Administrative Regulations of the Ministry of Health of the Russian Federation

Circle of applicants

2. The applicant for the provision of public services (hereinafter referred to as the "applicants") is the legal entity provided for in paragraph 19, a legal entity eligible to apply for registration, confirmation of registration (re-registration, registration renewal), modification of the registration dossier of drugs, other procedures related to registration, and carrying responsibility for the reliability of the information contained in the documents submitted by him in the registration dossier.

Requirements for the procedure for informing about the provision of public service

3. Information on the procedure for providing public services is provided by the Ministry of Health of Russia:

   1) by posting information, including the schedule for receiving applicants and phone numbers for inquiries (consultations) on the official website of the Ministry of Health of Russia in the information and telecommunication network 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 - the Unified Portal of State and Municipal Services (Functions));
   3) at information stands in the reception room of the Ministry of Health of Russia;
   4) by phone numbers for reference;
   5) in the mass media.
   Information on the procedure for providing public services is provided by the Ministry of Health of the Russian Federation at the address:
   127994, Moscow, Rakhmanovsky per., 3.
   Opening hours: on weekdays from 9-00 hours to 18-00 hours (Friday from 9-00 hours to 16 hours 45 minutes). Lunch break from 12-00 hours to 12 hours and 45 minutes.
   The phone for information: +7 (495) 628-44-53, (495) 627-29-44.
   The phone number of the registration of medicinal products:
   +7 (495) 627-24-00, ext. 2020, 2021, 2022.
   The phone of the department for regulating the circulation of registered medications:
   +7 (495) 627-24-00, ext. 2030, 2031, 2032, 4912.

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

   1) The Federal Tax Service (Federal Tax Service of Russia):
   127381, Moscow, Neglinnaya ul., 23;
   phone for inquiries: +7 (495) 913-00-09;
   the official website address: www.nalog.ru;
   schedule: on weekdays from 9-00 hours to 18-00 hours (Friday from 9-00 hours to 16 hours 45 minutes). Lunch break from 13-00 hours to 13 hours 45 minutes;
   2) Federal Treasury (Treasury of Russia):
   109097, Moscow, Ilinka Str., 9;
   telephones for information: +7 (495) 984-12-97, +7 (495) 984-13-36.
   the official website address: www.roskazna.ru;
   working hours: on weekdays from 9-00 hours to 18-00 hours (Friday from 9-00 hours to 16 hours 45 minutes). Lunch break from 13-00 hours to 13 hours and 45 minutes.
   3) The Ministry of Industry and Trade of the Russian Federation (Minpromtorg of Russia)
   109074, Moscow, Kitaygorodsky Proyezd, house 7;
   phone for information: +7 (495) 539-21-87;
   the official website address: www.minpromtorg.gov.ru;
   working hours: on weekdays from 9-00 hours to 18-00 hours (Friday from 9-00 hours to 16 hours 45 minutes). Lunch break from 12-00 hours to 12 hours and 45 minutes.

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

   the present Administrative Regulations and the list of regulatory legal acts of the Russian Federation regulating the issues on the provision of public services;
   the schedule for the reception of applicants and phone numbers for references (consultations);
   banking details for payment of state fee;
   samples of registration of applications and documents that are submitted for obtaining a public service;
   the procedure for obtaining advice;
   the procedure for appealing against decisions, actions or omissions of officials providing public services;
   information about the electronic address of the Single Portal.

6. Informing is carried out in oral or written form at personal appeal of the applicant or by means of telephone communication.

Requirements for information provided to applicants are completeness, reliability, clarity in presentation, visibility of forms, convenience and accessibility, efficiency.

II. Standard for the provision of public services
Name of state service

7. The state service for registration of drugs intended for circulation on the general market of medicinal products within the framework of the Eurasian Economic Union, in accordance with the Rules.

The name of the federal executive body, providing state service

8. The state service is provided by the Ministry of Health of Russia.

9. In the provision of public services, the Ministry of Health of Russia interacts with:

   1) the Federal Tax Service;
   2) the Federal Treasury;
   3) the Federal Service for Supervision of Health Care (Roszdravnadzor);
   4) Ministry of Industry and Trade of the Russian Federation;
   5) Authorized bodies (expert organizations) of the Member States of the Union.
   6) The Eurasian Economic Commission.
   7) Expert Committee on medicines.

10. It is prohibited to require the applicant to carry out actions, including approvals, necessary for obtaining a public service and related to applying to other state bodies and organizations, except for receiving 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) the issuance (referral) of the drug registration certificate to the applicant in accordance with the application No. 17 of the Rules, approved SmPC, instructions for medical use, the Normative document, package mock-ups, expert evaluation report, an agreed risk management plan for the use of the drug (if needed);
   2) issuing (sending) a notice of refusal to register a medicinal product;
   3) issuing (sending) to the applicant a notice refusing to amend the registration dossier of the registered medicinal product;
   4) issuing (sending) the applicant a notice of refusal to confirm the registration (re-registration) of the medicinal product;
   5) issuing (sending) the applicant a notice refusing to bring the registration dossier of the drug in line with the requirements of the EAEU;
   6) issuing (sending) an applicant a decision to recall (cancel) the registration certificate of a drug and to exclude a medicinal product from a single register;
   7) issuing (sending) to the applicant a duplicate of the registration certificate of the medicinal product issued in accordance with Appendix No. 17 of the Regulations.
   8) issuing (sending) the applicant a notice refusing to issue a duplicate of the registration certificate of the drug.
   9) placement of information in the Unified Register of Registered Medicines.

Terms for the provision of public services

12. The maximum period for registration and examination of a drug must not exceed 210 (two hundred and ten) calendar days from the date of filing an application for registration of a medicinal product specified in paragraph 19 of the Administrative Regulations till the date of issue of the registration certificate.
13. The maximum period for making variations in the registration dossier of a drug is 180 (one hundred and eighty) calendar days from the date of receipt of the documents specified in paragraph 20 of the Administrative Regulations.
14. The maximum period for making a decision to withdraw (cancel) the registration certificate of a drug and exclude a medicinal product from a single register is 5 working days from the date of the onset of one of the grounds specified in paragraph 160 (one hundred and sixty) of the Rules.
15. The maximum period of confirmation of registration (re-registration) of the medicinal product is 120 (one hundred and twenty) calendar days from the date of submission of the application for confirmation of registration (re-registration);
16. The maximum period for bringing the registration dossier of a medicinal product in accordance with the acts included in the law of the Union is 100 (one hundred) calendar days from the date of submission of the relevant application.
17. The maximum period for issuing (sending) a notice of refusal of registration of a medicinal product is 10 (ten) working days from the date of such decision.

List of regulatory legal acts governing relations arising in connection with the provision of public service

18. The provision of public services is carried out in accordance with the following regulatory legal acts:

   1) the Treaty on the Eurasian Economic Union of May 29, 2014 (Official site of the Eurasian Economic Commission http://www.eurasiancommission.org/, 05.06.2014);
   2) Agreement on common principles and rules for the circulation of medical devices (medical devices and medical equipment) within the framework of the Eurasian Economic Union of December 23, 2014 (Collected Legislation of the Russian Federation, 2016, No. 20, Article 2775);
   3) Decision of the Council of the Eurasian Economic Commission of 03.11.2016 No. 78 "On Rules for the Registration and Examination of Medicinal Products for Medical Use" (official website of the Eurasian Economic Union http://www.eaeunion.org/, November 21, 2016);
   4) By the decision of the Board of the Eurasian Economic Commission of December 22, 2015 № 172 "On the Approval of the Nomenclature of Medicinal Forms" (official website of the Eurasian Economic Union http://www.eaeunion.org/, December 30, 2015);
   5) Decision of the Council of the Eurasian Economic Commission of 03.11.2016 No. 84 "On the procedures for the formation and maintenance of a single register of registered medicines of the Eurasian Economic Union and information databases in the field of medicinal products circulation" (official website of the Eurasian Economic Union http: //www.eaeunion .org /, 21 November 2016);
   6) Decision of the Council of the Eurasian Economic Commission of 03.11.2016 No. 93 "On the Recognition of the Results of Inspection of the Manufacture of Medicines" (official website of the Eurasian Economic Union http://www.eaeunion.org/, November 21, 2016);
   7) Federal Law No. 210-FZ of July 27, 2010 "On the Organization of Provision of State and Municipal Services" (Collected Legislation of the Russian Federation, 2010, No. 31, Article 4179, 2011, No. 15, Article 2038, No. 27, Article 3873, 3880, No. 29, Article 4291, No. 30, Article 4587, No. 49, Article 7061, 2012, No. 31, Article 4322, 2013, No. 14, Article 1651, No. 27, art. 3477, 3480, No. 30, Article 4084, No. 51, Article 6679, No. 52, Articles 6952, 6961, 7009, 2014, No. 26, Article 3366, No. 30, Article 4264, No. 49, art. 6928, 2015, No. 1, Articles 67, 72, No. 10, Article 1393, No. 29, Articles 4342, 4376, 2016, No. 7, Article 916) (hereinafter - the Federal Law of July 27, 2010 N 210-FZ);
   8) Federal Law No. 8-FZ of February 9, 2009 "On providing access to information on the activities of state bodies and local self-government bodies" (Collected Legislation of the Russian Federation, 2009, No. 7, Article 776, 2011, No. 29, art. 4291, 2013, No. 23, Article 2870, No. 51, Article 6686, No. 52, Article 6961, 2014, No. 45, Article 6141, No. 49, Article 6928, 2015, No. 48, Article 6723 ; 2016, No. 11, article 1493);
   9) Federal Law No. 125-FZ, dated October 22, 2004, "On Archival Affairs in the Russian Federation" (Collected Legislation of the Russian Federation, 2004, No. 43, Article 4169; 2006, No. 50, Article 5280; 2007, No. 49 , article 6079, 2008, No. 20, article 2253, 2010, No. 19, article 2291, No. 31, article 4196, 2013, No. 7, article 611);
   10) The Tax Code of the Russian Federation (part two) (Collected Legislation of the Russian Federation, 2000, N 32, Articles 3340, 3341, 2001, N 1, Article 18, N 23, Article 2289, N 33, Article 3413, 3421, 3429, No. 49, Articles 4554, 4564, No. 53, Articles 5015, 5023, 2002, No. 1, Article 4, No. 22, Article 2026, No. 30, Articles 3021, 3027, 3033; 52, Articles 5132, 5138, 2003, No. 1, Articles 2, 5, 6, 8, 11, No. 19, Article 1749, No. 21, Article 1958, No. 22, Article 2066, No. 23, art. 2174, No. 24, Article 2432, No. 26, Article 2567, No. 27, Article 2700, No. 28, Articles 2874, 2879, Article 2886, No. 46, Articles 4435, 4443, 4444, No. 50 , Article 4849, No. 52, Article 5030, Article 5038, 2004, No. 15, Article 1342, No. 27, Articles 2711, 2713, 2715, No. 30, Articles 3083, 3084, 3088, No. 31, articles 3219, 3220, 3222, 3231, N 34, articles 3517, 3518, 3520, 3522, 3523, 3524, 3525, 3527, N 35, article 3607, N 41, article 3994, N 45, art. 4377, No. 49, article 4840, 2005, No. 1, articles 9, 29, 30, 31, 34, 38 , No. 21, Article 1918, No. 23, Article 2201, No. 24, Article 2312, No. 25, Articles 2427, 2428, 2429, No. 27, Articles 2707, 2710, 2713, 2717, No. 30, art. 3101, 3104, 3112, 3117, 3118, 3128, 3129, 3130; N 43, art. 4350; N 50, art. 5246, 5249; N 52, art. 5581; 2006, No. 1, art. 12, 16; N 3, art. 280; N 10
   11) by the Resolution of the Government of the Russian Federation of May 16, 2011 No. 373 "On the development and approval of administrative regulations for the performance of public functions and administrative regulations for the provision of public services" (Collected Legislation of the Russian Federation, 2011, No. 22, Article 3169; 5092, 2012, No. 28, Article 3908, No. 36, Article 4903, No. 50, Article 7070, No. 52, Article 7507, 2014, No. 5, Article 506);
   12) by the Resolution of the Government of the Russian Federation of November 24, 2009, No. 953 "On providing access to information on the activities of the Government of the Russian Federation and federal executive bodies" (Collected Legislation of the Russian Federation, 2009, No. 48, Article 5832, 2012, No. 17 , article 2002, 2013, No. 28, article 3838, No. 30, article 4107, 2014, No. 42, article 5735);
   13) by the Resolution of the Government of the Russian Federation No. 861 of October 24, 2011 "On Federal State Information Systems Providing Electronic and Public Services (Functions)" (Collected Legislation of the Russian Federation, 2011, No. 44, Article 6274, N 49, Article 7284, 2013, No. 45, Article 5807, 2014, No. 50, Article 7113, 2015, No. 1, Article 283, No. 8, Article 1175);
   14) by the Resolution of the Government of the Russian Federation of August 16, 2012 No. 840 "On the procedure for filing and reviewing 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 also the State Atomic Energy Corporation "Rosatom" and its officials "(Collected Legislation of the Russian Federation, 2012, No. 35, Article 4829, 2014, No. 50, Article 7113, 2015, No. 47, Article 6596, 2016, N 51, article 7370);
   15) Decree of the Government of the Russian Federation of June 19, 2012 No. 608 "On approval of the Regulations on the Ministry of Health of the Russian Federation" (Collected Legislation of the Russian Federation, 2012, No. 26, Article 3526, 2013, No. 16, Article 1970, No. 20, art. 2477, No. 22, Article 2812, No. 33, Article 4386, No. 45, Article 5822, 2014, No. 12, Article 1296, No. 26, Article 3577, No. 30, Article 4307, No. 37, art. 4969, 2015, No. 2, Article 491, No. 12, Article 1763, No. 23, Article 3333, 2016, No. 2, Article 325, No. 9, Article 1268, No. 27, Article 4497; N 28, item 4741, N 34, article 5255);
   16) Resolution of the Government of the Russian Federation of May 6, 2011 No. 352 "On approval of the list of services that are necessary and mandatory for the provision of public services by federal executive authorities and are provided by organizations involved in the provision of public services and determining the amount of payment for their provision "(Collected Legislation of the Russian Federation, 2011, No. 20, Article 2829, 2012, No. 14, Article 1655, No. 36, Article 4922, 2013, No. 33, Article 4382, No. 52, Article 7207);

