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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of January 21, 2022 No. 1

About regulations of the address of veterinary medicines 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 veterinary medicines on customs area of the Eurasian Economic Union (further - Rules).

2. Determine that:

a) registration of veterinary medicines and other related procedures, 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) registration of veterinary medicines and other related procedures can be performed according to the legislation of state member from the effective date of Item 1 of this Decision till December 31, 2027 for the purpose of the address of such veterinary medicines only in the territory of this state member (taking into account provisions of the subitem "i" of this Item);

c) the registration certificates of veterinary medicines 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 on customs area of the Union during the terms established according to the legislation of state members, but no later than December 31, 2027;

d) the registration certificates of veterinary medicines issued according to the subitem "b" of this Item are valid for the territories of the corresponding state member within 5 years;

e) registration files of the veterinary medicines registered according to subitems "an" and "v" of this Item are subject to reduction in compliance with Rules till December 31, 2027;

e) registration files of the veterinary medicines registered according to the subitem "b" of this Item are subject to reduction in compliance with Rules before expiry date of their registration certificates according to the subitem "g" of this Item;

g) in case of refusal in registration of veterinary medicines and in implementation of other related procedures according to subitems "an" and "b" of this Item the representative in the field of the address of veterinary medicines the body of state member (further - authorized body) informs on it authorized bodies of other state members (with indication of causes of failure);

h) the documents confirming compliance of production of veterinary medicines to requirements of rules of proper production practice of state members and issued by authorized bodies according to the legislation of state members till January 1, 2021 are valid before the termination of term of their action, but no later than December 31, 2025, and mutually are recognized authorized bodies of all state members;

i) the address of the veterinary medicines registered in state members according to their legislation and containing in the structure the veterinary medicines included in the list provided by appendix No. 4 to Rules stops from the effective date Item 1 of this Decision, their registration is cancelled, and veterinary medicines are subject to retirement on customs area of the Union;

j) during the term specified in the subitem "v" of this Item, the authorized body of state member can request from authorized body of other state member of the copy of documents and the data, the confirming quality, safety and efficiency of the veterinary medicines addressing in the territory of the state registered according to the legislation of this other state member before the date of entry into force of Item 1 of this Decision for the purpose of implementation of the state control (supervision) by assessment of conformity of these drugs to the specified documents (data).

The authorized body within 30 calendar days from the date of receipt of request represents the following copies of documents and the data in Russian:

copy of the application instruction of veterinary medicine;

data on methods of quality control of veterinary medicine (including specifications);

copies of protocols of researches (testing) of samples of veterinary medicine;

copies of techniques of determination of residual amount of active ingredients of pharmaceutical veterinary medicines and (or) their metabolites in raw materials of animal origin (for the veterinary medicines intended for the purpose of use for productive animals including for objects of aquaculture of animal origin) and data on specifications (in case of lack of the corresponding state standard);

copies of pages of reports on performing preclinical and clinical trials (testing) of veterinary medicine containing data on the period of carrying out researches (testing), quantity of experimental animals and the received results, or the copy of pages of the report on carrying out production researches (testing) of veterinary medicine, or the copy of pages of the report on carrying out researches (testing) of bioequivalence of veterinary medicine;

data on biological safety of veterinary medicine (for vaccines);

k) during the term specified in the subitem "v" of this Item, the authorized body can prohibit the address in the territory of the state of the veterinary medicine registered according to the legislation of other state member before the date of entry into force of Item 1 of this Decision in the following cases:

non-presentation of the copies of documents and data requested by it according to the subitem "k" of this Item, except for emergence of circumstances, independent of authorized body (including force majeure circumstances);

systematic detection of discrepancy of quality of this veterinary medicine to requirements of the regulating document of veterinary medicine following the results of implementation of selective control of quality of veterinary medicines (at least 3 different series within calendar year);

recognition of veterinary medicine by results of carrying out researches (testing) inefficient and (or) unsafe.

Discrepancy of content and (or) execution of the copies of documents and data provided according to the subitem "k" of this Item to requirements of the legislation of state member which authorized body sent inquiry cannot be the basis for address prohibition in the territory of this state of veterinary medicine;

l) before enforcement of general processes within the Union by means of which realization information exchange between authorized bodies (expert organizations) of state members and the Eurasian economic commission is performed (further - the Commission) exchange of documents and data on paper and (or) in electronic form is allowed;

m) permission of the disputable situations connected with the address of the veterinary medicines 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) authorized bodies (expert organizations) of state members including in case of:

registration of veterinary medicine;

registration confirmation of veterinary medicine;

entering into the registration file of veterinary medicine of changes;

reduction of the registration file of veterinary medicine in compliance with requirements of Rules;

recognition of registration of veterinary medicine;

inspection of production of veterinary medicines;

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

4. Ask authorized bodies:

a) till January 1, 2026 to develop system of use of antimicrobic veterinary medicines for the purpose of increase in efficiency used within the Union of measures of fight against antimicrobic resistance and to inform on it the Commission;

b) before the date of entry into force of Item 1 of this Decision together with the Commission to handle issue of possibility of simplification of the procedure of reduction of the registration file of veterinary medicines in compliance with requirements of Rules for separate groups of the veterinary medicines including made in state members and also question of establishment of additional requirements to pharmaceutical inspectors of the Union and if necessary to provide offers on modification of Rules.

