G/SPS/N/UKR/178  
 
5 August 2022  
(22-5854) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  UKRAINE  
If applicable, name of local government involved:   
2. Agency responsible:  Ministry of Agrarian Policy and Food of Ukraine  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Veterinary medicines  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Resolution of the Cabinet of Ministers of Ukraine 
"On approval of the Regulation on state registration of veterinary medicinal products" . 
Language(s):  Ukrainian . Number of pages:  27 
https://minagro.gov.ua/npa/pro -zatverdzhennya -polozhennya -pro-derzhavnu -
reyestraciyu -veterinarnih -likarskih -zasobiv 
6. Description of content:  The draft Resolution is developed in accordance with part four 
and part ten of Article 54 of the Law of Ukraine of 4 February 2021 No. 1206 
"On Veterinary Medicine" that establishes new requirements for state registration of 
veterinary medicinal products.  
Today, the basis for the circulation of medicines in most countries is state registration, 
which is a prerequisite for the placement of medicinal product on the market legally. 
The purpose of such registration is to provide the manufacturer with informatio n allowing 
to evaluate the benefit/risk balance for each product in order to resolve the issue of its 
admission into circulation.  
The draft Resolution provides for the approval of the Regulation on state registration of 
veterinary medicinal products. The s tate registration procedure provides for scientific 
evaluation of a veterinary medicinal product by the National Institute of Veterinary 
Medicine of Ukraine. Services for the scientific evaluation of a veterinary medicinal product 
are chargeable.  
The objec tive of the draft Resolution is to define the procedure for state registration of 
veterinary medicinal products and to implement the requirements of EU legislation into 
Ukrainian legislation.  
7. Objective and rationale: [X]  food safety, [X]  animal health,  [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   G/SPS/N/UKR/178  
 
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  8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and lan guage(s) in which these are available:  
Law of Ukraine "On Veterinary Medicine"  (available in Ukrainian)  
10. Proposed date of adoption (dd/mm/yy) : To be determined.  
Proposed date of publication (dd/mm/yy) : To be determined.  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : The Resolution shall enter into force from the day of its publication and 
shall be enacted simultaneously with the Law of Ukraine of 4 February 2021 No. 1206 -IX 
"On Veterinary Medicine " (to be enacted one year after the termination or cancellation of 
the martial law).  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 4 October  2022 
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body: