DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of September 23, 2022 No. 140

About regulations of the address of diagnostic 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 use 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 solved:

1. Approve the enclosed Regulations of the address of diagnostic means of veterinary appointment on customs area of the Eurasian Economic Union (further - Rules).

2. Determine that:

a) registration of diagnostic 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 diagnostic 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, 2028;

c) registration files of the diagnostic means of veterinary appointment registered according to the legislation of state members are subject to reduction in compliance with Rules till December 31, 2028;

d) the address on customs area of the Union till December 31, 2028 is allowed:

the diagnostic 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 conditions, stipulated in Item 185 Rules;

the diagnostic 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 diagnostic 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 diagnostic 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 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, 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 diagnostic means of veterinary appointment including in case of:

registration of diagnostic means of veterinary appointment;

registration confirmation of diagnostic means of veterinary appointment;

entering into the registration file of diagnostic means of veterinary purpose of changes;

reduction of the registration file of diagnostic means of veterinary appointment in compliance with requirements of Rules;

recognition of registration of diagnostic means of veterinary appointment;

inspection of production of diagnostic means of veterinary appointment;

b) determine the bodies authorized on implementation of registration of diagnostic means of veterinary appointment, other related procedures and (or) inspection of production of diagnostic means of veterinary appointment and to inform on it the Commission;

c) together with the Commission to handle issue of amendment of the list of cases in case of which import to customs area of the Union of the unregistered diagnostic means of veterinary appointment in the Union which is made in the third country is allowed and on quality exceeds the corresponding characteristics of the diagnostic means of veterinary appointment registered in the Union and to provide offers on modification of Rules.

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:

after 24 months from the date of the introduction of this Decision in force - for the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation;

after 48 months from the date of the introduction of this Decision in force - for the Kyrgyz Republic.

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 September 23, 2022 No. 140

Regulations of the address of diagnostic 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 diagnostic means of veterinary appointment which are not coming into direct contact with animals on customs area of the Eurasian Economic Union (further - the Union).

Regulation of the address of diagnostic means of veterinary appointment 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 diagnostic means of veterinary appointment, owners of such 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 diagnostic means of veterinary appointment, and other subjects of the address of such means authorized in the field of the address of diagnostic means of veterinary appointment.

These rules are not applied to diagnostic means of veterinary appointment, requirement for which arises in the conditions of military operations, in emergency situations, for diagnosis of the exotic, and also other diseases requiring the immediate measures according to the legislation 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 ensuring functioning of the market of diagnostic means of veterinary appointment within the Union by means of:

a) realization of single approaches to registration of diagnostic means of veterinary appointment;

b) ensuring unity of mandatory requirements to quality of diagnostic means of veterinary appointment in the territories of state members and their observance;

c) realization of single approaches to creation of system of quality assurance of diagnostic means of veterinary appointment;

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

3. Determinations

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

"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;

"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;

"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;

"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 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, registration or implementation of other procedures connected with registration, quality control, 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 and 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 of means;

"preregistration researches (testing) of means" - researches (testing) conducted for the purpose of quality evaluation 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 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 claim for means" - the claim of the subject of the appeal of means to quality of means which goes in writing to the address of the producer of means and to reference body for registration 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 of means for health of animals or the risks leading to undesirable impact on the environment and health of the person;

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

"means" - the diagnostic means of veterinary appointment which is representing reagent (reactant) or set (set) of specially picked up reagents (reactants), not coming into direct contact with animals, used by in vitro for identification of pathogens, assessment of the immune status and physiological condition of organism of animal;

"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;

"expert opinion" - the document containing results of examination of quality of means with the conclusion about possibility (impossibility) of registration of means, confirmation of its registration, 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.

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 and destruction of means

5. Production of the means which are in circulation on customs area of the Union shall conform to the requirements stated in annex 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 of production) for each production site on which production of means is performed, in form according to appendix No. 2 (further - the certificate).

7. On customs area of the Union production and realization is forbidden:

a) the means which are not registered according to these rules (except as specified, determined by these rules);

b) the means containing live pathogens (except as specified when specified is not applicable for specific means);

c) counterfeited and counterfeit means.

8. 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 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 so that means with smaller period of validity were shipped first of all (rule FEFO - "first expire first out");

e) means which period of validity 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 shall be net, dry, have proper illumination, in them the temperature condition and humidity established in instructions for use of means (in the presence) shall be supported;

g) rooms and the equipment for storage of means shall be net and 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 shall be 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 shall be approved by the responsible person;

k) the distributor delivering means performs their transportation in the conditions ensuring safety and integrity of means, protection them from impact of factors of the environment with observance of these conditions during the whole time of transportation;

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.

9. Additional requirements to storage, transportation and realization of the means which are in circulation are established by the legislation of state members.

10. Destruction of means is performed according to the legislation of state members.

III. Address of means

1. General principles of registration of means

11. 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 existing certificate.

12. 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.

13. Are subject to registration according to these rules:

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

b) new combinations of the means registered earlier;

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

14. 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 for the purpose of use in the cases determined by Item 326 of these rules;

d) the components intended for production of means;

e) the funds raised in the conditions of accredited test laboratories (centers) from separate components (the funds raised in the conditions of accredited test laboratories (centers) from separate components are not subject to realization, are used in this test laboratory (center) according to the legislation of state member);

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 of means;

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

h) the means which are medium for cultivation of microorganisms or cultivation and maintenance of cellular cultures.

15. Within the Union it is forbidden:

a) registration under one trade name of the means having different high-quality structure;

b) registration of the means containing live pathogens (except as specified when specified is not applicable for specific means);

c) 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) tongue peculiarities;

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

16. The registration of means or other procedures connected with registration (registration confirmation, entering into the registration file of means of changes, reduction of the registration file of means in 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.

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 the applicant's disagreement with the accepted one of authorized bodies (including reference body for registration) the decision following the results of registration of means or implementation of other procedures connected with registration, settlement of disagreements is performed according to subsection 16 of the Section IV of these rules.

19. Following the results of registration (registration confirmation, reduction of the registration file of means in compliance with requirements of these rules) in the register of 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):

                                                                                      DIAGS-EAES-NNNNNN-YY,

where:

DIAGS - means;

EEU - Union;

NNNNNN - 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, including in case of registration confirmation of means.

20. Registration term for the first time of the means registered according to these rules intended for identification of causative agents of infectious diseases of the animals included in the Code of health of land animals or the Code of health of water animals of the International epizootic bureau (further - Codes of MEB), and determinations of immune response, constitutes 5 years. After the specified term means is subject to registration confirmation then registration is drawn up for the unrestricted term (termless registration).

Registration for the first time of the means registered according to these rules intended for identification of causative agents of infectious diseases of the animals who are not included in Codes of MEB, and determination of immune response, and also the means which is not intended for identification of causative agents of infectious diseases of animals and determination of immune response is termless.

21. The register of 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.

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