. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/UKR/1 
16 September 2008 
 (08-4282) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UKRAINE
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Ministry of Health (MOH) of Ukraine, the State Committee for 
Technical Regulation and Consumer Policy (DSSU)  
Name and address (including telephone and fax numbers, e-mail and web-site 
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 [   ], 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):    
Medical products (ICS: 11.040) 
5. Title, number of pages and langua ge(s) of the notified document:   Technical Regulation 
No. 536 on medical products approved by the Cabinet of Ministers of Ukraine, dated 
11 June 2008 (19 pages, in Ukrainian). 
6. Description of content:   The Technical Regulation, in accordance with those which exist in 
international practice, determines terms and definitions, rules and mechanisms of 
regulation’s elaboration, design, conform ity assessment of the products, metrological 
compliance, monitoring, supervision by th e authorized institutions on conformity 
assessment in order to protect people and the environment. The Technical Regulation 
defines rules which classify medical products, ru les of realization of clinical research, 
description of procedures for evaluating co mpliance in accordance with the basic 
requirements and the requirements of national standards and form of a declaration of 
conformity.   
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Adaptation of Ukrainian legislation to EU legi slation in part where it relates to safety of 
medical products and procedures of conformity  assessment of such products. Assurance of 
providing medical & health-improving instituti ons and population of Ukraine  with good 
quality, safe and effective medical products, reducing low-quality me dical products, which 
are in market. 
8. Relevant documents:   European Council Directive 93/ 42/EEC(English), Laws of Ukraine 
"On confirmation of compliance"(2406-14 ), "On standardization"(2408-14), "On 
accreditation of conformity assessment bodies"(2407-14), "On standards, technical regulations and conformity assessment pro cedures"(3164-15), "On medicines" (123/96- 
VR), Decrees of Cabinet of Ministers of Uk raine N 59, "On approval of the Procedure of G/TBT/N/UKR/1 
Page 2  
 
  the appointment of conformity assessment of products, processes and services, the 
requirements of technical regulations", date d 24 January, 2007, N 1599 "On approval of the 
description and rules of the national mark of conformity", dated 29 November 2001, N 1585 
"On approval of the Technical Regulati ons of assessment’s modules and labelling 
requirements for national mark of conformity, which are used in technical regulations" 
dated 7 October 2003 (in Ukrainian). 
9. Proposed date of adoption:   
Proposed date of entry into force:   }2012 
10. Final date for comments:   - 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
WTO National Enquiry Point & Information Processing Centre 
04655, Kyiv, Lvivska Square, 8 Tel.: 272 1578, Fax: 272 1147 Email: ep@mfert.gov.ua 
 
Internet address where the text is available: 
http://zakon.rada.gov.ua/cgi-bin/laws/main. cgi?nreg=536-2008-%EF (in Ukrainian)