G/LIC/Q/RUS/4  
 
5 April 2018 
(18-2073) Page: 1/2 
Committee on Import Licensing  Original: English  
 
RUSSIAN FEDERATION  IMPORT LICENSING PRO CEDURES1 
QUESTIONS FROM THE EUROPEAN UNION T O THE RUSSIAN FEDERA TION 
 
The following communication, dated 27 March 2018 , is being circulated at the request of the 
delegation of  the European Union . 
 
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The EU regrets that the Russian Federation has not submitted its annual notification in accordance 
to article 7.3 of the Import Licensing Agreement with reference to the year 2017 and would 
strongly encourage the Russian Federation to comply with its notif ication's requirements.  
 
In the lack of any updated notifications and considering the increasing number of concerns of the 
EU traders on certain import licensing procedures applied by the Russian Federation, the EU would 
like to receive clarifications on t he import licensing procedures for pharmaceutical products.  
 
According to the information contained in the notification submitted by the Russian Authorities, 
referring to 2016 (G/LIC/N/3/RUS/3), the importations of specified medicines and pharmaceutical 
products are subject to licences. It is also stated that the us e of import licences enables the 
Government to restrict and monitor the quantities controlled substances imported but that the 
system is not intended to restrict the quantity or volume of imports.  
 
The notification also specifies that the maximum processi ng time for permit is 5 days and that the 
maximum processing time for licence is 15 days.  
 
Since the introduction of the Good Manufacturing Practice (GMP) certificate requirements, as from 
January 2016, the importations of pharmaceutical products are submi tted to complicated and 
burdensome procedures. Furthermore, for obtaining those certificates the timing is very long and 
goes normally beyond the 5 to 15 days declared in the notification.  
 
While the EU is aware of legislative developments that are ongoing  since the beginning of the year, 
we do not see real progress in the legislative procedure.  
 
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 notificati on, describing the import licensing 
procedures for the importation of medicines and pharmaceutical products?  
 
EU question No 2 : Could the Russian Federation clarify what is the average time for obtaining the 
GMP? Could the Russian Federation share its stat istics?  
 
In the notification (see page 22, reply to question 7.a), it is stated that the processing time should 
be between 5 days for obtaining a permit and 15 days for obtaining a license.  
 
EU question No 3 : Could the Russian Federation clarify to what permits and licenses the Russian 
Federation is referring to?  
 
                                                
1 See Understanding on procedures for the Review of Notifications (G/LIC/4).  G/LIC/Q/RUS/4  
 
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  EU question No 4 :  Could the Russian Federation clarify whether the GMP is included in the 
definition of licence above?   
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?  
 
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