January 2021 - rfxcel.com

Russia Pharma Serialization Update: “Notification Mode” Expedites Product Circulation

Russia pharma serialization has been underway for a little more than three years. The country’s National Track and Trace Digital System, which is known as Chestny ZNAK and covers a dozen industries, has been continually tweaked and refined since it was created a little more than three years ago.

Some important updates to Russia pharma serialization were made public toward the end of 2020. Here’s a quick rundown of what the government announced.

“Notification mode” will simplify Russia pharma serialization processes

As we noted last year, Russia’s Drug Circulation Monitoring System (MDLP) was compelled to develop new reporting requirements after technical problems created serious issues in the pharma supply chain.

In late October, the MDLP moved into so-called “notification mode” to help supply chain actors continue importing, distributing, and selling medicines in the event of errors or failures in Chestny ZNAK’s reporting system. This applied to over-the-counter and prescription medicines manufactured in Russia or imported into the country, including from the Eurasian Economic Union (EAEU).

Then, in early November, Decree 1779, “On Amendments to the Regulation on the Monitoring System for the Movement of Medicines for Medical Use,” consolidated measures to simplify and expedite reporting. This is why notification mode has also been referred to as “simplification mode” for Russia pharma serialization.

In essence, stakeholders can proceed with distribution or dispensing 15 minutes after they submit the required product information to the Government Information System for Marking (GIS MT), which catalogs all marked goods, even if they do not receive confirmation that the information has been accepted/approved in the system. (The “product information” pertains to Russia pharma serialization requirements, such as serial numbers and Global Trade Item Numbers.) The decree also simplifies importation, giving custom officials a 2-hour window to request product information.

For now, these Russia pharma serialization rules are to remain in effect until July 1, 2021. After that, notification mode will stop.

Final thoughts

As the leader in Russia pharma serialization, rfxcel knows the regulations are stringent and challenging. To help, we offer useful resources online, like this refresher course and white papers and webinars that explain the regulations in easy-to-understand language.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia pharma serialization laws is to talk with us directly. Consider our credentials:

  • We’re an official integration, software, and tested solution partner with the CRPT.
  • We’ve demonstrated that our solutions, including our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Russia pharma serialization requirements and ensure you stay compliant.
  • rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.
  • We’ve prepared for Russia pharma serialization and Chestny ZNAK since 2018.
  • We’re one of the few providers with active pharma implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global pharmaceutical and consumer goods companies, the quickest time to market while fully automating their compliance reporting.

Contact us today learn more about how we can help you with Russia pharma serialization and 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 you’ll be prepared and always be compliant with Russia’s complex regulations.

Russia Serialization Pilot to Combat Counterfeit Beer Set to Begin This Spring

Last October, Russia’s Ministry of Industry and Trade announced a supply chain pilot project to label beer and beer-based mixed drinks. Set to run from April 1, 2021, to February 28, 2022, its goal is to prevent counterfeit beer from entering the market and to protect consumers.

The pilot is part of Russia’s ongoing effort to serialize its entire supply chain. The country’s National Track and Trace Digital System, known as Chestny ZNAK and operated by the Center for Research in Perspective Technologies (CRPT), monitors the supply chains of more than a dozen industries, from pharmaceuticals and footwear to tires and tobacco.

Let’s take a look at the problem of counterfeit beer in Russia and globally, and what the pilot hopes to achieve.

The struggle with counterfeit beer and other alcohol

Counterfeit beer — and counterfeit wine, spirits, and other alcoholic drinks — is a global problem with a hefty monetary cost. For instance, it’s estimated that fake wine and spirts cost the global industry more than $3 billion a year in the EU alone. The illegal trade also decreases sales of legitimate products and has led to losses of industry jobs. For more insight into the problem, check out our two-part blog series about track and trace in the wine industry.

