Russian Serialization & Aggregation Regulations

(An Official publication of PharmaSecure)

The deadline is looming for manufacturers of pharmaceutical products manufactured in Russia or imported into Russia. From January 1st, 2020 they need to comply with the additional serialization and aggregation regulations for complete unit and batch level traceability.

Russia is known to have one of the most stringent serialization requirements in the world, and unlike regulations in other parts of the world, Russia Federal Law No. 425-FZ requires serialization on a wider range of pharmaceutical products – including over the counter (OTC). The new regulations also call for the inclusion of a crypto key and signature codes unique to Russia encoded on all 2D barcodes, in addition to information which is required by the EU FMD or the US DSCSA (Global Trade Item Number (GTIN), serial number, batch number, and expiration date).

While the new regulations ensure added security to monitor and combat counterfeiting, an augmentation of regulations totaling to 36 possible “compliance events” is anticipated, compared to the EU FMD (Falsified Medicines Directive) which has a maximum 7 compliance events. Aggregation activities such as individual change made to a batch to unit packing and unpacking need to be documented and reported to both trade partners and the Federal State Information System for Monitoring Drug Circulations (FSIS MDC). In recent developments, the initial 88 characters for AI 92 (Signature) was reduced to 44 characters when the amendment to Decree of the Government of Russia Federation No. 1556 was signed by Dmitry Medvedev. Additionally in the newly circulated OMS document, payment module fro crypto-codes have also been added ((Click here for OMS ver. 2.6)

With the compliance deadline fast approaching, our competent experts at PharmaSecure are ready to provide serialization and traceability solutions and help bring your production lines into compliance. Please contact our experts for a demo.