Russia release updated serialisation concept paper
Be4ward
Written by Be4ward on 12/11/2015
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.
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