There’s also a human cost. Counterfeit alcohol can contain toxic “ingredients” such as jet fuel, embalming fluid, and methanol. The danger is great enough that governments and industry associations have issued guidance to help consumers spot fakes and stay safe. Last year, for example, the Wine & Spirts Wholesalers of America advised travelers to remember the “4 Ps” — place, product, price, and packaging — when purchasing any kind of alcohol.

Though the problem is global, it’s particularly acute in Russia. In 2014, Russia’s Federal Service for Alcohol Market Regulation said half of beer and beer-based beverages sold in the country were fake. (Beer wasn’t even classified as an alcoholic drink in Russia until 2011. Before then-President Dmitry Medvedev signed the bill making that distinction, anything containing less than 10 percent alcohol was considered a foodstuff.)

Today, the Ministry of Industry and Trade estimates that counterfeit beer accounts for 5–12 percent of the country’s $8.8 billion market, resulting in approximately $1 billion in lost tax revenue. The ministry also estimates that labeling beer and monitoring it via Chestny ZNAK will increase revenue for legal producers by as much as $4 billion. And, of course, mandatory labeling will help ensure counterfeit beer, including potentially harmful knock-offs, never reaches consumers.

Details of Russia’s beer labeling pilot

The Russian government is aware of its counterfeit beer problem. Talking about the pilot after it was announced last October, Minister of Trade and Industry Denis Manturov said, “We think it is important to start with labeling in the alcohol segment in order to protect consumers. This is important as this sector is particularly vulnerable to illegal goods and counterfeiting.”

The CRPT, industry representatives, regulators, retailers, and other stakeholders have been discussing parameters, technical features, and timing. As we noted above, the pilot will last 11 months (April 2021–February 2022). Progress reports are due to the government on October 29 of this year and February 14 next year, and a final decision about when mandatory labeling will begin will be made after a full review of the pilot.

Any company can volunteer to participate; however, it seems the organizers prefer companies that use several packaging form factors and have more than one product line. If you want to participate, you must send a letter of consent on company letterhead to the Beer and Beer Drinks Commodity Group. Visit the Chestny ZNAK website for details or, better yet, contact us directly. We’re an official partner of the CRPT, and our ever-growing team in Moscow is always ready to help.

What products will be labeled?

The pilot will test labeling for beer, beer drinks, and low-alcohol drinks that are not required to be labeled with federal special and excise stamps.

What do manufacturers have to do?

The CRPT will assign a dedicated project manager, technical manager, and business process specialist to every manufacturer in the pilot. These people will work at the manufacturer’s facilities and oversee pilot operations.

Manufacturers’ representatives are expected to attend working group meetings to discuss progress and make recommendations for the regulatory framework, which will be finalized after the pilot is over. Manufacturers are also expected to:

  • Understand the business processes required for digital labeling
  • Choose a technology partner to supply and install labeling and integration systems
  • Determine how to apply the marking codes
  • Determine what technical solution is most suitable for their production line(s)
  • Arrange delivery and perform commissioning/start-up of labeling equipment
  • Integrate the equipment with the Automated Control Systems of the Enterprise and Technological Process (ACSTP)
  • Adapt their inventory systems to work with labeled goods
  • Adapt their business processes to new requirements for digital marking
  • Train key personnel to work with digital marking
  • Ensure their suppliers are sufficiently prepared to work with digital marking

As with the other product categories regulated in Chestny ZNAK, manufacturers must follow a few core steps for labeling and track and trace processes. First, they must register an account with Chestny ZNAK. Next, they must describe their products in Russia’s catalog of marked goods, which is managed by the Government Information System for Marking (GIS MT). Last, they have to order unique codes for each item (or, in some cases, for a group of goods), and put a Data Matrix code on each package, after which the goods may be to put into circulation and transferred for sale to wholesale or retail networks.

What do retailers have to do?

Retailers must scan the Data Matrix codes when they accept goods. This sends the product information to Chestny ZNAK and notifies the system that the products have arrived at the retail location.

