REGULATION  
on State Registration of Veterinary Preparations  
General  
1. This Regulation shall establish the mechanism of  state registration of veterinary preparations 
(the “registration”).  
2. Registration shall be carried out by the State Committee on Veteri nary Medicine based on the 
application submitted by the owner of the registration dossier or their representative (the “applicant”), a resolution of the State Pharm acological Commission on Veterinary Medicine and 
an expert opinion of the National Agency of Veterinary Preparations and Feed Additives or the 
National Agency of Veterinary Immunobiol ogical Preparations (the “agency”).  
The owner of the registration dossier shall be  a legal entity ensuring the collection and 
processing of information on all cases of negativ e reactions to a veteri nary preparation (the 
“preparation”).  
3. During registration of a domestic veterinary  immunobiological preparati on, the applicant must 
deposit strains (cultures) of microorganisms that are used in manufactur ing and controlling such 
preparation in the National Center of Strains of Microorganisms.  
4. It shall be prohibited to regi ster preparations that may wo rsen veterinary, sanitary and 
epizootic situation or cause harm to the health of people or animals.  
5. Decisions of the State Committee on Veterina ry Medicine on regist ering (re-registering), 
suspending or cancelling the re gistration of a preparation ma y be challenged in court.  
Procedure for registering a preparation  
6. To perform an expert examination of the regi stration dossier (the “exa mination”) and register 
the preparation, the applicant shall submit an application to the agency to conduct an 
examination of the preparation togeth er with the registration dossier.  
7. The registration dossier shall be a set of anal ytical and normative documents, documents of a 
specialized assessment (accreditation certificates, instructions on safety and residues of the products, materials of conducted clinical research ). Together with the registration dossier, the 
applicant shall also submit samples of the preparation.  
8. To obtain the registration (re-re gistration), the applicant shall submit a separate application 
and registration dossier for each pharmaceutical (b iological) form, concentration or formulation 
of the preparation.  
The form of the application, the list of material s in the registration dossier and the procedure for 
its forming shall be established by the State Committee on Vete rinary Medicine.  APPROVED by Resolution of the Cabinet of 
Ministers of Ukraine of 21 November 2007 No. 1349 9. The agency shall verify completeness and thoroughness of submitted materials and resolve on 
accepting the registration dossier for examination or  returning it to the a pplicant for additional 
elaboration.  
10. The agency shall conduct the examination on a contract basis within the term not exceeding 
210 days from the date of receiving the applicati on, the full set of documents and the appropriate 
payment.  
11. The agency shall determine whether regist ration testing is necessary, what scope of 
registration testing should  be carried out and whet her it is necessary to test the preparation in 
production conditions; organize the required testing, take other measures to verify information 
and data specified in the documents as well as prepare expert opinions.  
To obtain additional data regarding effectivene ss, safety and quality of the preparation, the 
agency may request additional documents a nd materials from the applicant during the 
examination. The time required to prepare them shall not be added to the term allowed for the 
examination.  
During registration testing, the quality, effectiveness, safe ty, reactivity or diagnostic 
characteristics of the preparation sha ll be studied in vitro and in vivo.  
12. During the examination, the agency shall provi de opinions on results of registration testing 
and the preliminary assessment of the regist ration dossier to the State Pharmacological 
Commission on Veterinary Medi cine, which would review th e said opinions and give 
recommendations to the agency regarding the ad visability of registering the preparation.  
13. Based on examination results, the agency shall prepare expert opinions, in which 
recommendations by the State Pharmacological Commission on Veterinary Medicine shall be 
included, and send those to the applicant and to the State Committee on Veterinary Medicine 
together with a copy of the application receive d in accordance with the procedure stipulated by 
paragraph 6 of the present Regulation.  
14. Based on the documents received from the agency, the State Committee on Veterinary 
Medicine shall approve the deci sion on registering or refusing to register the preparation.  
15. The State Committee on Veterinary Medicine sh all inform the applicant of the decision to 
register the preparation at the time of issuing the registration certificate within the term not 
exceeding 30 days after the date of approving the decision to register the preparation.  
The registration certificate shall be  issued in the name of the owne r of the registration dossier for 
a term of up to five years in the format established by the State Committee on Veterinary 
Medicine.  
16. After approving the decision on re gistration, the prepar ation shall be include d in the registry 
of veterinary preparations maintained by the State Committee on Veterinary Medicine.  
17. A decision to refuse registering a preparati on shall be notified to the applicant with an 
exhaustive explanation of reasons for such refusal.  
A decision to refuse registering a preparation may be approved, if:  the applicant submitted an incomplete set of documents or did not properly verify the quality, 
safety and effectiveness of the preparation; 
results of registration testing do not confirm the effectiveness and safety of the preparation for 
the health of people or animals; 
the period recommended by the applicant during which the preparation is washed out of animal’s 
body is insufficiently justified or does not ensure sa fety of products of animal origin intended for 
human consumption manufactured from animals th at were treated with the preparation;  
the use of the preparation submitted for registration is prohibited by law.  
