G/LIC/Q/RUS/5  
 
8 April 2019  
(19-2236) Page: 1/2 
Committee on Import Licensing  Original: English  
 
 RUSSIAN FEDERATION  IMPORT LICENSING PR OCEDURES  
REPLIES FROM THE RUS SIAN FEDERATION TO T HE   
QUESTIONS FROM THE E UROPEAN UNION CONTAI NED IN G/LIC/Q/RUS/4  
The following communication, dated 4 April 2019 , is being circulated at the request of the delegation  
of the Russian Federation . 
 
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EU question No 1 : Could the Russian Federation explain why the procedures for obtaining the GMP 
certificate are not described under item 7 of its annual notification, describing the import licensing 
procedures  for the importation of medicines and pharmaceutical products?  
 
Reply : GMP is not covered by the notification on import licencing  procedures  (G/LIC/N/3/RUS/3) 
due to the fact that  GMP is the requirement for registration of pharmaceuticals considered as 
conformity assessment procedure falling under the purview of the Agreement on Technical Barriers 
to Trade. In other words, GMP is not the requirement for imports of pharmaceuticals and is not 
covered by the Agreement on Import licensing procedures.  
 
EU questi on No 2 : Could the Russian Federation clarify what is the average time for obtaining the 
GMP? Could the Russian Federation share its statistics? In the notification (see page 22, reply to 
question 7.a), it is stated that the processing time should be between 5 day s for obtaining a permit 
and 15 days for obtaining a license.  
 
Reply : According to the information provided by the Ministry of Industry and Trade, the average 
time for obtaining the GMP -certificate is 113 days.  
 
GMP is not the requirement for importation o f pharmaceuticals. In this sense, it is not covered by 
the notification on import licensing procedures (G/LIC/N/3/RUS/3).  
 
As for mentioned page 22, reply to question 7.a of the notification the indicated processing time is 
correct.  
 
EU question No 3 : Could the Russian Federation clarify to what permits and licenses the Russian 
Federation is referring to?  
 
Reply : In the notification (section 7 of G/LIC/N/3/RUS/4) the Russian Federation refers to 
procedures of import licencing for pharmaceuticals. Initially , the importer is obliged to apply for 
permit to the Federal Service in Healthcare. After that, he should obtain import license in the Ministry 
of Industry and Trade. This procedure is the direct requirement for importation and falls under the 
purview of t he Agreement on Import licensing procedures.  
 
These requirements are applied to the registered medical products, while GMP is a part of registration 
procedures.  
 
EU question No 4 : Could the Russian Federation clarify whether the GMP is included in the de finition 
of licence above?  
 G/LIC/Q/RUS/5  
 
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  Reply : GMP is not included  in description of import licencing, because it is the inspection of 
production -sites. GMP is the requirement for registration of pharmaceuticals considered as 
conformity assessment procedure falling under the purview of the Agreement on Technical Barriers 
to Trade.  
 
EU question No 5 : Could the Russian Federation clarify the Russian Federation envisage any 
amendments to the current procedures and in what sense? Could they confirm that a bill of law was  
sent to the Duma early 2018 and inform about the current stage of this draft law?  
 
Reply : The Federal Law № 140 -FZ amended the Federal Law of 2010 № 61 -FZ "On Circulation of 
pharmaceutical products " in order to simplify registration and significantly redu ce its period. The 
Federal Law 140 -FZ entered into force in summer of 2018.  
 
In particular, these amendments provide for the following opportunities:  
 
-  to initiate a registration of a pharmaceutical on the basis of  a copy of the decision of the 
Ministry of Industry and Trade of the Russian Federation to conduct a GMP inspection (not 
only on the basis of a copy of a GMP certificate, as it was previously);  
-  to provide registration in case of changes in the quality of a pharmaceutical and (or) in the 
methods of quality control of a pharmaceutical without re -inspection.  
 
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