DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of December 12, 2023 No. 150

About Regulations of the address of disinfecting, disinsection and disacariasis means of veterinary appointment on customs area of the Eurasian Economic Union

According to Item 9 of the Protocol on information and communication technologies and information exchange within the Eurasian Economic Union (appendix No. 3 to the Agreement on the Eurasian Economic Union of May 29, 2014), Item 14 of the Protocol on application of sanitary, veterinary and sanitary and quarantine phytosanitary measures (appendix No. 12 to the Agreement on the Eurasian Economic Union of May 29, 2014) and Item 57 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Council of the Eurasian economic commission DECIDED:

1. Approve the enclosed Regulations of the address of disinfecting, disinsection and disacariasis means of veterinary appointment on customs area of the Eurasian Economic Union (further – Rules).

2. Determine that:

a) registration of disinfecting, disinsection and disacariasis means of veterinary appointment and the related procedures, and also other procedures necessary for release of such means in the address, stipulated by the legislation state members of the Eurasian Economic Union (further respectively – state members, the Union), begun and not completed on the date of entry into force of Item 1 of this Decision, are performed according to the legislation of state members;

b) the registration certificates of disinfecting, disinsection and disacariasis means of veterinary appointment and other documents necessary for release of such means in the address issued before the date of entry into force of Item 1 of this Decision or according to the subitem "an" of this Item are valid during the terms established according to the legislation of state members, but no later than December 31, 2032;

c) registration files of the disinfecting, disinsection and disacariasis means of veterinary appointment registered according to the legislation of state members are subject to reduction in compliance with Rules till December 31, 2032;

d) the address on customs area of the Union till December 31, 2032 is allowed:

the disinfecting, disinsection and disacariasis means of veterinary appointment registered according to the legislation of state members before the date of entry into force of Item 1 of this Decision taking into account provisions of Items 127 and 128 of Rules;

the disinfecting, disinsection and disacariasis means of veterinary appointment released according to other procedures, stipulated by the legislation state members, before completion of the procedure of their registration performed according to the procedure, provided by Rules;

e) before enforcement of general processes within the Union by means of which realization information exchange between the bodies (expert organizations) of state members authorized in the field of the address of disinfecting, disinsection and disacariasis means of veterinary appointment and the Eurasian economic commission is performed (further – the Commission) exchange of paper documents and (or) in electronic form is allowed;

e) permission of the disputable situations connected with the address of the disinfecting, disinsection and disacariasis means of veterinary appointment specified in the subitem "g" of this Item is performed with participation of the Commission (within its powers defined by the Agreement on the Eurasian Economic Union of May 29, 2014).

3. Ask state members before the date of entry into force of Item 1 of this Decision:

a) establish the amount of charges (duties) or other obligatory payments provided by Rules, and (or) procedure for their calculation (if necessary) taking into account complexity of the procedures and amount of works which are carried out by reference body for registration and (or) bodies (expert organizations) of state members authorized in the field of the address of disinfecting, disinsection and disacariasis means of veterinary appointment including in case of:

registration of disinfecting, disinsection or disacariasis means of veterinary appointment;

entering into the registration file of disinfecting, disinsection or disacariasis means of veterinary purpose of changes;

reduction of the registration file of disinfecting, disinsection or disacariasis means of veterinary appointment in compliance with requirements of Rules;

recognition of registration of disinfecting, disinsection or disacariasis means of veterinary appointment;

inspection of production of disinfecting, disinsection and disacariasis means of veterinary appointment;

b) determine the bodies authorized on implementation of registration of disinfecting, disinsection and disacariasis means of veterinary appointment and other related procedures and (or) on inspection of production of such means and inform on it the Commission.

4. This Decision becomes effective after 30 calendar days from the date of its official publication, except for Item 1 of this Decision which becomes effective on September 1, 2027.

