attached required documents.

    288. The officer responsible for the preparation of documents, who sent the interdepartmental request, is obliged to take the necessary measures to receive a response to the interdepartmental request.
    In the event that there is no response to an interdepartmental request within the prescribed period, the Ministry of Health of Russia takes measures as provided for by the legislation of the Russian Federation.

    289. Within one working day from the date the requested information is received by the Ministry of Health of Russia, such information is sent to the officer responsible for preparing the documents (the information contained in them), which appends them to the corresponding application.

    290. The inter-agency request is sent electronically through a unified system of inter-agency electronic interaction and regional systems of inter-agency electronic interaction connected to it in accordance with Law No. 210-FZ.

    291. Sending an interdepartmental request is allowed only for purposes related to the provision of public services.

    292. The result of the administrative procedure is the receipt by the Ministry of Health of the requested documents.

IV. Forms of control over the provision of public services

The procedure for monitoring compliance and enforcement
by responsible officials of regulations and other
regulatory legal acts establishing requirements for the provision of
public service, as well as their decisions

    293. Current control over the observance of the sequence of actions defined by administrative procedures for the provision of public services is exercised by the head and officials of the department for state regulation of the circulation of medicines of the Ministry of Health of Russia (hereinafter referred to as the department), who are responsible for organizing the work of providing public services through compliance and enforcement of the provisions of the Regulations, other regulatory legal acts of the Russian Federation, as well as carrying out an internal audit of the effectiveness of public services (hereinafter - check).

    294. The verification of the completeness and quality of the public service includes the verification, detection and elimination of violations of the applicants' rights, consideration, decision making and preparation of responses to complaints from applicants containing complaints about actions (inaction) and (or) decisions of officials responsible for providing public service.

    295. In the event of the discovery of violations of the rights of the applicants as a result of the inspection, the guilty officials are held accountable in accordance with the procedure established by the legislation of the Russian Federation.

    The order and regularity of scheduled and unscheduled inspections completeness and quality of the provision of public services, including order and forms of control for completeness and quality the provision of public services

    296. Monitoring the completeness and quality of the provision of public services includes checking, identifying and eliminating violations of the rights of applicants, reviewing, making decisions and preparing responses to complaints from applicants containing complaints about actions (inaction) and / or decisions of officials.

    297. The regularity of the check is established by the head of the department.

    298. Verification may be scheduled (based on the annual work plans of the department) and unscheduled.

    299. An unscheduled inspection is carried out on a specific appeal (complaint) of a natural or legal person.

    300. The results of planned and unscheduled inspections are documented in the form of a department report, which notes the identified deficiencies and makes instructions for their elimination.

Responsibility of officials of the Ministry of Health of Russia
for decisions and actions (inaction) taken (implemented)
by them in the course of the provision of public services

    301. The personal responsibility of officials of the Ministry of Health of Russia for the provision of public services is enshrined in their job regulations in accordance with the requirements of the legislation of the Russian Federation.

    302. The contractor responsible for the implementation of the relevant administrative procedures of the Regulations shall be personally liable for:

    1) compliance of the results of consideration of documents submitted by the applicant with the requirements of the legislation of the Russian Federation;
    2) compliance with the terms and procedure for receiving documents established by these regulations;
    3) compliance with the procedure, including the timing of the provision of public services;
    4) the accuracy of the information entered in the registries referred to in this Regulation.

Provisions characterizing order requirements and forms
control over the provision of public services
including by citizens, their associations and organizations

    303. Citizens, their associations and organizations have the right to control the provision of public services by receiving information by phone, by written requests, by e-mail, on the official website of the Ministry of Health of Russia, through the Single Portal and by other legal means.

V. The pre-trial (extrajudicial) procedure for appealing against the actions and decisions (inaction) of the Russian Ministry of Health, as well as of officials of Ministry of Health of Russia Information for the applicant about his right to file a complaint on the decision and (or) action (inaction) of the federal authority executive authority and (or) its officials

    304. Interested persons have the right to a pre-trial (out-of-court) appeal of actions (inaction) and / or decisions taken (carried out) by the Ministry of Health of Russia, officials of the Ministry of Health of Russia in the course of providing the state service in the manner provided for by state and municipal services ”(hereinafter - the complaint).

