G/TBT/W/507  
 
19 April 2018  
(18-2455) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
 RUSSIAN FEDERATION, KAZAKHSTAN  — PHARMACEUTICAL PRODU CTS - RESOLUTION 
1314 OF THE GOVERNME NT OF THE RUSSIAN FE DERATION ON DETERMIN ING 
COMPLIANCE OF MEDICI NAL PRODUCTS' MANUFA CTURERS WITH THE REQ UIREMENTS 
OF GOOD MANUFACTURIN G PRACTICE (NON -NOTIFIED); DRAFT DEC ISIONS OF THE 
BOARD OF THE E URASIAN ECONOMIC UNI ON 
STATEMENT BY THE EUR OPEAN UNION TO THE C OMMITTEE ON TECHNICA L BARRIERS TO TRADE  
21 AND 22 MARCH 2018  
The following communication, dated 16 April 2018, is being circulated at the request of the 
delegation of the European Union . 
 
____ ___________  
 
 
1.  The European Union would like to raise again its concern regarding measures which the Russian 
Federation has adopted introducing certification requirements for medicinal products, both for 
human and animal use.  
2.  At the moment, the most signifi cant concern relates to Resolution 1314 of the Government of 
the Russian Federation on determining compliance of medicinal products' manufacturers with the 
requirements of Good Manufacturing Practice, of 3  December 2015.  
3.  To the best of our knowledge, this resolution has still not been notified to the WTO. However, 
the resolution introduces a requirement of inspection and certification of production sites of 
medicines with regard to "Good Manufacturing Practice ", including foreign manufacturing sites, 
which is a pre -condition for the obtention of a marketing authorisation in the Russian Federation  
for importing companies . Therefore , the Resolution has a significant effect on trade and, in our 
view, the obligation laid down in the TBT Agreement to notify draft  measures so as to make 
possible their review by WTO members applies to it.  
4.  For the sake of brevity I recall our previous interventions in this Committee, however the EU 
would like to request, once again, that:  
- the measure is notified to the WTO, so as to make possible its review by WTO members 
with a view to take into consideration their comments for the finalisation of the measure  
- appropriate transition time and additional accompanying measures are taken by the RF, 
including in the area of organisation of inspections, so as to ensure that the GMP 
certification requirement can be timely complied with by foreign manufacturers without a 
negative impact on their exports to the Russian Federation. We understand that no 
action has led yet to such a transition period while the measure is fully in place since the 
beginning of 2016 for renewal of authorisations and since the beginning of 2017 for new 
authorisations (despite the draft amendments to Law 61 on veterinary pharmaceuticals 
only, posted for public dicuss ion last December – new adoption to our knowledge).  
- the necessary inspection capacity is progressively increased so as to satisfy the 
inspection requests by companies, including producing abroad and exports to the RF – 
could the RF give information on its inspection capacity in this regard?  G/TBT/W/507  
 
- 2 - 
 
  - the RF informs us about the state of play of the amendements to the current rules (Law 
No. 61-FZ of 12 April 2010) introduced to the Duma at the end of last year which allows 
foreign manufacturers to apply for marketing authorization while the GMP process is 
ongoing.  
- the specific issue for veterinary products of double inspection of sites manufacturing 
Active Pharmaceutical Ingredients and final products is reconsidered by the Russian 
Federation.  
 
 
__________