G/TBT/N/RUS/147  
28 July 2023  
(23-5154) 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 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 Nomenclature of dosage forms (1+3 pages in Russian); (1 page(s), 
in Russian), (3 page(s) , in Russian)  
6. Description of content:  The draft amendments to the Nomenclature of dosage forms 
updates the names of dosage forms and their definitions, taking into account the 
experience of regulation enforcement and their unification in accordance wit h the 
Pharmacopoeia of the Eurasian Economic Union.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:   
Protecting the life and health of patients (as end users of medicines) and healthcare 
institutions in general (as pr imary consumers of medicines);  
Protection of the interests of the manufacturers of medicines;  G/TBT/N/RUS/147  
 
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  Protection of the interests of the authorized bodies (expert organizations) that perform 
the procedure for evaluating the registration dossier of a medicinal prod uct to prove its 
safety and compliance with a given quality standard, best efficacy and a favorable benefit -
risk profile.  
Protection of human health or safety  
8. Relevant documents:   
Draft amendments to the Nomenclature of dosage forms.  
https://docs.eaeunion.org/ria/ru -ru/0106074/ria_13072023  
Decision No 172 of the Board of the Eurasian Economic Commission of December 22, 
2015 
https://docs.eaeunion.org/docs/ru -ru/0149286/clcd_30122015_172_doc  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  30 calendar days from the date of the official 
publication  
10. Final date for comments:  17 August 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@eurasiancommission.org  
Website: www.eurasiancommission.org