pharmaceutical regulation
Russian Laws

Order 58n dated August 2, 2012
"On approval of administrative regulations for import... of a specific batch of authorized and (or) unauthorized medicinal products..."

The legal document below was translated into Russian by CEG or a translation company on behalf of CEG.
This translation may contain inaccuracies. For all issues related to law enforcement practice, please contact the authorities of Russia / the EAEU and CEG company.
THE MINISTRY OF HEALTH
OF THE RUSSIAN FEDERATION


ORDER 58n
ON APPROVAL OF ADMINISTRATIVE REGULATIONS OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION ON PROVISION OF PUBLIC SERVICE TO ISSUE PERMITS FOR IMPORT INTO THE RUSSIAN FEDERATION OF A SPECIFIC BATCH OF AUTHORIZED AND (OR) UNAUTHORIZED MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS OF MEDICINAL PRODUCTS, SPECIFIC BATCH OF UNAUTHORIZED MEDICINAL PRODUCTS INTENDED FOR THE EXAMINATION OF MEDICINAL PRODUCTS FOR THE PURPOSE OF MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS, SPECIFIC BATCH OF UNAUTHORIZED MEDICINAL PRODUCTS FOR THE PURPOSE OF PROVIDING MEDICAL CARE ACCORDING TO VITAL INDICATIONS OF A SPECIFIC PATIENT

Dated August 2, 2012

Registration № 27438 dated March 4, 2013

(as amended by Order of the Ministry of Health of the Russian Federation of 07.10.2013 N704н)
Body of the Order
In accordance with the Federal Law of 27 July 2010 N 210-FZ "On Arrangement of Provision of of Public and Municipal Services" (Collection of Legislation of the Russian Federation, 2010, N 31, Art. 4179; 2011, N 15, Art. 2038, N 27, 3880, N 29, Art. 4291, N 30, Art. 4587, N 49, Art. 7061; 2012, N 31, Art. 4322) and the Decree of the Government of the Russian Federation of 16 May 2011 N 373 "On the Development and Approval of Administrative Regulations for the Execution of State Functions and Administrative Regulations for Provision of Public Services" (Collection of Legislation of the Russian Federation, 2011, N 22, Art. 3169, N 35, Art. 5092; 2012, N 28, Art. 3908, N 36, Art. 4903), I hereby order:

To approve the attached Administrative Regulations of the Ministry of Health of the Russian Federation on provision of public service to issue permits for import into the Russian Federation of a specific batch of authorized and (or) unauthorized medicinal products to be used in clinical trials of medicinal products, specific batch of unauthorized medicinal products intended for the examination of medicinal products for the purpose of marketing authorization of medicinal products, specific batch of unauthorized medicinal products for the purpose of providing medical care according to vital indications of a specific patient.

Minister /SIGNATURE/ V.I. Skvortsova
I. General Provisions
Subject of regulation

1. Administrative Regulations of the Ministry of Health of the Russian Federation on provision of public service to issue permits for import into the Russian Federation of a specific batch of authorized and (or) unauthorized medicinal products to be used in clinical trials of medicinal products, specific batch of unauthorized medicinal products intended for the examination of medicinal products for the purpose of marketing authorization of medicinal products, specific batch of unauthorized medicinal products for the purpose of providing medical care according to vital indications of a specific patient (hereinafter referred to as the Regulation), regulates the time frame and order of administrative actions, interaction between structural units of the Ministry of Health of the Russian Federation (hereinafter referred to as the Ministry), as well as interaction of the Ministry with other federal executive bodies in provision of the public service to issue permits for import into the Russian Federation of a specific batch of authorized and (or) unauthorized medicinal products to be used in clinical trials of medicinal products, specific batch of unauthorized medicinal products intended for the examination of medicinal products for the purpose of marketing authorization medicinal products, specific batch of unauthorized medicinal products for the purpose of providing medical care according to vital indications of a specific patient (hereinafter referred to as the public service).