Members of council of the Eurasian economic commission:

From the Republic of Armenia

M. Grigoryan

From the Republic of Belarus

I. Petrishenko

From the Republic of Kazakhstan

S. Zhumangarin

From the Kyrgyz Republic

A. Kasymaliyev

From the Russian Federation

A. Overchuk

 

Approved by the Decision of Council of the Eurasian economic commission of December 12, 2023 No. 150

Regulations of the address of disinfecting, disinsection and disacariasis means of veterinary appointment on customs area of the Eurasian Economic Union

I. General provisions

1. Scope

1. These rules determine procedure for regulation of the address of the disinfecting, disinsection and disacariasis means of veterinary appointment which are not coming into direct contact with animals (the used invitro in veterinary science), on customs area of the Eurasian Economic Union (further respectively - means, the Union).

Regulation of the address of means on customs area of the Union is performed according to the these rules, acts entering the right of the Union and the legislation of state members of the Union (further - state members) in the part which is not contradicting the right of the Union.

2. These rules extend to producers of means, owners of means (their representatives who are acting on the basis of the document certified in accordance with the established procedure), the bodies of state members, expert organizations of state members, the organizations subordinated to these bodies enabling the realization of means, and other subjects of the address of means authorized in the field of the address of means.

These rules are not applied to means, requirement for which arises in the conditions of military operations, in the emergency situations or other situations requiring acceptance of the immediate measures according to the legislation of state members, and also means which are developed on the instructions of public authorities of state members and also developed on the instructions of public authorities of the state members authorized in the field of safety and defense and which address is regulated by the legislation of state members.

2. Acceptance purpose

3. These rules are accepted for the purpose of ensuring functioning of the market of means within the Union by means of:

a) realization of single approaches to registration of means;

b) ensuring unity of mandatory requirements to quality, safety and efficiency of means in the territories of state members and their observance;

c) realization of single approaches to creation of system of quality assurance, safety and efficiency of means;

d) taking measures, necessary for consumer protection from use of low-quality, counterfeited and counterfeit means.

3. Determinations

4. For the purposes of these rules concepts which mean the following are used:

"safety of means" - the characteristic of means based on comparative analysis of efficiency of means and risk of causing in case of its use of harm to health of animal and (or) the person, and also the environment;

"import to customs area of the Union of means" - funds transfer through customs border of the Union for the purpose of their address on customs area of the Union;

"means excipient" - the substance of inorganic or organic origin used in means production process for giving of necessary properties to it;

"secondary package" - packaging in which means in primary package is located. The secondary package is consumer in case of receipt of funds in this packaging to the consumer;

"date of issue of series of means" - signature date the authorized person of the producer of means of the document (permission to realization of series of the means) confirming means series compliance to the requirements established by the license for production of means and (or) the certificate of conformity of production of means to requirements of these rules, registration files of means;

"disacariasis means" - the used invitro in veterinary science the substance or mix of substances of biological, biotechnological, mineral or chemical origin intended for destruction and (or) scaring away of pincers on livestock objects and objects of external environment;

"disinsection means" - the used invitro in veterinary science the substance or mix of substances of biological, biotechnological, mineral or chemical origin intended for destruction and (or) scaring away of insects on livestock objects and objects of external environment;

"disinfectant" - the used invitro in veterinary science the substance or mix of substances of biological, biotechnological, mineral or chemical origin intended for destruction of microorganisms on livestock objects and objects of external environment;

"active ingredient of means" - substance of biological, biotechnological, mineral or chemical origin as a part of means with which action efficiency of this means is connected;

"applicant" - the owner of means or the legal entity authorized by it, the physical person registered as the individual entrepreneur, or the physical person which are acting on the basis of the power of attorney which submit the application for registration of means or for implementation of other procedures connected with registration and necessary documents to authorized body;

"inspection" - the activities of authorized body performed for the purpose of assessment of conformity of production of means to requirements of these rules;

"the instruction on use of means" - the document accompanying the registered means, the regulating procedure for its use and also containing information on properties of this means:

"quality of means" - means compliance to requirements of the regulating document of the means for quality indicators causing suitability of its use according to purpose;

"counterfeit means" - the means which is in circulation on customs area of the Union with violation of requirements of the legislation of state members in the field of intellectual property;

"the international non-proprietary name of means" - the name of active ingredient of the means used for production of means, recommended by the World Health Organization;

"low-quality means" - the means which is not conforming to requirements of the regulating document of means;

