. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/UKR/71 
28 February 2012  
 (12-1139) 
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):  Active pharmaceutical 
ingredients (APIs, active subs tances, medical substances) 
5. Title, number of pages and language(s) of the notified document:  Draft Law of Ukraine 
"On Amendments to the Law of Ukraine" On Medical products" (concerning the definition of 
the term" active pharmaceutic al ingredients"), (1 page in Ukrainian language)  G/TBT/N/UKR/71 
Page 2  
 
6. Description of content:  For further harmonization of national legislation with international 
and European legislation the followings am endments are introduced  to the Draft Law:  
1. Part 6 of Article 2 of the Law of Ukrain e "On Medical products " to read as follows: 
 "active pharmaceutical ingredient (API, me dical substance, active substance) - any 
 substance (or mixture of substances) inte nded for use in the manufacture of the 
 medical products and when is used in  the manufacture of  a medicinal product 
 becomes its active ingredient. These substa nces have pharmacological or other direct 
 action, they are used to tr eat, diagnose or prevent dise ase, to change  the state, 
 structures or physiological functions of the body and for observation, treatment and 
 relief of symptoms" (According to the de finition in "The Rules Governing Medicinal 
 Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing 
 Practice Medicinal Products fo r Human and Veterinary Use"). 
2. For the text of the Law of Ukraine "On Medical products", the words "active 
 ingredient" and "substance" in various  cases should be replaced by "API". 
3. Part 12 of article 9, after the words "to the application for regi stration of medicinal 
 product" add the wo rds (except API). 
4. This Law enters into force after its publication. 
7. Objective and rationale, including the nature of urgent problems where applicable:  The 
purpose of the Draft Law is fu rther harmonization of national regulatory framework in the 
sphere of medical products with European legislation "The Rules Governing Medicinal 
Products in the European Union. Volume 4. EU  Guidelines to Good Manufacturing Practice 
Medicinal Products for Human and Veterinary Use" under the National Programme of Legal 
Approximation of Ukraine to the European Union.  
8. Relevant documents:   Law of Ukraine "On the National Programme of Legal 
Approximation of Ukraine to the European Un ion" (Ukrainian); Law of Ukraine "On the 
basis of Ukraine's legislation on health protection" (Ukrainian ); Law of Ukraine "On Medical 
products" (Ukrainian); Guidelin es "Medical products. Good Manufacturing Practices ", 
approved by the Order of the Ministry of Health of Ukraine from 03.10.2011 No 634 (Ukrainian); "The Rules Governing Medicinal Pr oducts in the European Union. Volume 4. 
EU Guidelines to Good Manufacturing Pr actice Medicinal Products for Human and 
Veterinary Use" (English). 
9. Proposed date of adoption:   
Proposed date of entry into force:    1 December 2012 
December 2012 
10. Final date for comments:  12 March 2012 
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://www.moz.gov.ua/u a/portal/Pro_20120112_1.html  (in Ukrainian)