G/TBT/N/UKR/282  
15 January 2024  
(24-0306) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UKRAINE  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Ministry of Health of Ukraine  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medicines, 
active pharmaceutical ingredients  
5. Title, number of pages and language(s) of the notified document:  draft Order of 
the Ministry of Health of Ukraine "On Approval of Amendments to the Annexes to the 
Medicines Quality Certification Procedure fo r International Trade and Confirmation for 
Exported Active Pharmaceutical Ingredients"; (10 page(s), in Ukrainian)  
6. Description of content:  the draft Order provides for amendments to the Annexes to the 
Medicines Quality Certification Procedure for Inter national Trade and Confirmation for 
Exported Active Pharmaceutical Ingredients, approved by the Order of the Ministry of 
Health of Ukraine No. 1310 of 25 July 2022 (notified in document G/TBT/N/UKR/216, 
G/TBT/N/UKR/216/Add.1).  
These amendments are aimed at  implementing into the national legislation the model 
certificate of a pharmaceutical product (CPP) recommended by WHO Expert Committee 
on Specifications for Pharmaceutical Preparations (WHO Technical Report Series 1033, 
WHO 2021), which, in particular, co ntains information on International Nonproprietary 
Name (INN), brand name of the pharmaceutical product as it is declared in the marketing 
authorization certificate and used within the territory of the exporting country and, if 
possible, the brand name of the pharmaceutical product in the importing country.  
Adoption of the amendments will ensure the right to receive high -quality, effective and 
safe medicines through the cooperation with other countries in the framework of mutual 
supply of medicines; improve  and simplify the procedure for certifying of the quality of 
medicines for international trade and confirming active pharmaceutical ingredients that 
are exported.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety; Quality requirements  G/TBT/N/UKR/282  
 
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  8. Relevant documents:   
Law of Ukraine "On Medicines"; Resolution of the Cabinet of Minister s of Ukraine No. 1419 
"Certain Measures for Ensuring the Quality of Pharmaceutical Products" of 28 October 
2004; Order of the Ministry of Health of Ukraine No. 1310 "On Approval of the Medicines 
Quality Certification Procedure for International Trade and C onfirmation for Exported 
Active Pharmaceutical Ingredients" of 25 July 2022.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  from the date of its official publication  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Ministry of Economy 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  
https://moz.gov.ua/article/public -discussions/proekt -nakazu -ministerstva -ohoroni -
zdorov%e1%be%bfja -ukraini -pro-zatverdzhennja -zmin-do-dodatkiv -do-porjadku -
sertifikacii -jakosti -likarskih -zasobiv -dlja-mizhnarodnoi -torgivli -ta-pidtverdzhennja -dlja-
aktivnih -farmacevtichnih -ingredientiv -scho-eksportujutsja  
https: //members.wto.org/crnattachments/2024/TBT/UKR/24_00473_00_x.pdf  
https://members.wto.org/crnattachments/2024/TBT/UKR/24_00473 _01_x.pdf