"the regulating document on means" - the document on quality control of means processed by the owner of means, containing list of indicators of quality of means with the description of their analytical techniques and researches (testing) or with indication of references to them, and also the corresponding eligibility criterions for these indicators of quality taking into account type (type) of means;

"the address of means" - the activities including development, conducting examination, implementation of registration or other procedures connected with registration, quality control, safety control, efficiency evaluation, production, storage, transportation, movement from the territory of one state member in the territory of other state members, transit (except for transit from the territory of the state which is not the member of the Union on the territory of the state which is not the member of the Union through customs area of the Union), import to customs area of the Union (export from customs area of the Union), advertizing, leave, realization, transfer, use, utilization and (or) destruction of means;

"primary package" - the packaging which is directly adjoining to means. The primary package is consumer in case of receipt of means in this packaging to the consumer;

"the owner of means" - the legal entity or physical person registered as the individual entrepreneur who have rights to the registered means, the registration file of means (including results of preregistration researches (testing) of means, the production technology of means) and bear responsibility for quality, safety and efficiency of means;

"preregistration researches (testing) of means" - researches (testing) conducted for the purpose of quality evaluation, safety and efficiency of the means represented for registration;

"the producer of means" - the organization performing activities for production, storage, realization and transfer of means;

"production site" - territorially isolated complex of the producer of means intended for implementation of all production process of means or its certain stage;

"production of means" - production of means at one, several or all stages of engineering procedure;

"realization of means" - wholesale and (or) retail trade by means;

"the registration file of means" - the set of documents represented for registration of means or implementation of other procedures connected with registration;

"registration number" - the specification symbol appropriated to means in case of its registration;

"the register of DDD-means of the Union" - the register of the registered means of the Union which are not coming into the direct contact with animals representing the general information resource containing data on means concerning which the registration or other procedures connected with registration are performed according to these rules created with use of means of the integrated information system of the Union;

"the register of producers" - the register of producers of means representing the general information resource containing data about the state members which are in the territories and the third countries producers of means which production is recognized following the results of inspection to the corresponding these rules, created with use of means of the integrated information system of the Union;

"the claim for means" - the claim of the subject of the appeal of means to quality, safety and (or) efficiency of means;

"reference body for registration" - the authorized body which adopted the corresponding statement, the registration file of means and other registration materials from the applicant and performing coordination of actions between the applicant and authorized bodies during registration of means or implementation of other procedures connected with registration;

"the risks connected with use of means" - the risks connected with quality, safety or efficiency of means for health of animals or the risks leading to undesirable impact on the environment and health of the person;

"means series" - the quantity of means made as a result of one production cycle;

"subjects of the address of means" - the authorized bodies, expert organizations, legal entities, physical persons registered as individual entrepreneurs and the physical persons participating in the address of means;

"the trade name" - the name of means which is appropriated by the owner of means and under which means is registered;

"authorized body" - the representative in the field of the address of means body of state member within which competence are decision making during the address of means, and also implementation of the state control (supervision) in the field of the address of means;

"counterfeited means" - the means accompanied with unreliable information about structure and (or) the producer of means;

"form of release of means" - the aggregate (physical) state of means corresponding to methods of its use and providing achievement of necessary effect;

"expert opinion" - the document containing results of examination of quality, safety and efficiency of means with the conclusion about possibility (impossibility) of registration of means, entering into the registration file of means of changes, reductions of the registration file of means in compliance with requirements of these rules, prepared by expert organization at the request of reference body for registration;

"expert organization" - the organization subordinated to authorized body which is carrying out expertize of means within registration of means or implementation of other procedures connected with registration and the address of means;

"efficiency of means" - set of the characteristics determining extent of achievement of the expected result of use of means.

Other concepts used in these rules are applied in the values defined by the Agreement on the Eurasian Economic Union of May 29, 2014, the international treaties and acts constituting the right of the Union.

II. Production, storage, transportation, realization, utilization and (or) destruction of means

5. Production of the means which are in circulation on customs area of the Union shall conform to requirements according to appendix No. 1.

6. Production of means on customs area of the Union is performed on the basis:

a) the license for production of means granted by authorized body according to the legislation of state member for each production site on which production of means is performed (in the presence of relevant requirements in the legislation of state member);

b) the certificate of conformity of production of means to requirements of these rules issued by authorized body no more than for 3 years (since date of the last day of the last inspection) for each production site on which production of means is performed, in form according to appendix No. 2 (further - the certificate).

