  
  
G/TBT/N/RUS/127  
14 December 2021  
(21-9313) 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 Guidelines for the preparation of a regulatory document on the quality 
of a medicinal product  (69 page(s), in Russian)  
6. Description of content:  The following are clarified:  
• the procedure for the preparation of a regulatory document on quality, taking into 
account the specifications for a medicine, including specifications for the active 
pharmaceutical substances (active substances, APIs), intermediates and finished 
pharmaceutical products, as well as pharmacopoeial monographs;  
• approaches to the identification and justification of the acceptance crit eria 
(acceptable limits) and the identification of analytical methods used to evaluate 
these criteria.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/RUS/127  
 
- 2 - 
 
  8. Relevant documents:  Draft amendments to the Guidelines for the preparation of a 
regulatory document on the quality of a medicinal 
product  https://docs.eaeunion.org/ria/ru -ru/0104992/ria_29112021  
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.eurasiancommission.org   
https://docs.eaeunion.org/ria/ru -ru/0104992/ria_29112021  
 