2. Permit to import into the Russian Federation of a specific batch of authorized and (or) unauthorized medicinal products to be used in clinical trials of medicinal products, specific batch of unauthorized medicinal products intended for the examination of medicinal products for the purpose of marketing authorization medicinal products, specific batch of unauthorized medicinal products for the purpose of providing medical care according to vital indications of a specific patient (hereinafter referred to as the permit) is issued to be submitted to the customs authorities for the purpose of import into the Russian Federation of a specific batch of authorized and (or) unauthorized medicinal products to be used in clinical trials of medicinal products, specific batch of unauthorized medicinal products intended for the examination of medicinal products for the purpose of marketing authorization medicinal products, specific batch of unauthorized medicinal products for the purpose of providing medical care according to vital indications of a specific patient (hereinafter referred to as the specific batch of medicinal products), except for import of unauthorized medicinal product into the Russian Federation that have the status of the goods of the Customs Union.

3. Provisions of the Regulations do not apply to the import of medicinal products for the purpose of humanitarian aid or assistance in emergency situations, as well as to the import of narcotic, psychotropic substances and their precursors included in section 2.12 of the Unified List of Goods whose import or export by the Member States of the Customs Union is prohibited or restricted within the framework of the Eurasian Economic Community in trading with third countries, approved by Decision No. 19 on single non-tariff regulation of the Customs Union of the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation, adopted by the Interstate Council of the Eurasian Economic Community of 27 November 2009, and in the list of narcotic, psychotropic substances and their precursors subject to control in the Russian Federation, approved Decree of the Government of the Russian Federation of 30 June 1998 N 681 (Collection of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8, Art. 663, No. 47, Art. 4666; 2006, N 29, Art. 3253; 2007, N 28, Art. 3439; 2009, N 26, Art. 3183, No. 52, Art. 6572; 2010, N 3, Art. 314, N 17, Art. 2100, N 24, Art. 3035, N 28, Art. 3703, N 31, Art. 4271, N 45, Art. 5864, N 50, Art. 6696, 6720; 2011, N 10, Art. 1390, N 12, Art. 1635, N 29, Art. 4466, 4473, Art. 42, N 5921, N 51, Art. 7534; 2012, N 10, Art. 1232, No. 11, Art. 1295, No. 19, Art. 2400, N 22, Art. 2864; N 37, Art. 5002).

Circle of applicants

4. Applicants for the public service (hereinafter referred to as the applicants) are:

1) manufacturers of medicinal products – for the purposes of own manufacture of medicinal products;

2) organization of medicinal product wholesale trade;

3) foreign developers of medicinal products and foreign manufacturers of medicinal products or other legal entities on behalf of the developer of medicinal products – for clinical trials of medicinal products, marketing authorization of a medicinal product, entry of a pharmaceutical substance in the state register of medicinal products and quality control of medicinal products;

4) research organizations, institutions of higher professional education and manufacturers of medicinal products – for the development, research, control of safety, quality and efficacy of medicinal products;

5) medical organizations, as well as organizations specified in sub-items 1-4 of this item, – to provide medical care according to vital indications of a specific patient.

Requirements to the procedure of notification of provision of of the public service

5. Information on the procedure for provision of the public service is rendered by the Ministry:

1) by posting information, including on the timetable for admission of applicant and telephone numbers for inquiries (consultations), on the official website of Minzdrav of Russia on the Internet: www.minzdravsoc.ru;

2) in the Federal Information System "State Register of Medicinal Products": www.grls.rosminzdrav.ru;

3) in the Federal State Information System "Unified Portal of Public and Municipal Services (Functions)": www.gosuslugi.ru (hereinafter referred to as the Unified Portal of Municipal Services (Functions));

4) on information stands in the reception room of Minzdrav of Russia: 127994, Moscow, GSP-4, Rakhmanovsky Lane, 3;

5) by phone number for inquiries: +7 (495) 628-44-53.

6. Information of executive bodies involved in provision of the public service.
Federal Tax Service (Federal Tax Service of Russia):
127381, Moscow, Neglinnaya St., 23.
Phone for inquiries: +7 (495) 913 00 09.
Information on the schedule of the Federal Tax Service of Russia is available on the official website of the Federal Tax Service of Russia on the Internet: www.nalog.ru.

