G/TBT/N/RUS/94  
7 January 2020  
(20-0073) 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   
Web-site: www.eurasiancommission.org , 
https://docs.eaeunion.org/ru -ru  
The Ministry of Health of the Republic of Belarus  
Fax: (017) 222 -46-27  
e-mail: mzrb@belcmt.by  
The Ministry of Health of the Russian Federation  
Tel: +7 (495) 628 -44-53 
E-mail: info@rosminzdrav.ru  
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:   
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):  
Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or 
more constituents which have been mixed together for therapeutic or prophylactic uses, 
not put up in measured doses or in forms or packings for retail sale (HS 3003); 
Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or 
unmixed products for therapeutic or prophylactic uses, put up in mea sured doses 
(including those in the form of transdermal administration systems) or in forms or 
packings for retail sale (HS 3004)  
5. Title, number of pages and language(s) of the notified document:  Draft 
amendments to Requirements for stability testing of drugs and pharmaceutical 
substances. (2 page(s), in Russian)  
6. Description of content:  The draft amendments to the Requirements for stability testing 
of drugs and pharmaceutical substances applie s to put into circulation on the territory of 
the Eurasian economic Union drugs and calls for the unified approach to the definition of 
"production date of the series" in order to exclude the possibility of automatic updates of 
the shelf life of the pharma ceutical substance by a simple repackaging, and the calculation 
of the shelf life of finished drugs, issued in circulation in the customs territory of the 
Eurasian economic Union for the purpose of elimination of the possibility of automatic G/TBT/N/RUS/94  
 
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  renewal of the  shelf life of the pharmaceutical substance by its simple repackaging, as 
well as the use in the production of substances with an expiration date not corresponding 
to the shelf life of finished drugs, which may lead to inconsistencies of expert reports and  
recognition.   
The draft guide has been prepared in order to:  
- protection of life and health of the patient (as the final consumer of medicines);  
- protection of the interests of the health care system as a whole (as the primary 
consumer of medicines)   
- protection of the interests of the authorized bodies (expert organizations) that 
perform the procedure of evaluation of the registration dossier of the drug from the 
position of proof of its compliance with the specified quality standard.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
Draft amendments to Requirements for stability  testing  of drugs and pharmaceutical 
substances   
https://docs.eaeunion.org/ria/ru -ru/0103838/ria_23122019  
Decision No.69 of the Board of the Eurasian economic Commission of 10 May 2018  
http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/drug_product
s.aspx  
9. Proposed date of adoption:  to be d etermined  
Proposed date of entry into force:  to be determined  
10. Final date for comments:  25 January 2020  
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   
Web-site: www.eurasiancommission.org , 
https://docs.eaeunion.or g/ru-ru  
https://docs.eaeunion.org/ria/ru -ru/0103838/ria_23122019  
http://www.eu rasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/drug_product
s.aspx