5. 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 effective date of this Decision.

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

B. Sultanov

From the Kyrgyz Republic

A. Kozhoshev

From the Russian Federation

A. Overchuk

 

Approved by the Decision of Council of the Eurasian economic commission of January 21, 2022 No. 1

Regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union

I. General provisions

1. Scope

1. These rules determine procedure for regulation of the address of veterinary medicines on customs area of the Eurasian Economic Union (further - the Union).

Regulation of the address of veterinary medicines 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 veterinary medicines, owners of veterinary medicines (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 veterinary medicines, and other subjects of the address of veterinary medicines authorized in the field of the address of veterinary medicines.

3. These rules are not applied to veterinary medicines which are intended for use in the conditions of military operations, in emergency situations, for prevention and treatment of diseases and defeats of the animals received as a result of impact of adverse chemical, biological, radiation factors or in other situations requiring acceptance of immediate measures according to the legislation of state members and also are 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

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

a) realization of single approaches to registration of veterinary medicines;

b) ensuring unity of mandatory requirements to quality, safety and efficiency of veterinary medicines 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 veterinary medicines;

d) taking measures, necessary for consumer protection from use of substandard, counterfeited and counterfeit veterinary medicines.

3. Determinations

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

"safety of veterinary medicine" - the characteristic of veterinary medicine based on comparative analysis of its efficiency and risk of damnification to health of animals;

"biological availability" - the speed and degree with which active ingredient or active part of its molecule from the dosed dosage form are soaked up and become available in the scene of action;

"biological veterinary medicine" - veterinary medicine which active ingredient is made or emitted from biological source. Immunological (immunobiological) veterinary medicines, biotechnological veterinary medicines, gene therapeutical veterinary medicines and bacteriophages belong to biological veterinary medicines;

"biotechnological veterinary medicine" - veterinary medicine which production is performed with use of bioengineering procedures and methods (including technologies of recombinant DNA, technology of controlled expression of the genes coding biologically active proteins in prokariota and eukaryotes including the changed cells of mammals), gibridomny method and method of monoclonal antibodies;

"import of veterinary medicines" - movement of veterinary medicines through customs border of the Union for the purpose of their address on customs area of the Union;

"veterinary drugstore" - the legal entity or his structural division, the physical person registered as the individual entrepreneur performing retail trade (realization) by veterinary medicines, their storage, leave and production guaranteeing quality and safety of the veterinary medicine made in this drugstore (the veterinary drugstore can perform wholesale trade if it is stipulated by the legislation state member);

"veterinary medicine" - the means representing substance or containing the substance or combination of substances coming into contact with organism of animal and intended for treatment, prevention of diseases of animals, rehabilitation, correction or change of physiological functions of organism of animal, preserving, prevention or abortion, euthanasia and also for diagnosis of diseases of animals (except for substances or their combinations which are not contacting to animal organism). Active ingredients, including pharmaceutical substances, and also veterinary medicines belong to veterinary medicines;

"veterinary medicine" - veterinary medicine in the form of dosage form;

"the reproduced veterinary medicine (generic)" - veterinary medicine which has the same quantitative and high-quality composition of active ingredients and the same dosage form, as reference veterinary medicine and which bioequivalence to reference veterinary medicine is confirmed by the corresponding researches (testing) of biological availability (different salts, ethers, isomers, mixes of isomers, complexes or derivatives of active ingredient are recognized the same active ingredient if their safety and efficiency significantly do not differ);

"excipient" - substance, except for pharmaceutical substances, being part of veterinary medicine for giving of necessary properties to it;

"secondary package" - packaging in which veterinary medicine in primary package is located. The secondary package is consumer in case of intake of veterinary medicine in this packaging to the consumer;

"the gene therapeutical veterinary medicine" - veterinary medicine which pharmaceutical substance is recombinant nucleic acid or includes the recombinant nucleic acid allowing to perform regulation, reparation, replacement, addition or removal of the genetic sequence;

"homeopathic veterinary medicine - the veterinary medicine made or made according to requirements of general pharmacopoeian clauses of the Pharmacopoeia of the Union about homeopathic dosage forms or in case of their absence - pharmacopeias of state members;

"active ingredient" - substance of biological, biotechnological, mineral or chemical origin as a part of veterinary medicine with which effect on organism of animal efficiency of this drug is connected;

