DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of April 22, 2024 No. 36

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

According to 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. Bring in the Regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of January 21, 2022 No. 1 (further – Rules), changes according to appendix.

2. Ask the Eurasian economic commission together with authorized bodies of state members of the Eurasian Economic Union within 6 months from the date of the introduction of this Decision in force to handle issue on modification of Rules, the veterinary medicines providing the procedure of registration at the initiative of state member of the Eurasian Economic Union registered according to Rules in one of state members of the Eurasian Economic Union.

3. This Decision shall enter into force upon the expiry of 30 calendar days from the date of its official publication.

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

 

Appendix

to the Decision of Council of the Eurasian economic commission of April 22, 2024 No. 36

The changes made to Regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union

1. In the text to replace the word "substandard" in the corresponding number and case with the word "low-quality" in the corresponding number and case, shall be replaced with words words of "clinical trials (testing)" "clinical trials (testing) of veterinary medicines", shall be replaced with words the word "destruction" in the corresponding case "destruction (utilization)" in the corresponding case, "preclinical and" shall be replaced with words words "preclinical researches (testing) of veterinary medicines and", shall be replaced with words the words "collection (duty)" in the corresponding case "collection (duty) or other obligatory payments" in the corresponding case, the word "reagents" shall be replaced with words "reactants (reagents)", the words "list of documents" in the corresponding case shall be replaced with words "the list of changes" in the corresponding case.

2. In Item 5:

a) the offer first of the paragraph of the eighth after words of "functions of organism of animal" to add with words "(including anesthetic)";

b) in the paragraph the twenty second shall be replaced with words words of "pharmacopoeian Article" "pharmacopoeian Article of the Pharmacopoeia of the Union";

c) in the paragraph twenty third shall be replaced with words words of "pharmacopoeian Article" "pharmacopoeian Article of the Pharmacopoeia of the Union";

d) to exclude the paragraph of the thirty second;

e) after the paragraph of the thirty fifth to add with the paragraph of the following content:

"low-quality veterinary medicine" – the veterinary medicine which is not conforming to requirements of the regulating document of veterinary medicine or pharmacopoeian Article of the Pharmacopoeia of the Union (in the presence);";

e) the paragraph of the thirty sixth after words "to quality control of veterinary medicine," to add with the words "drawn up by the owner of veterinary medicine and";

g) to add the paragraph of the thirty seventh after words of "preclinical researches (testing)" with words of "veterinary medicines";

h) the forty first after words of "preclinical researches (testing)" to add the paragraph with words of "veterinary medicines";

i) in the paragraph the fifty second shall be replaced with words words of "the third states" "the third countries";

j) the fifty fourth to state the paragraph in the following edition:

"reference veterinary medicine" – the veterinary medicine included in the register of veterinary medicines of the Union based on the registration file of the veterinary medicine containing results of all preclinical researches (testing) of veterinary medicine and clinical trials (testing) of veterinary medicine confirming its quality, safety and efficiency and also used as medicine of comparison and being standard by which are determined properties of veterinary medicine (are normalized);";

k) in the paragraph the fifty eighth the words "the veterinary medicine made" shall be replaced with words "amount of the veterinary medicine made";

l) after the paragraph of the sixty first to add with the paragraph of the following content:

"the authorized person of the producer of veterinary medicines" – the employee of the company who is certified according to the legislation of state member, on whom responsibility for quality of the veterinary medicines made and issued in realization is conferred and who guarantees that each series of veterinary medicine is made and checked according to Rules of proper production practice of the Eurasian Economic Union, and also taking into account provisions of the regulating document for veterinary medicine and the registration file of veterinary medicine;".

3. Add the Section II with Item of 71 following contents:

"71. Specifications and methods of quality control of veterinary medicines are determined according to the Pharmacopoeia of the Eurasian Economic Union approved by the Decision of Board of the Eurasian economic commission of August 11, 2020 No. 100 (further – the Pharmacopoeia of the Union), and in case of absence in it necessary pharmacopoeian Article – according to pharmacopeias of state members, and in case of absence in them pharmacopoeian Article – according to the regulating document on veterinary medicine.".

