G/TBT/N/RUS/121  
25 August 2021  
(21-6413) 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@eurasiancommissio n.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 t he 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 of marketing authorizatio n and assessment of medicinal 
products for human use https://docs.eaeunion.org/ria/ru -ru/0104808/ria%2013082021  
(109 page(s), in Russian)  
6. Description of content:  Detailed instru ctions are given for groups of unregistered 
medicines to which patients are granted access in case of threats of emergency situations, 
as well as groups of advanced therapy medicinal products, breakthrough therapy 
medicinal products, orphan medicinal produ cts. Additional features are provided for:  
• parallel consideration of applications by several recognition States during the 
mutual recognition procedure and making changes to the registration dossier 
before its consideration in the recognition States are introduced;  
• remote assessment of laboratory tests of methods of quality control of a 
medicinal product;  
• the use of electronic document management when providing module 1 of the 
registration dossier of a medicinal product.  G/TBT/N/RUS/121  
 
- 2 - 
 
  The section on the introduction of  post-registration measures has been revised.  
The Rules are supplemented with special procedures and appendices for:  
• registration of medicines in exceptional cases;  
• conditional registration of medicines;  
• accelerated assessment of medicines.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:  Draft Amendments to the Rules of marketing authorization and 
assessment of medicinal products for human use  
https://docs.eaeunion.org/ria/ru -ru/0104808/ria%2013082021  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  17 September 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/0104808/ria%2013082021