Russia release updated serialisation concept paper

Russia release updated serialisation concept paper

Having received a lot of feedback, Russia have issued an updated version of their concept paper. It appears that some of the feedback has been taken into account, but the result is still a very complex implementation, with much detail still to be resolved.

Below are some of the “headlines” as I see them from the updated concept paper. Please forgive me if you interpret what is said in the paper differently, but as usual with this sort of evolving and complex legislation, there is plenty of room for ambiguity and interpretation.

The overall system is referred to as the FGIS MDLP, or the system for the monitoring of movement of drugs from manufacturer to end consumer

Purpose

  • To guarantee the supply of high quality, effective and safe medicines
  • There is also a lot of language and functionality described to monitor and control drug pricing throughout the supply chain

Scope

  • Drugs manufactured in Russia for local use
    • This may also include the Eurasia Economic Union
  • Drugs manufactured in Russia for export
  • Drugs imported into Russia

Phased implementation

  • 25 December 2015 – Agreement to the FGIS MDLP in Russia
  • 31 August 2016 – Technical system design and supporting laws complete
  • 31 October 2016 – Pilot, including minimum required FGIS MDLP system capability
    • Including one local manufacturer and one importing manufacturer, together with minimal number other supply chain participants
  • 31 December 2016 – FGIS MDLP system fully implemented
  • 1 January 2017 – Drugs for the “seven high cost diseases” serialised and supply chain participants handling these drugs enabled to track & trace them
  • 1 January 2018 – Drugs on Russia’s list of “vital and essential medicines” to be serialised and supply chain participants handling these drugs enabled to track & trace them
  • 1 January 2019 – All drugs to be serialised and supply chain participants “to be gradually connected”

Full track & trace model

  • Central FGIS MDLP computer system to be provided by the government
    • All supply chain participants and agencies to connect to this electronically
  • Serial numbers issued from FGIS MDLP system
  • Secondary packaging (or primary if no secondary pack level), bundles and shippers to be marked with 2d code containing 6 items. No mention of human readable text being required as well.
    • Manufacturer code
    • Manufacturer product code
    • Registration number of product
    • Serial number
    • Lot or batch number
    • Expiry date
  • Aggregation inferred
  • Participants in the supply chain to include
    • Manufacturers
    • Importers
    • Exporters
    • Wholesalers
    • Drug stores
    • Medical organisations
    • Examination organisations
    • Destruction organisations

I am sure this raises as many questions for you as it answers. In my next post I will discuss some of the issues that this presents.

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com.

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