. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/UKR/70 
28 February 2012  
 (12-1138) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  UKRAINE  
If applicable, name of local governme nt 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 :   
Ministry of Economic Development and Trade of Ukraine 
01008, Kyiv, 12/2 M. Hrushevskoho str., Tel./Fax:  +38044 596 68 39 Email:  ep@me.gov.ua  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], 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 langu age(s) of the notified document:  Order of the Ministry 
of Health of Ukraine "On approval of proc edure for establishment prohibition (temporary 
prohibition) and restoring circulation of medici nal products in Ukraine" of 22 November 2012 
No 809, (15 pages in Ukrainian language)  
6. Description of content:  This Order is adopted according to  articles 15, 21 of the Law of 
Ukraine "On Medical products", poi nt 4 paragraph 4 of the Status of the Ministry of Health of 
Ukraine and point 8 paragraph 4 of the Status  of the State Service of Ukraine on medical 
products.  
This document takes into account the requireme nts of Directive 2001/83/EC of the European 
Parliament and European Council of 6 Novemb er 2001 "On the community code relating to 
medicinal products for human use" (as amende d), recommendations of the World Health 
Organization and Pharmaceutical Insp ection Cooperation Sc heme (PIC/S). 
This Order provides the separation in classes of bad quality medical products discrepancies 
that will ensure a differentiated  approach to the prohibition of trafficking of such medical 
products. 
The abovementioned Order also prescribes actions  of the State Service of Ukraine on medical 
products and its territorial bodies in the cases of detection in circul ation of bad quality, 
counterfeit and unregiste red medical products, which in turn  will improve the quality of 
medical products during their circulation, and also will ensure the final consumers by qualitative and safe medical products G/TBT/N/UKR/70 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable:  The 
purpose of adopting the Order was to strengthe n state control over the quality of medical 
products and harm onization of legislation of Uk raine with EU legislation.  
These goal can be achieved by: 
- Creation of transparent procedure for prohibition (suspension), withdraw from 
 circulation and renewal of me dical products circulation, including those imported into 
 the territory of Ukraine in vi olation of existi ng requirements; 
- Creation of effective state control over the identification, withdrawal from circulation 
 of bad quality, counterfeit and unregistered medical products. 
Order is adopted in order to ensure final us ers by qualitative and safe medical products 
8. Relevant documents:   Law of Ukraine "On the National Programme of Legal 
Approximation of Ukraine to the European Union "(Ukrainian); Law of Ukraine "On the 
basis of Ukraine's legislation on health protection" (Ukrainian ); Law of Ukraine "On Medical 
products" (Ukrainian); Law of Ukraine "On the pr imarily principles of the State Supervision 
(control) in the sphere of economic activity " (Ukrainian); Law of Ukraine "On consumers 
protection" (Ukrainian); Resolution of the Cabi net of Ministers of Ukraine of 14 September 
2005 No 902 "On approval of the procedure for conduction of the st ate control over the 
quality of medical products imported into the territory of Ukraine" (Ukrainian); 
Directive 2001/83/EC of the European Parliame nt and of the Council of 6 November 2001 
"On the community code relating to medici nal products for human use" (as amended) 
(English). 
9. Proposed date of adoption:   
Proposed date of entry into force:    17 February 2012 Official Visnyk of Ukraine, 
2012, No 11 (17.02.2012), page.  429 17 February 2012 
10. Final date for comments:  - 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
Ministry of Economic Development and Trade of Ukraine 
01008, Kyiv, 12/2 M. Hrushevskoho str., Tel./Fax: +38044 596 68 39 
Email:  mailto:ep@me.gov.ua  
Internet address where the text is available: 
http://zakon2.rada.gov.ua/laws/show/z0126-12  (in Ukrainian)