On December 29, 2017, Russia signed Law No. 425-FZ into law. It was put in place to streamline the quality control of pharmaceuticals, protect against counterfeit medicines, and monitor supply and demand and expenditure. The law has been phased in over the past two years, and now we’re just weeks away from Russia’s serialization deadline.
This quickly approaching deadline affects every component of the supply chain and puts into place some of the most — if not the most — aggressive compliance regulations in the world. Russian serialization requires the tracking of dozens of events throughout the supply chain, including commission/decommission, aggregation/disaggregation, and import/export. Without proper preparation, pharmaceutical companies operating in Russia or importing into Russia will fall behind and lose profits, if not be shut out altogether.
Here’s a rundown of the requirements and what you can do to be ready for 2020.
December 31, 2019, is the final deadline for the serialization of all products being manufactured in or imported into Russia. It includes serialization, aggregation, and event reporting for all pharmaceuticals. It will require complete unit- and batch-level traceability. These requirements will apply to all medicines, including over-the-counter (OTC) drugs.
Track & Trace Requirements
These updated track and trace requirements include a Unique Product Identification consisting of a two-part crypto tail — a Global Trade Item Number (GTIN) and a serial number.
Manufacturers will be required to apply a 2D Data Matrix code to secondary and tertiary levels of pharmaceutical packaging, including OTC medicines. This 2D code must include:
- GTIN/product code
- Serial number
- Verification key
- Crypto code
Initially, the law mandated an 88-character crypto code, but that was cut to 44 characters in August 2019. This simplifies the process as businesses are rushing to comply by the deadline.
The new law also has strict aggregation requirements. Members of the supply chain must report all changes within individual batches. Every change made must be reported to the government. Reports must detail how much of the batch is together and the location of removed or displaced units.
rfxcel & Russian Serialization
rfxcel is helping pharmaceutical companies prepare for these quickly approaching deadlines. All supply chain participants must report tracing information to Russia’s centralized Federal State Information System for Monitoring Drug Circulation. rfxcel is helping to streamline this process.
As of August 2019, rfxcel has doubled the size of its workforce in Russia. Our Compliance Management (rCM) and Serialization Processing (RSP) modules are built to help our clients achieve and stay compliant in Russia.
Our local teams in Russia are working around the clock to help with implementation. Our Traceability System (rTS) is already being used in Russia to ease the compliance process for local companies. For assistance reaching compliance by the 2020 deadline, reach out to rfxcel today!