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The Breakdown: Russia Serialization Requirements

Russia’s latest serialization regulations give pharma companies until 2020 for complete unit and batch level traceability. Originally the law – Federal Law No. 425-FZ – was to be complied with by 2019, but was pushed back by a year. While this extra year is certainly helpful to pharma companies, given the complexity of Russia serialization requirements, it still may not be enough time for pharma to prepare.

The Regulations:

Like the EU FMD or the US DSCSA, Russia serialization requires a 2D barcode on all individual units, with a GTIN, serial number, batch number, expiration date. However, Russia serialization also requires a Foreign Economic Activity Common Nomenclature (FEACN) code encoded on all 2D barcodes.

Additionally, Russia Federal Law No. 425-FZ requires serialization on all medications – including over the counter (OTC) medications, and also outlines special requirements regarding aggregation and separate serialization requirements for batches. While each individual unit must be serialized and a 2D barcode must be placed on the box or bottle, each batch must also be serialized with a 2D barcode placed on the box.

Aggregation will require individual members of the supply chain to report every change in individual batches. Reports must be produced around each individual change made to a batch and each member of the supply chain must report how much of the batch is left together, and where the removed units went.

Manufacturers shoulder most of the reporting responsibility under Russia serialization requirements, and foreign manufacturers have an even more rigorous set of requirements. Foreign manufactures can expect to have to report up to 36 different compliance events – for reference, the FMD only has a maximum 7 compliance events.

Much like the FMD, Russia serialization will be centralized through a database called the Federal State Information System for Monitoring Drug Circulation (FSIS MDC). Manufacturers will be expected to onboard with the FSIS MDC and report all serial numbers and batch numbers to the centralized system.

Finally, there are cryptography requirements in the system, and for the codes, that are unique to Russia.

Russia may have special requirements before the deadline:

While all prescription and OTC serialization and traceability are required by 2020, Russia also holds two lists of crucial and expensive medicines that require serialization before the 2020 deadline. The first are medications used to treat a list of diseases, including hemophilia, cystic fibrosis, and multiple sclerosis, which are rare and expensive to treat. The second includes medications considered vital and essential. Both potentially require serialization before 2019.

Conclusion:

Russia’s complex serialization and traceability regulations will be a challenge for all pharma companies. Manufacturers need to act now to be compliant by the January 1, 2020 deadline. Unlike regulations in other parts of the world, Russia requires the complete serialization and traceability of OTC medications. Manufacturers who produce OTC medications need to make sure that their manufacturing lines are ready. Companies who have yet to start converting their lines need to start now.

Under Russia serialization requirements there will not only be more compliance events, but there is also a heavy emphasis on aggregation. Batches will be serialized just as individual units are with multiple compliance events around aggregation and disaggregation.

The rfxcel promise:

rfxcel is the leading provider for worldwide traceability solutions. Since 2003, our solutions have helped pharma companies achieve global compliance. rfxcel recently announced our solutions module for Russia. With our 60 day, end-to-end implementation plan, rfxcel is ready to help you complete all serialization and traceability requirements, while also providing you with the business value you need.

For more information on serialization and traceability in Russia, click here.

We have Russian-speaking experts, based in Russia, as part of our European team.

Contact rfxcel today to see how rfxcel’s Russia compliance solution can help you!

Russia Serialization Requirements

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