A decision to refuse registering the preparation shall be the basis for returning the registration 
dossier to the applicant.  
Summary procedure for regis tering a preparation  
18. The summary procedure for registering a preparat ion shall be applied to preparations that are 
very similar, contain the same quantity of substances with the same effect and form, the results 
of relevant testing of which confirm their identic al bioaccesibility and bioequivalence as well as 
the fact that their therapeutic eff ect is essentially the same as that  of patented preparations (brand 
preparations) registered in Ukra ine and other countries; the summ ary procedure shall be applied 
also to preparations that were determined by the State Committee on Ve terinary Medicine to 
have the same registration criteria.  
19. The State Committee on Veterinary Medicine shall determine the procedure and list of 
documents required to conduct the examination a nd register the preparation pursuant to the 
summary procedure.  
20. The agency shall conduct the ex amination of the preparation on  a contract basis pursuant to 
the summary procedure within 90 days from the da te of receiving the application, the complete 
set of documents and the relevant payment.  
Procedure for re-registering a preparation  
21. A re-registration of a preparation shall be carrie d out if it is necessary to introduce changes to 
the registration dossier.  
If changes that are introduced to the registra tion dossier are Type A changes, no complete 
examination shall be carried out;  if those are Type B changes, a complete examination shall be 
carried out.  
22. To introduce changes to the registration dossier , the applicant shall su bmit to the agency the 
appropriate application and suppor ting documents and materials in accordance with the form, the 
list and the procedure establ ished by the State Committee on Veterinary Medicine.  
23. After introducing changes to th e registration dossier, a new re gistration certif icate shall be 
issued for the preparation with changed first five  digits of the registration number as well as 
figure 1 after a slash at the end of the number, wh ich corresponds to Type A changes, or figure 2, 
which corresponds to Type B changes.  24. The examination shall be carried out in acco rdance with paragraphs 6 – 13 of the present 
Regulation.  
25. A re-registration of the prepar ation due to the expiry  of the registration certificate shall be 
carried out pursuant to the su mmary registration procedure.  
To re-register the preparation, documents shall be submitted at least than three months in 
advance of expiry of the term of  the registration certificate.  
Suspending or cancelling the registration of a preparation  
26. The registration of a preparation shall be suspended by the State Committee on Veterinary 
Medicine, if:  
the preparation does not meet the requiremen ts specified in the registration dossier; 
the registration has been effected ba sed on incomplete or unfair data;  
the person who received the regist ration certificate does not observe requirements established by 
law. 
Resuming the registration of a preparation sh all be carried out by the State Committee on 
Veterinary Medicine after eliminating the reasons for which it had been suspended.  
27. The State Committee on Veterinary Medici ne shall approve the decision to cancel 
registration of a preparation t ogether with the decision to prohibit and wit hdraw it from 
circulation, if the preparation is ineffective under conditions determined for its use or is 
dangerous for the health of  humans or animals.  
28. The procedure for suspending, resuming and cance lling the registration of  a preparation shall 
be determined by the State Committee on Veterinary Medicine.  
    
 
 
REGULATION 
on State Registration of Feed Addi tives, Premixes and Finished Feed  
General  
1. This Regulation shall establish the mechanism of  state registration of feed additives, premixes 
and finished feed (the “registration”).  
2. Registration shall be carried out by the State Committee on Veteri nary Medicine based on the 
application submitted by the owner of the registration dossier or their representative (the “applicant”), a resolution of the State Pharm acological Commission on Veterinary Medicine and 
an expert opinion of the National Agency of Ve terinary Preparations and Feed Additives (the 
“agency”).  
The owner of the registration dossier shall be  a legal entity ensuring the collection and 
processing of information on all cases of negativ e reactions to feed additives, premixes and 
finished feed (the “product”).  
3. It shall be prohibited to register the product th at may worsen veterinary, sanitary and epizootic 
situation or cause harm to the health of people or animals, in particular, to the health of 
consumers through worsened characte ristics of products of  animal origin as well as create wrong 
consumers conceptions of such products.  
4. Decisions of the State Committee on Veterina ry Medicine on regist ering (re-registering), 
suspending or cancelling the registration of  a product may be challenged in court.  
Procedure for registering a product  
5. To perform an expert examination of the regi stration dossier (the “exa mination”) and register 
the product, the applicant shall s ubmit an application to the agency to conduct an examination of 
the product together with the registration dossier.  
6. The registration dossier shall be a set of anal ytical and normative documents, documents of a 
specialized assessment (accreditation certificates, instructions on safety and residues of the products, materials of conducted clinical research ). Together with the registration dossier, the 
applicant shall also submit samples of the product.  
7. To obtain the registration (re-re gistration), the applicant shall submit a separate application 
and registration dossier for each pharmaceutical (b iological) form, concentration or formulation 
of the product.  
