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Everything You Need to Know About Kazakhstan Pharma Serialization

Posted on by rfxadmin

Welcome to Part 2 of our series about Kazakhstan serialization and traceability requirements. Part 1 detailed the country context, including government efforts to achieve pharma independence. October 1, 2022, is the next deadline in the rollout of Kazakhstan pharma serialization, so today we’ll get into the specifics of the regulations, as well as regulations for other key industries. Let’s get started.

Kazakhstan pharma serialization: pilot, goals, operator, timeline, marking requirements

The transformation of Kazakhstan’s pharmaceutical supply chain began almost seven years ago, when the government in September 2015 issued guidelines on labeling, marking, and requirements for accessing and uploading data to a central portal. In November of the same year, the Ministry of Health tapped GS1 Kazakhstan to conduct a pilot for the traceability system, which is called the Special Information System for Marking and Traceability of Goods (IS MPT).

Pilot

The pilot ran from Sept. 9, 2019, to July 31, 2021. It was led by Kazakhstan’s state-run distributor, SK Pharmacy, which labeled 100,000 packages of 30 different drugs and traced them all the way through the supply chain to hospitals and pharmacies. Four domestic manufacturers, 1 importer, 2 distributors, 5 pharmacies, and 8 medical institutions also participated.

Goals

The goals of Kazakhstan pharma serialization — and labeling of other product categories — are essentially the same as regulatory goals in other countries:

      • Communicating product information to consumers
      • Combating counterfeit and falsified products
      • Eliminating gray markets (“Shadow market” seems to be the preferred term in Kazakhstan.)
      • Protecting consumers
      • Protecting legal businesses
      • Identifying entities that violate tax laws

The Kazakh government has also said that digital labeling will help businesses increase productivity, improve logistics, increase market share, ultimately leading to increased revenue.

IS MPT Operator

Kazakhtelecom JSC, the country’s largest telecommunications company, operates the IS MPT. Sometimes referred to as “the Single Operator,” it’s the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT) and Uzbekistan’s CRPT Turon. Its main offices are in Nur-Sultan (formally Astana) and Almaty.

As operator, Kazakhtelecom JSC is responsible for the following:

      • Generating marking codes
      • Providing traceability to the state
      • Interacting with the integrated system of the Eurasian Economic Commission (EEC) and operators in other Eurasian Economic Union (EAEU) states
      • Providing a digital passport of goods for market participants
      • Developing a free mobile application (NAQTY SAUDA) ​​to accept and withdraw marked goods from circulation (primarily for participants who are unable to purchase scanners)
      • Developing a free mobile application (NAQTY ÓNIM) for the public to participate in the system
      • Creating a 24/7 IS MPT contact center

In official government reporting dated Nov. 17, 2020, Kazakhtelecom JSC’s Chair of the Board Kuanyshbek Yessekeyev talked about the benefits of the IS MT. “Among its main advantages,” he said, “one can single out a decrease in the shadow market by 50 percent until 2025, which will lead to additional budget revenues by 2025 in the amount of 58.4 billion tenge [$122.5 million], according to our calculations.”

Yessekeyev also concluded that additional legal business revenues would reach 336.5 billion tenge [$706.5 million] by 2025.

Timeline

Here are the key dates for Kazakhstan pharma serialization:

Planning and pilot

      • September 2015: The government issues guidelines on labeling, marking, and requirements for accessing and uploading data to a central portal.
      • November 2015: The Ministry of Health taps GS1 Kazakhstan to conduct a pilot for IS MT.
      • 2018–2019: GS1 Kazakhstan conducts testing for the pilot.
      • Sept. 9, 2019: The pilot begins.
      • July 31, 2021: The pilot ends and the government issues serialization guidelines.
      • August 8, 2021: The Ministry of Health identifies 93 products — about 1% of all drugs in the country — for the first phase of serialization.

Rollout (note upcoming deadlines in October and early 2023)

      • June 5, 2022: The Ministry of Health delays the first phase of serialization from May 2022 until August 1, 2022.
      • August 2022: Mandatory serialization for the 93 products begins. This list includes drugs produced by four Kazakh manufacturers and 12 foreign manufacturers.
      • October 1, 2022: Mandatory serialization for 20% of drugs scheduled to begin.
      • January 1, 2023: Mandatory serialization for 60% of drugs and mandatory data reporting for 20% of drugs scheduled to begin.
      • April 1, 2023: Mandatory serialization of at least 80% of drugs scheduled to begin.
      • July 1, 2023: Mandatory serialization of 100% of drugs scheduled to begin

Note: At present, Kazakhstan pharma serialization regulations do not require aggregation.

Marking requirements

As in other EAEU and Commonwealth of Independent States (CIS) countries (e.g., Russia and Uzbekistan, respectively), products must be labeled with a DataMatrix code with four data points:

      1. A 14-digit product code (i.e., Global Trade Item Number, or GTIN) (GS1 Application Identifier 01)
      2. A 13-character randomized serial number (21)
      3. A four-character verification key (91)
      4. A 44-character verification code (92)

The maximum cost of one code will be 2.68 tenge ($0.0056) without VAT. Every code goes through the same five steps during its “lifetime”:

      1. The manufacturer applies a code to every package and sends them to a distributor.
      2. The distributor receives and scans the products, then sends them to the retailer (e.g., a store or supermarket).
      3. The retailer receives the new (legal) batch of goods, scans the codes, and sells the products.
      4. At checkout, the cashier scans each code (either with a scanner or using the NAQTY SAUDA app) and it’s withdrawn from circulation.
      5. Consumers can use the NAQTY ÓNIM app to learn more about the product.

Here are some images of the apps:

Kazakhstan pharma serialization Naqty Sauda

 

Other regulated products/industries

In 2019, Kazakhstan ratified an agreement for labeling of goods within the territory of the EAEU. In doing so, it agreed to the EEC’s decisions concerning labeling of fur products, shoes, perfumes, tires, and other products. Here is the latest information from IS MPT:

      • Tobacco products: Mandatory labeling of cigarettes began Oct. 1, 2020; April 1, 2021, for cigars, cigarillos, and other categories.
      • Fur products: Mandatory labeling began March 1, 2019.
      • Footwear: Production and import of unmarked shoes have been prohibited since Nov. 1, 2021; sale of unmarked shoes has been prohibited since April 1, 2022.
      • Alcohol: Mandatory labeling began April 1, 2021.
      • Light industry (primarily clothing and linens): A pilot ran from Dec. 15, 2020, to Dec. 31, 2021.
      • Dairy products: A pilot began on Oct. 1, 2020, and was extended in November 2021.
      • Soft drinks: A pilot ran from July 1, 2020, to Jan. 31, 2022
      • Jewelry: A pilot began in March 2022 and is scheduled to end on Oct. 31, 2022.

Final thoughts

That’s a lot to think about. We’ve provided the granular details of Kazakhstan pharma serialization requirements, but let’s boil them down to what you have to be ready for in just a few weeks: Mandatory serialization for 20 percent of drugs starts on October 1.

If this affects you, are you ready? The good news is that complying with Kazakhstan pharma serialization requirements doesn’t have to be difficult. The fastest way to ensure you’re ready for the October deadline — and all the 2023 deadlines — is to contact us and walk through our solutions with one of our supply chain experts.

We offer a holistic, fully validated, preconfigured, automated platform for compliance and L1-L5 connectivity. With rfxcel and Antares Vision Group, you’ll be prepared for regulations in the EAEU and everywhere else your supply chain goes.

 

Uzbekistan ASL BELGISI Update: Deadline for Pharma Serialization Extended

Posted on by rfxadmin

On February 7, 2022 — just 10 days after we posted our Uzbekistan ASL BELGISI update — the country’s State Tax Committee announced that it was “extending the timeframe for the phased introduction of mandatory digital markings” of pharmaceutical products.

The requirements were originally scheduled to take effect on February 1.

The extension was announced in a letter signed by Mubin Mirzaev, the first deputy chairman of the State Tax Committee. A new deadline was not stipulated, so the country’s serialization scheme for pharmaceuticals is effectively on hold until further notice. The letter did not mention 2022 deadlines for other regulated product categories (e.g., tobacco products; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks).

Delay or not, we expect the serialization and labeling requirements, which are based on Russia’s Chestny ZNAK system, to remain the same. Read our Uzbekistan ASL BELGISI update for more details about the regulations.

More provisions for Uzbekistan ASL BELGISI from the State Tax Committee

Deputy Chairman Mirzaev’s letter outlined two provisions:

      • A provision to instruct the State Tax Committee and CRPT Turon, which operates Uzbekistan ASL BELGISI, to submit proposals to the country’s Cabinet of Ministers for a system to recognize marking codes from other countries, “primarily markings applied [in] the territory of the Russian Federation.”
      • A provision to “implement a mechanism for electronic registration of non-resident foreign manufacturers of pharmaceutical products with the tax authorities.” Manufacturers would be assigned a non-resident taxpayer identification number (TIN) and would have to obtain a non-resident electronic digital signature (EDS).

The letter also said that the “norms for amending the Technical Regulations for the production of pharmaceutical products were transferred from the project for labeling ‘household appliances’ to the project for mandatory digital labeling of pharmaceutical products.”

As we wrote in our Uzbekistan ASL BELGISI update, a pilot for appliances began on July 1, 2021, and mandatory labeling is being introduced in phases. Vacuum cleaners, refrigerators, freezers, washing machines, TVs, and monitors were required to be labeled beginning December 1, 2021.

Final thoughts

The Uzbekistan ASL BELGISI delay illustrates a truth about supply chain regulations: Deadlines change. All the time. Announcements like the one we talked about today should never come as a surprise or catch you off guard.

The good news is that deadline changes are not the end of the world. What’s important is for you to have a supply chain solution that meets established standards, such as the world-leading GS1 standard. If your solution is fast, flexible, scalable, and automated — like our Traceability System — you will be ready to comply and keep your supply chain moving. All the time.

We’ll continue to monitor Uzbekistan ASL BELGISI as we do with other supply chain regulations. In just the last two weeks or so, we’ve written about the Africa supply chain (first of a two-part series), Egypt’s pharmaceutical regulations, Russia Chestny ZNAK requirements for beer and dietary supplements, the United Arab Emirates’ “Tatmeen” platform, and the U.S. Drug Supply Chain Security Act (DSCSA). Count on us to keep you informed about regulations around the world.

And contact us if you have any questions or want to see our solutions in action. Our digital supply chain experts are always here to listen to you, help you evaluate your needs, and work directly with you to design a solution customized for your business.

Russia Serialization Update: Chestny ZNAK Beer and Dietary Supplements Pilots Ending This Summer

Posted on by rfxadmin

We’re always keeping an eye on Russia’s National Track and Trace Digital System, known as Chestny ZNAK. Right now, there are two things to keep on your radar for 2022: the pilots for Chestny ZNAK beer and dietary supplements, both of which are scheduled to wrap up in August. Here’s a quick recap.

The Chestny ZNAK beer and dietary supplements pilots

Russia’s Ministry of Industry and Trade announced the Chestny ZNAK beer pilot in October 2020. It began on April 1, 2021, and was originally scheduled to end on February 28, 2022 — a little more than two weeks from the time we’re writing this. The pilot, or “experiment” as these test runs are called in Russia, also involves “beer-based beverages.”  It’s testing labeling for beer, beer drinks, and low-alcohol drinks that are not required to be labeled with federal special and excise stamps.

The pilot for dietary supplements began on May 1, 2021, and was originally scheduled to end on March 1, 2022. The Center for Research in Perspective Technologies (CRPT), which operates Chestny ZNAK, has not said much more than this. One thing to note, though, is that Chestny ZNAK has also referred to this product category as “biologically active food additives.”

At present, the Chestny ZNAK beer and dietary supplement pilots are slated to end on August 21, about five-and-a-half months from now. If you want to sell these products in the lucrative Russian market, you need to start thinking about compliance. If the CRPT follows its established protocol, there will be pilot reports and evaluations, then the regulations will go into full effect.