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

19. For registration of a medicinal product the applicant submits the following documents and materials to the Ministry of Health of Russia (as an authorized body of the reference state):

   1) an application on paper and (or) in the form of an electronic document in accordance with the established form in accordance with Appendix No. 2 to the Rules;
   2) documents confirming the payment of the fee (fee) for the registration and examination of the medicinal product in the event and in the manner established by the legislation of the Russian Federation;
   3) the registration dossier in accordance with Annexes 1 to 5 to the Rules on electronic media (additionally, module 1 of the registration dossier is submitted on paper (except for the risk management plan, the main dossier (master file) of the production site (production sites) and master- file on pharmacovigilance);
   4) samples of medicinal preparations.
   Standard samples of active pharmaceutical substances and related impurities, specific reagents and other materials necessary for testing samples of medicinal products specified in subparagraph 4 of paragraph 19 of the Administrative Regulations shall be submitted in consultation with the expert organization.
   Samples of medicinal products, specific reagents and other materials are presented in quantities agreed with the expert organization and required to conduct no more than 3-fold analysis in accordance with the requirements of the regulatory document on the quality of medicinal products or other specifications included in the registration dossier on time , agreed by the Ministry of Health of Russia, not included in the overall period of examination and registration of the medicinal product.
   It is not necessary to present samples, specific reagents and other materials if it is not possible to conduct tests in an expert organization due to the inaccessibility of samples of medicinal products (including their classification as orthopedic, narcotic, psychotropic or intended for the treatment of high-cost nosologies because of their high cost), impossibility of compliance conditions for the transportation of said samples to the territory of the Member State and (or) their storage, the absence of special equipment and consumables in an expert organization.
   19.1. The applicant submits the following documents to the Ministry of Health of Russia (as an authorized body of the state of recognition):
   1) an application on paper and (or) in the form of an electronic document in accordance with the established form in accordance with Appendix No. 2 to the Rules;
   2) documents confirming the payment of the fee (fee) for drug registration and examination of the medicinal product in the event and in the manner established by the legislation of the Russian Federation;
   3) module 1 of the registration dossier on paper and (or) on electronic media in the form of an electronic document.

20. To confirm drug registration (re-registration of the medicinal product), the applicant submits the following documents to the Ministry of Health of Russia (as an authorized body of the reference state):
   1) an application on paper and (or) in the form of an electronic document in accordance with Annex 2 to the Rules;
   2) documents confirming the payment of the fee (fee) for confirmation of registration (re-registration) and expertise in the case and procedure established in accordance with the legislation of the Russian Federation;
   3) modules 1 and 2 of the registration dossier, prepared in accordance with Annexes 1 to 5 to the Rules, on an electronic medium.
   21. In order to amend the registration dossier of the registered drug, the applicant submits the following documents to the Ministry of Health of Russia (as an authorized body of the reference state):
   1) application on paper and (or) electronic media in accordance with Appendix No. 2 to the Rules;
   2) documents confirming the payment of the fee (fee) for making changes in the cases and the procedure established in accordance with the legislation of the Russian Federation;
   3) documents in accordance with the classification of variations made to the registration dossier of the registered drug and the rules for their introduction in accordance with annexes 19 and 20 to the Rules.
   4) a list of the dates for submitting applications for variations in the registration dossier of the medicinal product to the states of recognition and documents confirming the payment of the fee (state due) for making changes to the registration dossier of the medicinal product (and its expertise, if necessary) in the cases and in the procedure established by the legislation of the states of recognition, indicating the numbers of the procedures for introducing changes in accordance with Appendix No. 19 to the Rules that were implemented in the states of recognition (when making changes to the registration dossier of a medicinal product registered under the procedure of mutual recognition).
   5) samples of medicinal products, standard samples of active pharmaceutical substances and related impurities, specific reagents and other materials necessary for conducting laboratory tests (if necessary and in agreement with the expert organization).

   21.1. To amend the registration dossier of the registered medicinal product, the applicant submits the following documents to the Ministry of Health of Russia (as an authorized body of the state of recognition):
   1) an application on paper and (or) electronic media in accordance with the established form in accordance with Appendix No. 2 to the Rules;
   2) documents confirming the payment of the fee (state due) for making changes in the cases and the procedure established in accordance with the legislation of the Russian Federation.

22. To bring the registration dossier of a medicinal product registered before the entry into force of the Agreement on Uniform Principles and Rules for the circulation of medicinal products within the framework of the Eurasian Economic Union of December 23, 2014 and until December 31, 2020, in accordance with the requirements of the Union, the applicant submits the following documents to the Ministry of Health of Russia (as an authorized body of the reference state):

23. For the withdrawal (cancellation) of the registration certificate of the medicinal product and the exclusion of the medicinal product from the single register, the holder of the drug registration certificate or a legal entity authorized by the holder of the registration certificate of the medicinal product shall submit to the Ministry of Health of Russia (as an authorized body of the reference state) an application for cancellation of drug registration.

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

25. The application and documents provided for in paragraphs 19-24 of the Administrative Regulations shall be submitted by the applicant to the Ministry of Health of Russia on paper or sent by registered mail with notification of delivery and inventory of the investment and in electronic form using public information and telecommunications networks in including the Internet, and through the Unified Portal of State and Municipal Services (functions).

The Ministry of Health of Russia is not entitled to require the applicant to indicate in the application information, as well as to submit documents not provided for in paragraphs 19-24 of the Administrative Regulations.

An exhaustive list of documents required in accordance with regulatory legal acts for the provision of public services, which are at the disposal of state bodies, bodies of local self-government and other bodies involved in the provision of state or municipal services, and which the applicant is entitled to submit, as well as methods their receipt by applicants, including in electronic form, the order of their presentation

25. For the provision of a public service, the following information that is in the possession of public authorities is required:

   1) The Federal Tax Service of Russia - information about the applicant contained in the Unified State Register of Legal Entities;
   2) Treasury of Russia - information on payment of state duty for the provision of public services;
   3) Authorized bodies (expert organizations) of the Member States - confirmation of the approval of the expert opinion of the expert institution of the Ministry of Health of Russia or confirmation of the approval by the Ministry of Health of Russia of the expert opinion of the reference state.
   4) Roszdravnadzor - information on the results of conducting pharmaceutical inspections of drug subjects for medical use for compliance with the rules of good laboratory practice, the rules of good clinical practice;
   5) Ministry of Industry and Trade of the Russian Federation - information on the results of the pharmaceutical inspection of subjects of circulation of medicinal products for medical use for compliance with the requirements of good manufacturing practices of the EAEU
   23. The applicant is entitled to submit information specified in paragraph 22 of the Administrative Regulations on his own initiative.
   24. It is prohibited to demand from the applicant:
   1) the submission of documents and information or the implementation of actions the provision or implementation of which is not provided for by regulatory legal acts of the Eurasian Economic Union and the Russian Federation 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, are available to other state bodies participating in the provision of public services, and which can be obtained through interagency information interaction.

A comprehensive list of grounds for refusal
in receiving documents required to provide
public service

25. There are no grounds for refusing to accept documents required for the provision of public services.

An exhaustive list of grounds for suspension
or refusal to provide a public service

   26. The grounds for suspension in the provision of public services are:
   - request from the Ministry of Health of Russia to provide missing additional information, necessary clarifications or clarifications of documents and data submitted in the registration dossier;
   - Settlement of disagreements in the Expert Committee on Medicines.
   27. The grounds for refusing to provide the Ministry of Health of Russia with a public service are:
   1) the unfavorable correlation of the expected benefit to the possible risks associated with the use of the medicinal product;
   2) non-confirmation of the effectiveness of the medicinal product by the information provided by the applicant;
   3) non-confirmation of the quality of the medicinal product;
   4) non-reproducibility of the proposed methods and methods of quality control of the medicinal product;
   5) submission of inaccurate information by the applicant;
   6) non-confirmation of compliance with the appropriate pharmaceutical practices of the EAEU based on the results of the appointed inspection during the registration of the medicinal product.
List of services that are necessary
and mandatory for the provision of public services,
including information on the document (s) being issued
by organizations participating in the provision of
public service

   28. Services that are necessary and mandatory for the provision of public services:
   a) assessment of the completeness, completeness and correctness of the submitted documents of the registration dossier;
   b) evaluation of documents and data submitted by the applicant in the registration dossier of the medicinal product for safety, efficiency and quality;
   c) conducting laboratory tests for compliance with the requirements of the normative document on the quality and reproducibility of the declared quality control procedures carried out in accredited testing laboratories;
   d) initiating, if necessary, an unscheduled or planned pharmaceutical inspection in cases specified in these Regulations;
   e) drawing up an expert report on the evaluation of the medicinal product by the reference state.
Documents issued by organizations involved in the provision of public services:
expert report on the evaluation of the safety, efficacy and quality of the medicinal product on the basis of examination of the medicinal product;
conclusion about the possibility or impossibility of recognizing the expert report on the assessment of the safety, efficacy and quality of the medicinal preparation prepared by the reference state.

The procedure, size and basis for levying state
fees or other fees charged for the provision of
public service

29. Payment of the state fee for the provision of public services is carried out in the amounts established by clause 2 of Article 333.32.1. Of the Tax Code of the Russian Federation prior to submission of the relevant application to the Ministry of Health of Russia, including using the Unified Portal of State and Municipal Services (functions) in the pre-filled details (organization).

The order, size and grounds for charging
for providing services that are necessary
and mandatory for the provision of state
services, including information on the calculation procedure
of the size of such a board

30. For carrying out examination of medicinal product for medical use at its registration; for the evaluation of the expert report on the assessment of the safety, efficacy and quality of the medicinal product for medical use; for the examination of a medicinal product with a well-studied medical application when it is registered; for the evaluation of the expert report on the assessment of the safety, efficacy and quality of the medicinal product with well-studied medical use when it is registered; for confirming the registration of a medicinal product for medical use; for making changes to the documents contained in the registration dossier of the registered medicinal product for medical use, requiring examination of the medicinal product for medical use; for making changes to the documents contained in the registration dossier of the registered medicinal product for medical use, which do not require the examination of the medicinal product for medical use; for bringing the registration dossier of the medicinal product for medical use in accordance with the requirements of the Eurasian Economic Union; for the issue of a registration certificate of a drug for medical use; for issuing a duplicate of the registration certificate of a medicinal product for medical use, a state fee is paid in the amounts provided for by paragraph 2 of Article 333.32.1 of Part Two of the Tax Code of the Russian Federation, before submitting a corresponding application to the Ministry of Health of Russia, including using the Unified Portal of State and Municipal Services functions), which are pre-filled in by the body (organization) with requisites.

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

31. The maximum waiting time in the queue in the case of a direct appeal of the applicant (his representative) to the Ministry of Health of Russia for the submission of documents required for the provision of public services is 15 minutes.
32. The maximum waiting time in the queue in the case of a direct request of the applicant (his representative) to the Ministry of Health of Russia to receive documents resulting from the provision of public services is 15 minutes.

Term and procedure for registration of the applicant's request
on the provision of public services and services,
provided by the organization involved in providing
State service, including in electronic form

33. Documents received from applicants to the Ministry of Health of Russia, including in the form of an electronic document, are subject to compulsory registration within 1 working day from the date of their receipt.
34. Reception and registration of documents submitted to the Russian Ministry of Health, including the use of information and communication technologies (in electronic form), carried out by officials of Russian Ministry of Health, responsible for the implementation of administrative procedures for admission and registration of documents for the provision of public services, an inventory, a copy of which, with a note on the date of receipt of the said application and documents on the day of receipt, shall be presented to the applicant or sent to him by registered mail with notification delivery or in electronic form.

The requirement for premises in which public service,
to the place of waiting and reception applicants,
placement and registration of visual, text
and multimedia information on the order of
provision of such services

   35. Premises, intended for provision of public services, are provided with equipment necessary for the provision of public services, office supplies, office furniture, air conditioning, access to the wardrobe, a telephone, a computer with the ability to print and output in the information and telecommunication network Internet, as well as access to documents (information) in electronic form or on paper medium.
   36. The visual, textual and multimedia information on the provision of public services is located on the information stand or the information terminal (installed in a convenient place for citizens), as well as on a single portal of public and municipal services (functions), on the website of Ministry of Health of Russia containing the information specified in the Administrative Regulations.
   Registration of visual, textual and multimedia information on the procedure for the provision of public services should correspond to the optimal visual and auditory perception of this information by applicants.
   37. Entry and movement through the premises in which the public service is provided should not create difficulties for persons with disabilities.
   In accordance with the legislation of the Russian Federation on the social protection of disabled people, they are provided with:
   conditions for unimpeded access to the facility (building, premises) in which the public service is provided, as well as for unimpeded use of transport, communications and information;
   possibility of independent movement in the territory, on which the objects (buildings, premises), which provide public services, as well as the entrance of such objects, and out of them, landing in the vehicle and alighting from it, including the use of wheelchairs ;
   support for people with disabilities who have persistent disorders of vision and self-movement;
   proper placement of equipment and media necessary to ensure unhindered access for disabled persons to objects (buildings, premises) in which a public service is provided, taking into account the limitations of their life;
   duplication of audio and visual information necessary for the disabled, as well as inscriptions, signs and other textual and graphic information with signs made in Braille's relief-dotted font;
   a sign language interpreter and a typhlo-sans-interpreter;
   admission of a guide dog to objects (buildings, premises) in which a public service is provided;
   helping disabled people to overcome barriers that prevent them from receiving public services on an equal basis with others.
   If you cannot fully accommodate the object in view of needs of disabled people, the Russian Ministry of Health in accordance with Article 15 of the Federal Law dated November 24, 1995 № 181-FZ "On social protection of disabled persons in the Russian Federation" shall take measures to ensure access for disabled persons to the place of service provision, or whenever possible, ensure that it is provided at the place of residence of the disabled person or remotely.

