G/TBT/N/RUS/154  
14 November 2023  
(23-7671) 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@eecommission.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 Marketing Authorisation and Assessment of Medicinal 
Products for Human Use  
https://docs.eaeunion.org/ria/ru -ru/0106296/ria_01112023;  (59 page(s), in Russian)  
6. Description of content:  The draft decision envisages updating the text of the Rules for 
Marketing Authorisation and Assessment of Medicinal Products for Human Use, taking into 
account the practice of enforcement of the Rules on the procedure for making 
amendments to the registration dossier of a medicinal pr oduct  G/TBT/N/RUS/154  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:   
- Protecting the life and health of a patient (as the end user of medicines);  
- protecting the interests of the healthcare system ;  
- protection of the interests of manufacturers of medicinal products and their authorized 
persons;  
- protection of the interests of authorized bodies (expert organizations) that perform the 
procedure fo r assessment of the registration dossier of a medicinal product from the 
position of proving its safety and compliance with a given quality standard  
8. Relevant documents:   
Draft amendments to the Rules for Marketing Authorisation and Assessment of Medici nal 
Products for Human Use (59 pages in Russian)  
https://docs.eaeunion.org/ria/ru -ru/0106296/ria_01112023  
Decision of the Council of the Eurasian Econ omic Commission No. 78 of November 3, 2016  
https://docs.eaeunion.org/docs/ru -ru/01411969/cncd_21112016_78  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  The effective date of the draft amendments will be 
30 calendar days after the date of official publication.; 6 months from adoption  
10. Final date for comments:  13 December 2023  
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@eecommission.org  
Website: www.eurasiancommission.org