It’s worth noting here that two other pilots have ended, but the CRPT hasn’t issued further guidance and they are still shown as “experiments” on the Chestny ZNAK website:

    • Bicycles: A seven-month pilot ended on May 31, 2020.
    • Wheelchairs: A pilot for hand-powered wheelchairs ran from September 1, 2019, to December 1, 2020. Another pilot for wheelchairs with an electric engine or other mechanical means for locomotion ran from December 1, 2020, to June 1, 2021.

Chestny ZNAK beer and dietary supplements requirements

We got into the details of the Chestny ZNAK beer and dietary supplements pilots when they were announced in early 2021. Take a look at those articles for in-depth information, including the specific products that are being tested and that will, we assume, be regulated alongside all the other industries: bicycles, bottled drinking water, dairy, footwear, fur, light industry, medications, perfumes, photo cameras and flash bulbs, tires, tobacco, and wheelchairs.

Serialization, aggregation, unit- and batch-level traceability, crypto codes, and electronic reporting and records management are the hallmarks of Chestny ZNAK. Beer and dietary supplements, like products in other categories, must be labeled with a 2D DataMatrix code encoded with the following:

    • A 14-digit Global Trade Item Number (GTIN)
    • A 13-digit serial number generated by the CRPT or the economic agent
    • A 4-digit verification key from the CRPT
    • A 44-digit verification code (i.e., crypto code) from the CRPT

Final thoughts

The Chestny ZNAK beer and dietary supplements pilots are part of Russia’s ongoing effort to serialize its entire supply chain by 2024. And as our General Director of Operations in Russia Victoria Kozlova noted in World Pharma Today, the system was designed “to guarantee the authenticity and declared quality of goods being purchased by customers.”

rfxcel has been prepared for these regulations since 2018, and we’ve established ourselves as the leader in Chestny ZNAK compliance. For example:

So, if you’re looking to do business in Russia — or even if you’re already working with another provider — contact us today. Also download our Chestny ZNAK white paper and read some of our other articles about the regulations:

 

 

 

 

 

UAE Pharmaceutical Traceability: Ensuring Transparency with the “Tatmeen” Platform

Posted on by rfxadmin

The global push for pharmaceutical traceability and serialization continues at a furious pace. Today, we’re looking at the United Arab Emirates (UAE), whose Ministry of Health and Prevention (MOHAP) in June 2021 announced the “Tatmeen” platform for UAE pharmaceutical products traceability. There are key deadlines this year, so let’s take a look.

UAE Pharmaceutical Products Traceability and the Tatmeen System

MOHAP established Tatmeen, which means “assurance” in Arabic, in Ministerial Decree No. 73 on June 14, 2021. Described as a “central command center,” it’s a GS1-based platform for UAE pharmaceutical products traceability. MOHAP’s partners include the Dubai Health Authority (DHA), Department of Health (Abu Dhabi), and EVOTEQ, a “digital transformation catalyst” based in the UAE, and GS1 UAE.

Tatmeen’s goals should sound familiar:

    • Fight counterfeits and illegal and substandard medications
    • Eliminate unauthorized imports
    • Improve recall management
    • Ensure expired and about-to-expire drugs don’t reach consumers
    • Forecast demand and avoid shortages
    • Move drugs where they’re needed quickly and safely
    • Protect pharma companies, including their intellectual property rights

These other aspects should also sound familiar:

    • Products are scanned at every node of the supply chain
    • Product information is reported into to a central repository (in this case GS1’s BrandSync platform)
    • Scanning captures and verifies data in real time and reports information into a central database
    • Hospitals and pharmacies scan when drugs arrive at their facility and when they’re dispensed
    • Patients and consumers can scan with mobile devices to validate products, report expired products, fakes, and suspected gray market activity

Tatmeen will integrate with the DHA’s electronic medical record system, Salama (incorrectly identified as “Salam” in some industry sources). It will also utilize DHA’s Tarmeez, a paperless drug and medical supplies management system that gives authorized users access to a centralized electronic catalog of all available inventory.

Tatmeen labeling and reporting requirements

All conventional medicines sold, distributed, or stored in the UAE are regulated and must be serialized. These products are exempt:

    • Free samples
    • Products imported for personal use only
    • Medical devices and supplies
    • General sales list (GSL) products

And —surprise, surprise — UAE pharmaceutical products traceability requirements should sound familiar. Secondary packaging must contain four data points in a GS1 DataMatrix code and in human-readable form:

    1. Global Trade Item Number (GTIN)
    2. Randomized serial number (up to 20 characters)
    3. Expiry date (in YYMMDD format)
    4. Batch or lot number

This example is adapted from the MOHAP’s serialization guide:

UAE DataMatrix Code

Aggregation requirements should also ring a bell: All logistic units must be aggregated and labeled with a GS1-128 barcode encoded with a serial shipping container code (SSCC). Manufacturers are responsible for aggregation.

If a brand owner regards an item as a trade item, “it may additionally be identified with a GTIN.” Distributors, wholesalers, and health facilities that unpack and re-pack products to deliver to points of dispensing are required to aggregate the logistic units using their own SSCC codes.

Marketing authorization holders (MAHs), brand owners, manufacturers, or their subsidiaries must register and upload the mandated product master data into the BrandSync platform.

Domestic and foreign manufacturers, third-party logistics providers, batch releasers, contract manufacturing organizations, distributors, licensing agents, and MAHs are responsible for collecting serialized product item traceability records and reporting them to Tatmeen.

UAE pharmaceutical products traceability rollout and 2022 deadline

There was a 6-month “status adjustment” period after Tatmeen was announced for manufacturers and marketing authorization holders to register with the BrandSync platform and begin using 2D DataMatrix codes. This deadline passed on December 13, 2021.

The next major deadline is December 13, 2022. By that date, all supply chain actors in the UAE must obtain a Global Location Number (GLN) from GS1 UAE to identify their organization, where it’s located, and other required information. Relevant stakeholders must also begin reporting serial numbers to Tatmeen and begin aggregation with GS1-128 barcodes and SSCCs.