The producer of means performs quality check and safety of each series of the issued funds for compliance to indicators of the regulating document for means and by results of this check processes the document confirming quality and safety of means.

7. Storage, transportation and realization of means are performed in case of observance of the following requirements:

a) the personnel involved in activities for storage, transportation and realization of means have necessary qualification as of day of the beginning of accomplishment of the job responsibilities, and also perform the necessary procedures connected with occupational health and personal hygiene;

b) means are stored separately from other products capable to exert impact on them, are protected from the harmful effects of light, temperature, humidity and other external factors capable to make negative impact on quality, safety and efficiency of means;

c) the means requiring special storage conditions are stored in these conditions using adequate measures of safety and if necessary are protected from illegal access;

d) shipment of means is organized in such a way that means with smaller expiration date are shipped first of all (rule FEFO - "first expire first out");

e) means which expiration date expired are without delay withdrawn from circulation or by their arrangement to the special room or zone of storage, or by use of the electronic means providing necessary isolation;

e) the rooms intended for storage of means are net, dry, have proper illumination, in them the temperature condition and humidity established in instructions for use of means (in the presence) are supported;

g) rooms and the equipment for storage of means are protected from penetration of insects, rodents or other animals;

h) the equipment exerting impact on storage conditions of means (conditioners, refrigerating chambers (refrigerators), the security and fire alarm, ventilating system, system of moistening and (or) drainage of air, thermohygrometers or other equipment used for registration of temperature and humidity, the equipment used for transportation, etc.) takes place and serviced according to instructions for use of this equipment;

i) the equipment used for control of storage conditions of means (gage) is confided and (or) is calibrated;

j) documentation contains the description of all processes which are carried out by the distributor, requirements to implementation of procedures are approved by the responsible person;

k) the realization of means is enabled in the conditions ensuring safety and integrity of means, protection them from impact of factors of the environment with observance of these conditions and requirements to storage and transportation during the whole time of realization;

l) the distributor developed and draws documentary up operations procedure in case of contingencies in the course of transportation of means and when conducting the corresponding investigation (for example, in case of violation of temperature condition, mechanical spoil of means, etc.);

m) the distributor (attracted by him the organization carrier) provides that the vehicles and the equipment used for transportation of means answered the purpose of their use, were properly completed for protection of means from undesirable impact which can lead to loss of quality of means or break integrity of packaging, and also were kept clean and were exposed to proper processing with use washing and disinfectants.

8. Utilization and (or) destruction of means are performed according to the legislation of state members.

III. Address of means

1. General principles of the address of means

9. On customs area of the Union the address of means under condition is allowed:

a) their registration according to these rules;

b) their productions on the production site having the current license on production of means (in the presence of relevant requirements in the legislation of state member) and the existing certificate;

c) their maintenances by the instruction for use of means and packaging with the text in Russian and in state language (in the presence of relevant requirements in the legislation of state member in the territory of which means addresses).

10. The address on customs area of the Union of low-quality, counterfeited, counterfeit means, the means which are not registered according to these rules (except as specified, the these rules determined by Item 239), and also means expired is forbidden.

Low-quality, counterfeited, counterfeit means, and also means expired are subject to retirement on customs area of the Union and the subsequent utilization and (or) to destruction or export from customs area of the Union (in case of detection at check points through frontiers of the state members located on customs border of the Union).

Utilization and (or) destruction of low-quality, counterfeited, counterfeit means, and also means expired are performed at the expense of their owner according to the legislation of state members.

Persons which allowed the address on customs area of the Union of low-quality, counterfeited, counterfeit means, and also means expired bear responsibility according to the legislation of state member in the territory of which violation established fact.

11. Requirements to structure, format and contents of the registration file of means, form and content of the expert opinion, order of registration of means and implementation of other procedures connected with registration of the basis for suspension of the address of means or cancellation of registration of means are established by these rules.

12. Are subject to registration according to these rules:

a) the means used separately or in combination among themselves;

b) new combinations of the means registered earlier;

c) the means registered earlier, but made in other forms and (or) in new concentration.

