ORDER
dated September 30, 2015 N 708
ON THE APPROVAL OF THE MODEL RULES
PROFESSIONAL ETHICS OF EVALUATORS

In accordance with article 20.1 of the Federal Law of July 29, 1998 N 135-FZ "On appraisal activities in the Russian Federation" (Collected Legislation of the Russian Federation, 1998, N 31, Art. 3813; 2014, N 30, Art. 4226) I order :

1. Approve the attached model rules of professional ethics for appraisers.

2. Establish that this order comes into force upon the expiration of sixty days from the date of its official publication.

The minister
A. V. ULYUKAEV

Approved by order of the Ministry of Economic Development
Russia from 30.09.2015 N 708

Model Rules of Professional Ethics for Appraisers

I. General Provisions

1.1. These standard rules of professional ethics for appraisers (hereinafter referred to as the Rules) determine ethical standards of conduct for appraisers when carrying out appraisal activities, interactions with customers, other appraisers, self-regulatory organizations of appraisers, with the media, as well as with legal entities that meet the conditions established by Article 15.1 of the Federal Law of July 29, 1998 N 135-FZ "On appraisal activities in the Russian Federation" (Collected Legislation of the Russian Federation, 1998, N 31, Art. 3813; 2014, N 30, Art. 4226) activity).

II. Basic Principles of Professional Ethics for Appraisers

2.1. Honesty.

Must act honestly and openly in their professional relationships.

2.2. Objectivity.

An appraiser must carry out professional activities independently and impartially.

The evaluator should avoid relationships that distort or affect the objectivity of his professional judgment.

2.3. Competence.

An appraiser is obliged to maintain professional knowledge and skills that provide a customer or a legal entity that meets the conditions established by Article 15.1 of the Federal Law on Appraisal Activity, with which the appraiser has entered into an employment contract (hereinafter referred to as the employer), to obtain, as a result of the assessment of the result, based on:

• due professional level of appraisal practice;
• compliance by the appraiser with the requirements of the Federal Law on Appraisal Activities, federal appraisal standards, other regulatory legal acts of the Russian Federation in the field of appraisal activities, standards and rules approved by the self-regulatory organization of appraisers, of which he is a member.

If the competence of the appraiser does not correspond to the level of the task assigned to him, he must:

• inform the customer about it;
• in agreement with the customer, take all measures to involve in the assessment specialists with qualifications corresponding to the level of the task assigned to them;
• if it is impossible to involve the above specialists in a timely manner, refuse to conduct an assessment and notify the employer of his refusal to conduct an assessment.

2.4. Professional conduct.

The appraiser is obliged:

• act in good faith and timely perform work in accordance with the requirements of the Federal Law on Appraisal Activities, federal appraisal standards, other regulatory legal acts of the Russian Federation in the field of appraisal activities, standards and rules approved by the self-regulatory organization of appraisers;
• not to admit in their practice situations that contribute to the emergence of a conflict of interest, including in the self-regulatory organization of appraisers.

2.5. Confidentiality.

The appraiser is obliged to ensure the confidentiality of information obtained as a result of professional activities, not to disclose this information to third parties, with the exception of cases provided for by the legislation of the Russian Federation.

III. Relations with customers

3.1. The appraiser should not mislead customers about the results of the appraisal, as well as about the possibilities of their use.

3.2. An appraiser should not:

• use knowingly false or knowingly misleading information when making an assessment;
• submit to customers (hereinafter referred to as a report) containing false information.

3.3. An appraiser should not be prejudiced in preparing the results of an appraisal for a specific client.

An appraiser should not take actions in the interests of customers that could call into question his independence.

3.4. An evaluator should not accept an assignment for an evaluation that involves the presentation of predetermined evaluation results and predetermined opinions and conclusions.

3.5. The appraiser's remuneration should not depend on the results of the appraisal, the recommendations contained in the report.

3.6. The appraiser should not hide or ignore the reliable facts about the appraisal object, which were known during the appraisal and drawing up the report.

3.7. The appraiser should not provide customers with false data about their professional capabilities, level of competence, qualifications and business reputation.

3.8. The appraiser should advise clients of potential conflicts of interest when conducting an appraisal.

3.9. The appraiser must provide the results of the appraisal under the assignment for appraisal only to persons authorized by the customers, with the exception of cases established by the legislation of the Russian Federation.