Final thoughts

We noted a few times that parts of the Tatmeen regulations should sound familiar. If you follow our blog and read our articles about pharmaceutical regulations in other countries — DSCSA in the United States, Chestny ZNAK in Russia, ANVISA in Brazil, ASL BELGISI in Uzbekistan, and so on — everything about UAE pharmaceutical products traceability should ring a bell.

As we said right at the start today, the global push for pharmaceutical traceability and serialization continues at a furious pace. Requirements may vary from country to country, but their essence is the same (e.g., protecting consumers, serialization, traceability, electronic reporting, central repositories, GS1 standards). Tatmeen is just one more example in a very large regulatory ocean.

It’s easy to feel swept up in this current. And, truth be told, if you’re not complying now or preparing to comply by published deadlines, you’re putting your business in jeopardy. If you have questions about Tatmeen or complying with pharmaceutical serialization and traceability regulations in any country, contact us today. In just a few minutes, our supply chain specialists can demonstrate how our award-winning Traceability System ensures you’re compliant in any country, today, tomorrow — always.

For even more information, check out our Global Compliance Page, download our Worldwide Pharmaceutical Compliance Requirements white paper, and catch up on other pharma news in our blog:

Uzbekistan Traceability: Advancing Supply Chain Transparency and Safety

Posted on by rfxadmin

Note about Uzbekistan traceability: On February 7, 2022 — just 10 days after we posted this article — Uzbekistan’s State Tax Committee announced that it was “extending the timeframe for the phased introduction of mandatory digital markings” for pharmaceutical products. The February 1 deadline is longer in effect for this product category. Read the details here.

 

On February 1, 2022, Uzbekistan traceability requirements for medicines and medical devices will go into effect. It’s the latest compliance deadline in the country’s push for serialization and digital marking regulations that will affect an array of industries. Here’s a breakdown of the law and the latest Uzbekistan traceability updates.

The Uzbekistan Traceability System: ASL BELGISI

The Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).

On November 20, 2020, the Uzbekistan government published Decree PKM-737, “Establishment of Obligatory Digital Labeling.” It mandates serialization for tobacco products; alcohol, including wine and wine products; beer and brewing products; appliances; medicines and medical devices; and water and soft drinks.

Furthermore, it requires supply chain participants to register with a national catalog of labeled goods; when an application is approved, the participant receives an account and is granted access to the system.

According to the CRPT Turon website, the “main task” of ASL BELGISI “is to guarantee consumers the authenticity and declared quality of the purchased products.” Like Chestny ZNAK, consumers can download a mobile app to scan products, report suspect products, and provide feedback about the system.

Marking requirements

Uzbekistan traceability requirements mirror those mandated in Chestny ZNAK. All domestically produced and imported goods must be marked with DataMatrix codes that are traced across the supply chain through a four-step process:

    1. CPRT Turon assigns a unique DataMatrix code to each product and the manufacturer or importer places it on the packaging.
    2. The product’s movements are traced throughout the supply chain, from the factory or point of importation to the consumer, via scanning of the DataMatrix code.
    3. Retailers scan the codes when products are stocked and sold.
    4. Consumers can use the ASL BELGISI app to check a product’s legitimacy (i.e., confirm that it’s not a counterfeit) and access product information.

To get DataMatrix codes, participants must be registered with ASL BELGISI, describe the goods in a national catalog of labeled goods, then formally order the codes and apply them to the products. The codes must be applied to packaging or a product label according to the ISO/IEC 16022-2008 “Automatic identification and data capture techniques – Data Matrix bar code symbology” specification. At present, each DataMatrix code costs 68 som (excluding VAT), which is quite literally a fraction of a U.S. dollar: $0.0063.

Like its Russian counterpart, ASL BELGISI uses “verification keys” and “verification codes.” These are also commonly known as crypto codes. CRPT Turon generates these codes.

Generally, the DataMatrix codes for products in every regulated industry must include four data points:

    • A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
    • A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
    • A four-character verification key generated by CRPT Turon
    • A 44-character verification code generated by CRPT Turon

For aggregation, a Serial Shipping Container Code (SSCC) number must be provided in a one-dimensional barcode following the ISO 15394:2009 “Packaging – Barcode and two-dimensional symbols for shipping, transport and receiving labels” specification.

Regulated industries and key dates/requirements

Uzbekistan traceability regulations currently apply to five product categories: tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; medicines and medical devices; and water and soft drinks. Below, we list the latest information about each category.

Filter cigarettes

    • January 1, 2021: only labeled products may be produced and imported
    • July 1, 2021: manufacturers may ship only labeled products to wholesalers
    • October 1, 2021: distributors may ship only labeled products to retailers
    • January 1, 2022: sale of unmarked cigarettes is prohibited
    • October 1, 2022: mandatory labeling for all types of tobacco products

Alcohol

    • January 1, 2021: only labeled products, including wine and wine products, may be produced and imported
    • December 1, 2021: alcoholic beverages packaged in metal containers, including aluminum containers, must be labeled
    • December 1, 2021: aggregation required for alcoholic beverages, including wine and wine products
    • November 1, 2022: aggregation required for alcoholic beverages packaged in metal containers, including aluminum containers

Beer and brewing products

Mandatory labeling began on April 1, 2021.

Appliances

A pilot for appliances began on July 1, 2021. Mandatory labeling is being introduced in phases. Vacuum cleaners, refrigerators, freezers, washing machines, TVs, and monitors were required to be labeled beginning December 1, 2021.

Medicines and medical devices

    • June 1, 2021: 6-month pilot for medicines and medical devices begins
    • January 28, 2022: CRPT Turon announces that the pilot is officially closed
    • February 1, 2022: only labeled products may be produced and imported

CRPT Turon reported that, during the pilot, all participants successfully registered with ASL BELGISI and registered agreed-upon product in the national catalog of labeled goods. They also successfully installed marking equipment on production lines, trained employees to use the equipment, and released batches of properly labeled, serialized products.