13. Are not subject to registration within the Union:

a) means, held for use as exhibition samples;

b) the means intended for carrying out preregistration researches (testing);

c) the means imported on customs area of the Union for the purpose of, stipulated in Item 239 these rules;

d) the components intended for production of means;

e) the samples of means intended for examination for the purpose of registration of means or implementation of other procedures connected with registration and standard samples;

e) the means which are not intended for realization on customs area of the Union (export to the third countries).

14. Within the Union it is forbidden:

a) registration under one trade name of the means having:

identical high-quality and quantitative composition of active ingredients of means (except for the means having the international non-proprietary name or the chemical name as the trade name);

different high-quality composition of active ingredients of means;

identical high-quality, but different quantitative composition of active ingredients of means;

b) registration under different trade names of the means having identical high-quality and quantitative structure and presented on registration by one owner in the form of 2 and more means. Registration under different trade names of the means having identical high-quality and quantitative structure in the following cases is allowed:

use of the offered trade name can contradict rules of law and morals or otherwise does not consider national cultural and (or) language peculiarities;

means was registered under different trade names according to the legislation of state members to the introduction of these rules in force.

15. The registration of means or other procedures connected with registration (entering into the registration file of means of changes, reduction of the registration file of means into compliance with requirements of these rules, recognition of registration of the means registered within the Union in the states which joined the Union after registration of means, cancellation of registration of means), and also suspension of the address of means are performed by authorized bodies.

16. The authorized body according to the legislation of state member can delegate the powers on registration of means and implementation of other procedures connected with registration, to expert organization.

17. The decision on registration of means or on implementation of other procedures connected with registration is accepted by authorized body based on results of examination of means.

18. In case of disagreement of the applicant and (or) one of authorized bodies with the decision made by reference body for registration following the results of registration of means or implementation of other procedures connected with registration, settlement of disagreements is performed according to subsection 12 of the Section IV of these rules.

19. Following the results of registration or reduction of the registration file of means in compliance with requirements of these rules in the register of DDD-means of the Union the registration number created according to the following scheme is assigned to means by use of the integrated information system of the Union (further - the integrated system):

XXXXX-EAES-NNNNNN-YY,

where:

XXXXX - the abbreviation designating means type:

DZAKS (for disacariasis means);

DZINS (for disinsection means);

DZIFS (for disinfectant);

EEU - Eurasian Economic Union;

NNNNN№-6-unit sequence number assigned by reference body for registration to means in case of registration;

YY - 2-unit alphabetic international code of state member which authorized body is reference body for registration.

The registration number assigned to means remains during all circulation period of means.

20. Registration of means according to these rules is termless.

21. The register of DDD-means of the Union is created and kept according to procedure according to appendix No. 3.

22. Examination of means is performed by the expert organization determined by authorized body according to the legislation of state member.

23. Authorized bodies and expert organizations provide confidentiality of the information containing in the registration file of means, received in the course of its registration or implementation of other procedures connected with registration according to the legislation of state members.

24. Before filing of application on registration of means or for the purpose of implementation of other procedures connected with registration, authorized bodies and (or) expert organizations of state members have the right to hold at the request of the applicant preregistration consultations according to the legislation of state members concerning registration of means or implementation of other procedures connected with registration including for the questions concerning carrying out preregistration researches (testing) of means, kind of the scheme of registration of means (or implementation of other procedures connected with registration) for the purpose of scoping of documents and data of the registration file of means, need of transfer of the registration file of means and (or) other registration materials on state language (if Russian in this state member is not state), format of filing of application and the registration file of means, need of provision of samples of means, standard samples, specific reactants (reagents), consumable materials necessary for conducting examination of samples of means for expert organization, and also on other questions connected with the address of means.

If Russian in state member is not state, the authorized body of this state member during preregistration consultations notifies the applicant by the official letter on need of representation of transfer of the registration file of means and (or) other registration materials on state language (in the presence of relevant requirements in the legislation of state member).

25. Only one authorized body can act as reference body for registration.

The applicant independently performs the choice of reference body for registration in case of filing of application about registration of means or for the purpose of initiation of other procedure connected with registration, except as specified, determined by these rules.

