   
  
G/TBT/W/636  
 
9 April 2019 
(19-2260) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
RUSSIAN FEDERATION, KAZAKHSTAN, KYRGYZ R EPUBLIC - PHARMACEUT ICAL 
PRODUCTS - RESOLUTIO N 1314 OF THE GOVERN MENT OF THE RUSSIAN  
FEDERATION ON DETERM INING COMPLIANCE OF MEDICINAL  
PRODUCTS' MANUFACTUR ERS WITH THE REQUIRE MENTS OF  
GOOD MANUFACTURING P RACTICE DRAFT DECISI ONS  
OF THE BOARD OF THE EURASIAN ECONOMIC UN ION  
STATEMENT BY THE EUROPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
6 AND 7  MARCH  2019 
The following communication, dated 5 April  2019, is being circulate d at the request of the delegation 
of the European Union . 
 
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1.  The European Union would like to raise concern s regarding measures adopted by the Russian 
Federation introducing certification requirements for medicinal products .  
2.  Since January 2016, Russia has required local 'Good Manufacturing Practice ' (GMP) certificates 
for production sites of medicines, including foreign manufacturing sites, as part of the marketing 
authorization application. This requirement was introduced wit hout any transition period and foreign 
manufacturers were not given sufficient time to obtain a GMP certificate before the entry into force 
of the new rules.  
3.  The long timelines of the GMP inspection procedure and the inspection capacity constraints, 
aggra vated by the lack of transition period, ha ve hindered access to the Russian market for foreign 
producers.  This is illustrated by the  very few  new drug registration applications filed by foreign 
companies in Russia in 2017 : only 35 new marketing aurhotizatr ions applications took place, which 
is about one tenth of the usual fi gure.  
4.  The latest GMP amendments to Federal Law 61, adopted in June 2018, have provided slight  
improvements in the process, allowing for the registration  of a product  in parallel to insp ection. 
However, we would like to highlight important  concerns that remain  and have a significant impact 
on trade . 
5.  In particular, in dustry still faces issues with regard to inspection capacity. We therefore ask the 
Russian Federation to take the  necessary  measures to  progressively increase  inspection capacity, in 
order to satisfy the inspection requests by companies, including those producing abroad and 
exporting to Russia. Inspections are still product -based, whereas site -based inspection s remove the 
need to inspect every time there is a new product.  Site-based inspections are the rule in the EU and 
other jurisdictions.  The EU encourages Russia to move to site -based inspectiosn, which would free 
up time and resources. Additionally, a risk -based approach to inspections would be more efficient, 
as reliance on the results of previous inspections would decrease the workload.  
6.  Moreover, i nspections are not standardized and lack transparency. This has led to de facto 
significant discrimination towards foreign manufacturing sites, where 30% of foreign sites, despite 
a majority having been approved by the European Medicines Agency and/ or the US Food and Drug 
Administration , have failed Russian inspections, compared to an almost zero percent failure rate of 
Russian sites.  Such difference is worrying, and calls for a revision of the procedures in place so as 
to ensure that Russia -based sites and foreign sites are treated in the same way.  In addition, G/TBT/W/636  
 
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  companies of which appl ications for GMP certification have been rejected receive limited feedback 
as to the reasons for their failure, and there is no possibility to take corrective measures  for minor 
errors, including clerical errors, which departs from common practice in the E U and other 
jurisdictions and is more trade -restrictive than necessary .  
7.  Finally, the European Union would like to call for the harmonisation of EAEU -level inspections, 
which would make the system more predictable and facilitate trade.  
8.  The European Union asks the Russian Federation to take the necessary actions to ensure these 
measures are not unecessarily trade -restrictive and do not discriminate against foreign products.  
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