31. The subitem "b" of Item 9 after words of "medicine" to add with words "(except for productions of pharmaceutical substance)".

4. Add with Item of 91 following contents:

"91. The producer of veterinary medicine performs quality check and safety of each series of the produced veterinary drug on compliance to indicators of the regulating document on veterinary medicine and by results of this check processes the document confirming quality and safety of veterinary medicine (the quality certificate, the analytical passport, etc.).".

5. Declare Item 10 invalid.

6. In the name of subsection 1 of the Section IV to replace the word "registration" with the word "addresses".

7. In Item 24:

a) the subitem "b" after words "having" to add with words "the current license and";

b) add with the subitem "v" of the following content:

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

8. Add with Item of 241 following contents:

"241. On customs area of the Union the address of low-quality, counterfeited, counterfeit veterinary medicines, the veterinary medicines which are not registered according to these rules (except as specified, the these rules determined by Item 340), and also veterinary medicines expired is forbidden.

Low-quality, counterfeited, counterfeit veterinary medicines, and also veterinary medicines expired are subject to retirement on customs area of the Union and to the subsequent destruction (utilization) 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).

Destruction (utilization) of low-quality, counterfeited, counterfeit veterinary medicines, and also veterinary medicines expired is 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 veterinary medicines, and also veterinary medicines expired bear responsibility according to the legislation of state member in the territory of which violation established fact.".

9. In paragraph one of Item 32 of the word" (registration confirmations, reductions of the registration file of veterinary medicine in compliance with requirements of these rules)" shall be replaced with words "or reductions of the registration file of veterinary medicine in compliance with requirements of these rules".

10. Item 36 in paragraph one:

a) after words "the statement and the registration file" to add with words of "veterinary medicine";

b) shall be replaced with words the word of "reactants" "reactants (reagents)".

11. In Item 38 of the word "in electronic form" shall be replaced with words "electronically".

12. In Item 41:

in the offer the first shall be replaced with words the words "in electronic form and" "in electronic form or";

the offer second to state in the following edition: "In case of the direction of the letter it is considered the registered mail received after 5 working days from the date of its sending, and in case of the direction in electronic form – in day of sending.".

13. In Item 42:

a) in paragraph one shall be replaced with words the word of "applicant" ", sent by the applicant in writing to reference body for registration within 90 calendar days from acceptance date by reference body for registration of the relevant decision,";

b) state the subitem "v" in the following edition:

"c) the documents submitted by the applicant within the procedure of entering into the registration file of the registered veterinary medicine of changes (further – the procedure of modification) according to the list according to appendix No. 6 (further – the list of changes);".

14. Add with Items 421 and 422 of the following content:

"421. In case of not receipt from the applicant in time, the reference body for registration specified in paragraph one of Item 42 of these rules, request about return of documents makes the decision on their further storage or destruction (utilization) according to the legislation of state member.

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

15. In Item 44:

a) in the subitem "b":

in the paragraph the second to exclude the words "in accredited laboratories (the test centers)";

word in paragraph five shall be replaced with words "assessment of conformity" "in) assessment of conformity";

b) state the subitem "v" in the following edition:

"d) execution of the expert opinion.".

16. In Item 46:

a) after the word "biological" to add with the word", biotechnological";

b) words "degree of the master or academic degree in main area" to exclude.

17. In Item 47:

a) in the paragraph the second the subitem "an" of the word", appointed examination, from the applicant or other persons interested in results of examination" shall be replaced with words "or groups of persons (both legal, and physical) which can act for the benefit of the applicant";

b) in the paragraph the second the subitem "b" of the word of "registration materials" shall be replaced with words "the registration file of veterinary medicine or documents supplementing the registration file of veterinary medicine".