26. Information exchange of reference body for registration with authorized bodies and (or) expert organizations, and also with the Eurasian economic commission (further - the Commission) is performed electronically with use of means of the integrated system.

27. About the made decisions concerning registration of means or implementation of other procedures connected with registration, the reference body for registration within 5 working days from acceptance date of the relevant decision informs authorized bodies and (or) expert organizations by use of means of the integrated system, and the applicant - by the direction of the official letter in electronic form or the registered mail with the assurance of receipt. In case of the direction of the letter it is considered the registered mail received after 5 working days from the date of the direction of the letter, and in case of the direction in electronic form - in day of the direction.

28. In case of completion of the procedure of registration of means or implementation of other procedures connected with registration with negative result the reference body for registration for the written request of the applicant sent to reference body for registration within 90 calendar days acceptance date by reference body for registration of the decision returns the following paper documents:

the registration file of means provided within the procedure of registration of means;

the documents submitted by the applicant within the procedure of entering into the registration file of the registered means of changes (further - the procedure of modification) according to the list of the changes of the registration file of means which are requiring or not requiring conducting examination of means (further - the list of changes), according to appendix No. 4;

the registration file of means updated according to these rules (further - the updated registration file), and explanatory note reasons, the reductions of the registration file of the means registered according to the legislation of state members before entry into force of these rules provided by the applicant within the procedure in compliance with requirements of these rules (further - the procedure of reduction in compliance of the registration file).

In case of absence in the specified terms of the written request from the applicant on return of the specified documents the reference body for registration makes the decision on their further storage, utilization and (or) destruction according to the legislation of state member.

29. In case of completion of the procedure of registration of means or implementation of other procedures connected with registration with positive result the applicant approves transfer of the instruction for use of means and prototype of packaging of funds for state language with authorized body of state member in the territory of which the address of means is planned if Russian in this state member is not state (in the presence of relevant requirements in the legislation of state member).

30. The expenses on registration of means or implementation of other procedures connected with registration and also on conducting inspections incurred by the applicant regarding observance of requirements of the these rules initiated in connection with implementation of the specified procedures are not compensated.

2. General principles of examination of means

31. Expertize of means is carried out by quality evaluation, safety and efficiency of means and includes:

a) examination of the registration file of means or the documents supplementing the registration file of means which provides:

check of completeness and reliability of the provided data on quality, safety and efficiency of means;

check of coordination of the documents which are part of the registration file of means or supplementing the registration file of means;

b) examination of samples of means in the cases provided by these rules which includes:

carrying out researches (testing) of samples of means (in the cases provided by these rules) on compliance to requirements of the regulating document of means;

assessment of conformity of the received results of researches (testing) of samples of means (in the cases provided by these rules) to requirements of the regulating document of means;

assessment of reproducibility of the means control methods provided by the applicant;

registration of results of researches (testing) of samples of means the protocol (protocols) of researches (testing) with indication of the used methods of quality control (in cases of carrying out researches (testing) of the samples of means provided by these rules);

c) assessment of conformity of the received results of researches (testing) of samples of means and data from the provided registration file of means regarding quality of means;

d) execution of the expert opinion.

32. Expertize of means is carried out by experts of expert organization, and also the experts of other expert organizations or organizations involved by expert organization in case of need.

33. The expert responsible for forming of the expert opinion shall have the higher veterinary, medical, pharmaceutical, biological, biotechnological and (or) chemical education, work experience in area of examination of means at least 3 years, and its competence shall be confirmed according to the legislation of state member.

34. When conducting examination of means:

a) the expert has no right:

be in any dependence from the face or groups of persons, both legal, and physical which can act for the benefit of the applicant;

request from the applicant or other persons the materials necessary for conducting examination. In case of insufficiency of data and (or) information in the registration materials which arrived in expert organization, for execution of the expert opinion the expert organization makes the corresponding inquiry in reference body for registration. The reference body for registration sends to the applicant the corresponding inquiry for submission of required materials;

disclose data which became known to the expert in connection with conducting examination of means, and also information carried to the state secret (the state secrets) according to the legislation of state members;

carry out expertize of means according to the unofficial address of the applicant, to independently collect materials for conducting examination, carry out expertize on commercial basis;

b) the expert shall:

carry out expertize of the registration file of means or the documents supplementing the registration file of means in full to draw the reasonable and objective conclusion on the questions raised before it or the motivated conclusion about impossibility of conducting examination of means;

petition before the head of expert organization for attraction to conducting examination of means of other experts (including from other expert organizations or the organizations) if necessary;

ensure safety of the provided registration materials;

provide utilization and (or) destruction of undrawn balances of means.