7. Recommendations on preparation of a set of documents and sample applications for permits are published in the Federal Information System "State Register of Medicinal Products".
Documents stipulated in item 17 of the Regulations in electronic form signed by electronic signature in accordance with the legislation of the Russian Federation on electronic signature are sent to the following e-mail address: vozlekpreparatov@rosminzdrav.ru.

8. Working hours of the Ministry: Monday – Thursday from 09-00 to 18-00, Friday from 09-00 to 16-45. Lunch break: from 12-00 to 12-45.

9. Permits or notifications of refusal to issue permits in hard copy are issued by the Ministry to the applicant or its authorized person upon submission of the original power of attorney certified by the seal and signature of the applicant's head, to the following address: 127994, Moscow, GSP-4, Rakhmanovsky Lane, 3.

10. Information on provision of of the public service is rendered in the form of responses to written requests from applicants, as well as in the form of on-call consultations.
II. Standard for provision of the public service
Name of the public service

11. Name of the public service – public service to issue permit to import into the Russian Federation of a specific batch of authorized and (or) unauthorized medicinal products to be used in clinical trials of medicinal products, specific batch of medicinal products intended for the examination of medicinal products for the purpose of authorization of medicinal products, specific batch of medicinal products for the purpose of providing medical care according to vital indications of a specific patient.

The name of the federal executive body, provision of the public service

12. The public service is rendered by the Ministry of Health of the Russian Federation.

13. When provision of the public service, the Ministry interacts with the Federal Tax Service.

Description of the result of provision of of the public service

14. Results of provision of of public service are as follows:

1) issue of the permit to the applicant;

2) issue of a notification to refuse to issue a permit to the applicant;

3) registration of the application to issue a permit and the results of the decision adopted by the Ministry on it in the register of import permits for a specific batch of authorized and (or) unauthorized medicinal products intended for human use, issued by the Ministry of Health of the Russian Federation, and decisions on refusal to issue a permit for import of a specific batch intended for human use of authorized and (or) unauthorized medicinal products, whose form is approved by Order of the Ministry of Health and Social Development of Russia of 2 November 2010 N 952н (registered by the Ministry of Justice of the Russian Federation on 29 November 2010 N 19071), as amended by the order of the Ministry of Health and Social Development of Russia of 3 August 2011 N 867н (registered by the Ministry of Justice of the Russian Federation on 30 September 2011 N 21955) (hereinafter referred to as the Register).

Time frame for provision of the public service

15. Time frame for provision of the public service does not exceed 5 working days from the date of registration of the application to issue a permit, attaching the necessary documents specified in item 17 of the Regulations, in the Ministry.

List of legal regulations governing the relationship in connection with provision of of the public service

16. Grounds for suspension of provision of the public service are:

1) Federal Law of 12 April 2010 N 61-FZ "On Circulation of Medicinal Products" (Collection of Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161; N 42, Art. 5293; N 49 , Art. 6409; 2011, N 50, Art. 7351; 2012, N 26, Art. 3446);

2) Federal Law of 27 July 2010 N 210-FZ "On Arrangement of Provision of of State and Municipal Services" (Collection of Legislation of the Russian Federation, 2010, N 31, Art. 4179; 2011, N 15, Art. .2038; N 27, Art. 3880; N 29, Art. 4291; N 30, Art. 4587; N 49, Art. 7061; N 31, Art. 4322);

3) Decree of the Government of the Russian Federation of 29 September 2010 N 771 "On the Procedure for Import of Medicinal Products for Human Use into the Russian Federation" (Collection of Legislation of the Russian Federation, 2010, N 41, Art. 5235; 2011 , N 24, Art. 3494; N 50, Art. 7390; 2012, N 37, Art. 5002);

4) Decree of the Government of the Russian Federation of 19 June 2012 N 608 "On Approval of Provision on the Ministry of Health of the Russian Federation" (Collection of Legislation of the Russian Federation, 2012, N 26, Art. 3526);

5) Decree of the Government of the Russian Federation of 24 October 2011 N 861 "On Federal State Information Systems Provision of Municipal Services via Electronic Means (Exercise of Functions)" (Collection of Legislation of the Russian Federation, 2011, N 44, Art. 6274; N 49, Art. 7284);

