  
  
G/TBT/N/RUS/118  
30 April 2021  
(21-3687) 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 th e notification shall be indicated if different from above:   
Russian Scientific and Technical Center for Information on Standardization, Metrology 
and 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 [   ], 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:  Draft 
amendments to the Rules for investigation of biol ogical medicinal products of the Eurasian 
Economic Union (156 page(s), in Russian)  
6. Description of content:  The draft amendments to the Rules for investigation of 
biological medicinal products of the Eurasian Economic Union provide for the elimination 
of differences in the requirements for pharmaceutical development, planning and 
conducting studies of the safety and quality of blood products, by establishing unified, 
objective and transparent rules for research of this group of drugs and also avoid the 
possibility of unreliable reporting on the safety of blood products from infectious agents 
that may be dangerous to life, health and well -being of patients.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Prevention of  deceptive practices and consumer protection; Protection of 
human health or safety  G/TBT/N/RUS/118  
 
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  8. Relevant documents:   
• Draft amendments to the Rules for investigation of biological medicinal products 
of the Eurasian Economic Union  
https://docs.eaeunion.org/ria/ru -ru/0104601/ria_19042021  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  30 June 2021  
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   
https://docs.eaeunion.org/ria/ru -ru/0104601/ria_19042021  
 