  
  
G/TBT/N/UKR/216  
1 July 2022  
(22-5123) 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 [  ], 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 the Medicines Quality Certification 
Procedure for International Trade and Con firmation for Exported Active Pharmaceutical 
Ingredients"; (32 page(s), in Ukrainian)  
6. Description of content:  The draft Order provides for approval of the the Quality 
Certification Procedure for medicinal products for international trade and confirmati on for 
exported active pharmaceutical ingredients and aims to remove barriers to medicine 
quality certification proceedings for international trade and confirmation for exported 
active pharmaceutical ingredients; to improve and simplify such certification proceedings.  
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  
8. Relevant documents:   
The Law of Ukraine "On medicines", available in Ukrainian  
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  G/TBT/N/UKR/216  
 
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://moz.gov.ua/article/public -discussions/proekt -nakazu -moz-ukraini -pro-
zatverdzhennja -porjadku -sertifikacii -jakosti -likarskih -zasobiv -dlja-mizhnarodnoi -torgivli -
ta-pidtverdzhennja -dlja-aktivnih -farmacevtichnih -ingredientiv -scho-ekspo rtujutsja  
 