The entire Russian pharma supply chain is about to change. It all started with bill No. 488-FZ, a part of Russia serialization regulation, signed by President Vladimir Putin.
The bill became law in January 2019. As implemented, the law calls for serialization codes to have a cryptographic aspect. In January 2020, serialization and crypto codes will become mandatory for all medicines imported into and traded inside Russia.
However, some in the pharma industry see it as problematic, including the representatives of the Association of International Pharmaceutical Manufacturers (AIMP). The law affects the entire global market, not only Russia. Therefore, it’s important to understand the serialization and crypto code requirements.
What is Russian Pharma Serialization?
Russia’s pharma serialization requirements are extremely complex. Other than being designed to protect consumers, Russia’s regulations are completely different from laws in other countries.
Every serialization law clearly defines unique product identification (UPID). The Russian serialization law requires every medicine that enters the country’s supply chain to have UPID. However, the Russian UPID consists of two parts: a serial number and a Global Trade Item Number (GTIN). On top of that, it has a two-part crypto “tail ” that makes it even more secure.
Defining Russian Crypto Code
Russia’s crypto code adds another layer of security to the UPID. It is designed to make the UPID safer and completely remove the risk of error from processes within the supply chain. Russian crypto code is actually a crypto tail comprising an electronic signature and a verification key.
The electronic signature is a sequence of 44 characters. The characters can be special symbols, numbers, and uppercase and lowercase letters. The verification key has four numbers and uppercase and lowercase letters.
This crypto code greatly mitigates the risk of error and makes it very difficult for counterfeit medicines to enter the supply chain. During the verification process, a medicine’s legality is established through the serial number, GTIN, electronic signature, and verification key. This data is nearly impossible to forge, guess, or reproduce.
The Impact of Russian Crypto Code on the Pharma Industry
Russia’s serialization and crypto code requirements are going to have a huge impact on the pharma industry. Such sweeping and complex changes tend to disrupt the supply chain if manufacturers and wholesale suppliers don’t work out a verification system that can process verification requests in real time.
Adding a crypto tail means an additional 48 characters have to be encoded into the data matrix. This means there will be new print and verification requirements. Furthermore, manufacturers will have to invest in equipment that can print the data matrices and verification systems that can read them.
How to Prepare
Wholesale suppliers and manufacturers can prepare by investing in printers and verification systems that can meet the new standards. Serialization is important to Russia — it’s being extended beyond the pharma industry to almost all product groups — so having the right equipment is vital to keep doing business there.
End-to-end traceability solutions also come into play, as they can be used to meet the new serialization and crypto code requirements. No matter what role your company plays in the supply chain, it would be smart to take the initiative and talk with your partners.
To ensure compliance with Russian serialization regulations, everyone in the supply chain has to work together. Contact rfxcel today to learn how you can get ahead of the curve!