Indicators of accessibility and quality of state services,
including the number of interactions of the applicant
with officials in the provision of state services and their duration,
the possibility of obtaining public services in a multifunctional center
provision of state and municipal services, information on the progress of the
State service, including using information and communication technologies

38. Indicators of accessibility and quality of public services are:

   1) open access for applicants and other persons to information on the procedure and terms for the provision of public services, on the procedure for appealing against actions (inaction) of officials of the Ministry of Health of Russia;
   2) compliance with the standard for the provision of public services;
   3) the number of the applicant's interactions with officials in the provision of public services and their duration;
   4) absence of the applicants' complaints about the actions (inaction) of officials of the Ministry of Health of Russia in the provision of public services;
   5) the completeness and relevance of information on the procedure for the provision of public services;
   6) provision of the possibility of submitting an application for the provision of a public service and other documents (information contained therein) necessary for the provision of a public service in the form of an electronic document and using the Unified Portal of State and Municipal Services (functions).

39. In the process of providing a public service, the applicant interacts with officials of the Ministry of Health of Russia when submitting an application for the provision of a public service and receiving documents on the results of considering an application for a public service.

Other requirements, including those taking into account the features
of provision of public services in multifunctional centers
of state and municipal services and peculiarities of state
services in electronic form

40. Other requirements, including taking into account the specifics of the provision of public services in multifunctional centers for the provision of state and municipal services, and the specifics of the provision of public services in electronic form, and using the Unified portal of state and municipal services (functions), are lacking.

III. Composition, sequence and timing of implementation
administrative procedures (actions), order requirements
their implementation, including the implementation of
administrative procedures (actions) in electronic form

List of administrative procedures

41. When providing a public service, the following administrative procedures are carried out:

   1) reception and registration of the application and documents for the registration of the medicinal product, the adoption of a decision on the start of the registration procedure for the medicinal product;
   2) sending a request to the applicant for provision of missing additional information, necessary clarifications or clarifications of documents and data submitted in the registration dossier, following the evaluation of the completeness, compilation and correctness of the documents presented in the drug registration dossier;
   3) execution and issuance of an assignment for the examination of the safety, efficacy and quality of the medicinal product; review of the expert report on the assessment of safety, efficacy and quality of the medicinal product;
   4) initiating the need for an unscheduled or planned pharmaceutical inspection
   5) sending to the applicant a request for provision of missing additional information, necessary explanations or clarifications of documents and data submitted in the registration dossier, based on the results of the examination; sending the request to the applicant in the form of comments from the State of Recognition, approved in Appendix No. 18 to the Rules;
   6) sending the applicant a decision on registration or refusal to register the medicinal product; sending an opinion to the authorized body of the reference state on the possibility or impossibility of recognizing the expert evaluation report prepared by the reference state;
   7) making changes to the documents contained in the registration dossier of the medical device;
   8) cancellation of the validity of the registration certificate;
   9) issuance of a duplicate of the registration certificate of the medicinal product;
   42. The heads of the structural divisions of the Ministry of Health of Russia, who, in accordance with the Administrative Regulations, provide public services, organize a documented record of the implementation of each stage of administrative procedures.

Reception and registration of applications and documents for registration,
the decision to start the procedure of drug registration

   43. The administrative procedure "Admission and registration of an application and documents for the registration of a medicinal product, the adoption of a decision on the beginning of the procedure for the registration of a medicinal product" is carried out in connection with the application for registration of a medicinal product and documents from the applicant to the Ministry of Health of Russia (as an authorized body of the reference state) specified in paragraphs 19, 19.1 of the Administrative Regulations using the Unified Portal of State and Municipal Services (functions).
   44. The application for drug registration and the documents provided for in paragraphs 19, 19.1 of the Administrative Regulations shall be adopted by the Ministry of Health of the Russian Federation (as an authorized body of the reference state) on the inventory, a copy of which, with a note of the date of receipt of the said application and documents on the day of receipt, is given to the applicant or sent to him by registered mail with notification of delivery or in the form of an electronic document signed by an electronic signature.
   45. The head of the structural subdivision of the Ministry of Health of Russia (his deputy) responsible for the provision of the public service, within one working day from the date of receipt of the application for registration and documents provided for in clauses 19, 19.1 of the Administrative Regulations, appoints the responsible officer from the staff of the unit responsible for registration of medicinal products preparations (hereinafter referred to as the responsible performer).
   Last name, first name and patronymic (last if available) of the responsible performer and his telephone number must be notified to the applicant on his written or oral appeal and are available to him and the authorized body (expert organization) of the state of recognition for viewing on the official website of the Ministry of Health of Russia.
   46. Within 14 (fourteen) working days from the date of receipt of the application for drug registration and documents provided for in paragraphs 19, 19.1 of the Administrative Regulations, the responsible executor shall verify the completeness and reliability of the information contained therein, including by comparing such information with information, presented in the order of interagency information interaction.
   47. Formation and submission of inter-departmental requests to bodies participating in the provision of public services are carried out by the responsible executor in accordance with Article 7.2 of Federal Law No. 210-FZ of July 27, 2010 within the framework of the administrative procedure related to the reception and registration of applications and documents for the registration of a drug, by taking a decision on the beginning of the procedure for the registration of a drug, within 10 working days from the date of receipt of the application and documents, 19.1, 19.1 of the Administrative Regulations, to the responsible executor, in order to obtain the information required for the provision of public services.
   Provision of information (data) necessary for the provision of public services is carried out, including in electronic form, using a single system of interagency electronic interaction and connected to it regional systems of interagency electronic interaction.
   48. If the application is submitted in violation of the requirements set forth in Appendix No. 2 to the Rules, there is a lack of information, necessary explanations or clarifications of documents and data submitted in the registration dossier of the Ministry of Health of Russia (as an authorized body of the reference state) for 10 (ten) workers days from the date of receipt of such application and documents of the registration dossier notifies the applicant about the need to eliminate the revealed violations and (or) present missing documents in time, not exceeding 90 (ninety) calendar days from the date of placement of the relevant notification in the information system of the Ministry of Health of Russia (as an authorized body of the reference state), by transmitting a notice to the applicant personally against receipt, or by sending a notification by registered mail with a delivery receipt or electronic transmission on telecommunication channels of communication or in the form of the electronic document signed by the electronic signature.
   49. In the event that the revealed violations are not eliminated within 90 days and (or) the missing documents are not submitted to the applicant, a notification on refusal to provide the state service with a justified reason for refusal is given (handed).
   50. Within 10 (ten) working days from the date of submission of the application and documents of the registration dossier corresponding to the requirements of the Rules, the Ministry of Health of Russia (as authorized by the body of the reference state) decides on the commencement of the examination procedure and drug registration process.
   51. The Ministry of Health of Russia places an application and documents of the registration dossier on the official website of the Ministry of Health of the Russian Federation in the Federal Information System "State Register of Medicines" in the information and telecommunication network Internet: www.grls.rosminzdrav.ru (hereinafter - the official website of the Ministry of Health of Russia), which are available only to the authorized bodies (expert organizations) of the states of recognition, and submits to the Eurasian Economic Commission information about the identification number of the application for registration of the drug preparation rata with the use of an integrated information system of the EAEU.
   The authorized bodies (expert organizations) of the states of recognition are entitled to get acquainted with the course of conducting expert work in the Ministry of Health of Russia (as an authorized body of the reference state), including correspondence between the applicant and the Ministry of Health of Russia (as an authorized body of the reference state) on the removal of comments and documents, submitted by the applicant in the process of examination and registration of medicinal products.

Registration and issue of the assignment for the examination of
safety, efficacy and quality of drugs, assessment of the possibility
or impossibility of recognizing the expert report
on the evaluation of the safety, efficacy and quality
of the medicinal product, deciding on the registration of the drug

   52. The administrative procedure "conducting an examination of the safety, efficacy and quality of drugs, assessing the possibility or impossibility of recognizing the expert report on the evaluation of the safety, efficacy and quality of the drug, deciding on the registration of a medicinal product" is made in connection with the decision of the Ministry of Health of Russia to start drug registration.
   53. Within four (4) business days from the day the decision was taken to initiate the procedure for the examination and registration of a medicinal product, the Ministry of Health of Russia (as an authorized body of the reference state) shall formatre and issue a task for conducting an expert examination of the safety, efficacy and quality of medicinal products to the federal state budget institution, which is under the jurisdiction of the Ministry of Health of Russia (hereinafter referred to as the expert institution).
   Before submitting the registration dossier materials for examination, the applicant is granted no more than 90 (ninety) calendar days not included in the period of registration and examination of the drug, for submitting materials missing in the registration dossier, on the comments of the Ministry of Health of Russia (as an authorized body of the reference state).
   The Ministry of Health of the Russian Federation (as an authorized body of the reference state) rejects the application for registration of the medicinal product in the event that documents and materials of the registration dossier are not submitted in due time on the remarks of the Ministry of Health of Russia (as an authorized body of the reference state) and (or) failure to confirm payment of the fee (state due) for registration and examination of the drug in cases and in the manner established by the legislation of the Russian Federation, and informs the applicant and the authorized bodies (eq confined organizations) of recognition by means of an integrated system within a period of not more than 4 (four) business days from the date of the decision.
   54. An expert institution within 90 (ninety) calendar days from the date of commencement of the examination, sends to the authorized bodies (expert organizations) of states the recognition of a copy of the reports with the formulation of comments and requests to the applicant in accordance with the annexes 6-8 to the Rules and the preliminary report on the evaluation in accordance with Annex 11 to the Rules.
   55. When conducting drug registration and examination of a medicinal product, the Ministry of Health of Russia (as an authorized body of the reference state) has the right to send a request to the applicant in writing and (or) electronically to provide the missing additional information, necessary explanations or clarifications regarding the documents submitted in the registration dossier data (in including suggestions for changes in SmPC, instructions for medical use, drug package layouts, normative document on quality or other documents of the registration dossier).
   If there are inquiries sent to the applicant, the authorized body (expert organization) of the state of recognition shall, within 30 calendar days from the date of receipt of the preliminary report on the evaluation of the expert institution, send requests to the expert institution, which within 5 (five) working days from the date of receipt of the latter request from the state of recognition forms a single request and sends it to the applicant.
   Interaction between the authorized bodies (expert organizations) when sending inquiries to the applicant is carried out electronically according to the form in accordance with Appendix No. 18 to the Rules using the means of the integrated system.
   The request can be handed over to the applicant personally on receipt, sent by mail by registered mail with a notice of delivery or transmitted electronically via telecommunication channels or in the form of an electronic document signed by an electronic signature. After the first request, subsequent requests are allowed only if additional questions arise on the data submitted by the applicant in response to the previous request.
   The applicant must submit a response to the request within a period not exceeding 90 (ninety) calendar days from the date of receipt of the request. If necessary, on the basis of the relevant application of the applicant, the response time to the request can be extended by the Ministry of Health of Russia (as an authorized body of the reference state). The general deadline for responding to inquiries should not exceed 180 calendar days.
   If the applicant fails to submit documents and materials requested by the Ministry of Health of the Russian Federation (as an authorized body of the reference state), the process of drug registration and examination of the medicinal product is terminated. On the decision adopted, the Ministry of Health of Russia (as an authorized body of the reference state) notifies the applicant and the authorized bodies (expert organizations) of the states of recognition within 14 (fourteen) business days from the date of such decision in writing and (or) electronically.
   The time of submission of documents by the applicant at the request of the Ministry of Health of Russia in the process of examination of the medicinal product is not included in the terms of examination and registration of the medicinal product.
   56. In case of detection during the drug registration procedure, facts that call into question the reliability of the information submitted by the applicant in the registration dossier regarding pre-clinical (non-clinical) drug trials and clinical trials tests) of medicinal products or the manufacture of a medicinal product, including the manufacture of a pharmaceutical substance or the organization of a pharmacovigilance system, the Ministry of Health of the Russian Federation (as an authorized body of the reference state) initiates the inspection by the pharmaceutical inspectorate of that State for compliance with the requirements of relevant appropriate pharmaceutical practices. Such inspections may also be initiated in cases specified in paragraphs 31, 33, 35, 37 to 39 of the Regulations.
   Examination of the medicinal product in the case of initiating a pharmaceutical inspection is not suspended. At the same time, the preparation of an expert evaluation report is completed by the reference state only after the expert organization of the reference state receives the results of the inspection. An unscheduled pharmaceutical inspection with a report on the inspection carried out should be conducted at the time of registration of the drug, but not exceeding 180 calendar days from the date of the decision of the authorized body (expert organization) to initiate the inspection.
   The applicant organizes a visit to the production site, the research center, the pharmacovigilance system of the holder of the registration certificate within 30 calendar days after receiving information on the need for an inspection or specifies a specific period of visit, but not more than 90 calendar days after receiving the information.
   57. Within a period not later than 155 calendar days from the date of submission of the application for registration, the Ministry of Health of Russia sends to the states of recognition and to the applicant a draft of a final expert evaluation report in accordance with Annex 16 to the Rules, together with the applicant's replies to the inquiries, the SmPC project, draft instructions for medical use (leaflet), project layouts of packages, draft regulatory document on quality, and, if necessary, a draft of risk management plan for the use of the drug. The Ministry of Health of Russia (as an authorized body of the reference state) places on its official website an expert opinion of an expert institution that is accessible only to authorized bodies (expert organizations) of the states of recognition.
   If the expert agency has prepared a negative draft of the final expert evaluation report and the Russian Ministry of Health made a decision to refuse drug registration in accordance with paragraph 114 of the Rules, examination and registration of the drug is terminated. The authorized body (expert organization) notifies the applicant about the adopted decision within 14 (fourteen) business days from the date of adoption of such decision in written and (or) electronic form with the application of the said final expert evaluation report.
   If the expert agency has prepared a positive draft of final expert evaluation report, it is reviewed by authorized bodies (expert organizations) of the states of recognition.
   58. Based on the results of the examination of the draft expert evaluation report in accordance with paragraph 57 of the Administrative Regulations, in the absence of comments from the authorized bodies (expert organizations) of the States of recognition or after their withdrawal in accordance with paragraph 59 of the Administrative Regulations, the expert institution, together with the authorized bodies (expert organization) of the recognition states complete the examination procedure of the medicinal product within 10 working days (175th calendar day from the date of submission of the application for registration).
   59. If there are comments from the competent authorities (expert organizations) of the states regarding the draft final evaluation report, the draft of SmPC, the draft of instruction on medical application, the draft of package layout or the draft of Normative Document on quality, the draft of risk management plan for the use of the medicinal product (if necessary), if necessary, the expert institution shall carry out consultations with the authorized bodies (expert organizations) of the states of recognition in the (10 days) in the form in accordance with Appendix No. 18 to the Rules (165th calendar day from the date of submission of the application for registration).
   60. In the presence of unresolved differences in the framework of mutual consultations and the receipt of a conclusion on the impossibility of recognizing the expert evaluation report prepared by the expert institution, with justification of the reasons for the negative decision to the Ministry of Health of Russia (as an authorized body of the reference state), the authorized bodies of the states of recognition, and also The Expert Committee, including on paper, by the Expert Committee within a period not exceeding 60 (sixty) calendar days from the date of sending by states is recognized A conclusion on the impossibility of recognizing a positive expert evaluation report prepared by an expert institution, a procedure for resolving disagreements is conducted in accordance with the procedure established by the Commission.
   In case the disagreement between the expert institution and the authorized bodies of the states of recognition regarding the recognition of the expert evaluation report is settled, the Ministry of Health of Russia (as an authorized body of the reference state) passes to the completion of the examination procedure and the procedure for issuing the final documents in accordance with paragraphs 57, 61 and 62 of the Administrative regulations.
   In case the disagreement between the authorized bodies of the reference state and the states of recognition regarding the recognition of the expert evaluation report is not settled, the Ministry of Health of Russia (as the authorized body of the reference state) shall pass to the completion of the examination procedure and the procedure for issuing the final documents in accordance with paragraphs 57, 61 and 62 At the request of the applicant, the issuance of the registration certificate may be suspended until the disagreements of the authorized bodies of other recognition states and the Ministry of Health of Ross (as an authorized body of the reference state).
   61. After deciding on the possibility of drug registration in accordance with paragraphs 57 and 60 of the Administrative Regulations, the Ministry of Health of Russia (as an authorized body of the reference state) shall, within a period of not more than 30 calendar days, issue a registration certificate of the medicinal product to the applicant in accordance with Annex No. 17 to the Rules approved by SmPC, instructions for medical use, a Normative document, packaging mock-ups, an expert evaluation report, and, if necessary, an agreement for risk management plan in the application of the drug (if necessary approved applicant receives SmPC, instruction for use and layout packages of the drug in the official language of the state of the reference). Within the specified period within 10 working days, the applicant is obliged to translate the SMPC, the draft of instruction for medical use, the layouts of the packages into the languages of the Member States, if there is a corresponding requirement in their legislation.
   62. The Ministry of Health of Russia (as an authorized body of the reference state) places information on the registration of a drug and its active pharmaceutical substances in a single registry with the application of approved SmPC, instructions for medical use, package layouts, a Normative document, and the final expert assessment report compiled in accordance with Annex 16 to the Rules, after the confiscation of confidential data and data on experts, a summary of the systematic way of risk when applying a medicament (if necessary) in accordance with the procedure of creating and maintaining a common registry.
   63. The Ministry of Health of the Russian Federation (as an authorized body of the reference state) shall, at the request of the applicant, within a period not exceeding five (5) working days from the date of receipt of this request, provide access to the authorized bodies (expert organizations) of the recognition states to the drug registration dossier and an expert report by evaluation through an integrated system using additional documents and information provided by the applicant to the requests of the Ministry of Health of Russia (as an authorized body of the reference state).

