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Russia Serialization Deadlines

Russia Serialization Deadlines: More Changes for Pharma & Other Industries | rfxcel Update

For our first blog post of the new year, we want to update you on the latest changes to the Russia serialization deadlines, announced just a few days ago.

But first, Happy New Year from rfxcel! We wish everyone a happy, healthy, and prosperous 2020! That goes for your supply chains too!

rfxcel Russia Serialization Deadlines Recap

Before we get into the details, please remember that rfxcel is the leader in the Russian supply chain space. You can count on us to update you with the latest news as it happens. And of course, we’re the only solution provider you need if you’re doing business in Russia or thinking about entering its lucrative markets.

Here are just a few of the exciting things that have been happening for us in Russia:

  • We’ve tripled the size of our Moscow-based team of supply chain and compliance experts over the last year.
  • We partnered with a blue-chip international apparel brand to ensure they remain compliant with all of the country’s supply chain regulations and that all of their products always make it into stores. This positions us as a leading provider of supply chain solutions for the consumer goods industry in Russia.
  • We have continued our role as the thought leader and market leader in Russia. For example, we published Russia 2020: A Guide to Pharmaceutical Supply Chain Complianceand Russia 2020: A Guide to Consumer Goods Supply Chain Compliance,easy-to-understand white papers that explain the fundamentals of the Russian legislation and put it all in context. We’ve also been reporting on the Russian compliance landscape for years: See some of our updates here, here, here, and here.
  • We became an official partner of the Center for Research in Perspective Technologies (CRPT), the crypto code authority that manages Russia’s National Track and Trace Digital System, known as Chestny ZNAK.
  • Last, we can announce that we’re working with a major Indian multinational pharmaceutical company to keep them compliant with Russia’s stringent serialization requirements.

We promise that our teams in Moscow, the EU, and the United States will continue to monitor everything that’s going on in Russia. It’s going to be a big, busy year for Russian compliance, so check our blog often and contact us directly to make sure you stay up to speed and maintain your competitive edge.

And remember, no matter what happens, the time to start preparing is now! We’ve been ready for these regulations since 2018. We’re an approved partner of the CRPT. Our powerful software ensures companies in any industry will remain compliant while mastering their supply chains with end-to-end traceability and rich, actionable data mined right down to the unit level.

The Latest Russia Serialization Deadlines Changes

Okay, now it’s time for the meat and potatoes. The Russian government announced a lot of changes to its serialization timeline, so we’ll keep it simple and list them one by one for pharma and the other product groups, which range from perfume to light industry.

Pharma

  1. Most importantly, the deadline for serializing medicines was pushed back to July 2020. The original deadline we’d been keeping our eyes on was January 1.
  2. Drugs manufactured after July 1, 2020, must bear unique identification. Dispensing entities must be able to authenticate and decommission these drugs. If any drug doesn’t meet these requirements, it cannot be dispensed.
  3. Any drugs manufactured before July 1, 2020, may be used until the end of their shelf life. For the 12 nosologies — medications used in the high-cost treatment of rare medical conditions (e.g., hemophilia, cystic fibrosis, Gaucher disease, and myeloid leukemia) — the manufacturing cut-off is December 2019.
  4. Unique product identification is optional until the new July 1 deadline. This includes the use of mandated 44-character crypto code.

Russia Serialization Deadlines Continues in Other Groups: Perfumes and Toilet Water, Cameras, Tires, and Light Industry Products

On January 8, 2020, Decrees 1953, 1956, 1957, and1958 were signed concerning rules for serialization of perfumes and toilet water, cameras, tires, and light industry products such as bed linens and clothing for adults and children. Voluntary labeling began, but the regulations call for a phased introduction of mandated labeling for each group.

Perfume and toilet water
  1. Companies must register with Chestny ZNAK by March 31, 2020.
  2. Mandatory serialization of products produced in or imported to Russia begins October 1, 2020. On the same date, companies must be able to transfer product information to Chestny ZNAK.
  3. The sale of non-serialized merchandise produced or imported into Russia before October 1, 2020, maybe sold until September 30, 2021.
Cameras
  1. Companies must register with Chestny ZNAK by February 29, 2020.
  2. Starting October 1, 2020, non-serialized photo products will be banned.
  3. Products not sold by October 1, 2020, must be serialized until December 1, 2020.
Tires
  1. All companies must register with Chestny ZNAK within seven days of the regulation deadline, which has yet to be announced.
  2. Beginning November 1, 2020, the production and import of non-serialized tires, as well as their sale by companies working directly with manufacturers and importers, is prohibited.
  3. Products not sold by November 1, 2020, must be serialized by March 1, 2021.
  4. From March 1, 2021, all companies must be able to transfer information (e.g., acquisition, sales dates) to Chestny ZNAK.
Light industry products (e.g., bed linens and clothing for adults and children)
  1. Starting January 1, 2021, non-serialized goods will be banned.
  2. Products not sold by January 1, 2021, must be serialized by February 1, 2021.

Final Thoughts on Russia Serialization Deadlines and Requirements

As these most recent developments show, if you want to do business in Russia, it’s imperative to have up-to-the-minute information. You must also be nimble, ready to adapt to changes to ensure your operations aren’t disrupted. With rfxcel as your partner, you’ll always have the intel and connections you need and always be able to pivot on short notice. In other words, you’ll always be ready. Contact us today to learn more about how partnering with us in Russia will be the best decision you make in 2020!

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