6) Decree of the Government of the Russian Federation of 16 August 2012 N 840 "On the Procedure for Filing and Review of Complaints Against Decisions and Actions (Inaction) of Federal Executive Bodies and Their Officials, Federal Civil Servants, Officials of State Extra-Budgetary Funds of the Russian Federation" (Collection of Legislation of the Russian Federation, 2012, N 35, Art. 4829);

7) Decree of the Government of the Russian Federation of 16/05/2011 N 373 "On the Development and Approval of Administrative Regulations for the Execution of State Functions and Administrative Regulations for Provision of Public Services" (Collection of Legislation of the Russian Federation, 2011, N 22, Art. 3169, N 35, Art. 5092; 2012, N 28, Art. 3908, N 36, Art. 4903);

8) Order of the Ministry of Health and Social Development of Russia of 2 November 2010 N 952н "On Approval of the Form of the Register of Import Permits for a Specific Batch of Unauthorized Medicinal Products Intended for Human Use, Issued by the Ministry of Health and Social Development of the Russian Federation, and Decisions on Refusal to Issue a Permit for Import of a Specific Batch Intended for Human Use of Unauthorized Medicinal Products"(registered by the Ministry of Justice of the Russian Federation on 29 November 2010 N 19071), as amended by Order of the Ministry of Health and Social Development of Russia of 3 August 2011 N 867н "On Amendments to the Order of the Ministry of Health and Social Development of the Russian Federation of 2 November 2010 N 952н "On Approval of the Form of the Register of Import Permits for a Specific Batch of Unauthorized Medicinal Products Intended for Human Use, Issued by the Ministry of Health and Social Development of the Russian Federation, and Decisions on Refusal to Issue a Permit for Import of a Specific Batch Intended for Human Use of Unauthorized Medicinal Products" (registered by the Ministry of Justice of the Russian Federation on 30 September 2011 N 21955).

A comprehensive list of documents required in accordance with regulatory legal acts for provision of the public service and services that are necessary and mandatory for provision of the public service

17. To obtain permit in the Ministry, an application and its electronic copy are required, which are submitted in the manner prescribed by the customs legislation of the Customs Union (indicating the name of the medicinal product and (or) pharmaceutical substance, dosage form, dose, concentration, packaging, name of the manufacturer of the medicinal product and (or) pharmaceutical substance, country of origin of the medicinal product and (or) pharmaceutical substance), attaching copies of the founding and registration documents of the applicant (charter, marketing authorization, certificate of registration with the tax authorities), as well as the following documents:

1) application according to the form in Appendix N 1 to these Regulations;

2) substantiation of the quantity of imported medicinal products and (or) pharmaceutical substances;

3) quality certificate (analysis protocol) of imported medicinal products (except for the case of import of a medicinal product to provide medical care according to vital indications of a specific patient) and (or) pharmaceutical substances issued by the manufacturer of medicinal products;

4) in the case of import of a specific batch of authorized and (or) unauthorized medicinal products to be used in clinical trials of medicinal products:

a) copy of permit of the Ministry to conduct clinical trial of the medicinal product;

b) copies of documents (mock-ups and (or) photographs of packages) confirming the proper labeling of medicinal products for their use exclusively in clinical trials;

5) in the case of import of a medicinal product to provide medical care according to vital indications of a specific patient:

a) conclusion of a council of physicians of a federal institution or institutions of the Russian Academy of Medical Sciences where a specific patient receives medical care signed by the chief physician or a person assuming their duties and its electronic copy signed by electronic signature on prescription of an unauthorized medicinal product to provide medical care according to vital indications and on the need of its import;

b) appeal of an authorized executive body of a constituent entity of the Russian Federation in the form of an electronic document signed with an electronic signature regarding the need to import an unauthorized medicinal product to provide medical care according to vital indications of a specific patient, attaching a copy of the conclusion of a council of physicians of an institution of the constituent entity of the Russian Federation where the patient receives medical care on prescription of an unauthorized medicinal product to provide medical care according to vital indication and on the need of its import signed by the chief physician (director) or the person assuming their duties;

c) a copy of the passport or birth certificate of the patient who is prescribed an unauthorized medicinal product according to vital indications certified by the federal institution (institution) that provides medical care in the form of an electronic document signed with an electronic signature <*>.
<*> Subitem "d" of item 11 of the rules for the import of medicinal products for human use into the Russian Federation, approved by Decree of the Government of the Russian Federation of 29 September 2010 N 771.

