. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/UKR/87 
21 December 2012  
 (12-7049) 
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 [   ], 2.10.1 [   ], 5.6.2 [X], 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 language(s) of the notified document:  The Resolution of the 
Cabinet of Ministers of Ukraine "On amending the procedure for state quality control of 
medicinal products imported to Ukraine" of 8 Augu st 2012 No 793, (6 pages, in Ukrainian).    
6. Description of content:  This Resolution amends the proce dure for State quality control of 
medicinal products imported to Ukraine, approved by the Cabi net of Ministers of Ukraine 
dated 14 September 2005 No. 902.  
This procedure defines the mechanism of State quality control of medicinal products imported 
to Ukraine, which is to prevent the circula tion of counterfeit, substandard and unregistered 
medicines, adopts a requirement of havi ng a Good Manufacturi ng Practices (GMP) 
certificates certified by Ukrainian authorities. 
The Resolution defines the mechanism of st ate control through visual inspection and 
laboratory analysis and issue of its report. Du ration of state control is established no more 
than 8 days. This procedure does not a pply to immunobiological preparations.  G/TBT/N/UKR/87 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
The adoption of the draft caused by the need to  improve the legislation regulating the actions 
of entities involved in the registration and im portation of medicinal produc ts into the territory 
of Ukraine, and government bodies involved in State registration of me dicinal products, state 
quality control; to achieve parity interests and enforce the State's own social functions in health care.  
8. Relevant documents:   The Law of Ukraine "On medici nal products", the Resolution the 
Cabinet of Ministers of Ukraine of 26 May 2005 No. 376 "On approval of state registration 
(re-registration) of medicinal pr oducts and the size of the fee for their state registration (re-
registration)".   
9. Proposed date of adoption:   
Proposed date of entry into force:    8 August 2012 
5 September 2012 (par.8 of p.5 of the Order and its annex - enter into force on 1 January 2013) 
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:  ep@me.gov.ua  
Internet address where the text is available: 
http://zakon1.rada.gov.ua/laws/show/793-2012-%D0%BF   (in Ukrainian)