Whether you manufacture medicinal products in Russia, or you plan on importing them into Russia, you need to fully understand the country’s new regulations regarding pharma compliance. FMD (EU) and DSCSA (US) compliance regulations are slightly different than those of Russia.
Here are the most important factors of Russian pharma compliance you need to consider.
Deadlines for Product Serialization
The deadline for product serialization in Russia (both manufactured in and imported into the country) is December 31, 2019.
However, there’s an earlier deadline for the VED (Vital and Essential Drugs) products and 7HCN (Seven Nosologies). The deadline for serializing these products to enable full traceability in the pharmaceutical supply chain was the end of 2018.
Tracking and Reporting Compliance Events
Russian pharma compliance regulates that all foreign pharmaceutical manufacturers and distributors must track and report up to 36 compliance events, as opposed to 7 compliance events that EU FMD regulates.
Foreign manufacturers and distributors must track a wide range of product transactions and movements, as well as packaging changes, and report to the FSIS MDC (Federal State Information System for Monitoring Drug Circulation) via XML uploads with electronic signatures. Also, they must send their reports within 5 business days.
Prescription and OTC Products Requirements
Russian compliance regulations dictate the tracking and tracing of both prescription drugs and OTC (over-the-counter) products. Both EU and US regulations include only prescription drugs and high-value medicines.
This is now a bit of a challenge for both EU and US pharma companies because they are already in the process of storing their product master data – many have already finished compiling it. If they want to distribute to Russia, they now have to source their product master data for OTC products as well.
Furthermore, EU and US pharma companies that plan on distributing their medicinal products to Russia now have to make sure they serialize their products to meet all the Russian pharma compliance deadlines. All their manufacturing lines must include OTC product serialization.
While there are no aggregation requirements included in the FMD and DSCSA compliance regulations, Russian pharma compliance requires documenting and reporting aggregation. All aggregation and disaggregation operations are considered compliance factors.
Also, every serial number of medicinal products in Russia must also contain a unique identifier. This is an extra layer of security against counterfeit drugs entering the supply chain.
These are the most vital factors to have in mind when manufacturing pharmaceutical products in or importing them into Russia.
We can help you properly keep track of all the products in the supply chain, with the help of our rfxcel traceability platform. Don’t hesitate to contact us for more information, we’re here for you 24/7.