IV. Relationship between appraisers

4.1. An appraiser must express an opinion on the reports of other appraisers impartially and objectively.

V. Relationship of appraisers - members of a self-regulatory organization of appraisers with appraisers - members of elected
bodies of the self-regulatory organization of appraisers

5.1. Appraisers - members of elected bodies should not carry out actions that entail the emergence or pose a threat of a conflict of interest between the self-regulatory organization of appraisers and its members, as well as between members of the self-regulatory organization of appraisers.

5.2. Members of a self-regulatory organization of appraisers should not disseminate false information about a self-regulatory organization of appraisers, appraisers - members of elected bodies of a self-regulatory organization of appraisers and other appraisers, customers.

Vi. Relationship of appraisers with the media and rating agencies

6.1. Appraisers should not use false, misleading statements to advertise their activities, or make unrealistic promises in advertisements.

6.2. Appraisers should not provide the media and rating agencies with any false information about themselves and their professional practice, as well as about their clients.

6.3. An appraiser must not take part in campaigns that defame other appraisers, including in the media.

6.4. Appraisers' speeches and publications in the media must contain reliable information.

6.5. Publication by an appraiser of defamatory information about other appraisers is unacceptable.

Vii. Relationship of appraisers with employers

7.1. The professional judgment of an appraiser should not be influenced by the opinion of the employer.

7.2. If the appraiser receives an order from the employer to conduct an appraisal with the achievement of predetermined appraisal results and pre-agreed opinions and conclusions, the appraiser must refuse to carry out the appraisal.

MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION
ORDER of August 23, 2010 N 708н
ON APPROVAL OF THE RULES OF LABORATORY PRACTICE

In accordance with Article 11 of the Federal Law of April 12, 2010 N 61-FZ "On the Circulation of Medicines" (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161) I order:

1. Approve the Laboratory Practice Rules according to the appendix.

2. To recognize as invalid the Order of the Ministry of Health of the Russian Federation of June 19, 2003 N 267 "On the approval of the Rules for laboratory practice" (registered by the Ministry of Justice of the Russian Federation on June 25, 2003 N 4809).

The minister

T.A. GOLIKOVA

Application

to the Order

Ministry of Health

and social development

Russian Federation

LABORATORY PRACTICE RULES

I. General Provisions

1. The laboratory practice rules establish the requirements for the organization, planning and conduct of preclinical studies of drugs for medical use, the registration of results and quality control of these studies on the territory of the Russian Federation.

2. Organization of a preclinical study of a medicinal product for medical use (hereinafter referred to as a preclinical study) is carried out by its developer.

3. For the organization and conduct of preclinical research, its developer may involve research organizations of any form of ownership, educational institutions of higher professional education that have the necessary material and technical base and qualified specialists in the relevant field of research.

4. Preclinical studies include conducting biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and other studies of a medicinal product for medical use by applying scientific assessment methods in order to obtain evidence of its safety, quality and efficacy.

5. Control over the conduct of preclinical studies of medicines in accordance with the Regulations on the Federal Service for Surveillance in Healthcare and Social Development, approved by Decree of the Government of the Russian Federation of June 30, 2004 N 323 (Collected Legislation of the Russian Federation, 2004, N 28, art. 2900 ; 2006, N 52, Art. 5587; 2007, N 12, Art. 1414; N 35, Art. 4310; 2009, N 2, Art. 244; N 33, Art. 4086; 2010, N 35, Art. 4574 ), carried out by the Federal Service for Surveillance in Healthcare and Social Development.

II. Conducting a preclinical study

medicinal product

6. Preclinical studies are carried out according to the plan approved by the developer of the medicinal product with keeping a protocol and drawing up a report on the results of the preclinical study.

The preclinical study plan sets out the schemes and schedule for the preclinical study (including its stages and parts), describes the goals, objectives, methods (including methods for summarizing and evaluating the results), as well as measures to ensure the safety of the animals participating in it.

The preclinical study protocol records the actions associated with performing the preclinical study procedures, carried out in accordance with the approved plan for this preclinical study.

The report on the results of the preclinical study includes: a description of the preclinical study of the medicinal product, the research methods used and the results obtained, the statistical analysis of the results obtained, as a conclusion based on the results of the preclinical study - the conclusion on the possibility of conducting a clinical study of the medicinal product for medical use.

7. A preclinical study of a medicinal product for medical use with the use of animals is carried out in accordance with the legal norms for the use of animals during preclinical studies.

