Russia Begins Its Pharma Supply Chain Pilot

Last week, GS1 Healthcare raised the awareness of new documents available on the Russian Federation government website.  Actually, the news was contributed to that group by Brian Daleiden of TraceLink, who has been very generous with contributions of news and documents from multiple markets.  These Russian documents explain the basis for a voluntary pharma supply chain pilot that the government is beginning this quarter.  Of course, these documents are only provided officially in the native Russian language. 

You may be surprised to hear that I actually took a full year of Russian language courses when I was in college.  It was fun, but really hard, and I had to stop it because it was taking too much of my study time.  All that is left in my head about Russian is how to pronounce some of the letters.  That sometimes helps me recognize words that sound the same in English, but look unrecognizable to those without a similar experience.  In other words, it offers no real value for translating government documents like these.  So, I just use Google Translate.

Google Translate works fairly well on these particular documents, but the results are still not good enough for anyone to trust for compliance purposes, even for a pilot.  It is a government pilot, after all.  So here are the RxTrace, Google Translate unofficial translations of the two Russian pilot documents.

1. Minutes of the October 25, 2016 meeting of the Russian Federation Strategic Development and Priority Projects discussing the priority project known as “Implementation of an automated system for monitoring the movement of drugs from the manufacturer to the end user to protect the public from counterfeit medicines and surgical removal from circulation of counterfeit and substandard drugs” (click on the link to open the PDF)

This document is intended to serve as a high-level description of the proposed pharma supply chain pilot.  It lays out basic project details like which departments of the government will participate, where the funding comes from and how much, what the intended results are, and the timing of the major milestones.  It also includes a section that describes some of the pilot operational details.  According to this document, the voluntary pilot will run from January 1, 2017 through December 31, 2017.  Then, the “second stage” will run from January 1, 2018 through December 31, 2018 and will require the same labeling on “100% of medicines”.  According to this document, that part will be mandatory.

The original version of this document can be found here.

The pilot is intended to follow a system known as “Federal Public information system for monitoring the movement of drugs from the manufacturer to the final consumer”, or, “FGIS MDLP” (see “The Next Markets To Impose Pharma Serialization and Tracing?”).  I will try to post a translation of that document in the future.

2. Text of Russian Federation Decree and Resolution “On carrying out controls on labeling pilot (identification) signs and monitoring over the circulation of certain types of drugs for medical use” (click on the link to open the PDF)

This document is the official approval of the pilot proposal that is described in the previous document, signed by the Prime Minister of the Russian Federation, Dmitry Medvedev on January 24, 2017.  This approval comes a few months later than the timeline in the first document sets for this approval.  Consequently this document adjusts the pilot timeframe to February 1, 2017 through December 31, 2017.  There is no mention of the “second stage” that was mentioned in the previous document, but it does give the government until February 1, 2018 to submit a report of the assessment of the pilot.  That makes it appear to be an approval only for the voluntary first stage.

The original version of this document can be found here.

It is my understanding that there are quite a few multi-national pharma manufacturers who are lined up to participate in the pilot.  Certainly those companies already have professional translations of these two important documents, and more.  Now you have an unofficial translation.  I will watch for news as the pilot progresses.