Confirmation of an agreement (disagreement)
by the Ministry of Health of Russia (as a state of recognition) on expert
conclusions of the reference state based on the results of
examination of safety, efficacy and quality of drugs

64. Administrative procedure "Confirmation of the approval (non-coordination) by the Ministry of Health of Russia (as a state of recognition) of the expert opinion of the reference state on the basis of the safety, efficacy and quality of medicinal products examination" is carried out in connection with the receipt from the applicant of the documents to the Ministry of Health of Russia (as an authorized body of the state of recognition) specified in clause 19.1 of the Administrative Regulations on paper and in electronic form.

   65. The application for drug registration under the procedure of mutual recognition and the documents provided for it in paragraph 64 of the Administrative Regulations shall be taken by the Ministry of Health of the Russian Federation (as an authorized body of the state of recognition) on an inventory, a copy of which with a note on the date of receipt of this application and documents on the day of receipt is given to the applicant or sent to him by registered mail with a notice of delivery or in the form of an electronic document signed by an electronic signature.
   66. The head of the structural subdivision of the Ministry of Health of Russia (his deputy) responsible for the provision of the public service, within one working day from the date of receipt of the application for drug registration and documents provided for it in paragraph 64 of the Administrative Regulations, appoints the responsible officer from the staff of the unit responsible for registration of medicinal products (further - the responsible executor).
   Last name, first name and patronymic (last if available) of the responsible performer and his telephone number must be notified to the applicant on his written or oral appeal and are available to him and the authorized body (expert organization) of the state of recognition for viewing on the official website of the Ministry of Health of Russia.
   67. An authorized official of the structural subdivision of the Ministry of Health of the Russian Federation (as an authorized state body of recognition) responsible for the provision of public services analyzes daily the data of the relevant information systems of the member states of the Union for the establishment of facts of placement of expert opinions in them in accordance with the results of the safety, efficiency and quality examination medicinal preparations in accordance with subparagraph "b" of paragraph 63 of the Rules.
   68. The Ministry of Health of Russia (as an authorized body of the state of recognition) within 14 (fourteen) business days from the date of filing the application rejects the application for registration of the medicinal product under the procedure of mutual recognition in case of non-compliance of the application with the requirements of the Rules and / or non-confirmation of payment of the fee (fee) for drug registration and examination of the medicinal product in the cases and in the manner provided for by the legislation of the Russian Federation.
   69. On the basis of the conclusion of the expert institution and within a period not exceeding 50 (fifty) calendar days after access to the expert report of the reference State for evaluation, if necessary, the Ministry of Health of Russia (as an authorized body of the state of recognition) shall forward the request to the applicant and to the authorized body organization) of the reference state in accordance with Appendix No. 18 to the Rules.
   The applicant sends a response to the request to the authorized body (expert organization) of the state of recognition within a period not exceeding 90 (ninety) calendar days. The term of the applicant's response to the request is not included in the general period for the examination and registration of the medicinal product. The Ministry of Health of Russia (as an authorized body of the state of recognition) within five (5) working days from the receipt of the applicant's response provides access to the authorized body (expert organization) of the reference state through the integrated information system of the EAEU.
   If the requested documents and information are not submitted in due time by the applicant, the examination and registration of the drug shall be terminated.
   Within 10 (ten) working days from the date of the decision, the applicant is notified of the decision taken (in electronic and (or) paper form).
   70. Within a period not exceeding 50 (fifty) calendar days from the date of filing with the Ministry of Health of Russia (as an authorized body of the state of recognition) applications for the registration of a drug (in the absence of inquiries to the applicant) or within a period not exceeding 20 (twenty) calendar days from the date of receipt of the applicant's response to the request, the Ministry of Health of Russia (as an authorized body of the state of recognition), using the integrated information system of the Union, sends to the authorized body (expert organization) of the reference state conclusion about the possibility or impossibility of recognition of expert evaluation report prepared by the reference state.
   71. If the expert evaluation report prepared by the expert organization of the reference state can not be recognized, the Ministry of Health of Russia (as an authorized body of the state of recognition) sends to the authorized body (expert organization) of the reference state, other recognition states participating in the drug registration procedure, the applicant and Expert Committee conclusion on the impossibility of recognizing this expert evaluation report, with the following reasons:
   a) the ratio of the expected benefit to the possible risks associated with the use of the medicinal product is not favorable;
   b) the applicant has not proven the effectiveness of the medicinal product;
   c) the quality of the drug is not confirmed;
   d) the applicant submitted inaccurate information;
   e) according to the results of the appointed inspection during the registration of the drug, a discrepancy was revealed to the appropriate pharmaceutical practices of the EAEU, which is critical.
   72. In the event that, following the procedure for resolving disagreements in the Expert Committee, the Ministry of Health of Russia (as an authorized body of the state of recognition) decides that the data presented in the expert evaluation report can not be recognized as sufficient to confirm the quality and (or) effectiveness, and (or) favorable "benefit-risk" ratio of the medicine. The Ministry of Health of Russia (as an authorized body of the state of recognition) refuses to register the drug.
   73. If the Ministry of Health of the Russian Federation (as an authorized body of the state of recognition) recognizes an expert evaluation report prepared by the reference state, a decision is made to register the medicinal product, and not later than 10 (ten) working days:
   a) issues the registration certificate of the medicinal product to the applicant in accordance with Appendix No. 17 to the Rules, as well as the SmPC approved guidelines for medical use, the layouts of packages in the state language of the State of Recognition, subject to the relevant requirements in the legislation of the State of Recognition;
   b) coordinates the normative document on quality issued by the reference state;
   c) places information about the medicinal product and its active pharmaceutical substances in a single registry with the application of approved SmPC, instructions for medical use, package layouts, an agreed risk management plan for the use of the medicinal product (if necessary) in accordance with the order of formation and maintenance single registry.
   74. The registration certificate of a medicinal product is issued by the Ministry of Health of Russia (as an authorized body of the state of recognition) with the validity of the registration certificate established by the reference state.