More about the requirements for medicines and medical devices

In addition to a DataMatrix code that includes a 14-digit product code (i.e., GTIN), a 13-character randomized serial number, a 4-character verification key, and a 44-character verification code, packaging must have a human-readable GTIN, lot number, expiration date, manufacturing date, and serial number.

Digital marking must be applied directly to packaging on the production line in a “specially designated place” and not be larger than 10×10 millimeters. The codes must be affixed in a way that prevents them from being separated from packaging during the entire shelf life of the product. Codes may not be printed on external packaging material, including transparent film/wraps, and my not be obscured by other information.

Water and soft drinks

This product category includes bottled water, soft drinks, and fruit and vegetable juices.

    • June 1, 2021: pilot for water and soft drinks begins
    • March 1, 2022: only labeled products may be produced and imported

Final thoughts

In June 2021, CRPT Turon announced that it had issued more than 350 million codes, including more than 200 million for tobacco products, almost 130 million for alcohol products, and approximately 20 million for beer products.

As of today (January 28, 2022), it reports that it has issued nearly 583 million codes for tobacco products, more than 300 million for alcohol products, almost 143 million for beer products.

These figures illustrate a simple fact: Strict serialization and traceability regulations are here to stay in Uzbekistan. Russia has led the way with Chestny ZNAK, which arguably has the world’s toughest supply chain requirements, and we should watch the regulatory landscape in the other Newly Independent States (NIS) — Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and Ukraine.

As we said above, ASL BELGISI, the Uzbekistan traceability system, mirrors Russia’s Chestny ZNAK. rfxcel is an undisputed leader in Chestny ZNAK compliance. Consider these facts:

  • We’re an official CRPT partner for medications, bottled drinking water, tobacco, footwear, tires, light industry, perfumes, dairy, bicycles, and wheelchairs.
  • We’ve demonstrated to the CRPT that our solutions for traceability and compliance meet its stringent requirements.
  • We’re accredited as an IT company by Russia’s Ministry of Digital Development, Communications, and Mass Media.
  • We’re one of the few providers with active implementations in Russia (e.g., major global consumer goods and pharmaceutical companies).
  • We have an ever-growing Moscow-based team that knows the regulations and brings expertise in key areas of supply chain management and technology.
  • We’ve led the way in thought leadership with white papers and industry updates and information. (See the list below for a sample.)

We’ve also developed end-to-end traceability and compliance hubs for governments that want to lock down their supply chains with the best digital technologies and solutions. Read more about those here and here.

Contact us today to learn more about our traceability and compliance solutions. Our digital supply chain experts will share a short demo of our award-winning Traceability System and show you how to remain compliant and agile no matter where you do business.

A sample of our Chestny ZNAK coverage:

 

Requirements for Russia’s Textile and Apparel Supply Chain

Posted on by rfxadmin

There’s always something interesting going on with Chestny ZNAK, Russia’s National Track and Trace Digital System. (Well, we think it’s interesting, and chances are you do too if you’re reading this.). Adjustments, pilots beginning and ending, mandatory product labeling going into effect … it’s a treasure trove of track and trace. Such is the case with today’s topic: Russia’s textile and apparel supply chain.

Technically, Chestny ZNAK refers to some facets of the textile and apparel supply chain as “clothing items and light industry goods.” The category includes coats, shirts, blouses, and linens.

Globally, footwear and some items made with fur are certainly part of the textile and apparel supply chain. Chestny ZNAK, however, treats these as separate categories, so we’re not including them in today’s discussion. We’ve written about footwear before — mandatory serialization and other requirements went into effect on July 1, 2020 — and you can learn more about requirements for fur (and all regulated product categories) by downloading our “Overview of Chestny ZNAK Compliance for Key Industries” white paper. It’s fully updated for 2021 and available in both English and Russian.

Okay, let’s get into clothing items and light industry goods in Russia’s textile and apparel supply chain.

Serialization in Russia’s textile and apparel supply chain

A pilot for clothing/light industry products was conducted during the second half of 2019, and mandatory labeling began on January 1, 2021. To date, Chestny ZNAK reports that more than 130,000 textile and apparel supply chain stakeholders have been issued more than 1.4 billion marking codes.

All products must be labeled with a DataMatrix code containing four data points:

  • A 14-digit Global Trade Item Number (GTIN)
  • A 13-digit serial number
  • A 4-digit verification key
  • A 44-digit verification code (i.e., crypto code)

The Center for Research in Perspective Technologies (CRPT), which manages Chestny ZNAK, issues verification keys, crypto codes, and serial numbers. Manufacturers, importers, wholesalers, and retailers, referred to as “economic agents,” can also generate serial numbers.

Before economic agents are issued codes, they must create a “product card” for Russia’s catalogue of marked goods. These must note four product attributes

  • The product name
  • The 4-character EAEU Combined Nomenclature of Foreign Economic Activity (TN VED) code
  • The corresponding GTIN
  • The trademark (if any)

New goods produced in Russia must be marked before leaving the factory. For importation from other Eurasian Economic Union (EAEU) countries (Armenia, Belarus, Kazakhstan, and Kyrgyzstan), codes must be applied before the goods enter Russia’s textile and apparel supply chain. For imports from all other countries, codes must be applied before customs processes begin.

Economic agents must have an encrypted digital signature and equipment to handle codes, including scanners, printers, and point-of-sale cash registers connected to the internet (for retail sales).

These are the broad strokes of compliance for the textile and apparel supply chain. For full details, be sure to download our white paper.

Final thoughts

Russia’s textile and apparel supply chain is large and lucrative. But to participate and succeed, you need to be able to navigate Chestny ZNAK’s strict requirements. To do this, you need the right partner, one that knows the regulations, has a local team, and actually has active in-country implementations.

Right off the bat, we can say that we’re the only official CRPT software or integration partner for clothing items and light industry goods. In fact, we’re the only official CRPT partner for several other industries; we’ve proven that our signature rfxcel Traceability System integrates seamlessly with Chestny ZNAK and meets regulatory requirements for key industries. We were also recently accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.

