News | March 15, 2019

Russian Serialization Regulations Are Looming


Compliance Deadline for 12 Nosologies Products must be Compliant by October 2019

The year is early, but there have already been significant movements in the regulatory landscape. It was already known that manufacturers of pharmaceutical products sold in Russia would need to be in compliance with the recently-announced serialization and aggregation regulations by 1st January 2020, but at the end of 2018, Russia published an update to Federal Law No. 425-FZ. This update included guidance for producers of the 12 Nosologies, specifying an earlier deadline of 1st October, 2019. This gives manufacturers of these products very little time before they must be in complete compliance with the new serialization requirements.

What are the 12 Nosologies?
The 12 Nosologies products are medications which are used in the treatment of rare medical conditions with significantly expensive treatments: haemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, myeloid leukaemia, multiple sclerosis, immunosuppressive therapy for organ transplant patients, Hemolytic-uremic syndrome, juvenile arthritis with systemic onset and Mucopolysaccharidosis type I, II and IV. Any and all medicines falling under these categories must be labelled, serialized and reported in order to be compliant.

What is Required for Compliance?
As with most Track & Trace initiatives, it is important that products must be accounted for at every step of their journey – starting at production and ending at distribution to patients. These recorded events must also be transmitted to both trade partners and the Federal State Information System for Monitoring Drug Circulations (FSIS MDC). Unlike existing regulations (for example, from the EU's FMD and the DSCSA in the United States), the Russian regulations require a broader range of product movements to be recorded. These recorded events must also be transmitted to both trade partners and the Federal State Information System for Monitoring Drug Circulations (FSIS MDC).

On top of that, there are requirements for additional information to be displayed on each individual unit. The regulations call for the inclusion of a crypto key and code, along with the information which is required by U.S. and European regulations (a GTIN and serial number). In addition, the Russian regulations require aggregation of all units, which also needs to be recorded and reported in the same manner as all individually serialized products. The aggregation process does not require the addition of a crypto code or key, but it does require that any activities such as a unit pack and unpack need to be documented and reported. There are, all told, a total of 36 possible "compliance events" which can occur to a package that must be recorded and reported – a significant increase from the requirements of other pharmaceutical regulations.

What Products must be Serialized?
Unlike the EU's regulations, which are primarily concerned with high-value medications and prescription drugs, the Russian regulations cover a much wider range of pharmaceutical products, including over-the-counter medicines. What this means is that pharmaceutical manufacturers who have perhaps not had to implement a serialization program now find themselves in the position of having to implement one, and implement it quickly.

We are Here to Help
With a short timeline to compliance deadlines, and a framework that is considered to be more complex than other similar regulations, it is vital for manufacturers to work with a partner who has a firm understanding of the requirements and experience with rolling out Track & Trace programs at any scale quickly and efficiently. Our experts have followed the development of Russia's regulations closely and we are ready to help bring your production lines into compliance.

Source: Mettler-Toledo Product Inspection

Mettler-Toledo Product Inspection