Confirmation of registration (re-registration)
of a medicinal product

   75. The administrative procedure "Confirmation of the registration (renewal of registration) of the drug" is carried out in connection with the receipt from the applicant of the application for confirmation of the registration (registration renewal) of the medicinal product (hereinafter - application for confirmation of registration) on the paper carrier to the Ministry of Health of Russia (as an authorized body of the reference state) and (or) in the form of an electronic document in accordance with Appendix No. 2 to the Rules, with the attachment of the documents specified in paragraph 20 of the Administrative Regulations.
   The application for registration confirmation and attached documents shall be accepted by the Ministry of Health of the Russian Federation on the inventory, a copy of which, with a note on the date of receipt of the said application and documents on the day of receipt, shall be presented to the applicant or sent to him by registered mail with a receipt or in the form of an electronic document signed by an electronic signature.
   The Ministry of Health of Russia assigns to the application for registration renewal a unique number, formed using an integrated system, and informs the applicant on the day of reception.
   The head of the structural subdivision of the Ministry of Health of Russia (his deputy) responsible for providing the state service, within one working day from the date of receipt of the application for confirmation of registration and documents provided for in paragraph 20 of the Administrative Regulations, appoints the responsible executor from among the employees of the unit performing the confirmation of registration of medicinal products further - the responsible executor).
   Last name, first name and patronymic (last if available) of the responsible performer and his telephone number must be notified to the applicant on his written or oral appeal and are available to him and the authorized body (expert organization) of the state of recognition for viewing on the official website of the Ministry of Health of Russia.
   76. Within 5 working days from the date of submission by the applicant of an application for confirmation of registration, the Ministry of Health of Russia provides access to the registration dossier of medicinal products for the authorized bodies (expert organizations) of states using the means of the integrated system.
   77. Within 14 working days from the date of submission of the application for confirmation of registration, the responsible executor shall assess the completeness, compilation and correctness of the registration dossier documents before sending the registration dossier materials for examination, including by comparing such information with information submitted in the order of interdepartmental information interaction.
   Formation and sending, if necessary, of interdepartmental requests to bodies participating in the provision of public services is carried out by the responsible executor in accordance with Article 7.2 of the Federal Law of July 27, 2010 No. 210-FZ within the framework of the administrative procedure related to the reception and registration of applications and documents to confirm the drug registration, to take a decision on the start of the procedure for confirming the registration of the drug, within 10 working days from the day of submission of statements and documents provided for in paragraph 20 of the Administrative Regulations, to the perpetrators, in order to obtain the information necessary for the provision of public services.
   Provision of information (data) necessary for the provision of public services is carried out, including in electronic form, using a single system of interagency electronic interaction and connected to it regional systems of interagency electronic interaction.
   78. If the application is submitted in violation of the requirements specified in Annex 2 to the Rules, there is a lack of information, necessary clarifications or explanations of documents and data submitted in the registration dossier, the Ministry of Health of Russia (as an authorized body of the reference state) within the time specified in paragraph 46 of the Administrative Regulations, notifies the applicant of the need to eliminate identified violations and (or) submission of missing documents within a period not exceeding 90 calendar days from the day of clearance in the information system of the Ministry of Health of Russia (as an authorized body of the reference state), by transmitting a notice to the applicant personally against receipt, or by sending a notification by registered mail with a delivery notification, or by electronic transmission via telecommunications channels or in the form of an electronic document, signed by an electronic signature
   The time for which the applicant submits documents on the remarks of the Ministry of Health of Russia (as an authorized body of the reference state) is not included in the terms of confirmation of registration (registration renewal) and examination of the medicinal product.
   79. If, within 90 days, the revealed violations are not eliminated and / or the missing documents are not submitted, the applicant and authorized bodies (expert organizations) of the recognition states are sent (handed in) notification of rejection of the application for confirmation of registration in written and (or) electronic form.
   80. The Ministry of Health of Russia within 30 calendar days from the date of submission of the application for confirmation of registration issues an assignment to the expert institution for the examination of the medicinal product and the preparation of an expert evaluation report in the manner prescribed by the Rules.
   81. Within 50 calendar days from the date of submission of the application for confirmation of registration (during the examination of the medicinal product), the Ministry of Health of Russia sends to the authorized bodies (expert organizations) of states the recognition of the preliminary expert evaluation report prepared by the expert organization in accordance with Annex 11 to the Rules, using the means of an integrated system.
   82. Approval of the preparatory and final expert evaluation reports, consideration of the requests of the authorized bodies (expert organizations) of the recognition states is carried out using the means of the integrated system with the implementation of consultations on the form in accordance with Annex No. 18 to the Rules.
   83. The Ministry of Health of Russia, when carrying out the procedure for confirming the registration (registration renewal) and examination of the medicinal product, has the right to send to the applicant a request in writing and (or) electronically about the submission of missing additional information, necessary explanations or clarifications regarding the submitted documents and registration dossier data (including proposals for changes in SmPC, instruction on medical use, drug package layouts, normative document on quality or other e documents of the registration dossier).
   84. The applicant must, within a period not exceeding 90 calendar days from the receipt of the request from the Ministry of Health of Russia, submit a response to the specified request.
   The time for submission of documents by the applicant at the request of the Ministry of Health of Russia is not included in the time of confirmation of registration (registration renewal) and examination of the medicinal product.
   85. The Ministry of Health of the Russian Federation reviews the applicant's responses, including responses to the requests of the authorized bodies (expert organizations) of the states of recognition within a period of no more than 20 calendar days from the receipt of the response.
   86. In the event that the applicant fails to submit the requested documents and data within the prescribed period, examination and confirmation of registration (registration renewal) of the medicinal product shall be terminated. The Ministry of Health of Russia notifies the authorized bodies (expert organizations) of the state of recognition and the applicant about the adopted decision within 14 working days from the date of adoption of such a decision in written and (or) electronic form.
   87. Within a period not exceeding 90 calendar days from the date of submission of the application for confirmation of drug registration, the Ministry of Health of Russia approves the final expert evaluation report compiled by the expert organization in accordance with Annex 16 to the Rules and sends it using the integrated system to the authorized bodies (expert organizations) of all states of recognition participating in the procedure for confirming the registration (re-registration) of a medicinal product.
   88. If, based on the results of drug examination, it is established that the "benefit-risk" ratio is assessed positively and the registration dossier, taking into account the changes introduced, meets the requirements, the Ministry of Health of Russia:
   a) issues to the applicant an indefinite registration certificate for the medicinal product in accordance with the form in accordance with Appendix No. 17 to this Regulation, approved the SmPC, instructions for medical use, a quality standard document, drug package mock-ups, expert evaluation report and, if necessary, an agreed risk management plan when using a medicinal product;
   c) places the necessary information on the medicinal product and its active pharmaceutical substances in a single register, a summary of the agreed risk management plan for the use of the medicinal product (if necessary).
   89. The grounds for the refusal of the Ministry of Health of Russia (as an authorized body of the reference state) to confirm the registration (registration renewal) of the medicinal product are:
   a) the following serious health risks associated with the use of the medicinal product at the time of registration confirmation (re-registration):
   the proven unfavorable benefit-risk relationship or the identified lack of therapeutic efficacy, subject to the conditions of use of the drug described in the approved SmPC;
   the facts established by pharmacovigilance data indicating an unfavorable benefit-risk ratio (including a significant excess of the frequency of reporting of any undesirable reactions in comparison with the data specified in the approved SmPC);
   the discrepancy between the qualitative and quantitative composition of the drug declared or the repeated inconsistency of the quality of the medicinal product during its circulation on the common drug market of the EAEU declared at the time of its registration;
   unreliable or non-actualized data of the registration dossier accompanying the application for confirmation of registration (re-registration);
   b) the failure by the holder of the registration certificate to comment on or fail to respond to questions raised during the examination of the medicinal product within the allotted time;
   c) failure by the holder of the registration certificate to fulfill the obligations of pharmacovigilance or obligations under the registration procedure on terms.

The procedure for agreeing an expert report on the evaluation of the reference state in order to confirm the registration (renewal of registration) of the drug

   90. The administrative procedure "Approval of the expert report on the evaluation of the reference state for the purpose of confirming the registration (registration renewal) of the medicinal product" is carried out in connection with the receipt from the applicant of the application to confirm the registration (re-registration) of the medicinal product with the Ministry of Health of Russia on the confirmation of registration) on paper and (or) in the form of an electronic document in accordance with Appendix No. 2 to the Rules, with the enclosed documents, in paragraph 16.1 of the Administrative Regulations.
   91. The applicant submits to the Ministry of Health of Russia (as an authorized body of the state of recognition) the documents specified in paragraph 60 of the Administrative Regulations, no later than 14 working days from the date of submission of the application for confirmation of registration in the reference state.
   The application for registration confirmation and attached documents shall be accepted by the Ministry of Health of the Russian Federation on the inventory, a copy of which, with a note on the date of receipt of the said application and documents on the day of receipt, shall be presented to the applicant or sent to him by registered mail with a receipt or in the form of an electronic document signed by an electronic signature .
   92. The Ministry of Health of Russia (as an authorized body of the state of recognition) within 20 calendar days from the date of submission by the authorized state body (expert organization) of the preliminary state of the preliminary expert assessment report in accordance with Annex 11 to the Rules, assesses it and, if necessary, body (expert organization) of the reference state using the means of the integrated system.
   93. Within 20 calendar days from the date of receipt of the final expert report on the evaluation of the reference state in accordance with Annex 16 to the Rules, the Ministry of Health of Russia (as an authorized body of the state of recognition) creates, approves and, using the means of the integrated system, sends to the authorized body (expert organization ) of the referent state the conclusion on the possibility or impossibility of recognizing the expert report on the evaluation of the reference state in accordance with Annex 18 to the Rules m.
   94. Approval of the preparatory and final expert evaluation reports is carried out using the means of the integrated system with the implementation of consultations on the form in accordance with Annex No. 18 to the Rules.
   95. If, based on the results of drug testing in the reference country, it is established that the benefit-risk ratio is assessed positively and the registration dossier, taking into account the changes introduced, meets the requirements, the Ministry of Health of Russia (as an authorized body of the state of recognition):
   a) issues to the applicant perpetual registration certificates of the medicinal product in the form according to Appendix No. 17 to the Rules;
   b) places the necessary information on the medicinal product and its active pharmaceutical substances in a single register, a summary of the agreed risk management plan for the use of the medicinal product (if necessary).
   96. If it is not possible to recognize the expert report on the evaluation of the reference state, the Ministry of Health of Russia (as an authorized body of the state of recognition) sends an electronic and / or paper report on the impossibility of recognizing this expert report with justification of the decision taken by the authorized body (expert organization) of the reference state and the states of recognition participating in the procedure for confirming the registration (re-registration) of medicinal products about the drug, the applicant and the Expert Committee.
   97. The expert committee shall, within a period not exceeding 60 calendar days from the date of receipt of the opinion of the Ministry of Health of the Russian Federation (as an authorized body of the state of recognition) that it is impossible to recognize the expert report on the assessment of the reference state, shall proceed with the disagreement procedure in accordance with the procedure established by the Commission.
   98. The grounds for the refusal of the Ministry of Health of Russia (as an authorized body of the state of recognition) in recognizing the expert report on the evaluation of the reference state are:
   a) serious health risks associated with the use of the medicinal product at the time of registration confirmation (re-registration):
   the proven unfavorable benefit-risk relationship or the identified lack of therapeutic efficacy, subject to the conditions of use of the drug described in the approved SmPC;
   the facts established by pharmacovigilance data indicating an unfavorable benefit-risk ratio (including a significant excess of the frequency of reporting of any undesirable reactions in comparison with the data specified in the approved SmPC);
   the discrepancy between the qualitative and quantitative composition of the drug declared or the repeated inconsistency of the quality of the medicinal product during its circulation on the market of the Union declared at the time of its registration;
   unreliable or non-actualized data of the registration dossier accompanying the application for confirmation of registration (re-registration);
   b) the failure by the holder of the registration certificate to comment on or fail to respond to questions raised during the examination of the medicinal product within the allotted time;
   c) failure by the holder of the registration certificate to fulfill the obligations of pharmacovigilance or obligations under the registration procedure on terms.
   99. The Ministry of Health of Russia (as an authorized body of the state of recognition) refuses to confirm the registration (re-registration) of the medicinal product if, following the examination of the medicinal product and after the procedure for resolving the disagreements in the Expert Committee, it is established that the expert evaluation report prepared by the expert organization of the reference state, can not be recognized by the Ministry of Health of Russia for the reasons specified in paragraph 68 of the Administrative Regulations.

Bringing the registration dossier of a
medicinal product registered before entry
by virtue of the Agreement on Unified Principles and Rules of Treatment by
medicines within the framework of the Eurasian Economic
Union of December 23, 2014 and until December 31
2020, in accordance with the requirements of the EAEU

   100. Administrative procedure "Bringing the registration dossier of a medicinal product registered before the entry into force of the Agreement on Uniform Principles and Rules for the circulation of medicinal products within the framework of the Eurasian Economic Union of December 23, 2014 and until December 31, 2020, in accordance with the requirements of the EAEU "is carried out in connection with the application from the applicant to the Ministry of Health of Russia (as an authorized representative of the referent state) to bring the registration dossier of the medicinal product into conformity with the requirements of the EAEU (hereinafter - the application for bringing it into conformity) on paper and (or) in the form of an electronic document in accordance with Appendix No. 2 to the Rules, with the attachment of the documents specified in paragraph 17 of the Administrative Regulations.
   The application for conformity and attached documents shall be accepted by the Ministry of Health of the Russian Federation on the inventory, a copy of which, with a note of the date of receipt of the said application and documents on the day of receipt, shall be presented to the applicant or sent to him by registered mail with a notification of delivery or in the form of an electronic document signed by an electronic signature.
   The Ministry of Health of the Russian Federation assigns to the application a unique number generated using an integrated system and informs the applicant on the day of reception.
   101. The applicant has the right, at the time of bringing in conformity with the requirements of the Union, to simultaneously make changes in the registration dossier of the registered medicinal product. In this case, the procedure for making such changes and assessing the dossier for compliance with the acts included in the law of the Union shall be carried out in accordance with Appendices No. 19 and 20 to the Rules.
   102. Within 14 working days from the date of filing by the applicant of the documentы specified in paragraph 70 of the Administrative Regulations, the Ministry of Health of Russia (as an authorized body of the reference state) assesses the completeness, compilation and correctness of processing the submitted documents of the registration dossier of the medicinal product before sending the registration dossier of the drug for examination, including by comparing such information with information submitted in the order of interdepartmental information interaction.
   Formation and sending, if necessary, of interdepartmental requests to bodies participating in the provision of public services is carried out in accordance with paragraph ___ of the Administrative Regulations.
   103. The Ministry of Health of Russia (as an authorized body of the reference state) may, within the time specified in paragraph 72 of the Administrative Regulations, send observations on the completeness, compilation and correctness of the submitted documents to the applicant's registration dossier of the drug.
   104. The applicant must, within a period not exceeding 90 calendar days from the receipt of the Russian Ministry of Health's response, submit missing documents to the registration dossier.
   The time for which the applicant submits documents on the deficiency letters of the Ministry of Health of Russia (as an authorized body of the reference state) is not included in the timing of the examination of the medicinal product when the registration dossier of the medicinal product is brought in accordance with the requirements of the EAEU.
105. The Ministry of Health of the Russian Federation (as an authorized body of the reference state) rejects the application for conformity in the case of the applicant's failure to submit the missing materials of the drug registration dossier on the remarks of the Ministry of Health of Russia and (or) failure to confirm payment of the fee (fee) for bringing the registration dossier of the medicinal product in line with requirements of the EAEU in cases and in the manner established by the legislation of the Russian Federation.
   106. Within 30 calendar days from the date of submission of the application for bringing the registration dossier in compliance, the Ministry of Health of Russia (as an authorized body of the reference state) issues to the expert institution the task to conduct an expert examination of the medicinal product and to prepare an expert evaluation report in accordance with the Rules.
   107. The Ministry of Health of the Russian Federation (as an authorized body of the reference state) in conducting the examination of the drug during the procedure for bringing the registration dossier of the medicinal product in compliance with the requirements of the EAEU has the right to send the applicant in writing and (or) electronically the request for additional information, clarifications or elaboration, concerning the submitted documents and the data of the registration dossier of the drug (including proposals to amend the SmPC , instructions for medical use, package mock-ups, Normative document on quality or other documents of the registration dossier).
   108. The applicant must, within a period of not more than 90 calendar days from the receipt of the request from the Ministry of Health of Russia, submit a response to the specified request.
   The time for submission of documents by the applicant at the request of the Ministry of Health of Russia is not included in the timing of the examination of the drug when the registration dossier of the medicinal product is brought in accordance with the requirements of the EAEU.
   109. If the applicant fails to submit the requested documents and data within the prescribed period, the examination and the procedure for bringing the registration dossier of the medicinal product in accordance with the requirements of the EAEU shall be terminated. The Ministry of Health of Russia notifies the authorized bodies (expert organizations) of the state of recognition and the applicant about the adopted decision within 14 working days from the date of adoption of such a decision in written and (or) electronic form.
   110. Based on the results of the examination of the registration dossier of the medicinal product and subject to a positive decision on the compliance of the registration dossier of the medicinal product with the requirements of the Rules, the Ministry of Health of Russia (as an authorized body of the reference state):
    a) issueы the registration certificate of the drug to the applicant in accordance with Appendix No. 17 to the Rules with approved SmPC, instructions for medical use, a Normative document on quality control, drug package mock-ups, an agreed risk management plan (if necessary);
   b) submits information on the registration of a drug in a single register.
   The Ministry of Health of Russia (as an authorized body of the reference state) issues an indefinite registration certificate to the applicant if the medicinal product has been registered in 3 Member States for 5 years or more.
   The Ministry of Health of Russia (as an authorized body of the reference state) issues to the applicant a registration certificate with a validity period of 5 years and the need to confirm registration (re-registration) at the end of its validity period if the medicinal product has been registered in 3 member states for less than 5 years.
   111. The Ministry of Health of the Russian Federation (as an authorized body of the reference state) refuses to bring the registration dossier of the medicinal product in compliance with the requirements of the EAEU, if the results of examination of the registration dossier of the medicinal product establish that its quality is not confirmed, or in accordance with part two of paragraph 178 of the Rules unfavorable "benefit-risk" ratio was discovered.

