  
  
G/TBT/N/RUS/140  
31 May 2023  
(23-3702) 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: ww w.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):  Medicinal 
products  
5. Title, number of pages and language(s) of the notified document:  Draft 
amendments to the Rules for marketing authorization and assessment of medicinal 
products for human use; (24 page(s), in Russian)  
6. Description of content:  The draft amendments to the Rules for marketing authori zation 
and assessment of medicinal products for human use provide for the updating of the Rules 
for marketing authorization and assessment of medicinal products for human use with 
account of the experience of law enforcement of these Rules on the procedure  for 
marketing authorization of medicinal products and bringing the registration dossier in line 
with the requirements of the Eurasian Economic Union.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of huma n health or safety  
8. Relevant documents:  https://docs.eaeunion.org/ria/ru -ru/0105925/ria_14042023   G/TBT/N/RUS/140  
 
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  9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  60 days from notification  
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.eurasian commission.org  
 