Are Your Products Already in Compliance with Russian Serialization Regulations?

Compliance Deadline for Nosology Products Comes Closer

Pharmaceutical manufacturers selling their products in Russia had been aware of the recently announced serialization and aggregation regulations. However, at the end of 2018, Russia published an update to Federal Law No. 425-FZ, including an earlier deadline for Nosology products. Instead of 1st January 2020, manufacturers will now have to comply with the regulations by 1st October 2019. This means manufacturers must ensure that their products comply with the new guidelines in a much shorter time frame.

The new serialization and aggregation regulations apply to 12 Nosology products. Included in this category are expensive medications that are used for treating rare medical conditions. Hemophilia, cystic fibrosis, myeloid leukemia and multiple sclerosis are just some of the diseases that are being treated through the use of Nosology products.

What do I need to consider to comply?

To comply with current regulatory requirements, pharmaceutical products must be traceable along the entire supply chain. The implementation of nationally different track & trace requirements is one of the biggest challenges for pharmaceutical manufacturers. In Russia, the recorded events must be sent to the respective trading partners and to the Federal State Information System for Monitoring Drug Circulations (FSIS MDC). The new Russian serialization and aggregation regulations, require a broader range of product movements to be recorded. Like all recorded events, these must also be transmitted to trading partners and FSIS MDC.

According to the new regulations, it is also a requirement to display additional information on the product using a crypto code and crypto key. A crypto code contains this information, divided into two parts. The first part is the identification part and consists of a GTIN and a serial number. The second parts serves for control and verification. It contains a sequence of characters that are created through a cryptic transformation of an identification code.

What products must be serialized?

The EU regulations apply to high quality and prescription medicines. However, the new Russian serialization regulations affect a larger volume of pharmaceutical products, including over-the-counter medicines. Many manufacturers producing such drugs do not have a serialization system in place. In order to be able to comply with the new regulations, they need to implement one quickly.