    305. The subject of the complaint may be actions (inaction) and (or) decisions taken (carried out) by the Ministry of Health of Russia, an official of the Ministry of Health of Russia in providing state services, including in the following cases:

    1) violation of the application registration period;
    2) violation of the deadline for the provision of public services;
    3) the requirement from the applicant of documents not provided for by the regulatory legal acts of the Russian Federation for the provision of state services;
    4) the refusal to accept from the applicant the documents, the submission of which is provided for by the regulatory legal acts of the Russian Federation for the provision of state services;
    5) refusal to provide state services, if the grounds for refusal are not provided for by these regulations;
    6) the requirement from the applicant in the provision of public service fees that are not provided for in the regulatory legal acts of the Russian Federation;
    7) the refusal of the Ministry of Health of Russia and (or) an official of the Ministry of Health of Russia providing the state service to correct misprints and errors issued as a result of the provision of the state service documents or a violation of the period established by the legislation of the Russian Federation for such corrections.

    306. The complaint is submitted in writing on paper or in electronic form.

    307. A complaint can be sent by mail, using the official website of the Ministry of Health of Russia and the Single Portal, and can also be received at the personal reception of the applicant.

    308. The complaint must contain:

    1) the name of the body providing the state service, the last name, first name (if any) of the patronymic of the official of the Russian Ministry of Health, whose decisions and / or actions (inaction) are appealed;
    2) the last name, first name (if available) of the applicant's middle name, information about his place of residence or the name, information about his location of the applicant, as well as the contact telephone number (s), e-mail address (es) (if any) and postal address which the answer will be sent to the applicant;
    3) information about the appealed decisions and (or) actions (inaction) of the Ministry of Health of Russia, an official of the Ministry of Health of Russia;
    4) the arguments on the basis of which the applicant does not agree with the decisions and (or) actions (inaction) of the Ministry of Health of Russia, an official of the Ministry of Health of Russia.
    The applicant may submit documents (if available), confirming the arguments of the applicant, or copies thereof.

    309. Registration of a complaint to the Russian Ministry of Health is the basis for the commencement of the pre-trial (out-of-court) appeal procedure.

    310. A complaint received by the Ministry of Health of Russia is subject to consideration by an official authorized to consider such complaints within 15 working days from the date of its registration, and in case of an appeal against the refusal of the Ministry of Health of Russia, an official of the Ministry of Health of the Russian Federation to receive the documents from the applicant or in correction Mistakes and errors made, or in the case of an appeal against a violation of the established deadline for such corrections, within 5 working days from the date of its registration.

    311. There are no grounds for suspending the consideration of a complaint by the Rules.

    312. Based on the results of the consideration of the complaint, the Ministry of Health of Russia takes one of the following decisions:

    1) satisfies the complaint, including in the form of cancellation of the decision, correction of typos and errors made by the Ministry of Health of Russia in the documents issued as a result of the provision of the state service;
    2) refuses to satisfy the complaint.

    313. Not later than the day following the day of the decision indicated in clause 312 of the Regulations, the complainant is sent a written and electronic form (if there is an appropriate indication in the complaint) based on the results of the consideration of the complaint.

    314. The applicant has the right to receive, and officials of the Russian Ministry of Health are required to provide the applicant with the information and documents necessary to substantiate and consider the complaint, unless otherwise provided by the legislation of the Russian Federation.

    315. The decision on the results of the consideration of the complaint may be appealed by the applicant by filing a complaint with the head of the Ministry of Health of Russia.

    316. In the event that a complaint shows signs of an administrative offense or a crime, the official authorized to consider complaints immediately sends the available materials to the prosecution authorities.

State authorities, organizations and persons authorized to consider complaints to whom the complainant may be sent in a pre-trial (extrajudicial) procedure

    317. Applicants have the right to appeal against actions (inaction) and / or decisions of the Ministry of Health of Russia, officials of the Ministry of Health of Russia - the head of the Ministry of Health of Russia.

Ways to inform applicants on the procedure for filing
and consideration of complaints, including through the use of the portal
state and municipal services (functions)

318. The applicants are informed about the procedure for filing and considering the complaint on the official website of the Russian Ministry of Health and on the Single Portal.

List of regulatory legal acts
regulating the procedure for pre-trial (extrajudicial) appeal of decisions
and actions (inaction) of the body providing the public service,
as well as his officials

    319. Relations arising in connection with the pre-trial (extrajudicial) appeal of decisions and actions (inaction) of the Ministry of Health of Russia, as well as officials of the Ministry of Health of Russia are governed by the following regulatory legal acts:
    - Law No. 210-FZ
    - Resolution of the Government of the Russian Federation of August 16, 2012 No. 840 “On the procedure for filing and consideration of complaints against decisions and actions (inaction) of federal executive bodies and their officials, federal civil servants, officials of state extra-budgetary funds of the Russian Federation, and state corporations, which, in accordance with federal law, have the authority to provide public services in a specified area of activity, and their officials. ”

Placement of information on the Single Portal

    320. The information specified in section V of the Regulations is subject to mandatory placement on the Single Portal.