"preclinical trials (testing) of veterinary medicine" - biological, microbiological, immunological (immunobiological), toxicological, pharmacological, physical, chemical researches (testing) including studying of processes of absorption, distribution, change and removal of veterinary medicine, other researches (testing) of veterinary medicine conducted using scientific evaluation methods for the purpose of receipt of proofs of safety, quality and efficiency of veterinary medicine;

"applicant" - the owner of veterinary medicine 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 veterinary medicine or for implementation of other procedures connected with registration and necessary documents to authorized body;

"production of veterinary medicines" - production by veterinary drugstore of veterinary medicines for certain animals according to recipes of veterinarians;

"immunological (immunobiological) veterinary medicine" - the veterinary medicine intended for forming of active or passive immunity, either determination of the immune status of animal, or diagnosis (development) of the specific acquired change of the immunological answer to allergenic substances. Vaccines, anatoxins, toxins, serums, immunoglobulins and allergens belong to immunological (immunobiological) veterinary medicines;

"the application instruction of veterinary medicine" - the document accompanying the registered veterinary medicine regulating procedure for its use and also containing information on properties of this drug;

"research (testing) of bioequivalence of veterinary medicine" - preclinical trial (testing) of veterinary medicine regarding its compliance to reference veterinary medicine by determination of its biological availability and the period of its semi-removal after introduction to animal in the same dosage form and dosage, as reference veterinary medicine;

"high-quality veterinary medicine" - the veterinary medicine conforming to requirements of the regulating document of veterinary medicine or pharmacopoeian Article (in the presence);

"quality of veterinary medicine" - compliance of veterinary medicine to requirements of the regulating document of veterinary medicine or pharmacopoeian Article (in the presence);

"clinical trial (testing) of veterinary medicine" - research (testing) conducted for the purpose of efficiency evaluation of veterinary medicine by studying of diagnostic, medicinal, preventive, pharmacological properties of this drug in the course of its use, and also for the purpose of data acquisition about possible adverse reactions of organism of animal that type for which this drug will be used, to use of veterinary medicine and about effect of its interaction with other veterinary medicines and (or) feed additives, sterns;

"counterfeit veterinary medicine" - the veterinary medicine 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;

"dosage form" - the condition of veterinary medicine corresponding to methods of its introduction and use and providing achievement of necessary effect;

"medicinal vegetable raw materials" - the fresh or dried-up plants, seaweed, mushrooms or lichens or their parts, integral or crushed, used for production or production of veterinary medicines;

"material balance" - ratio between amount of initial raw materials, materials, semi-products and intermediate products, necessary for production of one series of veterinary medicine on the equipment specified in the registration file of veterinary medicine and quantity of actually received finished goods, by-products, waste and losses (ratio of theoretically possible and almost received exit of finished goods);

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

"narcotic veterinary medicine" - the veterinary medicine containing drugs and included in lists of the drugs, psychotropic substances and their precursors which are subject to control according to the legislation of state members, and also the Agreement on procedure for movement of drugs, psychotropic substances and their precursors on customs area of the Customs union of October 24, 2013 and Regulations on import to customs area of the Eurasian Economic Union and export from customs area of the Eurasian Economic Union of drugs, psychotropic substances and their precursors (appendix No. 10 to the Decision of Board of the Eurasian economic commission of April 21, 2015 No. 30);

"adverse reaction" - side effect, undesirable reaction, undesirable unexpected reaction, undesirable serious reaction in case of use of veterinary medicine, individual intolerance, lack of efficiency of veterinary medicine, feature of interaction with other veterinary medicines, other facts and circumstances posing threat of life or to health of animal or influencing change of the attitude of the expected advantage towards possible risk of use of veterinary medicines;

"substandard veterinary medicine" - the veterinary medicine which is not conforming to requirements of the regulating document of veterinary medicine or pharmacopoeian Article (in the presence);

"undesirable unexpected reaction" - undesirable reaction, nature, severity and which outcome do not correspond to information containing in the application instruction of veterinary medicine;

"undesirable reaction" - the inadvertent adverse reaction of organism of animal connected using veterinary medicine or assuming availability at least of possible interrelation using veterinary medicine;

"undesirable serious reaction" - undesirable reaction which leads to the death of animal poses threat for his life, leads to congenital anomalies or malformations and requires intervention of the veterinarian (or the specialist in the field of veterinary science) for prevention of development of the specified conditions;

"the regulating document on veterinary medicine" - the document on quality control of veterinary medicine containing list of indicators of quality of veterinary medicine 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 dosage form;

"the address of veterinary medicines" - the activities including development, carrying out preclinical trials (testing), clinical trials (testing), examinations, registration or implementation of other procedures connected with registration, quality control, assessment of safety and efficiency, production, 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 veterinary medicines;