18. To add Item 48 after words of "research (testing)" with words of "samples of veterinary medicine".

19. In paragraphs one and the second Item 50 of the word "The international epizootic bureau" shall be replaced with words "World Health Organization of animals".

20. The offer second of Item 53 and the offer first of Item 57 after words of "researches (testing)" to add with words of "samples of veterinary medicine".

21. State Item 58 in the following edition:

"58. In case of attraction by reference body for registration according to Item 45 of these rules of other expert organizations or organizations the reference body for registration appoints one of them responsible for generalization of all results of examination of veterinary medicine.".

22. In the offer the first Item 68 of the word "45 working days" shall be replaced with words "45 working days from the date of receipt of the decision of reference body for registration on conducting examination of veterinary medicine".

23. The offer first of Item 69 after words of "researches (testing)" to add with words of "samples of veterinary medicine".

24. In paragraph three of Item 70 of figure "90" to replace with figures "95".

25. Paragraphs the first – third Item 77 to recognize invalid.

26. In paragraph one of Item 78 of the word", and also transfer of the drafts of the instruction for use of veterinary medicine and the text approved by reference body for registration on the project of prototype of packaging from Russian on state language of state member in the territory of which the address of veterinary medicine is supposed (in the presence of relevant requirements in the legislation of state member)" to exclude.

27. In Item 79:

a) replace figures "20" with figures "15";

b) words" and to make transfer from Russian into state language of state member in the territory of which the address of veterinary medicine, approved by reference body for registration of the draft of the instruction for use of veterinary medicine and the text on the project of prototype of packaging of veterinary medicine is supposed (in the presence of relevant requirements in the legislation of state member)" to exclude.

28. In Item 81 of the word", and also in case of representation on the electronic medium of transfer from Russian into state language of state member in the territory of which the address of veterinary medicine, approved by reference body for registration of the draft of the instruction for use of veterinary medicine and the text on the project of prototype of packaging of veterinary medicine is supposed (in the presence of relevant requirements in the legislation of state member)" and "(including to their transfer from Russian into state language of state member in the territory of which the address of veterinary medicine is supposed (in the presence of relevant requirements in the legislation of this state member))" to exclude.

29. Declare Item 82 invalid.

30. In Item 88:

a) the offer first to add with the words "with maintaining confidentiality of information about the experts who are in the expert opinion";

b) the offer second to exclude.

31. In Item 89:

a) in the subitem "b" of the word "and in state language of state member in the territory of which the address of veterinary medicine is supposed (in the presence of relevant requirements in the legislation of state member)" to exclude;

b) in the subitem "v" of the word "and in state language of state member in the territory of which the address of veterinary medicine is supposed (in the presence of relevant requirements in the legislation of state member)" to exclude.

32. In the subitem "v" of Item 91 of the word", and (or)" to exclude non-presentation of transfer from Russian into state language of state member in the territory of which the address of veterinary medicine, the draft of the instruction for use of veterinary medicine and the text on the project of prototype of packaging of veterinary medicine is supposed (in the presence of relevant requirements in the legislation of state member).

33. The offer second of the subitem "an" of Item 92 after words of "researches (testing)" to add with words of "samples of veterinary medicine".

34. In Item 113 of figure "10" to replace with figures "15".

35. In Item 118:

a) in paragraph one of the word "based on data of pharmakonadzor" to exclude;

b) word in paragraph three", their transfer from Russian into state language of state member in the territory of which veterinary medicine in accordance with the terms of registration addresses (in the presence of relevant requirements in the legislation of state member), and" shall be replaced with words "and them".

36. In Item 120 of the word "and (or) non-presentations of their transfer from Russian into state language of state member in the territory of which veterinary medicine in accordance with the terms of registration addresses (in the presence of relevant requirements in the legislation of state member)" to exclude.

37. In Item 126:

a) the offer first to add with the words "with maintaining confidentiality of information about the experts who are in the expert opinion";

b) the offer second to exclude.

38. In Item 127:

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