Note: This is an update to a September 2018 blog post about Russian serialization requirements. 

Russia has made some important changes to its pending pharma serialization regulations, set to take effect in January 2020. Decree No. 1118 of August 30 amends the procedure for applying drug labeling codes.

The most significant change concerns the length of the crypto code required on all medicine packaging: It has been cut in half, from 88 to 44 characters. The decree also removes the option of adding a batch number and expiry date. The upshot is that the data matrix will be less unwieldy for packaging and labeling processes without sacrificing security.

Russia’s Federal Service for Surveillance in Healthcare (Roszdravnadzor) developed the methodology for applying abbreviated codes. More than 30 pharmaceutical companies have tested applying revised codes, demonstrating that they simplify the process of setting quality and print speed parameters.

The second change concerns packaging logistics. Russian regulations stipulate that packaging must have “inseparability.” In other words, you should not be able to remove a code from packaging without damaging the packaging. Under the new guidelines, companies can opt to affix codes on packaging at a printing facility instead of on the production line.

Decree No. 1118 also explains why codes may be withheld from a license holder. These include if Russia’s track and trace system does not contain information about a drug or if a serialized Global Trade Item Number (GTIN) for which a crypto code is requested has already been used. The decree also provides reasons why codes would be canceled or invalidated.

Dmitry Alkhazov, Director General of Operations at CRPT, which is responsible for Russia’s Drug Circulation Monitoring System, said these changes improve the country’s serialization measures and “ensures [the] stability” of crypto codes.” He also said the decree was the result of coordinated efforts among stakeholders. “The entire regulatory framework is ready to launch the mandatory labeling of drugs. The development and adoption of these changes is the result of a constructive dialogue between the industry, the regulator, and operator[s].” Read more here.

Contact us today if you have any questions about Russia’s serialization regulations. Our team of experts working in Russia continues to grow, and they can help ensure you’re ready for January 2020, including the revised crypto code guidelines.

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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

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!

The next deadline for the Drug Supply Chain Security Act (DSCSA) is November 27, so the clock is ticking for the pharma industry. To meet the DSCSA’s Saleable Returns Verification requirement, wholesale distributors (WDs) must initiate a verification request to verify returned products before reselling them, and manufacturers that receive a verification request must provide a verification response within 24 hours.

Though time is short, there is a solution: The Verification Router Service (VRS). Before we talk about that, let’s quickly see what the new DSCSA Saleable Returns Verification requirement is all about.

What Is the DSCSA Saleable Returns Verification?

Pharmaceutical manufacturers and WDs must constantly deal with saleable products that have been returned. Starting in November 2019, things will change.

The DSCSA Saleable Returns Verification requires WDs to verify the serialized product identifiers on returned products before reselling or restocking them. As we said above, when WDs submit a verification request, manufacturers must provide the verification response within 24 hours.

However, because of projected return volumes, the Big 3 and other WDs need manufacturers to provide verification responses almost instantaneously — at the sub-second level. So, in a few short months, manufacturers and WDs will have to be able to minimize the operational impact of the Saleable Returns Verification by leveraging the VRS.

What Is the Verification Router Service?

The VRS was initiated by the Healthcare Distribution Alliance (HDA) with feedback from the pharma industry. It is an automated service that verifies if a Product Identifier (PI) is valid. A PI has four components: a Global Trade Item Number (GTIN ), a unique serial number, a lot ID, and an expiration date.

There are multiple VRS providers, each responsible for determining if a specific group of PIs is valid. A WD can call any VRS provider to verify if a PI is valid. If a provider does not manage the PI in question, it will automatically route the verification request to the appropriate provider. All of this happens in real time, and VRS ensures that information is accurate and up to date.

Interoperability standards help streamline communication within the VRS network by helping all parties structure data properly and ensure it is error-free. Thanks to VRS, everyone in the pharmaceutical supply chain can exchange data quickly and securely and verify a product’s validity for sale. Ultimately, this will promote the safety of patients and consumers, and ensure the authenticity of products.

rfxcel Is Helping Companies Prepare for Deadlines

rfxcel is the industry thought leader in VRS. We extended the testing of VRS and are implementing a pilot program for the U.S. Food and Drug Administration (FDA). Applying our expertise in supply chain track and trace, serialization, and compliance solutions, we are helping the pharma industry prepare for the November DSCSA Saleable Returns Verification deadline.

We’re doing this by keeping testing completely transparent. In fact, we’re sharing pilot deliverables with all VRS providers, including WDs, manufacturers, repackagers, national/regional pharmacies, and dispensers. On top of that, rfxcel will collaborate with VRS providers to ensure that test conditions are viable.

Over the course of the last couple of months, we have learned a lot of valuable lessons from testing our VRS to help you meet DSCSA. For more information on how you can be ready for the November deadline, contact us today!