"the commonly accepted (grouping) name" - the name of the veterinary medicine which does not have the international non-proprietary name, or combination of the veterinary medicines united in group under one name proceeding from identical high-quality composition of active ingredients;

"primary package" - the packaging which is directly adjoining to veterinary medicine. The primary package is consumer in case of intake of veterinary medicine in this packaging to the consumer;

"side effect" - the reaction of organism to use of veterinary medicine described in appropriate section of the application instruction of veterinary medicine;

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

"producer of veterinary medicines" - the organization which is performing activities for production, storage, realization and transfer of veterinary medicines and having the permission (license) for such type of activity issued to representatives (for the third countries - competent) body of the manufacturing country;

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

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

"psychotropic veterinary medicine" - the veterinary medicine containing psychotropic substances and included in lists of the drugs, psychotropic substances, their analogs and precursors which are subject to control according to the legislation of state members, and also international treaties within the Union;

"radio pharmaceutical veterinary medicine" - veterinary medicine which contains in form one, ready for use, or several radionuclides (radioactive isotopes);

"developer of veterinary medicines" - the legal entity, the physical person registered as the individual entrepreneur or physical person who developed veterinary medicine and in parts or in full conducted researches (testing) of veterinary medicine;

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

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

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

"the register of veterinary medicines of the Union" - the register of the registered veterinary medicines of the Union representing the general information resource containing data on veterinary medicines 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 veterinary medicines representing the general information resource containing data about the state members which are in the territories and the third states producers of veterinary medicines which production is recognized following the results of pharmaceutical inspection to the corresponding Rules of proper production practice of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 77, created with use of means of the integrated information system of the Union;

"the register of pharmaceutical inspectors of the Union" - the register of pharmaceutical inspectors of the Union in the field of the address of veterinary medicines representing the general information resource containing the information about pharmaceutical inspectors of the Union and created with use of means of the integrated information system of the Union;

"reference veterinary medicine" - the veterinary medicine for the first time registered on customs area of the Union based on the registration file of the veterinary medicine containing results of all preclinical and clinical trials (testing) confirming its quality, safety and efficiency;

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

"recipe" - the purpose of veterinary medicine in writing issued by the veterinarian according to the legislation of state member for the purpose of production and (or) leave of veterinary medicine;

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

"series of veterinary medicine" - the veterinary medicine made from homogeneous raw materials as a result of one production cycle;

"specification" - the document containing list of indicators of quality, references to analytical techniques and researches (testing), and also regulation (numerical (quantitative) limits, the ranges and other criteria) for the specified quality indicators which are established by the producer or the developer of veterinary medicine;

"subjects of the address of veterinary medicines" - the authorized bodies, expert organizations, legal entities, physical persons subordinated to these bodies registered as individual entrepreneurs and the physical persons participating in the address of veterinary medicines;

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

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

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

"pharmakonadzor" - the activities of authorized bodies and owners of veterinary medicines directed to identification, assessment and prevention of adverse reactions in case of use of veterinary medicines and intended for control of safety and efficiency of veterinary medicines, early detection of the negative changes connected with the attitude of the expected advantage towards possible risk of use of veterinary medicines for development and deployment of the measures aimed at providing efficiency and safety in case of use of veterinary medicines;

"pharmacopoeian Article" - Article (monograph) establishing requirements of pharmacopeia to veterinary medicines, excipients and materials, and also to researches (testing) and methods of their carrying out;

"pharmaceutical inspection" - the activities of authorized body performed for the purpose of assessment of conformity of production of veterinary medicines to requirements of Rules of proper production practice of the Eurasian Economic Union;

"pharmaceutical substance" - the veterinary medicine intended for production and production of veterinary medicines;

"pharmaceutical veterinary medicine" - veterinary medicine which active ingredient has synthetic, natural, biological or biotechnological origin (radio pharmaceutical veterinary medicines belong to pharmaceutical veterinary medicines);

"the pharmaceutical inspector" - the employee of authorized body or expert organization authorized on conducting pharmaceutical inspection of production of veterinary medicines and included in the register of pharmaceutical inspectors of the Union;

"examination of the relation of the expected advantage to possible risk of use of veterinary medicine" - the examination including examination of quality of veterinary medicine and examination of the registration file of veterinary medicine for the purpose of determination of opportunity (impossibility) of registration of this drug or implementation of other procedures connected with registration;

"expert opinion" - the document containing results of examination of safety, quality, efficiency of veterinary medicine and the attitude of the expected advantage towards possible risk of use of veterinary medicine with the conclusion about possibility (impossibility) of registration of veterinary medicine, confirmation of its registration, entering into the registration file of veterinary medicine of changes, reductions of the registration file of veterinary medicine 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 performing conducting examination of veterinary medicine within registration of veterinary medicine or implementation of other procedures connected with registration and the address of veterinary medicine;

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