G/TBT/N/UKR/258  
31 May 2023  
(23-3690) 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 Resolution 
of the Cabinet of Ministers of Ukraine "On Amendments to the Procedure for State Quality 
Control of Medicinal Products Imported to Ukraine"; (1 page(s ), in Ukrainian)  
6. Description of content:  At the beginning of the imposition of martial law, the 
Government of Ukraine has established that a conclusion about the quality of imported 
medicinal products, including registered medicinal products in foreign  packaging 
manufactured for the needs of foreign markets, that do not comply with the approved 
registration documents, may be issued, inter alia, without the mandatory availability of a 
document confirming that the conditions of manufacture of medicinal pr oducts comply 
with the requirements for the manufacture of medicinal products in Ukraine, except for 
active pharmaceutical ingredients (substances).  
At the same time, the confirmation of compliance of the manufacturing conditions of 
medicinal products with  the GMP requirements in force in Ukraine was introduced to prove 
that medicinal products are constantly manufactured and controlled in accordance with 
quality standards that are appropriate for their intended use. According to Compilation of 
Community Pro cedures on Inspections and Exchange of Information (EC 
EMA/572454/2014) only a GMP inspector can assess the compliance of production with 
GMP requirements.  
In order to provide Ukrainian consumers with quality and safe medicinal products, the 
draft Resoluti on of the Cabinet of Ministers of Ukraine cancels the possibility of issuing a 
conclusion about the quality of imported medicinal products without a document 
confirming that the conditions of production of medicinal products meet the requirements 
for the p roduction of medicinal products in Ukraine, except for active pharmaceutical 
ingredients (substances).  G/TBT/N/UKR/258  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Quality requirements  
8. Relevant documents:   
Resolution of the Cabinet of Ministers of Ukraine No 902 "On Approval of the Procedure 
for State Quality Control of Medicinal Products Imported to Ukraine" of September 14, 
2005 (as amended)  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  6 month after its 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/art icle/public -discussions/proekt -postanovi -kabinetu -ministriv -
ukraini -pro-vnesennja -zmini -do-porjadku -zdijsnennja -derzhavnogo -kontrolju -jakosti -
likarskih -zasobiv -scho-vvozjatsja -v-ukrainu  
https://members.wto.org/crnattachments/2023/TBT/UKR/23_09933_00_x.pdf