8. Collection, registration, processing and storage of primary data of a preclinical study should provide an accurate and reasonable representation of the efficacy and safety of the medicinal product and the objectivity of the data obtained during the study.

9. The primary data of the preclinical study should reflect the initial observations and manipulations during the preclinical study (records in worksheets, laboratory journals, photographs and films, printouts from automated devices, electronic media, records of environmental parameters in animal rooms, certificates for animals, animal health logs, equipment operation and maintenance logs, settlement procedures).

10. The production of medicinal products for preclinical research is carried out in accordance with the rules for organizing the production and quality control of medicinal products (Article 45 of Federal Law No. 61-FZ "On the Circulation of Medicines").

11. The organization conducting preclinical research has staff with education, training, qualifications and work experience appropriate to the types of research used in preclinical research.

12. The head of the organization conducting the preclinical study coordinates the plan for the preclinical study, organizes the work on its implementation, appoints the responsible executor, the preclinical study quality control group, provides in the prescribed manner the advanced training and training of employees.

13. The executive officer appointed by the head of the organization conducting the preclinical study organizes and controls:

a) conducting a preclinical study in accordance with the approved plan;

b) selection of co-executors from among the employees of the organization conducting the preclinical study of the medicinal product for medical use, involved in participation in studies of the quality, efficacy and safety of the medicinal product in accordance with the preclinical study protocol;

c) registration of the protocol of the preclinical study, changes to it and the report on the results of the preclinical study;

d) proper implementation of standard laboratory and production procedures approved by the organization (hereinafter - approved procedures);

e) ensuring access of co-performers to the materials of the preclinical study;

f) confidentiality of the results of the preclinical study;

g) safety of medicinal product samples obtained for its preclinical study;

h) fulfillment of the requirements of these Rules.

14. The responsible executor and co-executors are obliged to know:

a) an approved preclinical study plan;

b) requirements for the proper implementation of approved procedures;

c) requirements for the registration of the protocol of the preclinical study and the report on its results;

d) information about the investigational medicinal product and the comparative medicinal product;

e) their functions when performing preclinical research.

15. In the process of conducting a preclinical study of a medicinal product, the responsible executor and co-executors shall ensure:

a) preparation and implementation of key stages of the study, collection, registration and documentation of the data obtained;

b) keeping records of unforeseen circumstances and taking measures to eliminate them;

c) preparation of a report on the results of a preclinical study, including a conclusion on the possibility of conducting further clinical trials of a medicinal product for medical use.

16. To ensure independent quality control of the preclinical study conducted by the head of the organization conducting the preclinical study, a group of specialists of the organization with the appropriate qualifications and not participating in this preclinical study (hereinafter referred to as the quality control group) is formed.

III. Quality assurance system

preclinical studies

17. The quality of preclinical studies is ensured by control by:

a) the developer of the medicinal product;

b) the head of the organization conducting the preclinical study, the responsible executor;

c) a quality control group that carries out an independent systematic verification of materials, primary data of preclinical research and the activities of the responsible executor and co-performers related to preclinical research, in order to confirm the fact of carrying out these activities and assess the compliance of the procedures for collecting, processing, documenting and providing the obtained results of preclinical research the requirements of the legislation of the Russian Federation in the field of circulation of medicines, these Rules, the protocol for the preclinical study of the medicinal product, the approved procedures, as well as the assessment of the reliability of the materials of the preclinical study.

18. The head of the organization conducting the preclinical study establishes the frequency of independent verification of the preclinical study, and also determines the procedures for the admission of authorized representatives of the developer of the medicinal product to control the quality of the preclinical study.

19. Control over the conduct of preclinical studies includes:

a) drawing up a list of preclinical studies conducted in the organization, indicating for each study the organizer, the responsible executor, the name of the investigational medicinal product, the test systems used, the start date of the preclinical study and the state at the current time;

b) control over the implementation of the preclinical study plan;

c) the appointment of a responsible executor and co-executors for each preclinical study;

d) registration of a protocol for a preclinical study of a medicinal product;

e) assessment of the reliability of methods, protocols and results of preclinical research;

f) compliance with the requirements of the approved standard procedures and their compliance with these Rules;

g) monitoring of the current preclinical study;

h) drawing up reports on the results of independent audits, conclusions on the progress of the preclinical study and recommendations for eliminating the identified deficiencies.

