G/TBT/N/RUS/120  
30 July 2021  
(21-5994) 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 guideline 
for the pharmaceutical development of m edicinal products for use in paediatric practice 
(55 page(s), in Russian)  
6. Description of content:  The draft guideline on the pharmaceutical development of 
medicines for use in paediatric practice provides for the need to establish unified 
approaches to  the process of pharmaceutical development of medicines for use in 
paediatric practice to create safe and high -quality medicines intended for use for the 
paediatric population, to provide additional guarantees of a favo urable benefit -risk ratio 
for this cr itical group of patients, and the possibility of their adequate use by children of 
different age groups and not creating an unnecessary burden on patients and (or) persons 
providing care for them.  
7. Objective and rationale, including the nature of urgent  problems where 
applicable:  Protection of human health or safety  G/TBT/N/RUS/120  
 
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  8. Relevant documents:   
Draft guideline for the pharmaceutical development of medicinal products for use in 
paediatric practice  
https://docs.eaeunion.org/ria/ru -ru/0104714/ria_19072021  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  28 August 2021  
11. Texts available from:  National enquiry point [X] 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   
 
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   
https://docs.eaeunion.org/ria/ru -ru/0104714/ria_19072021