18. Documents to receive the public service must be submitted in Russian or have a certified translation into Russian according to established procedure.

Copies of the documents provided for in subitems 1-4 of item 17 of the Regulations must be certified by a signature and seal of the applicant.

Electronic documents signed by electronic signature in accordance with the legislation of the Russian Federation on electronic signature are accepted at: vozlekpreparatov@rosminzdrav.ru.

In the absence of a certificate of electronic signature, one must contact the certification center of the Ministry at: www.crt.rosminzdrav.ru.

A comprehensive list of documents required in accordance with regulatory legal acts for provision of the public service at the disposal of state authorities who participate in provision of of the public service and which the applicant has the right to submit

19. When provision of the public service, the Ministry cannot require the applicant to provide other documents not stipulated by the legislation of the Russian Federation, as well as documents (copies of marketing authorization and certificate of registration with the tax authority referred to in the first paragraph of item 17 of the Regulations, and a copy of the document specified in sub-item "a" of sub-item 3 of item 17 of the Regulations) confirming the information at the disposal of:

1) Federal Tax Service of Russia – on entry of information on the applicant into the Unified State Register of Legal Entities and on registration of the applicant with the tax authority;

2) Ministry – on the applicant's permit to conduct a clinical trial of a medicinal product (in case of import of a specific batch of authorized and (or) unauthorized medicinal products to be used clinical trials of medicinal products) based on data from the register of issued permits for conducting clinical trials of medicinal products.

The applicant has the right to submit documents specified in this item on its own initiative. It is prohibited to require from the application submission of documents and information or actions that are not provided for in regulatory legal acts regulating relations arising in connection with provision of of the public service.

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

20. There are no grounds for refusal to accept documents required for provision of of the public service.

Exhaustive list of grounds for suspension or refusal to render the public service

21. Grounds for refusal to render the public service are:

1) incomplete or inaccurate information in the documents submitted by the applicant to obtain a permit;

2) prohibition of human use of the medicinal product in countries of the Customs Union.

There are no grounds for suspension of provision of of the public service.

Procedure, amount and grounds for charging state duty or other fees for provision of of the public service

22. There is no fee for provision of of the public service to the applicant.

The maximum waiting time when submitting a request for the public service and upon receipt of the result of the service rendered

23. The maximum waiting time when submitting an application and documents in order to receive the public service and when receiving the result of the public service is 15 minutes. (as amended by Order of the Ministry of Health of the Russian Federation of 07/10/2013 N 704н)

Time frame and procedure for registering an applicant's request for the public service, including in electronic form

24. Documents received by the Ministry from the applicant (including those submitted in the form of an electronic document) to receive the public service are registered with the Department for Affairs and sent to the Department of State Regulation of Medicinal Products Circulation, responsible for provision of the public service (hereinafter referred to as the Department), on the day they are received.

Documents received by the Ministry from the applicant are accepted by the Department for Affairs according to the inventory, whose copy indicating the date of acceptance of these documents is sent (given) to the applicant.

25. The procedure for accepting and registering documents, including those submitted using information and communication technologies (in electronic form), is established by regulatory legal acts, which set out the rules of document flow in the Ministry.

Requirements for the premises where the public service is rendered, to the waiting location, receival of applications, placement and execution of visual, textual information on the procedure for provision of the service

26. The room where citizens are received must ensure convenience for citizens and officials of the Ministry. Places where the public service is rendered must be equipped with air conditioning (cooling and heating), means of fire extinguishing and alarms.

In places where the public service is rendered, there must exist public spaces (bathrooms) and storage areas for outdoor clothing.

Entry and movement through the premises where the public service is rendered must not create difficulties for persons with disabilities.

27. Places for obtaining information on provision of of the public service must be equipped with information stands, a telephone, a computer with a printer and access to the Internet and photocopying equipment.

