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The Breakdown: Russia Serialization Requirements

Note: Russia changed its serialization requirements in August 2019. Read about those changes here. Also, since this blog first appeared, we’ve written “Russia 2020: A Guide to Pharmaceutical Supply Chain Compliance,”  an easy-to-understand white paper that explains the fundamentals of the Russian legislation and puts it all in context. If you’re interested in what’s in store for consumer goods in Russia, check out our white paper about that industry.

 

Russia’s latest serialization regulations give pharma companies until 2020 for complete unit- and batch-level traceability. Originally, companies had to comply with Federal Law No. 425-FZ by 2019, but that deadline was pushed back 1 year. While this extra time will be helpful to pharma companies, given the complexity of Russia serialization requirements, it still may not be enough for pharma to prepare.

The Regulations

Like the EU Falsified Medicines Directive (FMD) or the U.S. Drug Supply Chain Security Act (DSCSA), Russia serialization requires a 2D barcode on all individual units, with a GTIN, serial number, batch number, and expiration date. However, Russia also requires a Foreign Economic Activity Common Nomenclature (FEACN) code encoded on all 2D barcodes.

Additionally, the law requires serialization on all medications, including over-the-counter (OTC) medications, and outlines special requirements regarding aggregation and separate serialization requirements for batches. While individual units 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 on the box.

Aggregation will require members of the supply chain to report every change in individual batches. Reports must be produced around each change made to a batch, and supply chain actors 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. Foreign manufacturers have an even more rigorous set of requirements, and can expect to have to report up to 36 different compliance events. As a comparison, the FMD has a maximum of seven 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 it.

Last, there are cryptography requirements that are unique to Russia.

Russia may have special requirements before the deadline

Although serialization and traceability are required for prescription and OTC drugs by 2020, Russia has two lists of crucial and expensive medicines that require serialization before then. The first are medications used to treat a list rare and expensive-to-treat diseases, such as hemophilia, cystic fibrosis, and multiple sclerosis. 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 other countries’ regulations, Russia requires the complete serialization and traceability of OTC medications. Manufacturers who produce OTC medications need to make sure that their lines are ready. Companies who have yet to start converting their lines need to start now.

Furthermore, there will not only be more compliance events, but there will be 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, we are ready to help you complete all serialization and traceability requirements while providing you with the business value you need. We have Russian-speaking experts, based in Russia, as part of our European team. Contact rfxcel today to see how our Russia compliance solution can help you!

For more information on serialization and traceability in Russia, click here, and to learn more about Russian pharma compliance click here.

 

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