The most recent update to the Russia serialization regulations give pharma companies until 2020 to complete unit and batch level traceability. At the beginning, the law – Federal Law No. 425-FZ – was to be complied with by 2019. The law was pushed back by a year to help pharma companies to be ready. Due to the complexity of Russia serialization requirements, one additional year still may not be enough time for pharma to be ready.
The Challenges in Regulations:
Similar to the US DSCSA or the EU FMD, a 2D matrix barcode on all individual units, containing a GTIN, serial number, batch number, and expiration date are requirements on the Russia serialization. But here is the difference, Russia serialization requires a Foreign Economic Activity Common Nomenclature (FEACN) code encoded on all the 2D matrix barcodes.
Russia Federal Law No. 425-FZ requires something that was not required under the EU FMD or the US DSCSA. Russia law requires serialization on all medications – including over the counter (OTC) medications. In addition, describes specific requirements regarding aggregation and separate serialization requirements for batches. Each individual unit must be serialized and a 2D matrix barcode must be placed on the carton or bottle. In addition, each batch must also be serialized with a 2D matrix barcode placed on the carton.
Aggregation will require the report of every change in individual batches to each individual members of the supply chain. The reports must include each individual change made to a batch. Also, these reports must contain 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. They have to be prepared to report up to 36 different compliance events in comparison with the FMD that only has a maximum of 7 compliance events.
Similar to 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.
There are cryptography requirements in the system, and for the codes, that are unique to Russia. Cryptography is necessary, since the regulations require the application of a crypto key and code to a product's unique identifier encoded in a barcode to be compliant.
Cryptography:
The word "cryptography" in terms of Russia compliance means taking some information and combining it with other data that is randomly generated according to specific mathematical principles.
For Russia cryptography, the Global Trade Item Number (GTIN) and serial numbers are used as baseline information to generate a unique crypto key and code for that pairing of information. The crypto key and code are used in Russia serialization and verification processes for two main reasons. The first is to provide additional protection mechanisms to guard against potential counterfeiting or duplication of product identifiers for products in the market. The second is to provide a secure "Offline" mode for pharmacy endpoints in their verification process that can be scanned locally during times of intermittent or disabled internet connections.
Russia special requirements before the 2020 deadline:
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:
All pharma companies are facing a big challenge with the Russia complex serialization and traceability regulations. With very specific regulations and different from the ones in other parts of the world, Russia requires the complete serialization and traceability not just to the prescribed medicine, but also including all the OTC medications. OTC medications companies need to have their manufacturing lines ready to be in compliance. Manufacturers who have yet to start preparing their lines need to start now to be sure they will be in compliance by the January 1, 2020 deadline.
The Vanguard Vision Commitment:
Vanguard Vision is the leading provider for worldwide systems integration for serialization and traceability solutions. Since 2017, our services have helped pharma companies achieve global compliance. Vanguard Vision is ready to help you complete all serialization and traceability requirements, while also providing you with the business value you need.