G/TBT/N/RUS/96  
9 January 2020  
(20-0200) 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:   
The Ministry of Health of the Russian Federation  
Tel: +7 (495) 628 -44-53 
E-mail: info@rosminzdrav.ru  
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:   
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 mixed or 
unmixed products for therapeutic or prophylactic uses, put up in measured doses 
(including those in the form of transdermal administration systems) or in forms or 
packin gs for retail sale (HS 3004); - Opacifying preparations for X -ray examinations; 
diagnostic reagents designed to be administered to the patient (HS 300630)  
5. Title, number of pages and language(s) of the notified document:  The draft 
guidelines for the assessment of the quality and research of drugs based on liposomes, 
micelles and drug -containing coating of nanoparticles. (82 page(s), in Russian)  
6. Description of content:  The draft guidelines for quality assessment and re search of 
liposome -based drugs, micelles and drugs containing nanoparticle coatings apply to the 
development of copied drugs from the liposome, micelle and drug group, containing 
nanoparticle coatings for subsequent registration on the territory of the Eur asian 
economic Union and provides for the need to establish uniform requirements for the 
evidence -based study of the equal effectiveness and interchangeability of copied and 
reference drugs based on liposomes, micelles and drugs containing nanoparticle coa tings 
used in the treatment and prevention of human diseases, in order to:  
identification of ineffective and (or) non -equivalent drugs at the pre -registration stage, 
resulting in the risk of harm to human life and health;  
elimination of the need to duplica te studies of these groups of drugs in each of the 
member States of the Union.   G/TBT/N/RUS/96  
 
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  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) by ensuring the use of proven equally effective and 
interchangeable copied medicines;  
- protection of the interests of patients participating in the study by clearly regulating 
the procedure for  conducting bioequivalence studies of these groups of drugs.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
The draft guidelines for the assessment of the quality and research of drugs based on 
liposomes, micelles and drug -containing coating of nanoparticles  
https://docs.eaeunion.org/ria/ru -ru/0103833/ria_23122019  
9. Proposed date of adoption:  to be determined  
Proposed date of entry into force:  to be determined  
10. Final date for comments:  25 March 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@eurasiancommission.org  
Website: www.eurasiancommission.org  
https://docs.eaeunion.org/ria/ru -ru/0103833/ria_23122019