20. If the quality control group reveals deficiencies, deviations from the preclinical study plan, violations of the requirements of these Rules, the responsible executor and the head of the organization conducting the preclinical study shall be provided with appropriate comments and recommendations for their elimination.

21. By the end of the preclinical study, the quality control group draws up a conclusion on its progress, which is brought to the attention of the head of the organization organizing the preclinical study and the organization conducting the preclinical study, the responsible executor, which is attached to the report on its results.

22. Premises intended for conducting preclinical studies are designed, located and operated in order to ensure the high-quality performance of the conducted preclinical studies.

23. For experimental research, the presence of a vivarium is required.

24. Premises for experimental animals should:

a) provide optimal physical, chemical and biological parameters for keeping experimental animals and conducting preclinical studies;

b) ensure isolation (quarantine) of incoming animals, sick animals and animals suspected of carrying infections;

c) allow the separate keeping of different species of animals and animals of the same species used for the study of various medicinal products;

d) comply with the established requirements in the field of sanitary and epidemiological welfare of the population and veterinary medicine.

25. Feed, equipment and inventory for caring for animals must be stored in rooms isolated from places where animals are kept.

26. Premises for conducting preclinical research, including for work with objects of research hazardous to human health and life, must comply with the established sanitary and hygienic rules.

27. Archival premises should have a limited access regime that ensures the confidentiality of materials and data obtained during preclinical studies.

28. The order of access to the archives and the circle of persons from among the employees of the organization conducting preclinical research is determined by its head.

29. Organizations conducting preclinical studies of a medicinal product must be equipped with equipment that has passed metrological control and verification in accordance with the established procedure.

30. Operation of the equipment is carried out in accordance with the technical documentation for use.

31. The results of preventive inspections of equipment and current repairs are recorded in a special log, available at any time to employees operating the equipment or providing its maintenance, containing the following information:

a) name and model of the device, manufacturer, country of origin, serial (factory) number of the device;

b) inventory number, dates of receipt, registration and commissioning of the device;

c) the location of the device;

d) last name, first name, patronymic (if any) and position of the employee (s) responsible for using the device;

e) last name, first name, patronymic (if any) of persons, indicating the organization and structural unit, responsible for the maintenance of the device;

f) detailed records of the planned maintenance of the equipment, dated and certified by the signature of the responsible person;

g) detailed records of any damage, failure, repair of the device, dated and certified by the signature of the persons responsible for the use and maintenance of the device;

h) detailed records of instrument verification, dated and certified by the signature of the person responsible for instrument maintenance.

32. Preclinical studies are carried out using biological, chemical, physical and information systems or their combinations (hereinafter - test systems).

The type, size and characteristics of test systems should correspond to the types of preclinical studies. The conditions for conducting preclinical studies on test systems should exclude the influence of external factors that can affect the quality and reliability of the data obtained.

33. Preclinical studies are carried out on healthy animals. All procedures related to animal care (feeding, drinking, changing bedding, replanting, washing cages, cleaning the rooms where animals are kept) are described in approved procedures.

34. Newly arrived animals are isolated to assess their health status. Sources of entry, conditions and date of entry of animals should be documented. In the event of deterioration in the health of animals and their death, not related to the preclinical study, these animals must be isolated from the main group and subjected, if necessary, to treatment, if allowed by the protocol of the preclinical study, or humane killing. Diagnosis, treatment and results should be documented in an animal health register.

35. To ensure individual observation during the study, animals must be identified. The method for identifying the animal is documented. All cages, aviaries, containers intended for keeping animals are subject to labeling. Animals intended for preclinical research of different drugs are spatially isolated from each other.

36. Animal feed and water should provide nutritional needs in accordance with the requirements established in the preclinical study plan, be free of pathogenic microorganisms and harmful impurities, and should not interfere with the preclinical study results.

37. Places of keeping animals and production facilities are subject to periodic sanitization, which does not affect the results of preclinical studies, in accordance with approved procedures.

38. The organization conducting the preclinical study must have approved procedures that describe in detail and consistently the procedure for carrying out (performing) all laboratory and production operations, including:

a) receipt, identification, labeling, processing, sampling, use, storage and destruction / disposal of investigational medicinal products and comparative medicinal products;

b) maintenance and verification of measuring instruments and equipment for environmental monitoring;

c) preparation of reagents, nutrient media, feed;

d) keeping records, reports and their storage;

e) maintenance of premises containing test systems;

f) reception, transportation, placement, description, identification and care of test systems;

g) handling of test systems, including neutralization, destruction or disposal of the test system;

h) implementation of a program to ensure the quality of preclinical research of a medicinal product.