To learn more about our leadership in Russian supply chain compliance, check out these recent blog posts:

If you have questions about the textile and apparel supply chain in Russia — or any other market where you’re doing business or want to do business — contact us today to schedule a demo. See how our powerful software can ensure you’ll remain compliant with textile and apparel supply chain regulations around the world.

 

Mandatory Dairy Product Labeling in Russia to Begin in Two Months

Posted on by rfxadmin

It’s going to be a busy year for dairy product labeling in Russia. (If you missed our earlier overview, be sure to check it out.) In fact, it’s going to be a busy year for product labeling in Russia generally. A quick look at our blog reveals that the National Track and Trace Digital System, or Chestny ZNAK, is not relenting on its goal of transforming Russia’s supply chain by 2024:

But let’s stay focused on dairy product labeling, which is scheduled to commence on June 1 for two product categories, then will be phased in for two other categories later in the year.

Dairy product labeling in Russia: background

The Chestny ZNAK pilot for dairy product labeling from July 15, 2019, to December 31, 2020. The dairy supply chain has a unique configuration because Chestny ZNAK will share track and trace duties with the “Mercury” electronic veterinary certification system, which tracks animal products in Russia.

Dairy product labeling requires a DataMatrix code containing four data points: a 14-digit Global Trade Item Number (GTIN), a 13-digit serial number, a 4-digit verification key, and an expiration date.

Other dairy product labeling requirements include the following:

  • Product packaging must have a blank field up to 15×15 mm to accommodate the DataMatrix code.
  • Caps on PET bottles must be able to accommodate either printing or labeling with a laser.
  • Manufacturers can have unusually shaped cartons or bottles tested to determine if the form factor affects dairy product labeling and scanning accuracy/reliability.
  • Aggregation is required; the parent-child relationship must be maintained between the aggregation and the individual units within it.

If you want to learn more about Russian dairy product labeling, download our “Russia Chestny ZNAK and the Dairy Industry” white paper. It’s fully updated for 2021 and really drills down into the details.

While we’re at it, if you want to learn about product labeling and serialization for all of the industries regulated in Russia, download our “Overview of Chestny ZNAK Compliance for Key Industries.” This is also fully updated for 2021 and is our most comprehensive publication about Russian supply chain compliance.

The June 1 dairy labeling requirements

Mandatory dairy product labeling begins June 1 for cheeses and ice cream and other edible ice with or without cocoa. Only serialized products can be sold after this date. However, products produced or imported into Russia before June 1 may be sold until the product’s expiration date.

Companies were permitted to begin labeling these cheese and ice cream products as early as January 20, 2021. They were also allowed to transfer dairy product labeling data to the Government Information System for Marking (GIS MT), which catalogs all labeled goods in Russia’s supply chain. To transfer data to GIS MT, you must be registered with Chestny ZNAK.

The table below shows Russia’s product classification codes (OKPD2) and the corresponding Eurasian Economic Union (EAEU) Combined Nomenclature of Foreign Economic Activity (TN VED) codes for labeling these products. This information comes from Chestny ZNAK.

Russia Dairy Product Labeling

 

Final thoughts

rfxcel is the leader in Chestny ZNAK compliance. Not just for dairy product labeling — for labeling requirements in all regulated industries. We know these regulations can be tough to decipher. To help, we have useful resources, like the stories we linked above, our Chestny ZNAK refresher course, our white papers, and our webinars.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia dairy product labeling requirements is to talk with us directly. When we say we’re the leader in Russian compliance, consider our credentials:

  • We’re an official integration, software, and tested solution partner with the Center for Research in Perspective Technologies (CRPT), which operates Chestny ZNAK.
  • We were recently accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.
  • We’re one of the few providers with active implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year.
  • Our Moscow-based team provides our clients, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting.

We’ve also demonstrated that our solutions, including our signature rfxcel Traceability System (rTS), Compliance Management (rCM), and Serialization Processing (rSP), can meet the stringent Russia dairy serialization requirements and ensure you stay compliant. In fact, we had to prove this to the CRPT to be named an official partner. rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.

So contact us today learn more about how we can help you with dairy product labeling and other Chestny ZNAK compliance. No matter how far along you are in your preparations to comply, you should talk to us — even if you’re already working with another provider. Our powerful software ensures companies in any industry remain compliant with Russia’s complex regulations.

 

 

 

 

Russia Chestny ZNAK Bottled Drinking Water Pilot Ending Soon

Posted on by rfxadmin

A year ago today — April 1, 2020 — Russia started its Chestny ZNAK bottled drinking water pilot. Chestny ZNAK is Russia’s National Track and Trace Digital System, which is transforming how the country runs and regulates the supply chain for everything from pharmaceuticals to fur. It’s managed by the Center for Research in Perspective Technologies (CRPT).

If all goes as planned, the Chestny ZNAK bottled drinking water pilot will wrap up on June 1. Let’s take a quick look at the pilot and what we can expect going forward.

The Chestny ZNAK bottled drinking water pilot

As we said, the pilot (or “experiment,” as these projects are called in Russia) began on April 1, 2020, and is scheduled to end just two months from now, on June 1. The bottled drinking water category includes mineral and carbonated waters, waters without sweeteners or other flavoring, and non-carbonated water. The table below shows the Eurasian Economic Union Combined Nomenclature of Foreign Economic Activity (TN VED) code for the products that must be labeled, as provided by Chestny ZNAK.

 

BOTTLED DRINKING WATER

Pilot: April 1, 2020–June 1, 2021

TN VED CodeDescription
2201Beverages and spirits and vinegar: waters, including natural or artificial mineral waters and aerated (i.e., carbonated) waters, not containing added sugar or other sweetening matter nor flavored; ice and snow

 

Like pilots for other industries, the Chestny ZNAK bottled drinking water pilot tests end-to-end tracking and tracing of marked goods from manufacturing sites or import/customs locations to final sale to consumers. It’s also designed to determine the best approaches for marking and tracing products, including testing methods of applying codes to different types of packaging, such as PET bottles and bottles with irregular shapes.