The form of the application, the list of material s in the registration dossier and the procedure for 
its forming shall be established by the State Committee on Vete rinary Medicine.  APPROVED  
by Resolution of the Cabinet of Ministers of Ukraine of 21 November 2007 No. 1349  8. The agency shall verify completeness and thoroughness of submitted materials and resolve on 
accepting the registration dossier for examination or  returning it to the a pplicant for additional 
elaboration.  
9. The agency shall conduct the examination on a contract basis within the term not exceeding 90 
days from the date of receiving the application,  the full set of documents and the appropriate 
payment.  
10. The agency shall determine whether regist ration testing is necessary, what scope of 
registration testing should be carried out and whether it is necessary to test the product in 
production conditions; organize the required testing, take other measures to verify information 
and data specified in the documents as well as prepare expert opinions.  
To obtain additional data regarding the effectiv eness, safety and quality of the product, the 
agency may request additional documents a nd materials from the applicant during the 
examination. The time required to prepare them shall not be added to the term allowed for the 
examination.  
During registration testing, the quality, effectiveness, safe ty, reactivity or diagnostic 
characteristics of the product shall be studied in vitro and in vivo.  
11. During the examination, the agency shall provi de opinions on results of registration testing 
and the preliminary assessment of the regist ration dossier to the State Pharmacological 
Commission on Veterinary Medi cine, which would review th e said opinions and give 
recommendations to the agency regarding the advisability of regi stering the product.  
12. Based on examination results, the agency shall prepare expert opinions, in which 
recommendations by the State Pharmacological Commission on Veterinary Medicine shall be 
included, and send those to the applicant and to the State Committee on Veterinary Medicine 
together with a copy of the application receive d in accordance with the procedure stipulated by 
paragraph 5 of the present Regulation.  
13. Based on the documents received from the agency, the State Committee on Veterinary 
Medicine shall approve the deci sion on registering or refusing  to register the product.  
14. The State Committee on Veterinary Medicine sh all inform the applicant of the decision to 
register the product at the time of issuing th e registration certificate within the term not 
exceeding 30 days after the date of approvi ng the decision to register the product.  
The registration certificate shall be  issued in the name of the owne r of the registration dossier for 
a term of up to five years in the format established by the State Committee on Veterinary 
Medicine.  
15. After approving the decision on re gistration, the product shall be included in the registry of 
veterinary products maintained by the St ate Committee on Veterinary Medicine.  
16. A decision to refuse registeri ng a product shall be notif ied to the applicant with an exhaustive 
explanation of reasons for such refusal  
A decision to refuse registering a product may be  approved, if the inspection of information and 
documents submitted by the applicant uncovered the fact that the applicant submitted an incomplete set of registration dossier documents or  did not properly verify the quality and safety 
of the product or there are other indications mentioned in paragra ph 3 of the present Regulation.  
A decision to refuse register ing the product shall be  the basis for return ing the registration 
dossier to the applicant.  
Procedure for re-registering a product 
17. A re-registration of the product shall be carried out if it is necessary to introduce changes to 
the registration dossier.  
If changes that are introduced to the registra tion dossier are Type A changes, no complete 
examination shall be carried out;  if those are Type B changes, a complete examination shall be 
carried out.   
18. To introduce changes to the registration dossier , the applicant shall su bmit to the agency the 
appropriate application and suppor ting documents and materials in accordance with the form, the 
list and the procedure establ ished by the State Committee on Veterinary Medicine.  
19. After introducing changes to th e registration dossier, a new re gistration certif icate shall be 
issued for the product with changed first five digi ts of the registration number as well as figure 1 
after a slash at the end of the number, which co rresponds to Type A changes, or figure 2, which 
corresponds to Type B changes.  
20. The examination shall be carried out in acco rdance with paragraphs 5 – 12 of the present 
Regulation.  
21. A re-registration of the product due to the expiry of the registration certif icate shall be carried 
out pursuant to the same procedure as that us ed for general examination of the registration 
dossier stipulated by th e present Regulation.  
To re-register a product, documents shall be submitted at least three months in advance of expiry 
of the term of the registration certificate.  
Suspending or cancelling the registration of a product  
22. The registration of a product shall be susp ended by the State Committee on Veterinary 
Medicine, if:  
the product does not meet the requirements specified in the registration dossier; 
the registration has been effected ba sed on incomplete or unfair data;  
the person who received the regist ration certificate does not observe requirements established by 
law. 
Resuming registration of a product shall be car ried out by the State Committee on Veterinary 
Medicine after eliminating the reason s for which it had been suspended.  
23. The State Committee on Veterinary Medici ne shall approve the decision to cancel 
registration of a product together with the decisi on to prohibit and withdr aw it from circulation, if the product is ineffective under conditions determ ined for its use or is dangerous for the health 
of humans or animals.  
24. The procedure for suspending, resuming and cancelling the registration of a product shall be 
determined by the State Committee on Veterinary Medicine.  
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