G/TBT/N/RUS/101  
24 July 2020  
(20-5092) 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.eurasi ancommission.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 Scientif ic and Technical Centre for Information on Standardization, Metrology and 
Conformity Assessment  
(Standartinform, National enquiry point for the TBT Agreement)  
Tel: +7(495) 531 -26-59  
Fax: +7(495) 531 -27-05  
E-mail: enpoint@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):  
Medicaments consisting of two or more constituents mixed together for therapeutic or 
prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 
3002, 3005 or 3006) (HS 3003); Medicaments consisting of mixed or unmixed products for 
therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of 
transdermal administration" or in forms or packings for retail sale (excl. goods of heading 
3002, 3005 or 3006) (HS 3004)  
5. Title, number of pages and language(s) of the notified document:  The Draft 
amendments to the Rules of the Good Manufacturing Practice in the Eurasian Economic 
Union (30 page(s), in Russian)  
6. Description of content:  The D raft amendments to the Rules of the Good Manufacturing 
Practice in the Eurasian Economic Union applies to medicinal products put into circulation 
on the territory of the Eurasian Economic Union and envisages the need to establish a 
unified approach to the procedures for qualification and validation of medicinal products, in 
order to prove that the parameters of critical processes (equipment) meet the specified 
requirements, as well as in case of significant changes in premises, equipment and 
processes that may affect the quality of finished products, which makes it possible to 
ensure stable output of products with a given level of quality at pharmaceutical 
enterprises.  G/TBT/N/RUS/101  
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Prevention of deceptive practices and consumer protection; Protection of 
human health or safety; Quality requirements  
8. Relevant documents:   
• Draft amendments to Rules good manufacturing practice the Eurasian Economic 
Union :  
https://docs.eaeunion.org/ria/ru -ru/0104038/ria_16062020  
• Decision No.77 of the Council of the Eurasian Economic Commission of 
3 November  2016:  
http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LSl/Pages/drug_pro
ducts.aspx  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  60 days from notification  
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 
Website: www.eurasiancommission.org  
E-mail: dept_techregulation@eecommission.org  
http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LSl/Pages/drug_products.a
spx  
https://docs.eaeunion.org/ria/ru -ru/0104038/ria_16062020