35. The expert to whom conducting examination of means is entrusted independently and independently conducts researches (testing) of samples of means, estimates the results received by it personally and (or) other experts and formulates conclusions concerning the questions posed within the competence.

36. The expert involved to conducting examination of means is warned about responsibility for forming of the conclusion containing unreasonable or counterfeited conclusions according to the legislation of state member.

37. In case of impossibility of carrying out by expert organization of examination of the samples of means provided by the applicant, the decision on the place and conditions of conducting such examination is accepted by reference body for registration according to the legislation of state member.

Delivery of samples of means to the venue of examination of samples of means (including in the test laboratory (center) of this or other state member or reference laboratory (center) of the third country allocated with body, competent of the established field of activity, appropriate authority) is performed by the applicant at own expense. Expenses on delivery of compensation are not subject.

38. In case of impossibility of conducting examination of the samples of means provided by the applicant because of their unfitness for conducting examination the reference body for registration notifies on it the applicant by methods and in time which are stipulated in Item 27 these rules, from the date of receipt of the relevant information from expert organization.

The applicant within 45 working days from the date of receipt of such notification repeatedly represents necessary samples of means to expert organization. Implementation of registration of means or other procedures connected with registration and providing examination of means samples for this period stops.

In case of not receipt within 45 working days in expert organization of samples of means or repeated representation by the applicant of the samples of means unsuitable for conducting examination, the expert organization within 5 working days from the date of renewal of the procedure of registration of means informs on it reference body for registration which within 5 working days from the date of its informing makes the decision on completion of the procedure of registration of means or implementation of other procedures connected with registration and providing examination of means samples and notifies on it the applicant, authorized bodies and (or) expert organizations by methods and in time which are stipulated in Item 27 these rules.

39. When conducting examination of means the reference body for registration and (or) expert organizations through reference body for registration has the right to send to the applicant by methods and in time which are stipulated in Item 27 these rules, single request about the submission of missing (additional) information, necessary explanations or amendments concerning the documents which are part of the registration file of means, and the data specified in the registration file of means (including offers on modification of the instruction for use of means, prototypes primary and in the presence of secondary packagings of means (further - prototypes of packagings), the regulating document on the means or other documents which are part of the registration file of means).

In case of the additional questions concerning the data provided by the applicant in the response to prior request, the direction of the additional specifying requests it is performed through reference body for registration.

40. The term of submission by the applicant of responses to the requests of reference body for registration specified in Item 39 of these rules and (or) expert organization shall not exceed 90 working days from the date of receipt by it the corresponding request. If preparation of the response to such request requires carrying out additional researches (testing) of means and (or) representation of materials it is impossible in the specified time, the applicant has the right to file in reference body for registration petition (in Russian in a free form) about prolongation of term of representation of reply to the request (with reasons for need of increase in term). In the presence of good causes to believe that at the scheduled time reply to the request cannot be provided, the specified term can be extended by reference body for registration. At the same time aggregate term of the response of the applicant to request shall not exceed 180 working days.

41. The term of submission by the applicant of responses to the request (requests) of reference body for registration specified in Item 39 of these rules and (or) expert organization is not included into terms of conducting examination of means, registration of means and implementation of other procedure connected with registration of means.

42. In case of non-presentation by the applicant in stipulated in Item 40 these rules the term of the these rules of documents and data requested according to Item 39 examination of means stops. The reference body for registration notifies the applicant, authorized bodies and (or) expert organizations on the made decision by methods and in time which are stipulated in Item 27 these rules.

43. By results of examination of means preliminary and final expert opinions of the commission of experts of expert organization in form according to appendix No. 5 are drawn up.

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