39. The approved procedures should have a clear, consistent statement of the work performed, contain instructions on the requirements for reagents, solvents, instruments, equipment, time and conditions of the procedure.

40. Compliance with approved procedures is carried out in order to ensure the quality, reliability, accuracy and reproducibility of the results of the preclinical study.

41. Deviation from the approved procedure must be documented and agreed with the responsible executor and included in the preclinical study protocol.

42. The approved procedures are subject to timely revision in order to update them. The preclinical research organization should maintain a catalog of approved procedures in force, indicating their version, effective date and revision date.

43. Employees of the organization conducting preclinical research should have all the necessary approved procedures in their workplaces and undergo training in case of their revision.

IV. Investigational drugs and medicines

comparison means

44. The developer of a medicinal product or another organization that organizes a preclinical study shall submit to the organization conducting the preclinical study:

a) the investigational medicinal product and its description;

b) a medicinal product, a product that is used to assess by scientific methods the quality, efficacy and safety of the investigational medicinal product based on a comparison of their physical, chemical, biological and pharmaceutical properties (hereinafter referred to as the reference medicinal product);

c) regulatory documentation for the investigational medicinal product, indicating the temperature regime, conditions and periods of its storage, stability data, information on measures to ensure the safety of working with the investigational medicinal product;

d) solvents and a description of the dissolution procedure, devices for administering the drug (if necessary).

45. The investigational medicinal product and the comparative medicinal product must have clearly identifiable packages that provide protection during transportation and storage from contamination or deterioration.

46. ​​The organization conducting the preclinical study should:

a) keep records of medicinal products upon receipt, consumption, return to the developer or their destruction / disposal;

b) take measures to ensure the identification of investigational medicinal products and comparative medicinal products indicating the trade and international non-proprietary name or chemical name, chemical formula, batch number, date of issue, storage conditions and shelf life, the inscription "For preclinical use";

c) organize the storage of the investigational medicinal product separately from the reagents and reference medicinal products, subject to the storage conditions ensuring the stability of the investigational medicinal product during the entire shelf life established in the documents of the medicinal product developer.

V. Planning and conducting a clinical trial

47. A preclinical study should be carried out in accordance with its approved plan and accompanied by a protocol that certifies the implementation of the procedures of the preclinical study plan.

48. The preclinical study plan includes:

b) a description of the goal and objectives of the preclinical study;

d) information about the investigational medicinal product (physical, chemical, biological, pharmaceutical, pharmacological properties, storage and use conditions);

e) information about the reference drug (physical, chemical, biological, pharmaceutical, pharmacological properties, storage and use conditions);

f) a list of planned methods of preclinical research;

g) the name of the test system intended for use in preclinical research, with the justification for its choice;

h) methods and routes of administration of the investigational medicinal product and the reference medicinal product;

i) the planned scheme of the preclinical study;

j) legal and ethical standards for the use of animals;

k) a list and justification of the planned methods for assessing the quality, efficacy and safety of the investigational medicinal product;

l) a list and justification for the choice of methods for statistical processing of the results of preclinical research;

m) a list of materials and data of preclinical research to be stored in the archive;

o) list of used literature.

49. The protocol of preclinical research reflects:

a) the name of the preclinical study;

b) the purpose and objectives of the preclinical study, approved by its plan;

c) the names and legal addresses of the developer of the medicinal product, involved by the developer of the organization that organizes the preclinical study, and the organization that conducts it;

d) a description of the preclinical research methods and test systems used;

e) methods and routes of administration of the investigational medicinal product and the reference medicinal product;

f) a description of the production of the investigational medicinal product and the comparative medicinal product;

g) a description of the preclinical study scheme used;

h) a list of approved procedures that have been completed confirming compliance with legal and ethical standards for the treatment of animals;

i) the methods used to assess the quality, efficacy and safety of the investigational medicinal product;

j) the methods used for the statistical processing of the results of the preclinical study of the medicinal product;

k) deviations from the approved preclinical study plan, their reasons and justification.

49. Changes made to the preclinical study protocol, as well as deviations from the preclinical study plan (unplanned events, unforeseen circumstances, omissions) are recorded indicating the reasons, numbered, signed by the responsible executor, dated and attached to the report on the results of the preclinical study.