Chestny ZNAK, which is now in its fourth year of operation, generally requires products to be labeled with a 2D DataMatrix code containing four data points: a Global Trade Item Number (GTIN), a serial number, a verification key, and a verification code (i.e., crypto code).

The DataMatrix codes being used in the Chestny ZNAK bottled drinking water pilot must contain three data points: a 14-digit GTIN, a 13-character serial number, and a 4-character verification code. An optional fourth data point can include information such as the minimum retail price and expiration date. Product packaging is required to have a blank field up to 15×15mm to accommodate the code.

The pilot’s goals include the following:

  • Supply chain actors order DataMatrix codes and apply them to products.
  • All labeling information is transferred electronically to Chestny ZNAK.
  • Products in shipping packages are aggregated; codes for each unit in the aggregation are also aggregated.
  • Marked products enter circulation.
  • Products are tracked and traced in the supply chain, and stakeholders exchange Universal Transfer Documents (UTDs) to record transfer of codes.
  • Consumers purchase goods, which are withdrawn from circulation at checkout via point-of-sale cash registers and scanning devices.

Final thoughts

The CRPT has not announced when mandatory marking of bottled water products will begin. If the pilot ends on schedule, there will likely be a final report and review period, so it could be late 2021 or even early 2022 before you’ll have to comply.

Regardless, the time to think about compliance is now. If you want more details about the Chestny ZNAK bottled drinking water pilot — or any of the regulated industries — start by downloading our white papers. We’ve updated all of our Russia white papers for 2021 and included even more details about what you need to know and do to be compliant.

You should also contact us. We’ve been prepared for Russia’s regulations since 2018. Here a just a few of the reasons why we’re the leader in Chestny ZNAK compliance:

  • We are an official software and integration partner of the CRPT.
  • We’re accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.
  • We are one of only a few providers with in-country implementations; clients include global consumer goods and pharma companies.
  • 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.

We’ll be posting more about what to expect with Chestny ZNAK requirements in 2021. There’s definitely a lot going on — including pilots for biologically active food additives and beer getting under way now — so check back often.

CRPT Partner in Russia’s Supply Chain: Traceability and Compliance

Posted on by rfxadmin

The Center for Research in Perspective Technologies (CRPT) operates Russia’s National Track and Trace Digital System. Known as Chestny ZNAK, the supply chain system was established by Federal Law No. 425-FZ, signed on December 29, 2017. rfxcel has been prepared for these regulations since 2018, and is now an established CRPT partner.

Let’s take a look at what it means to be a CRPT partner, including the benefits it brings to our customers.

What is the CRPT?

The CRPT is a public-private partnership akin to the European Medicines Verification Organization. Its many responsibilities include generating the serial numbers and verification codes (i.e., crypto codes) required by Chestny ZNAK.

Business giant USM is the CRPT’s principal partner, with a 51 percent stake. USM was founded in 2012 and has interests in many of Russia’s key sectors, including metals/mining, telecom, technology, and internet. According to USM, Chestny ZNAK is the country’s first public-private partnership in the IT sector and the first of its kind at the federal level. Private investments totaling more than 200 billion rubles ($2.5 billion) are expected over the next 15 years.

rfxcel as CRPT partner

Last year, rfxcel earned official CRPT partner status in 10 of the 11 industries for which the organization has chosen partners: medications, footwear, tires, light industry, perfumes, dairy, bottled drinking water, bicycles, wheelchairs, and tobacco. Furthermore, we are the only official CRPT partner for several of these industries.

To be named a CRPT partner, a solutions provider must prove it can work with Chestny ZNAK, comply with its strict serialization requirements, and support companies that do business in Russia.

For example, to be named an official integration, software, and tested solution partner for medications, members of our Moscow team met with the CRPT to demonstrate the rfxcel Traceability System, answer technical questions, and share examples of compliance reports. After an internal evaluation, the CRPT notified rfxcel that it had validated its solution and designated the company as an official partner on its website.

What does being a CRPT partner mean for our customers?

The benefits we bring as a CRPT partner are pretty straightforward. First and foremost, we have proven that our signature rfxcel Traceability System integrates seamlessly with Chestny ZNAK and meets regulatory requirements for key industries.

Russian law calls for serialization, aggregation, unit- and batch-level traceability, crypto codes, and electronic reporting and records management. Our rfxcel Serialization Processing and Compliance Management solutions ensure you’ll comply with these mandated labeling and reporting requirements. Plus, our solutions have a Russian-language user interface that makes integration and start-up much quicker.

The other benefit of being a CRPT partner is that we’re trusted. The CRPT knows our solutions, knows our team in Moscow, and knows that we take compliance very seriously. They know our customers include major pharmaceutical and consumer goods brands. They know we’re committed to making the transformation of Russia’s supply chain smooth and effective, and support the mission “to guarantee the authenticity and declared quality of goods being purchased by customers.”

So, when you work with rfxcel in Russia, you’re working with a CRPT partner that is equipped to deliver quick integration and compliance today, tomorrow — always.

Sneak peek: another recent rfxcel accomplishment in Russia

We’ll share more details about this soon, but earlier this month we received accreditation as an IT company from Russia’s Ministry of Digital Development, Communications, and Mass Media. The Ministry develops and implements national policy and legal regulations for a range of industries, from telecommunications to Internet governance.

That’s all we’ll say for now. The official IT company accreditation is another reason why we continue to be the leader in Chestny ZNAK integration, operability, and compliance.

Final thoughts

We are proud of being an official CRPT partner. It’s proof that our software ensures companies in any industry will remain compliant while they do business in Russia.

Contact us today for more information about how we can help you succeed with Chestny ZNAK. And be sure to download our white paper about Russian compliance. Fully updated for 2021, including information about new pilots for beer and beer-based drinks and biologically active food additives , it’s an easy-to-understand guide to Russia’s strict supply chain regulations for every industry.

New Russian Serialization Pilot for Biologically Active Food Additives

Posted on by rfxadmin

A new Russian serialization pilot for biologically active food additives was announced last month. It’s scheduled to run from April 1 of this year to March 1, 2022.

