G/TBT/N/RUS/149  
21 September 2023  
(23-6311) 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:  RUSSIAN FEDERATION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Eurasian Economic Commission  
Department for Technical Regulation and Accreditation  
Tel: +7(495)669 -24-00 
Fax: +7(495)669 -24-15 
E-mail: dept_techregulation@eurasiancommission.org  
Website: www.eurasiancommission.org   
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:   
Russian Scientific and Technical Center for Information on Standardization, Metrology a nd 
Conformity Assessment  
(Standartinform, National enquiry point for the TBT Agreement)  
Tel: +7(495) 531 -26-59 
E-mail: info@gostinfo.ru  
Website: www.gostinfo.ru   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 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):  Medical 
products  
5. Title, number of pages and language(s) of the notified document:  The Draft 
Amendments to the Decision of the Council of the Eurasian Economic Commission No. 83 
of November 3, 2016 (101 pages in Russian)  
https://docs.eaeunion.org/ria/ru -ru/0106217/ria_30082023;  (101 page(s), in Russian)  
6. Description of content:  The draft am endments to the Decision of the Council of the 
Eurasian Economic Commission No. 83 of November 3, 2016 provides for the 
establishment of uniform approaches to the procedures for conducting pharmaceutical 
inspections of clinical  
centers for compliance with the requirements of the Rules of Good Clinical Practice  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of the rights and well -being of the subjects of clinical trials;  
Protection of the interests of drug m anufacturers;  G/TBT/N/RUS/149  
 
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  Protection of the interests of authorized bodies (expert organizations) performing 
inspections of clinical centers for compliance with the requirements of the Rules of Clinical 
Practice  
8. Relevant documents:   
The Draft Amendments to the Decision of the Council of the Eurasian Economic 
Commission No. 83 of November 3, 2016  
https://docs.eaeunion.org/ria/ru -ru/0106217/ria_30082023  
Decisi on of the Board of the Eurasian Economic Commission No. 83 of November 3, 2016  
https://docs.eaeunion.org/docs/ru -ru/01411936/cncd_21112016_83  
9. Proposed date of adoption:  Not less than 30 calendar days from the date of the official 
publication.  
Proposed date of entry into force:  To be determined Not less than 30 calendar days 
from the date of the official publication.  
10. Final date for comments:  20 October 2023  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Eurasian Economic Commission  
Department for Technical Regulation and Accreditation  
Tel: +7(495)669 -24-00 
Fax: +7(495)669 -24-15 
E-mail: dept_techregulation@eurasiancommission.org  
Website: www.eurasiancommission.org