Amendments to the registration dossier of registered medicinal products
(general provisions)

   112. Amendments to the registration dossier of a registered drug shall be made in accordance with the classification of changes made to the registration dossier of the registered medicinal product and the rules for their introduction in accordance with Appendices No. 19 and 20 to this Regulation. Expertise of making amendments to the registration dossier of medicinal products is carried out in accordance with Appendix No. 20 to this Regulation. An expert report on the assessment of changes in the registration dossier of a drug is made based on the results of this examination in accordance with Annex No. 21 to this Regulation.
   113. Prior to submitting an application for variations that are not classified in Annex 19 to the Rules, the applicant has the right to request the Ministry of Health of Russia (as an authorized body of the reference state) to send a recommendation on the classification of the change.
   The Ministry of Health of Russia (as an authorized body of the reference state) within 45 calendar days after receiving the request from the applicant sends a recommendation to the applicant, the other Member States and to the Expert Committee on Medicines under the Commission in electronic and / or paper form. The specified term can be extended for another 45 calendar days, if the Ministry of Health of Russia finds it necessary to consult the Expert Committee.
   114. Within 5 working days from the date of submission of the application for changes and documents specified in paragraph 18 of the Administrative Regulations, the Ministry of Health of Russia (as an authorized body of the reference state) assesses the completeness, compilation and correctness of the documents submitted, including by comparing such information with information submitted in the order of interdepartmental information interaction.
Formation and sending, if necessary, of interdepartmental requests to bodies participating in the provision of public services is carried out in accordance with paragraph ___ of the Administrative Regulations.
   115. In the event that an application for alterations is made in violation of the requirements established by the Rules and / or the application contains inaccurate information or documents confirming the changes, is not fully represented by the applicant or contains inaccurate information, the Ministry of Health of Russia (as the authorized body of the reference state) in no later than 14 working days from the date of receipt of such application and documents, send to the applicant in writing and (or) electronically the request on presenting the missing additional information, or on making necessary clarifications or on providing details related to the submitted documents in the drug registration dossier (including proposals to amend the SmPC, instructions for medical use, packages layouts, the Normative document on quality or other documents of the registration dossier).
   116. The applicant submits a response to a request by the Ministry of Health of Russia (as an authorized body of the reference state) or an expert organization within a period not exceeding 90 calendar days from the date of receipt of the request.
   The time for which the applicant submits the documents at the request of the Ministry of Health (as an authorized body of the reference state) or an expert organization in the process of making variations and examination of the drug is not included in the terms of the examination and the procedure for introducing changes in the medicinal product.
   117. In the event of failure to respond within the prescribed period, the Ministry of Health of Russia (as an authorized body of the reference state) decides to terminate the examination and the procedure for making changes to the dossier of the medicinal product and notifies the applicant about it’s decision within 14 working days from the date of such decision in written form and (or) electronically.
   118. When submitting several changes or filing several applications for changes in relation to each change in accordance with Section II or subparagraph 4.1.1 of Appendix No. 19, the applicant shall submit to the Ministry of Health of Russia (as an authorized body of the reference state) a separate notification or file on making changes in the registration dossier of the registered drug for medical use, with the exception of cases determined by the Rules.
   119. If the changes introduced affect the information and data of the registration certificate, the Ministry of Health of Russia (as an authorized body of the reference state), in case of a positive decision, issues to the applicant a new registration certificate under the old number for the remaining period of the registration of the drug.

Amendments to the registration dossier of medicinal products registered
in more than one Member State

   120. The administrative procedure "Amendments to the registration dossier of medicinal products registered in more than one Member State" is carried out in connection with the application from the applicant to the Ministry of Health of Russia (as an authorized body of the reference State) to make changes in the form according to Appendix No. 2 to Rules on paper and (or) electronic media (hereinafter - application for changes), dossier for change (notification) containing the elements listed in Appendix IV of Appendix No. 19 to the Rights and the documents specified in paragraph 18 of the Administrative Regulations, as well as in connection with the receipt of information using the Unified Portal of State and Municipal Services (functions).
   The application for amendments and attached documents shall be accepted by the Ministry of Health of the Russian Federation on the inventory, a copy of which, with a note of the date of receipt of the said application and documents on the day of receipt, shall be delivered to the applicant or sent to him by registered mail with a receipt or in the form of an electronic document signed by an electronic signature .
   The Ministry of Health of Russia assigns to the application for modification a unique number, formed using the integrated information system of the Union, and informs the applicant on the day of reception.
   121. Depending on the procedure required for the amendments made by the applicant, in accordance with Appendix No. 19 to the Rules, the Ministry of Health of Russia (as an authorized body of the reference state) shall additionally perform the following actions:
   121.1. The notification procedure for making insignificant changes of IA type:
   1.1. Within 5 working days from the date of submission of the application for changes and documents specified in paragraph 18 of the Administrative Regulations, after the evaluation of the submitted documents, in accordance with paragraph 85 of the Administrative Regulations, the Ministry of Health of Russia (as an authorized body of the reference state) to the dossier for making changes (notification) through an integrated system.
   1.2. Within 30 calendar days from the moment of providing access to the dossier for making changes (notification) through the integrated system, the Ministry of Health of Russia (as an authorized body of the reference state):
   • notifies the applicant and the relevant state bodies of recognition of approval or rejection of the change;
   • if the change is rejected, notifies the applicant and the relevant state authorities of the recognition of the grounds for such a decision;
   • notifies the applicant and the relevant state authorities of the need to change the conditions for the decision to register the medicinal product, including the general characteristics of the medicinal product and any conditions, obligations or restrictions affecting the registration of the medicinal product or changes in the labeling or leaflet caused by a change in the overall characteristic of the medicinal product drug, in connection with the introduction of a change.
   1.3. If the changes lead to a revision of the information on the medicinal product in accordance with paragraph 1.6 of Appendix No. 19, the Ministry of Health of Russia (as an authorized body of the reference state) shall, for no more than 15 working days from the date of filing the application for amendments, post information on making changes to the single registry with the application of the modified approved general characteristics of the medicinal product, the instructions for medical use, the layouts of the packages, the Normative document, in accordance with the order of the formation of a single registry, and issue a modified general characteristics of the medicinal product, instructions for medical use, package layouts, a quality standard document, a registration certificate (if necessary) to the applicant.
   121.2. The procedure for notification of insignificant changes of IB type:
   2.1. Within 5 working days from the date of submission of the application for changes and documents specified in paragraph 18 of the Administrative Regulations, after the evaluation of the submitted documents, in accordance with paragraph 85 of the Administrative Regulations, the Ministry of Health of Russia (as an authorized body of the reference state) provides access to the dossier for making changes (notification) through an integrated system.
   2.2. If the appliaction satisfies the requirements of the Rules, the Ministry of Health of Russia (as an authorized body of the reference state) recognizes receipt of a valid notification within 30 calendar days from the moment of providing access to the dossier for modification (notification) through an integrated system, and takes a positive decision on the approval (acceptance) of the notification.
   2.3. If within 30 calendar days from the date of receipt of the notification, the Ministry of Health of Russia (as an authorized body of the reference state) does not send an electronic or paper statement to the applicant about the impossibility of accepting the notification and making this change in the registration dossier, the notification shall be recognized as to be approved (adopted) by the Ministry of Health of Russia.
   2.4. In the event that the Ministry of Health of the Russian Federation (as an authorized body of the reference state) makes a conclusion that it is impossible to accept (approve) the notification of the applicant about making changes, such an opinion within 30 calendar days, from the receipt of the notification, is sent to the applicant and the relevant authorities of the state of recognition in electronic or paper form indicating the grounds for a negative conclusion.
   2.5. The applicant has the right to repeatedly submit to the Russian Ministry of Health (as an authorized body of the reference state) a supplemented dossier for change (notification) in accordance with the negative conclusion within 30 calendar days from the date of receipt of the negative conclusion.
   2.6. The Ministry of Health of the Russian Federation (as an authorized body of the reference state) shall, in no later than 5 working days from the date of submission of the supplemented notification to the reference state, after completing the completeness and compilation of the submitted materials, submits a supplementary dossier for the introduction of changes (notification) to the relevant state authorities of recognition using the integrated system and within not more than 30 calendar days from the date of receipt of the additional notice, takes the measures specified in paragraph 2.8. Administrative Regulations.
   2.7. If the applicant does not submit a supplementary notice specified in subparagraph 2.5. item 91.2. the application is recognized as rejected by all authorized bodies (expert organizations).
   2.8. Based on the results of the actions specified in subparagraphs 2.1. - 2.6. item 91.2. The Ministry of Health of Russia (as an authorized body of the reference state) takes the following measures:
   • notifies the applicant and the relevant state bodies of recognition of approval or rejection of the change;
   • if the change is rejected, notifies the applicant and the relevant state authorities of the recognition of the grounds for such a decision;
   • notifies the applicant and the relevant state authorities of the need to change the conditions for the decision to register the medicinal product, including the general characteristics of the medicinal product and any conditions, obligations or restrictions affecting the registration of the medicinal product or changes in the labeling or leaflet caused by a change in the overall characteristic of the medicinal product drug, in connection with the introduction of a change.
   2.9. If the changes lead to a revision of the information on the medicinal product in accordance with paragraph 1.6 of Appendix No. 19, the Ministry of Health of Russia (as an authorized body of the reference state) within no more than 10 working days from the period specified in paragraph 2.6. Of the Administrative Regulations, places information on making changes in the single register with the application of the changed in approved general characteristics of the medicinal product, instructions for medical use, package layouts, the Normative document, in accordance with the procedure for the formation and maintenance of a single register, and also gives the modified general characteristics of the medicinal preparation, the instruction on medical application, breadboard models of packages, the normative document on quality, the registration certificate (if necessary) to the applicant.
   121.3. Procedure for the examination of significant changes of type II.
   3.1. The Ministry of Health of Russia (as an authorized body of the reference state), in no later than 14 working days from the date of submission of the application for changes and documents specified in paragraph 18 of the Administrative Regulations, after assessing the completeness, compilation and correctness of the submission, provides access to the dossier variation using the means of the integrated system.
   3.2. The Ministry of Health of Russia (as an authorized body of the reference state) within the period specified in subparagraph 3.1. item 91.3. Of the Administrative Regulations, has the right to send to the applicant remarks on completeness, compilation and correctness of the submitted documents of the drug registration dossier.
   3.3. The applicant must, within 90 calendar days from the receipt of the Russian Ministry of Health's request, submit missing documents to the registration dossier based on the comments received from the Ministry of Health of Russia (as an authorized body of the reference state).
   The time for which the applicant submits documents on the remarks of the Ministry of Health of Russia is not included in the terms of examination of the medicinal product and the procedure for making changes (variations).
   3.4. The Ministry of Health of Russia (as an authorized body of the reference state) rejects the application for changes in the case of failure to submit materials on remarks and (or) failure to confirm payment of the fee (fee) for making changes in the cases and procedure established by the legislation of the Russian Federation.
   3.5. Within 60 calendar days from the date of receipt of the application for amendment, the Ministry of Health of Russia (as an authorized body of the reference state) prepares a draft expert evaluation report and a draft decision on the application for amendment and sends them to the relevant state recognition authorities in paper and / or electronic form.
   The Ministry of Health of Russia has the right to shorten or extend the specified period in the order established by the Rules.
   3.6. During the period specified in sub-clause 3.5. item 91.3. (As an authorized body of the reference state) has the right to send a request to the applicant in writing and (or) electronically about the missing additional information, necessary explanations or clarifications of the submitted documents and data of the registration dossier (including proposals to amend the general characteristics medicinal product, instructions for medical use, drug packaging models, regulatory documentation on quality or other documents of the registration dossier).
   Copies of inquiries to the applicant The Ministry of Health of Russia sends to the appropriate state bodies of recognition in accordance with the form in accordance with Appendices No. 6-8 to the Rules.
   3.7. The applicant must submit a response to the request indicated in sub-paragraph 3.6. item 91.3. Administrative regulations, within a period of not more than 90 calendar days from the receipt of the request.
   The time for submission of documents by the applicant at the request of the authorized body or expert organization is not included in the terms of the examination and the procedure for making changes.
   3.8. In the event that the requested documents and data are not submitted in due time by the applicant, the examination and procedure for making changes shall be terminated. On the adopted decision, the Ministry of Health of Russia (as an authorized body of the reference state) notifies the applicant and the relevant authorities of the state of recognition within 10 working days from the date of the decision in writing and electronically.
   3.9. Following the results of consideration by the authorized bodies of the states of recognition of the documents specified in subparagraph 3.2. item 91.3. The Ministry of Health of Russia (as an authorized body of the reference state) takes the following measures:
   • notifies the applicant and the relevant state bodies of recognition of approval or rejection of the change;
   • if the change is rejected, notifies the applicant and the relevant state authorities of the recognition of the grounds for such a decision;
   • notifies the applicant and the relevant state authorities of the need to change the conditions for the decision to register the medicinal product, including the general characteristics of the medicinal product and any conditions, obligations or restrictions affecting the registration of the medicinal product or changes in the labeling or leaflet caused by a change in the overall characteristic of the medicinal product drug, in connection with the introduction of a change.
   3.10. If the changes lead to a revision of the information on the medicinal product in accordance with paragraph 1.6 of Appendix No. 19 to the Regulations, the Ministry of Health of Russia (as an authorized body of the reference state) shall, within 10 working days from the adoption of the decision approving the change, post information on making changes to the single registry with attachment of the modified approved general characteristics of the medicinal product, instructions for medical use, package layouts, normative document on quality, in accordance with the procedure formed and provides a modified general characteristics of the medicinal product, instructions for medical use, packaging models, a quality standard document, a registration certificate (if necessary) to the applicant.

