G/SPS/N/UKR/207  
5 September 2023  
(23-5933) 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):  Active substances of veterinary medicinal products  
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 Order of the Ministry of Agrarian Policy and Food 
of Ukraine "On Approval of the Requirements of Good Practice for Distribution of Active 
Substances used in Vet erinary Medicinal Products" . Language(s):  Ukrainian . Number of 
pages:  15 
https://minagro.gov.ua/npa/pro -zatverdzhennya -vimog -nalezhnoyi -praktiki -realizaciyi -
diyuchih -rechovin -veterinarnih -preparativ  
https://members.wto.org/crnattachments/2023/SPS/UKR/23_12181_00_x.pdf  
https://members.wto.org/crnattachments/2023/SPS/UKR/23 _12181_01_x.pdf  
6. Description of content:  The draft Order provides for the approval of the requirements of 
good practice for distribution of active substances used in veterinary medicinal products. 
These requirements w ill apply to importers and market operators, as well as to 
manufacturers who distribute the active substances they have manufactured with the aim 
of using them as starting material in veterinary medicinal products.  
The adoption of the Order will ensure com pliance with the basic principles and rules, which 
guarantee that the distributed active substances are registered in accordance with the 
established law; their storage conditions are constantly observed, including during 
transportation; contamination of o ne with another is excluded; and delivery of goods is 
ensured within the specified time limits.  
The draft Order is aimed at improving the production of veterinary medicinal products and 
implementing into Ukrainian legislation the provisions of Commission I mplementing 
Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution 
practice for active substances used as starting materials in veterinary medicinal products 
in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council.  
7. Objective and rationale: [  ] 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/207  
 
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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, chapte r 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 language(s) in which these are available:  
Law of Ukraine of 4 February 2021 No. 1206 -IX "On Veterinary Medicine" (will be enacted 
one year after the termination or cancellation of the martial law)  (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 dat e of publication , and/or  
(dd/mm/yy) : The Order will enter into force one year from the date of enactment of the 
Law of Ukraine of 4 February 2021 No. 1206 -IX "On Veterinary Medicine" (will be enacted 
one year after the termination or cancellation of the ma rtial law) and one year from the 
date of the approval of these requirements.  
[ ] 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 November 2023  
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:   
Ministry of Economу of Ukraine  
Department for Trade Agreements and Export Development  
12/2 Hrushevskoho Str.  
Tel: +(38 044) 596 6839  
Fax: +(38 044) 596 6839  
Email: ep@me.gov.ua  
Website: https://www.me.gov.ua  
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:   
Ministry of Economу of Ukraine  
Department for Trade Agreements and Export Development  
12/2 Hrushevskoho Str.  
Tel: +(38 044) 596 6839  
Fax: +(38 044) 596 6839  
Email: ep@me.gov.ua  
Website: https://www.me.gov.ua