Vi. Primary data from preclinical studies

50. The organization conducting preclinical research should keep all the primary data of preclinical research, the results of measurements and observations, calculations and data conversion, records of equipment verification, reports (including intermediate), as well as other materials and documents directly related to to a specific preclinical study.

51. Samples of medicinal products, weighed portions and other materials must have an individual code that allows to unambiguously identify the study, the test system used, methods, type of study, as well as a link to the responsible executor and co-executors who were directly involved in their receipt, preparation or conduct preclinical research.

52. The primary data of the preclinical study must be recorded, signed, dated and filed at the beginning of the preclinical study. Their destruction, substitution, change of dates or rewriting is not allowed. Data on electronic media, if possible, are duplicated in paper form.

53. Corrections of the primary data of the preclinical study are made in the form of additions, which are signed and dated by the responsible executors, indicating the reasons for the errors.

54. The primary data of a preclinical study should allow to restore the course of a specific preclinical study.

55. After the preclinical study, the materials, samples of the investigational medicinal product and the reference medicinal product are transferred to the archive.

Vii. Preclinical study report

56. After the end of the preclinical study, a report on its results is drawn up, which is signed by the responsible executor and co-performers, approved by the head of the organization that conducted the preclinical study, and certified by the seal of this organization.

57. The report on the results of a preclinical study should contain detailed results of this study, a conclusion on the possibility of conducting a clinical study of a medicinal product for medical use, and also include the following information:

a) the name of the preclinical study;

b) the names and legal addresses of the developer of the medicinal product, involved by the developer of the organization that organized the preclinical study, and the organization that conducted it;

c) the dates of the beginning and completion of the preclinical study and its stages;

d) the purpose and objectives of preclinical research;

e) a description of the investigational medicinal product, including information on its composition, physical, chemical, biological, pharmaceutical and pharmacological properties;

f) description of the reference medicinal product, including information on its composition, physical, chemical, biological, pharmaceutical and pharmacological properties;

g) the type of preclinical study, characteristics and justification of the test system selected for each type of study;

h) the scheme of the preclinical study;

i) a description of the methods of statistical processing of the results of preclinical research;

j) the results of the preclinical study, presented in the form of summarizing tables (graphs) with the appropriate statistical processing, comments on them, discussion of the results;

k) if available - dated and signed interim reports of the responsible executor on the stages or parts of the preclinical study of the medicinal product;

l) a description of all deviations that could affect the quality of the results obtained;

m) an indication of where and how the results of the preclinical study will be stored;

o) conclusions about the quality, efficacy and safety of the medicinal product;

o) reports of the quality control group.

58. In the case of experimental studies using animals, the report on the results of the preclinical study must indicate:

a) species, age, number of animals in each group, sex, body weight indicators, source and nature of nutrition;

b) dosage regimen, frequency rate and route of administration of the investigational medicinal product;

c) information on compliance with legal and ethical standards for the treatment of animals.

59. Additions to the report on the results of the preclinical study of a medicinal product are drawn up in the form of attachments containing a link to the corresponding section of the report (paragraph, figure, table, etc.), and signed by the responsible executor, approved by the head of the organization that conducted the preclinical study, and sealed this organization.

VIII. Respect for data confidentiality,

obtained during the preclinical study

60. The employees of the organization conducting this study and the quality control group participating in the preclinical study are obliged to maintain confidentiality with respect to any data obtained in the course of its conduct, in accordance with the legislation of the Russian Federation.

61. The organization conducting the preclinical research must ensure the confidentiality of the results obtained during the preclinical research within the framework of its obligations and in accordance with the legislation of the Russian Federation.

IX. Storage of preclinical study materials

62. After the completion of the preclinical study, all primary data, as well as duly certified copies of the plan and protocol of the preclinical study, the report on its results and the conclusion of the quality control group should be stored in separate rooms specially allocated for these purposes.

63. Materials of preclinical research, placed in the archive, should be marked in accordance with the storage order for quick retrieval. The storage period for archival materials is determined by an internal act of the organization conducting preclinical research.

64. Samples of the investigational medicinal product and the reference medicinal product must be stored for a period established by the developer of the medicinal product.

65. The functions of archiving and maintaining the archive should be assigned to special workers of the organization conducting preclinical research.