Amendments to the registration dossier of medicinal products registered under the national procedure (only in the reference state)

   122. The administrative procedure "Amendments to the registration dossier of medicinal products registered under the national procedure (only in the reference state)" is carried out in connection with the application from the applicant to the Ministry of Health of Russia (as an authorized body of the reference state) to amend the form in accordance with Annex No. 2 to the Rules (hereinafter - an application for amendments), a dossier for a change (notification) containing the elements listed in Appendix IV of Appendix No. 19 to the Rules, and documents as specified in paragraph 18 of the Administrative Regulations, as well as in connection with the receipt of information using the Unified Portal of State and Municipal Services (functions).
The application for amendments and attached documents shall be accepted by the Ministry of Health of the Russian Federation on the inventory, a copy of which, with a note of the date of receipt of the said application and documents on the day of receipt, shall be delivered to the applicant or sent to him by registered mail with a receipt or in the form of an electronic document signed by an electronic signature.
The Ministry of Health of Russia assigns to the application for variation a unique number, formed using the integrated information system of the EAEU, and informs the applicant on the day of reception.
   123. Depending on the procedure required for the amendments made by the applicant, in accordance with Annex No. 19 to the Rules, the Ministry of Health of Russia (as an authorized body of the reference state) shall additionally perform the following actions:
   124 Notification of insignificant changes of IA type.
   1.1. The Ministry of Health of Russia within 30 calendar days from the date of receipt of the notification specified in paragraph 50 of the Administrative Regulations takes the following measures:
   • notifies the applicant of acceptance (approval) or refusal to approve the change;
   • in case of refusal to approve the change, notify the applicant of the reasons for such decision;
   • if necessary, makes other changes in the order and terms provided by Appendix No. 19 to the Rules.
   1.2. In the event that the changes lead to a revision of the information on the medicinal product in accordance with Section 1.6. Appendices No. 19 to the rules, the authorized body of the reference state within 50 calendar days from the date of receipt of the notification specified in paragraph 92 of the Administrative Regulations, places information on making changes in the single register with the attachment of the changed approved general characteristics of the medicinal product, instructions for medical use, layouts packages, the normative document on quality in accordance with the procedure for the formation and maintenance of a single register, and also issues the modified general characteristic of a drug, instruction for medical use, packages mock-ups, normative document, registration certificate (if necessary) to the applicant.
   124.1. Procedure for notification of minor changes of IB type.
   2.1. Within 5 working days from the date of submission of the application for amendments and documents specified in paragraph 92 of the Administrative Regulations, the Ministry of Health of Russia (as an authorized body of the reference state) assesses the completeness, compilation and correctness of the documents submitted, including by comparing such information with information submitted in the order of interdepartmental information interaction.
   Formation and sending, if necessary, of interdepartmental requests to bodies participating in the provision of public services is carried out in accordance with paragraph ___ of the Administrative Regulations.
   2.2. If the notice satisfies the requirements of the Rules, the Ministry of Health of Russia (as an authorized body of the reference state) confirms receipt of a valid notification within 30 calendar days from the receipt of the notification.
   2.3. If within 30 calendar days from the date of receipt of the notification, the Ministry of Health of Russia (as an authorized body of the reference state) does not send an electronic or paper statement to the applicant about the impossibility of accepting the notification and making this change in the registration dossier, the notification shall be recognized as being approved (accepted) by the Ministry of Health of Russia.
   2.4. If the Ministry of Health of the Russian Federation makes a conclusion that it is impossible to accept (approve) the notification of the applicant about making changes, such an opinion within 30 calendar days from the receipt of the notification shall be sent to the applicant in electronic or paper form indicating the grounds for the negative conclusion.
   2.5. The applicant is entitled to repeatedly submit to the Russian Ministry of Health a supplemented dossier for change within 30 calendar days from the date of receipt of the negative conclusion in accordance with the negative conclusion.
   2.6. When submitting a supplementary notice specified in subparagraph 2.5. item 94.2. The Ministry of Health of Russia (as an authorized body of the reference state) reviews newly submitted documents and data in period no more than 30 calendar days from the date of its receipt, after which it takes the measures indicated in subparagraph 2.8. item 94.2. Administrative Regulations.
   2.7. If the applicant does not submit a supplementary notice specified in subparagraph 2.5. item 94.2. Administrative order, the application is recognized as rejected.
   2.8. Based on the results of the actions specified in subparagraphs 2.1. - 2.7. item 94.2. Administrative Regulations, the Ministry of Health of Russia takes the following measures:
   • notifies the applicant of acceptance (approval) or refusal to approve the change;
   • in case of refusal to approve the change, notify the applicant of the reasons for such decision;
   • if necessary, makes other changes in the order and terms provided by Appendix No. 19 to the Rules.
   2.9. In case the changes lead to a revision of the information on the medicinal product in accordance with paragraph 1.6 of Appendix No. 19 to the Rules, the Ministry of Health of Russia within 10 working days from the period specified in subparagraph 2.6. item 94.2. Of the Administrative Regulations, places information on making changes in the single registry with the attachment of the modified approved general characteristics of the medicinal product, instructions for medical use, package layouts, the Normative document in accordance with the procedure for the formation and maintenance of a single register, and also gives the modified general characteristics of the medicinal product , instructions for medical use, mock-ups of packages, normative document on quality, registration certificate (if necessary) the applicant.
   124.2. Procedure for the examination of significant changes of type II.
   3.1. The Ministry of Health of Russia (as an authorized body of the reference state) assesses the completeness, compilation and correctness of the documents submitted, including by comparing such information with information submitted in the order of interagency information interaction, in not later than 14 working days from the date of submitting the application for making changes.
Formation and sending, if necessary, of interdepartmental requests to bodies participating in the provision of public services is carried out in accordance with paragraph ___ of the Administrative Regulations.
   3.2. If the application meets the requirements of the Rules, the Ministry of Health of Russia (as an authorized body of the reference state) recognizes receipt of a valid application within 30 calendar days from the receipt of the application.
   3.3. The Ministry of Health of Russia (as an authorized body of the reference state) within the period specified in subparagraph 3.1. item 94.3. Of the Administrative Regulations, have the right to send to the applicant remarks on completeness, compilation and correctness of the submitted documents of the drug registration dossier.
   3.4. The applicant must, within 90 calendar days from the receipt of the Russian Ministry of Health's request, submit missing documents to the registration dossier on the comments of the Ministry of Health of Russia (as an authorized body of the reference state).
   The time for which the applicant submits documents on the remarks of the Ministry of Health of Russia is not included in the terms of examination of the medicinal product and the procedure for making changes.
   3.5. The Ministry of Health of Russia (as an authorized body of the reference state) rejects the application for changes in the case of failure to submit materials on remarks and (or) failure to confirm payment of the fee (fee) for making changes in the cases and procedure established by the legislation of the Russian Federation.
   3.6. Within 60 calendar days from the date of receipt of a valid application for amendment, the Ministry of Health of Russia (as an authorized body of the reference state) completes the examination of the medicinal product and prepares an expert evaluation report.
   The Ministry of Health of Russia has the right to shorten or extend the specified period in the order established by the Rules.
   3.7. During the period specified in subparagraph 3.6. item 94.3. The Ministry of Health of Russia has the right to send to the applicant a request in writing and (or) electronically about the missing additional information, necessary explanations or clarifications of the submitted documents and data of the registration dossier (including proposals to amend the general characteristics of the medicinal product, instructions for medical use , drug packaging models, Normative document or other documents of the registration dossier).
   3.8. The applicant must provide a response to the request indicated in sub-clause 3.7. item 94.3. Administrative regulations, within a period of no more than 90 calendar days from the receipt of the request.
   The time for submission of documents by the applicant at the request of the authorized body or expert organization is not included in the terms of the examination and the procedure for making changes.
   3.9. In the event that the requested documents and data are not submitted in due time by the applicant, the examination and procedure for making changes shall be terminated. The Ministry of Health of Russia (as an authorized body of the reference state) notifies the applicant within 10 working days from the date of the decision in writing and electronically
   3.10. Within 10 working days from the date of completion of the period specified in subparagraph 3.6. item 94.3. Administrative Regulations, the Ministry of Health of Russia takes the following measures:
   • notifies the applicant of acceptance (approval) or refusal to approve the change;
   • in case of refusal to approve the change, notifies the applicant of the reasons for such decision;
   • if necessary, makes other changes in the order and terms provided by Appendix No. 19 to the Rules.
   3.8. In the event that the changes lead to a revision of the information on the medicinal product in accordance with paragraph 1.6 of Appendix No. 19 to the Rules, the Ministry of Health of Russia (as an authorized body of the reference state) shall, within 10 working days from the date of completion of the examination, places information on making changes in the single registry with the attachment of the modified approved general characteristics of the medicinal product, instructions for medical use, package layouts, the Normative document in accordance with the procedure for the formation and maintenance of a single register, and also gives the modified general characteristics of the medicinal product , instructions for medical use, mock-ups of packages, normative document on quality, registration certificate (if necessary) the applicant.

The procedure for agreeing on changes to the registration dossier
for drugs registered more than in one Member State

   125. The administrative procedure "Harmonization of changes in the registration dossier of medicinal products registered in more than one Member State" is carried out in connection with the application from the applicant to the Ministry of Health of Russia (as an authorized body of the state of recognition) of an application for amending the form in accordance with Annex No. 2 to Rules on paper and (or) electronic media (hereinafter - application for making changes) and documents specified in paragraph 18.1. Administrative Regulations, as well as in connection with the receipt of information using the Unified Portal of State and Municipal Services (functions).
   The application for amendments and attached documents shall be accepted by the Ministry of Health of the Russian Federation on the inventory, a copy of which, with a note of the date of receipt of the said application and documents on the day of receipt, shall be delivered to the applicant or sent to him by registered mail with a receipt or in the form of an electronic document signed by an electronic signature.
   126. Depending on the procedure required for the amendments made by the applicant, in accordance with Annex No. 19 to the Rules, the Ministry of Health of Russia (as an authorized body of the state of recognition) shall additionally perform the following actions:
   127 The procedure for notification of making insignificant changes IA type:
   1.1. Within 30 calendar days from the moment of providing access to the dossier for making changes (notification) through the integrated system, the Ministry of Health of Russia (as an authorized body of the state of recognition):
   • notifies the applicant and the relevant state bodies of recognition of approval or rejection of the change;
   • if the change is rejected, notifies the applicant and the relevant state authorities of the recognition of the grounds for such a decision;
   • notifies the applicant and the relevant state authorities of the need to change the conditions for the decision to register the drug, including the general characteristics of the medicinal product and any conditions, obligations or restrictions affecting the registration of the medicinal product or changes in the labeling or leaflet caused by a change in the overall characteristic of the medicinal product drug, in connection with the introduction of a change.
   1.2. If the changes lead to a revision of the information on the medicinal product in accordance with clause 1.6 of Appendix No. 19, the Ministry of Health of Russia (as an authorized body of the state of recognition) in no more than 10 workers from the date of providing access to the dossier for making changes (notification) through the integrated system places information on making changes in a single registry with the attachment of the changed approved general characteristics of the medicinal product, instructions for medical use, packaging layouts, normative document quality, in accordance with the procedure of creating and maintaining a common registry, and gaves a change in the overall characteristics of a drug for medical use instruction layouts packages normative document quality, registration certificate (if necessary) to the applicant.
   127.1. The procedure for notification of insignificant changes of IB type:
   127.2 Procedure for the examination of significant changes of type II:
   3.1. Within 30 calendar days from the date of receipt of the draft expert evaluation report and the draft decision of the reference state specified in subparagraph 3.5. item 91.3. The Ministry of Health of Russia (as an authorized body of the state of recognition) decides on the recognition or non-recognition of the expert evaluation report prepared by the expert organization of the reference state, and notifies the authorized body (expert organization) of the referent state thereof.
3.2. Within 20 calendar days after getting access to the draft evaluation report, the Ministry of Health of Russia (as an authorized body of the state of recognition), if necessary, sends a request to the applicant and to the authorized body (expert organization) of the reference state in accordance with Appendix No. 18 to the Rules.
   3.3. The applicant must, within a period of no more than 90 calendar days from the receipt of the request of the Ministry of Health of Russia (as an authorized body of the state of recognition) send a response to the request.
   The time for the applicant to submit a response to the request of the Ministry of Health of Russia is not included in the terms of examination of the drug and the procedure for making changes.
   3.4. If the applicant fails to submit documents and data requested by the Ministry of Health of the Russian Federation (as an authorized body of the state of recognition) in due time, the examination and procedure for making changes in the given state of recognition ceases. The Ministry of Health of Russia notifies the applicant about the adopted decision within 10 working days from the date of making the decision in electronic and paper form.
   3.5. If within the period specified in subparagraph 3.1. item 97.3. Administrative Regulations The Ministry of Health of Russia (as an authorized body of the reference state) will not send a conclusion on the impossibility of recognizing the expert evaluation report prepared by the expert organization of the reference state, the decision is considered by the Ministry of Health of Russia.
   3.6. If in accordance with subparagraphs 3.1. and 3.2. item 97.3. The decision referred to in sub-clause 3.5. item 97.3. Administrative regulations, recognized by all authorized bodies, Ministry of Health of Russia conducts following actions:
   a) notifies the applicant and the relevant state authorities of recognition of approval or rejection of the change;
   b) upon rejection of the change, notifies the applicant and the relevant state authorities of the recognition of the grounds for such a decision;
   c) notifies the applicant and the relevant state authorities of the need to change the conditions for the decision to register the drug, including a general description of the medicinal product and any conditions, obligations or restrictions affecting the registration of the medicinal product or changes in the marking or the leaflet due to a change in the overall performance drug, in connection with the introduction of a change.
   3.7. If the changes lead to a revision of the information on the medicinal product in accordance with paragraph 1.6 of Appendix No. 19 to the Regulations, the Ministry of Health of Russia (as an authorized body of the reference state) shall, within 10 working days from the adoption of the decision approving the change, post information on making changes to the single registry with application of the modified approved general characteristics of the medicinal product, instructions for medical use, package layouts, normative document on quality, in accordance with the procedure formed and provides a modified general characteristics of the medicinal product, instructions for medical use, packaging models, a quality standard document, a registration certificate (if necessary) to the applicant.