The following information is published on information stands:

1) regulatory legal acts of the Russian Federation governing the provision of the public service;

2) text of the Regulation;

3) samples of execution of documents that are submitted by the applicant to receive the public service;

For citizens in the queue, as well as to facilitate filling out of the documents necessary to receive the public service, special places are allocated equipped with chairs, tables (stands) to be able to fill out documents, with writing paper, pens, blanks of documents.

Indicators of accessibility and quality of the public service, including the number of interactions of the applicant with officials in receiving the public service and their duration, the ability to obtain information on the progress of provision of of the public service, including using information and communication technologies

28. Indicators of accessibility and quality of the public service are:

a) open access of applicants to information on the procedure and time frame for provision of of the public service, the procedure for appealing against the actions (inaction) of officials of the Ministry;

b) compliance with the time frame for provision of of the public service;

c) absence of complaints from applicants regarding the actions (inaction) of officials of the Ministry in provision of the public service.

29. When providing the public service, the applicant interacts with officials of the Ministry:

1) to submit the documents required for provision of of the public service;

2) when receiving a permit or notification of refusal to issue a permit.

30. Information on the progress (stage) of the decision-making process by the Ministry to issue a permit or a decision to refuse to issue a permit is provided to the applicant through oral appeal, and is also published on the Unified Portal of Public and Municipal Services (Functions) in accordance with the Decree of the Government of the Russian Federation of 24 October 2011 N 861 "On Federal State Information Systems Provision of Municipal Services via Electronic Means (Exercise of Functions)" (Collection of Legislation of the Russian Federation, 2011, N 44, Art. 6274, N 49, Art 7284).
III. Composition, order and time frame for execution of administrative procedures, requirements for their execution, including the implementation of the administrative procedure in electronic form
31. In provision of the public service, the administrative procedure "Review of documents and making a decision on issue of the permit or a decision to refuse to issue a permit" is carried out.

Diagram of provision of of the public service is given in Appendix N 2 to the Regulations.

Administrative actions that are part of the administrative procedure, duration and (or) the maximum duration of their execution

32. Grounds for the start of the administrative procedure are the receipt from the applicant of the application and documents referred to in item 17 of the Rules in the Ministry.

33. When the application and documents registered in accordance with item 24 of the Rules of the regulations are received in the Department, the person responsible for their review, appointed by the director of the Department or authorized deputy director of the Department (hereinafter referred to as the responsible officer), within 2 working days from the date of registration of these applications and documents checks the information contained in them in order to determine:

1) existence of all documents specified in item 17 of the Regulations;

2) veracity of the documents;

3) consistency of information between individual documents.

Last name, first name and patronymic (if any) of the responsible officer and their telephone number are communicated to the applicant at their written or oral request.

34. If the applicant has not submitted the documents specified in the first paragraph of item 19 of the Regulations, the responsible officer:

1) from the Federal Tax Service, requests and receives information to check whether the information about the applicant has been entered in the Unified State Register of Legal Entities and whether the applicant has been registered with the tax authority within the framework of interdepartmental information exchange;

2) checks whether the applicant has a permit to conduct a clinical trial of a medicinal product (in case of import of a specific batch of authorized and (or) unauthorized medicinal products to be used clinical trials of medicinal products) based on data from the register of issued permits for conducting clinical trials of medicinal products.

35. Based on the results of the verification of information contained in the application and the submitted documents, the responsible officer within 1 working day after the completion of the verification provided for in item 33 of the Regulations:

1) in the absence of grounds given in item 21 of the Regulations, prepares a decision to issue a permit and the permit;

2) if there are grounds given in item 21 of the Regulations, prepares a decision to refuse to issue a permit and a notification of refusal to issue a permit indicating the reasons for the refusal.

36. Decision to issue a permit and the permit (decision to refuse to issue a permit and a notification of refusal to issue a permit) are agreed with the head of the department for authorization of medicinal products of the Department, the deputy director of the Department and approved by the director of the Department within 1 working day.

37. A permit or a notification of refusal to issue a permit is issued in writing on the blank of the Ministry.

Permit to import a specific batch of unauthorized medicinal products to provide medical care according to vital indications of a specific patient is issued in the form of an electronic document signed with an electronic signature.

