G/TBT/N/RUS/158  
29 February 2024  
(24-1880) 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 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 [  ], 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):  Medicinal 
products  
5. Title, number of pages and language(s) of the notified document:  Draft 
amendments to the Rules for Investigation of Biological Medicinal Products in the Eurasian 
Economic Union; (140 page(s), in Russian)  
6. Description of content:  The draft amendments to the Rules for Investigation of 
Biological Medicinal Products in 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 medicines based on human somatic cells 
and medicines containing genetically modified cells by establishing uniform, objective and 
transparent rules fo r research of these groups of medicines.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of life and health of the end users of medicinal products;  
Protection of the interests of manufacturers of medicines based on hu an somatic cells 
and medicines containing genetically modified cells, authorized bodies (expert 
organizations) in the sphere of healthcare of the Member States of the Union  G/TBT/N/RUS/158  
 
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  8. Relevant documents:   
Draft amendments on the Rules for Investigation of Biological Medicinal Products of the 
Eurasian Economic Union (140 pages in Russian)  
https://docs.eaeunion.org/ria/ru -ru/0106437/ria_09022024  
Decision № 89 of the Council of the Eurasian Economic Commission of November 3, 2016  
https://docs.eaeunion.org/docs/ru -ru/01411954/chcd_21112016_89  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  16 March 2024  
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