Cancellation of the registration certificate

   128. The administrative procedure "Cancellation of the validity of the registration certificate" is carried out when the applicant submits an application for the cancellation of the validity of the registration certificate of a drug in accordance with Annex 10 to the Rules.
   129. Within the next business day from the day the application received by the Ministry of Health of Russia (as an authorized body of the reference state) to cancel the validity of the medical product registration certificate, the responsible executor appointed by the head of the department responsible for the registration of drugs considers the information and grounds indicated as a cancellation of drug registration.
   130. The responsible executor, within 5 working days from the date of receipt of the application to the Ministry of Health of Russia to cancel the registration certificate of the drug, prepares the draft order on the cancellation of the validity of the registration certificate, which is registered by the head of the department responsible for the registration of medicinal products and submitted for signature to the head of the Ministry of Health of Russia its substitute).
   131. Not later than the next working day after the day of signing the order to revoke the validity of the registration certificate, the responsible executor shall enter the relevant information into a single register of medical devices registered within the Union.

Issue of duplicate of registration
certificate of the drug

   132. Administrative procedure "Issuance of duplicate registration certificate of a medicinal product" is carried out in connection with the receipt from the holder of the registration certificate or an authorized person by the Ministry of Health of Russia of an application for the duplicate registration certificate of a medicinal product, using the Unified portal of state and municipal services (functions).
   133. Within 10 working days from the date of receipt of the application for the duplicate of the registration certificate of the drug, the Ministry of Health of Russia draws up a duplicate of the registration certificate of the medicinal product on the blank of the registration certificate marked as "duplicate" and "the original of the registration certificate is recognized as inoperative" and issues such a duplicate to the holder of the registration certificate or the person authorized by him or send it by registered mail with a notice of delivery.
   134. The application for a duplicate of a drug registration certificate shall be submitted by the holder of the registration certificate or by the person authorized by him to the Ministry of Health of Russia on paper or sent by registered mail with a notice of service and an inventory of the attachment or in electronic form signed by an electronic signature using information and telecommunication networks, including the Internet, including the Unified Portal for Public and municipal services (functions).
   135. An application for a duplicate registration certificate of a medicinal product, as well as a copy of a duplicate of the registration certificate of a medicinal product, shall be attached to the registration dossier for a medicinal product.

IV. Forms of control over the provision of
public service

The procedure for the ongoing monitoring of compliance
and execution by responsible officials all positions, regulations
and other normative legal acts,
setting requirements for the provision of
state service, and decision-making

   136. The monitoring of compliance with the sequence of actions defined by the administrative procedures for the provision of public services is carried out by the head and officials of the Department of State Regulation of Drug Administration of the Ministry of Health of the Russian Federation (hereinafter referred to as the Department) responsible for organizing the work for the provision of public services by conducting compliance checks and execution by responsible executors of the provisions of the Administrative Regulations, other normative legal acts of the Russian Federation, as well as during the internal audit of the effectiveness of the provision of public services (hereinafter referred to as verification).
   137. Inspections of the completeness and quality of the provision of public services include the conduct of inspections, the identification and elimination of violations of the rights of applicants, consideration, decision-making and preparation of responses to complaints from applicants that contain complaints about actions (inaction) and (or) decisions of officials responsible for provision of public services.
   138. In the event that the violations of the applicants' rights are discovered as a result of the inspections conducted, the guilty officials are held accountable in accordance with the procedure established by the legislation of the Russian Federation.

The order and frequency of planned
and unscheduled inspections on the completeness and quality of the provision of
State services, including the order and forms
on control over completeness and quality of delivery
of public service

   139. The control over the completeness and quality of the provision of public services includes the conduct of inspections, the identification and elimination of violations of the applicants' rights, consideration, decision-making and preparation of responses to complaints from applicants who complain about actions (inaction) and (or) decisions of officials.
   140. The frequency of inspections is established by the head of the Department.
   141. Inspections can be planned (carried out on the basis of the annual work plans of the Department) and unplanned.
   142. Unscheduled inspections are conducted on a specific request (complaint) of an individual or a legal entity.
   143. The results of scheduled and unscheduled inspections are formalized in the form of an act of the Department, in which the identified shortcomings are noted and proposals for their elimination are given.

Responsibility of officials of the federal body
of executive power for decisions and actions (inaction),
taken (carried out) by them in the course of providing
public service

   144. The personal responsibility of officials of the Ministry of Health of Russia for the provision of public services is fixed in their official regulations in accordance with the requirements of the legislation of the Russian Federation.
   145. The executor responsible for the implementation of the relevant administrative procedures of the Administrative Regulations shall be personally responsible for:
   1) the conformity of the results of consideration of documents submitted by the applicant to the requirements of the legislation of the Russian Federation;
   2) compliance with the deadlines and procedure for receiving documents;
   3) compliance with the procedure, including the timing of the provision of public services;
   4) reliability of information entered in the state register of medical products and organizations that manufacture and manufacture medical devices.

The provisions characterizing the requirements for order
and forms of control over the provision of state
services, including by citizens, their associations
and organizations

146. Citizens, their associations and organizations can control the provision of public services by receiving information by telephone, by written requests, by e-mail, on the official website of the Ministry of Health of Russia and through the Unified Portal of State and Municipal Services (functions).

V. Pre-judicial (extrajudicial) procedure for appealing
actions of decisions and actions (inaction) of the Ministry of Health of Russia,
as well as officials of the Ministry of Health of Russia

Information for the applicant on his right to pre-trial
(extrajudicial) appeal of actions (inaction) and decisions,
accepted (carried out) during the granting
public service

   147. The applicant has the right to file appeal against the actions (inaction) of officials of the Ministry of Health of Russia and decisions taken (carried out) by them during the provision of public services in a pre-trial (extrajudicial) procedure.
   148. The applicant can file a complaint, including in the following cases:
   violation of the registration deadline;
   violation of the term for the provision of public services;
   the requirement that the applicant submit documents that are not provided for by the regulatory legal acts of the Eurasian Economic Union and the Russian Federation for the provision of public services;
   refusal to accept documents, the submission of which is provided for by the regulatory legal acts of the Eurasian Economic Union and the Russian Federation for the provision of public services;
   refusal to provide a public service if the grounds for the refusal are not provided for in the regulatory legal acts of the Eurasian Economic Union;
   the requirement for the applicant to pay, when providing public services, a fee not provided for by regulatory legal acts of the Russian Federation;
   refusal of officials to correct misprints and mistakes in the information requested.

Subject of complaint

149. The subject of a pre-trial (extrajudicial) appeal is a violation of the rights and legal interests of the applicant, unlawful decisions, actions (inaction) of officials in the provision of public services, violation of the provisions of the Administrative Regulations, improper conduct or violation of official ethics in the provision of public services.

State authorities and authorized officials
for consideration of the complaint, officials to whom may be
sent a complaint

150. Applicants may apply in a pre-trial (extrajudicial) manner with a complaint in:
1) The Ministry of Health of the Russian Federation - to the Minister of Health of the Russian Federation on decisions and actions (inaction) of the head of the Ministry of Health of Russia.

The procedure for filing and reviewing a complaint

   151. The complaint is submitted to the Ministry of Health of Russia in writing or electronically, using the Unified Portal of State and Municipal Services (functions).
   152. The complaint must contain:
   the name of the body that provides the provision of public services, as well as the last name, first name, patronymic of the official, whose decisions, actions (inaction) are appealed;
   surname, first name, patronymic, information on the place of residence of the applicant - an individual or name, information on the location of the applicant - legal entity, as well as the contact phone number (number), e-mail address (address) (if available) and postal address, which must be sent to the applicant;
   information on the appealed decisions, actions (inaction) of officials of the Ministry of Health of Russia;
   arguments on the basis of which the applicant does not agree with the decision, action (inaction) of an official of the Ministry of Health of Russia. The applicant may submit documents (if any) confirming the applicant's arguments or copies thereof.
   153. If the complaint is submitted through the applicant's representative, a document confirming the authority to act on behalf of the applicant is also submitted. As a document confirming the authority to act on behalf of the applicant, the following can be submitted:
   a power of attorney issued in accordance with the legislation of the Russian Federation (for individuals);
   a power of attorney stamped in accordance with the legislation of the Russian Federation certified by the applicant's seal and signed by the applicant's head or authorized by the person in charge (for legal entities);
   a copy of the decision on appointment or election or an order appointing an individual to a position whereby such an individual has the right to act on behalf of the applicant without a power of attorney.
   154. The complaint can be sent to the Ministry of Health of Russia by mail, by e-mail, using the Internet, from the official website of the Ministry of Health of Russia, from the Unified Portal of State and Municipal Services (functions).
   155. If the complaint is submitted in person, the applicant submits a document certifying his identity in accordance with the legislation of the Russian Federation.
   156. The complaint is examined by authorized officials.
   157. In response to the results of the examination of the complaint, the following shall be indicated:
   the name of the body that provides the state service, the position, the surname, name, patronymic of the official who made the decision on the complaint;
   number, date, place of decision, including information about the official, decision or action (inaction) of which is appealed;
   surname, name, patronymic or the name of the applicant;
   grounds for deciding on the complaint;
   the decision taken on the complaint;
   if the complaint is found to be justified, - the deadline for the elimination of the violations identified, including the time period for the provision of the result of the public service;
   information on the procedure for appealing the decision taken on the complaint.
   158. The response based on the results of consideration of the complaint shall be signed by the official authorized to consider the complaint.
   159. In case of establishing, in the course or according to the results of the complaint, signs of the composition of an administrative offense or signs of a corpus delicti, an official authorized to consider a complaint shall forward the relevant materials to the prosecutor's office.

Terms of complaint consideration

   160. A complaint submitted to the Ministry of Health of Russia is subject to registration no later than the next working day from the day it was received.
   161. A complaint submitted to the Ministry of Health of Russia is subject to review by an official authorized to handle complaints within one month from the date of its registration.
   162. In case of an appeal against the refusal of the Ministry of Health of Russia to receive documents from the applicant or to correct misprints and mistakes, the complaint is considered within 10 (ten) working days from the date of its registration.

List of reasons for suspension of consideration
complaints in the event that the possibility of suspension
is provided by the legislation of the Russian Federation

163. There are no grounds for suspending consideration of the complaint.

The result of consideration of the complaint

   164. Based on the results of consideration of the complaint, the Ministry of Health of Russia decides whether to satisfy the complaint or refuse to satisfy it.
   165. Upon satisfying the complaint, the Ministry of Health of Russia takes exhaustive measures to eliminate the revealed violations, including the issuance of the result of the state service to the applicant.
   166. The Ministry of Health of the Russian Federation refuses to satisfy the complaint in the following cases:
   filing a complaint by a person whose powers are not confirmed in accordance with the procedure established by the legislation of the Russian Federation;
   presence of an effective court decision, arbitration court on a complaint about the same subject and on the same grounds;
   the existence of a decision on the complaint made earlier in accordance with the requirements of the rules for appeal against the same applicant and for the same subject matter of the complaint.
   167. The Ministry of Health of Russia has the right to leave a complaint unanswered in the following cases:
   presence in the complaint of obscene or offensive language, threats to life, health and property of an official, as well as members of his family;
   the text of the complaint can not be read, the answer to the complaint is not given, it is not subject to referral, which is reported to the complainant who sent the complaint, if his name and postal address are readable;
   the lack of information about the decision appealed against, the action (inaction) (as expressed by whom it was accepted), the name of the applicant, the postal address or the e-mail address on which the reply should be sent.

Procedure for informing the applicant about the results of
consideration of a complaint

168. A motivated response on the results of the examination of the complaint is signed by the official authorized by the Ministry of Health of Russia for examination of the complaint and sent to the applicant in writing or at the request of the applicant - in the form of an electronic document signed by an electronic signature of the official authorized to consider the complaint, the form of which is established by the legislation of the Russian Federation, no later than one day after the day of taking a decision on the results of the consideration of the complaint.

The procedure for appealing the decision on the complaint

169. The applicant is entitled to appeal against the decision on the complaint in the manner prescribed by the legislation of the Russian Federation.

The applicant's right to receive information and documents,
necessary for the justification and consideration of the complaint

170. The applicant has the right to receive exhaustive information and documents necessary to substantiate and examine the complaint.

Ways of informing applicants about the procedure for filing
and consideration of the complaint

171. The Ministry of Health of Russia provides counseling to applicants about the procedure for appealing decisions, actions (inaction) of officials of the Ministry of Health of Russia, including by phone, e-mail, and personal reception.

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Administrative Regulations of the Ministry of Health of the Russian Federation

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