The government has not said much more than this about the pilot. It has revealed a lot more about the Russian serialization pilot for beer and beer-based drinks, which it announced last October. Read our blog post about that to get all the details.

Let’s take a look at what we do know about the Russian serialization pilot for biologically active food additives. After that, we’ll give you a sneak peek at what we’re doing to make sure stakeholders in every industry regulated by Russia’s National Track and Trace Digital System, known as Chestny ZNAK, know exactly what to do to comply with the strict requirements.

Russian serialization pilot for biologically active food additives

As we said above, the Russian government hasn’t said much about the new pilot, which was formalized through a draft decree entitled “On Conducting an Experiment on the Labeling of Biologically Active Food Additives by Means of Identification in the Territory of the Russian Federation.”

Chestny ZNAK has shared a list of what products will be labeled and their corresponding Eurasian Economic Union Combined Nomenclature of Foreign Economic Activity (TN VED) codes. It’s also been reported that the Center for Research in Perspective Technologies (CRPT), which operates Chestny ZNAK, will provide equipment to pilot participants.

Here are the products that will be included in the Russian serialization pilot for for biologically active food additives. It’s a long list. Be sure to scroll down to our “Final Thoughts” to read about our plans for Russian supply chain compliance!

BIOLOGICALLY ACTIVE FOOD ADDITIVES

Pilot Dates: April 1, 2021–March 1, 2022

TN VED CodeDescription
1210 20 9000Oil seeds and oleaginous fruits; miscellaneous grains, seeds, and fruit; industrial or medicinal plants; straw and fodder
1212 21 000 0Locust beans, seaweeds, and other algae, sugar beet and sugar cane, fresh, chilled, frozen or dried, whether or not ground; fruit stones and kernels and other vegetable products (including unroasted)
1504 10 1000Fish liver oils and their fractions with Vitamin A content not exceeding 2500 iu/g
1504 20 900 0Other fish fats, oils, and their fractions, other than fish liver oils, other than solid fractions
1516 10 900 0Other animal fats and oils and their fractions
1517 90 990 0Other edible mixtures or preparations of animal or vegetable fats or oils or fractions of different fats or oils of this chapter, other than edible fats or oils
1702 90 950 0Other, including invert sugar and other sugar and sugar syrup blends containing in the dry state 50% by weight of fructose
1704 90 550 0Throat and cough lozenges not containing cocoa
1806 31 0000Other product containing cocoa, in blocks, slabs, or bars, filled
1806 32 100 0Cocoa and cocoa preparations (other preparations containing cocoa, not filled, but with added cereal grains, fruits, or nuts in blocks, slabs, or bars)
1806 32 900 0Other preparations containing cocoa, but not filled, in blocks, slabs, or bars
1806 90 700 0Preparations containing cocoa and intended for manufacture (preparation) of drinks
1806 90 900 0Other preparations containing cocoa
2101 12 920 1Preparations with a basis of extracts, essences, or concentrates of coffee
2106 10 800 0Other protein concentrates and textured protein substances
2106 90 590 0Other sugar syrups with flavoring or coloring additives
2106 90 920 0Other food preparations not containing butter fat, sucrose, isoglucose (i.e., high-fructose corn syrup), glucose, and starch, or containing less than 1. 5% by weight of butter fat, 5% by weight of sucrose or isoglucose, 5% by weight
2106 90 980 3Mixtures of vitamins and minerals for use as a balanced dietary supplement
2106 90 980 9Other food preparations not elsewhere specified or included
2106 90 9801Sugar- (sucrose) free chewing gum and/or with a sugar substitute product
2202 90 100 9“Others” under Code 2202: “Beverages and spirits and vinegar”
2202 99 190 0Other beverages not containing preparations of headings 0401 to 0404 or fat obtained from preparations of headings 0401 to 0404:

  • 0401: Milk and cream, not concentrated nor containing added sugar or other sweetening matter
  • 0402: Milk and cream, concentrated or containing added sugar or other sweetening matter
  • 0403: Buttermilk, curdled milk and cream, yogurt, kephir (a.k.a. kefir), and other fermented or acidified milk and cream, whether or not concentrated or containing added sugar or other sweetening matter or flavored or…
  • 0404: Whey, whether or not concentrated or containing added sugar or other sweetening matter; products consisting of natural milk constituents, whether or not containing added sugar or other sweetening…
2936 21 000 0Vitamins A and their derivatives
3002 90 500 0Cultures of microorganisms
3204 19 000 0Synthetic organic coloring matter and preparations based thereon, including mixtures of coloring matters of the subheadings 320411 to 320419:

  • 320411: Disperse dyes and preparations based thereon
  • 320412: Acid dyes, whether or not premetallized, and preparations based thereon; mordant dyes and preparations based thereon
  • 320413: Basic dyes and preparations based thereon
  • 320414: Direct dyes and preparations based thereon
  • 320415: Vat dyes (including those usable in that state as pigments) and preparations based thereon
  • 320416: Reactive dyes and preparations based thereon
  • 320417: Pigments and preparations based thereon
  • 320419: Tanning or dyeing extracts; tannins and their derivatives; dyes, pigments, and other coloring matter; paints and varnishes; putty and other mastics; inks
3503 00 100 9Other gelatin and its derivatives
3507 90 900 0Other prepared enzymes not elsewhere specified or included

Final thoughts

Our team in Russia fields many, many questions about Chestny ZNAK, and industries that must comply with the supply chain regulations. They love hearing from people and helping them understand the rules for doing business in Russia.

If you follow our blog (and we know you do), you know we’re the leader in Russian compliance. You also know we write a lot about Russian supply chain regulations. Most recently, we covered the pilot for beer, updated labeling requirements for cheese and ice cream products, and “notification mode” in the pharma supply chain. We also did a Chestny ZNAK refresher course.

For even more information, visit our solutions for Russian compliance page, download our latest Chestny ZNAK white paper, and contact our team to schedule a quick demo of our solutions for Russian compliance.

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