66. The head of the organization conducting preclinical studies notifies the developer of the medicinal product in writing of the intention to destroy any materials of the preclinical study of the medicinal product stored in the archive, as well as of the reorganization and / or liquidation of the organization and structural units directly involved in preclinical studies.

67. Any materials about preclinical research stored in the archives of the organization that conducted preclinical research can be destroyed only after the official consent of the developer of the medicinal product.

The Association assists in the provision of services in the sale of timber: at competitive prices on an ongoing basis. Timber products are of excellent quality.

• Signed 23.07.2001
• Registered with the Ministry of Justice 06.09.2001
• Published on September 17, 2001
• Effective date 18.10.2001

Order "Specifics of registration for railway transportation in large-tonnage containers"

Order of the State Customs Committee of Russia N 708, Ministry of Railways of the Russian Federation N 19 of July 23, 2001
"On approval of the Instruction on the specifics of customs clearance and
customs control of goods transported in large-tonnage
containers by rail in transit
through the territory of the Russian Federation "

In order to develop transit rail container traffic, simplify and accelerate customs clearance and customs control procedures, we ORDER:

1. To approve the attached Instruction on the specifics of customs clearance and customs control of goods transported in large containers by rail in transit through the territory of the Russian Federation (hereinafter referred to as the Instruction).

2. The chiefs of customs shall provide, as a matter of priority, customs clearance and customs control of goods transported in large-tonnage containers by rail in transit through the territory of the Russian Federation, including weekends and holidays and, if necessary, around the clock.

3. The chiefs of railway stations shall ensure that the customs authorities are provided with the documents necessary for the purposes of customs clearance and customs control of goods, and assist in carrying out customs inspections.

4. Head of the Department of Freight and Commercial Work of the Ministry of Railways of Russia Yu.M. Kosov, Head of the Main Directorate for Organization of Customs Control of the State Customs Committee of Russia A.V. Galaktionov ensure that interested organizations are informed about border railway stations at which the use of the Instruction is permitted.

5. Control over the implementation of this Order shall be entrusted to the First Deputy Chairman of the State Customs Committee of the Russian Federation V. I. Meshcheryakov and Deputy Minister of Railways of the Russian Federation S. A. Grishin.

Chairman of the State
Customs Committee of the Russian Federation
M.V. Vanin

Minister of Railways
Russian Federation
N.E. Aksenenko

Instructions on the features of customs clearance
and customs control of goods transported
in large containers by rail
by transport in transit through the territory
Russian Federation

1. This Instruction applies to goods transported in large-tonnage containers by rail in transit through the territory of the Russian Federation (hereinafter referred to as goods), with the exception of goods whose transit through the territory of the Russian Federation is prohibited or restricted.

2. Goods are subject to declaration to the customs authority of the Russian Federation, in the region of operation of which the border railway station for entry into the customs territory of the Russian Federation is located.

3. An additional copy of the road bill is used as a customs declaration if it is provided and its electronic copy by the consignor or the railway station of departure to the customs authority of departure.

4. The customs authority of departure puts a directing stamp in column 26 "Customs marks" of the additional copy of the road bill, and in the upper right corner - the reference number assigned according to the registration log of the document of control over the delivery of goods, and the code of goods for the TN VED of Russia at the level of the first four signs and certifies this information with an imprint of a personal number seal. A copy of the additional copy of the road bill remains with the customs office of departure. The original of the additional copy of the road bill is sent together with the goods to the customs authority of destination.

5. When goods arrive, the customs authority of destination shall put down the stamp "Goods arrived" in column 11 of the additional copy of the road bill and certify it with an imprint of a personal numbered seal.

6. The customs authorities do not require the mandatory submission of an invoice, as well as an indication of the cost of goods in transport and shipping documents, provided that these documents must contain a sufficiently detailed description of the goods that allows them to be identified for the purposes of customs clearance and customs control.

7. Customs inspection of goods is carried out in cases of violation of the integrity of the imposed means of identification, as well as in the presence of information or direct detection of signs of a prepared, committed or committed violation of customs legislation.

8. Fees for customs clearance of goods are levied in the amount established by the Instruction on the collection of customs fees for customs clearance, approved by Order of the State Customs Committee of Russia dated 09.11.2000 N 1010 (registered by the Ministry of Justice of Russia on December 14, 2000, N 2497), using the customs receipt order ...

9. Delivery of goods must be made within the time frame established by the customs authority of the Russian Federation, determined at the rate of 220 km per day.