G/TBT/N/UKR/294  
24 April 2024  
(24-3379) 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):  Medicinal 
products  
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 Procedure for 
Confirmation of Compliance of Medicinal Products Manufacturing Conditi ons with the 
Requirements of Good Manufacturing Practice"; (3 page(s), in Ukrainian)  
6. Description of content:  The draft Order provides for the approval of amendments to 
the Procedure for Confirmation of Compliance of Medicinal Products Manufacturing 
Conditions with the Requirements of Good Manufacturing Practice, approved by the Order 
of the Ministry of Health of Ukraine No. 1130 of 27 December 2012.  
The amendments to the Procedure will provide legislative regulation of the mechanism 
for extending the v alidity of the GMP Conclusion, as well as the possibility of extending 
the validity of the GMP certificate until the end of 2024 issued by the authorized body of 
an EU member state, the United Kingdom or a state that has a mutual recognition 
agreement with  the EU or Ukraine.  
Approval of the amendments to the Procedure will align it with EU requirements.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Harmonization; Reducing trade 
barriers and facilitating trade  
8. Relevant documents:   
Law of Ukraine "On Medicinal Products"  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  From the date of its official publication  G/TBT/N/UKR/294  
 
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  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.  
Kyiv 01008  
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/povidomlennja -pro-opriljudnennja --
proektu -nakazu -ministerstva -ohoroni -zdorov%e2%80%99ja -ukraini -pro-
zatverdzhennja -zmini -do-porjadku -provedennja -pidtverdzhennja -vidpovidnosti -umov -
virobnictva -likarskih -zasobiv -vimogam -nalezhnoi -virobnichoi -praktiki  
https://members.wto.or g/crnattachments/2024/TBT/UKR/24_02779_00_x.pdf  
https://members.wto.org/crnattachments/2024/TBT/UKR/24_02779_01_x.pdf