Whether you manufacture medical products in Russia or plan on importing them into the country, you need to understand the regulations for pharma compliance that will go into effect in January 2020. Here are the five most important aspects to consider.
1. Deadlines for Product Serialization
Under the new regulations, the deadline for serialization for products manufactured in Russia or imported into the country is December 31, 2019. Other regulations that came into effect at the end of 2018 called for serialization of products on the Essential Drugs List and “Seven Nosologies,” a state program that helps patients access high-cost treatments for orphan diseases (i.e., rare diseases).
2. Tracking and Reporting Compliance Events
Russian pharma compliance stipulates that all foreign pharmaceutical manufacturers and distributors must track and report up to 36 compliance events. This is a much higher standard than other regulations, including the EU’s Falsified Medicines Directive (FMD), which requires seven compliance events, and the Drug Supply Chain Security Act (DSCSA) in the United States.
Foreign manufacturers and distributors must track a wide range of product transactions and movements, as well as packaging changes, and report to Russia’s Federal State Information System for Monitoring Drug Circulation via XML uploads with electronic signatures. These reports must be submitted within five business days.
3. Reporting Requirements
The new reporting requirements differ depending on the business type and model. The business use case dictates the type of compliance events to track and report, as well as different sequences of those events.
4. Prescription and OTC Products Requirements
The new regulations dictate the tracking and tracing of both prescription drugs and over-the-counter (OTC) products. This is unlike EU and U.S. regulations, which cover only prescription drugs and high-value medicines.
This is a challenge for EU and U.S. pharma companies that are either in the process of storing their product master data or that have already finished compiling it. If these companies want to distribute in Russia, they now also have to source their product master data for OTC products.
Furthermore, pharma companies in the EU or United States that want to do business in Russia have to make sure they serialize their products to meet the pharma compliance deadlines. All their manufacturing lines must include OTC product serialization.
5. Aggregation Requirements
FMD and DSCSA compliance regulations do not have aggregation requirements. Russian pharma compliance, however, will require documenting and reporting aggregation. In other words, all aggregation and disaggregation operations are considered compliance factors. Furthermore, every serial number for medicines in Russia must contain a unique identifier. This is an extra layer of security against counterfeit drugs entering the supply chain.
These are the most notable facets of the Russian compliance regulations that foreign companies must keep in mind as 2020 approaches. rfxcel’s Traceability Platform (rTS) can help you properly keep track of all the products in your supply chain. If you want to ensure you’ll be fully compliant with the new Russian regulations, contact us for more information. Our supply chain experts, including staff in Russia, are ready to help!
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