38. The following information is specified in the permit:

1) trade name of the medicinal product and (or) pharmaceutical substance;

2) name of the manufacturer of the medicinal product and (or) pharmaceutical substance;

3) amount of the medicinal product and (or) pharmaceutical substance;

4) country from which a specific batch of medicinal products will be imported into the Russian Federation;

5) import method and the expected date of import of a specific batch of medicinal products;

6) the following is indicated in the case of import of a medicinal product to provide medical care according to vital indications of a specific patient:

a) last name, first name, patronymic and date of birth of the patient;

b) details (batch, number, who issued, date of issue) of the birth certificate or passport of the patient;

c) full name and legal address of the institution where the patient received medical care;

d) diagnosis;

e) amount of medicinal product required to provide medical care.

39. Permit or a notification of refusal to issue a permit is sent (given) to the applicant within 1 working day from the date of signing.

Information on the decision to issue a permit or the decision to refuse to issue a permit is also provided to the applicant at their oral request.

40. Application for a permit and the results of the decision of the Ministry are subject to be registered in the Register.

41. Relevant information will be entered in the Register within 1 working day from the date of:

1) receipt of application for a permit by the Department;

2) approval by the Director of the Department of a decision to issue a permit or a decision to refuse to issue a permit.
IV. Forms of monitoring over provision of of the public service
Procedure for monitoring the compliance and execution of provisions of the Regulations by officials

42. Monitoring over the order of actions stipulated by the administrative procedure for provision of of the public service is carried out by officials of the Ministry responsible for management of provision of the public service.

43. The monitoring is carried out by checking compliance with and execution by officials of the Ministry of provisions of the Regulations, other regulatory legal acts of the Russian Federation, as well as by conducting internal monitoring of the efficiency of provision of of the public service.

44. List of officials engaged in the monitoring is established by individual legal acts of the Ministry.

45. The frequency of the monitoring is established by the Minister of Health of the Russian Federation or authorized deputy minister of health of the Russian Federation.

46. Director of the Department arranges documentation of implementation of each administrative action of the administrative procedure, indicating the date of its execution and the signature of the responsible officer.

The procedure and frequency of scheduled and unscheduled inspections of the completeness and quality of provision of of the public service, including the procedure and forms of control over the completeness and quality of provision of of the public service

47. Monitoring of completeness and quality of provision of of the public service includes scheduled and unscheduled inspections (hereinafter referred to as inspections) aimed at identification and elimination of causes and conditions that resulted in the violation of the applicants' rights, as well as review, making decisions and preparing responses to appeals containing complaints about decisions, actions (inaction) of officials of the Ministry.

48. Inspections are carried out on the basis of orders of the Ministry.

49. Scheduled inspections are carried out no more than once a year.

Unscheduled inspections are carried out when the Ministry receives information about violations of applicants' rights.

Responsibility of officials of the Ministry of Health of Russia for decisions and actions (inaction) taken by them when provision of the Public service

50. Personal responsibility of officials of the Ministry is established in their job regulations in accordance with the requirements of the legislation of the Russian Federation.

51. The officer responsible for the implementation of the administrative procedure of the Regulations is personally responsible for the compliance of the results of the review of documents with the requirements of the legislation of the Russian Federation.

52. Based on the result of the inspections, in case of detection of violations of the applicants' rights, the guilty officials are held liable in the manner established by the legislation of the Russian Federation.

Provisions characterizing the requirements for the procedure and forms of monitoring over provision of of the public service, including by citizens, their unions and organizations

53. Citizens, their associations and organizations can control provision of of the public service by receiving information via telephone, by written request, via e-mail, on the official website of the Ministry on the Internet through the Unified Portal of Public and Municipal Services (Functions).
V. Prejudicial (extrajudicial) procedure for appealing against decisions and actions (inaction) of the Ministry of Health of the Russian Federation and its officials
54. The applicant may appeal through prejudicial (extrajudicial) procedure with a complaint about violation of the procedure for provision of the public service (hereinafter referred to as the complaint).

