G/TBT/N/RUS/95  
8 January 2020  
(20-0090) 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 indi cated 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):  Human 
blood; animal blood prepared for therapeutic, prophylactic or diagnostic use; immune 
serums, other blood fractions and immunological products, modified or unmodified, 
including those obtained by biotechnology; vaccines, toxins, cultures of microorganisms 
(except yeast) and similar products; immune sera, other blood fractions and 
immunological products, modified or unmodified, including those obtained by 
biotechnology; Medicinal products consisting of a mixture of two or more components fo r 
therapeutic or prophylactic use, but not packaged in dosage forms or in forms or packages 
for retail sale; Medicinal products consisting of mixed or unmixed products for therapeutic 
or prophylactic use, packaged in the form of dosage forms (including med icinal products.  
5. Title, number of pages and language(s) of the notified document:  Draft 
amendment to decision № 93 of the Council of the Eurasian economic Commission of 
3 November 2016. (2 page(s), in English)  
6. Description of content:  The Draft amendment to decision No. 93 of the Council of the 
Eurasian economic Commission of 3 Nove mber 2016 applies to the claimed for registration 
in the territory of the member States of the Eurasian economic Union drugs during the 
transition period and establishes the possibility, until 31 December 2020 submission of 
applicants for state registratio n, re-registration, confirmation of registration, amendments 
to registration dossier of medicinal products in accordance with the legislation of a 
member state of the Eurasian economic Union, documents issued by the authorized 
bodies of the member States c onfirming the compliance of the production of medicines 
with the requirements of good manufacturing practice of the Eurasian economic Union, or 
for medicines produced in the member States, documents issued by the authorized bodies 
of the member States conf irming the compliance of the production of medicines with the 
requirements of good manufacturing practice of the member States.  G/TBT/N/RUS/95  
 
- 2 - 
 
  Until December 31, 2025, it is established that applicants can submit documents issued 
by the authorized bodies of the member St ates confirming the compliance of the 
production of medicines with the requirements of good manufacturing practice of the 
Eurasian economic Union, or for medicines produced in the member States, when re -
registering, confirming registration, amending the re gistration dossier of medicines in 
accordance with the legislation of the member States, requirements of good 
manufacturing practices of member States.  
The draft amendment has been prepared in order to:  
- protection of life and health of the patient (as th e final consumer of medicines);  
- protection of the interests of drug manufacturers by reducing the costs of 
manufacturers associated with repeated inspections for compliance with the requirements 
of good manufacturing practices of the Eurasian economic Un ion. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
• Draft amendment  to decision № 93 of the Council of the Eurasian economic 
Commission of 3 November 2016: https: //docs.eaeunion.org/ria/ru -
ru/0103829/ria_23122019   
• Decision of the Council of the Eurasian economic Commission  «Оn recognition of 
the results of inspection of production of medicines»: 
http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/drug
_products.aspx   
9. Proposed date of adoption:  to be determined  
Proposed date of entry into force:  to be determined  
10. Final date for comments:  24 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_techregul ation@eurasiancommission.org  
Website: www.eurasiancommission.org  
https://docs.eaeunion.org/ria/ru -ru/0103829/ria_23122019  
http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/drug_product
s.aspx