55. The subject of the complaint may include actions (inaction) related to:

1) violation of the registration deadline for the applicant's request for the public service;

2) failure to render the public service in a timely manner;

3) requesting documents from the applicant not provided for by regulatory legal acts of the Russian Federation for provision of of the public service;

4) refusal to accept the applicant's documents that must be submitted according to regulatory legal acts of the Russian Federation for provision of of the public service;

5) refusal to the render public service if the grounds for the refusal are not provided for by federal laws and other regulatory legal acts of the Russian Federation adopted in accordance with them;

6) requesting a fee from the applicant when provision of the public service that is not provided for by the regulatory legal acts of the Russian Federation;

7) refusal of the Ministry that renders the public service, official of the Ministry to correct typos and errors in documents issued as a result of provision of of the public service or a violation of a deadline for such corrections.

The applicant may submit documents (if any), serving as the grounds, or their copies.

56. In case of appeal against the actions (inaction) of an official of a unit of the Ministry, the complaint is submitted to the head of the corresponding unit of the Ministry.

In case of appeal against the actions (inaction) of the head of a unit of the Ministry, the complaint is addressed to the Deputy Minister of Health of the Russian Federation in charge of this unit in accordance with the distribution of duties, established by the order of the Ministry.

Complaint against actions (inaction) of the Deputy Minister of Health of the Russian Federation is addressed to the Minister of Health of the Russian Federation.

57. Through prejudicial procedure, applicants have the right to submit a complaint in written form by mail, through a multifunctional center, using the Internet information and telecommunication network, the Unified Portal of Public and Municipal Services (Functions), or the complaint can be submitted during the applicant's visit to the Ministry.

The complaint is subject to mandatory registration within three days from the date of its submission to the Ministry.

58. When the applicants submits a complaint in written form or in the form of an electronic document, it must be considered within 15 working days from the day of its registration, and in the case of appeal against the refusal of Ministry, an official of the Ministry to accept documents from the applicant or to correct typos and errors or in the event of an appeal against a violation of the established term for such corrections – within 5 working days from the date of its registration, unless the Government of the Russian Federation has established a different time period.

59. Consideration of a complaint can be suspended if a suspension is provided for by the current legislation of the Russian Federation.

60. Grounds for initiating the procedure of prejudicial (extrajudicial) appeal against the actions (inaction) of the official of the Ministry responsible for provision of the public service is filing of a complaint by the applicant.

61. The complaint must contain:

1) name of the Ministry, name of an official of the Ministry or a government employee whose decisions and actions (inaction) are appealed against;

2) last name, first name, patronymic (if any), information about the place of residence of the applicant – individual or name, information about the location of the applicant – legal entity, as well as contact telephone number(s), e-mail address(es) (if any) and the mailing address to which the response shall be sent to the applicant;

3) information on the appealed decisions and actions (inaction) of the Ministry, an official of the Ministry or a government employee;

4) reasons of the applicant to disagree with the decision and action (inaction) of the Ministry, an official of the Ministry or a government employee.

62. Based on the results of consideration of the complaint, the Ministry takes one of the following decisions:

1) satisfy the complaint, including by canceling the decision, correcting typos made by the Ministry and errors in documents issued as a result of provision of of the public service, returning of fees to the applicant not provided for by regulatory legal acts of the Russian Federation or otherwise;

2) refuses to satisfy the complaint.

63. No later than the day following the day the decision is made, a motivated response is sent to the applicant on the results of consideration of the complaint in written form and, at the request of the applicant, in electronic form.

64. The decision on the complaint can be appealed in the manner prescribed by item 56 of the Regulations.

65. Applicants have the right to apply to the Ministry for information and documents necessary to justify and consider the complaint.

66. Applicants are informed on the procedure for filing and review a complaint in accordance with item 5 of the Regulations.

If during or based on the results of consideration of the complaint, signs of an administrative offense or a crime are established, an official authorized to consider complaints immediately sends all available materials to the prosecution authorities.
Annex 1
Annex 2
Application to receive a permit for import into the Russian Federation of a specific batch of authorized and (or) unauthorized medicinal products
Flowchart "Composition, order and time frame for the administrative procedure carried out when provision of the public service to issue a permit to import a specific batch of medicinal products for human into the Russian Federation"
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