When a consumer purchases a product, the cashier scans the code on the packaging using a scanner connected to a point-of-sale cash register. The data is synchronized with the information in the catalog of marked goods and the item is officially removed from circulation. If the data doesn’t match, the product is counterfeit or otherwise illegitimate and cannot be sold.

Final thoughts

Russia wants to complete the transformation of its supply chain by 2024, a scant three years from now. What we’ve talked about today — fighting counterfeit beer and protecting consumers — follows the ultimate goal of Chestny ZNAK, which the government says is “to guarantee the authenticity and declared quality of goods being purchased by customers.”

rfxcel has been prepared for the Russian regulations since 2018, and we’ve established ourselves as the leader in Russian supply chain compliance. Chestny ZNAK compliance is embedded in our Compliance Management and Serialization Processing solutions, which are part of our award-winning rfxcel Traceability System.

We’re also an official software and integration partner of the CRPT, and one of only a few providers with in-country implementations. Our systems use Russian language, currency, and processes, and our customers include major global consumer goods and pharmaceutical companies.

And our qualifications go on and on. Connect with one of our supply chain experts today. If you’re looking to do business in Russia — or even if you’re already working with another provider — you should talk to us.

Russia Dairy Serialization Update: Mandatory Labeling for Cheese and Ice Cream

Some important updates to Russia dairy serialization were made public on January 13, 2021. The regulations pertain to cheese and ice cream products, as well as products with certain shelf lives.

Supply chain laws governing the country’s National Track and Trace Digital System, which is known as Chestny ZNAK and covers a dozen industries, have been continually tweaked and refined since it was created a little more than three years ago. Let’s take a look at what’s new for the dairy industry.

New rules for Russia dairy serialization

The Russia dairy serialization regulations were put forth in Decree No. 2099 of December 15, 2020; they will go into effect for different products at different times.

The first products to fall under mandatory labeling are cheeses, ice cream, and other edible ice. Companies can begin labeling these goods and transferring data to the Government Information System for Marking (GIS MT), which catalogs all marked goods, as early as January 20, 2021, but they must be registered with Chestny ZNAK to do so.

Mandatory labeling begins for these cheese and ice cream products on June1, 2021. Only serialized products are allowed to be sold after this date. However, products produced or imported into Russia before June 1 may be sold until the product’s expiration date.

Deadlines for cheese and ice cream stakeholders

The Russia dairy serialization regulations for cheese and ice cream products apply to manufacturers, importers, wholesalers, and retailers. Here are the key dates:

  • June 1, 2021: Manufacturers and importers must begin labeling and transferring product data to GIS MIT.
  • December 1, 2021: All stakeholders must transmit information about the retail sale of goods to Chestny ZNAK. (This occurs via point-of-sale cash registers connected to the internet.)
  • September 1, 2022: Using Universal Transfer Documents (UTDs), stakeholders must transmit information on the turnover of goods (including wholesale sales) and the withdrawal of goods.
  • December 1, 2023: Unit-level serialization of products with a shelf life of more than 40 days begins. Each product’s unique identification code must be indicated in the UTD.

Labeling of other dairy products with a shelf life of more than/less than 40 days

Manufacturers, importers, wholesalers, and retailers must comply with the Russia dairy serialization regulations for these products, which include the following:

  1. Milk and cream
  2. Buttermilk, fermented milk products (e.g., curdled milk and cream, yogurt, kefir (a fermented milk drink)
  3. Butter and other fats and oils made from milk, milk pastes
  4. Milk whey and other dairy products not included in other groups
  5. Dairy products for baby food
  6. Drinks containing milk fats

Mandatory labeling of products with a shelf life of more than 40 days begins on September 1, 2021. Products with a shelf life of less than 40 days must be labeled beginning December 1, 2021. Only serialized products may be sold after these dates. However, products produced or imported into Russia before these dates may be sold until the product’s expiration date.

Furthermore, for both categories:

  • December 1, 2021: All stakeholders must transmit information about the retail sale of goods to Chestny ZNAK. (This occurs via point-of-sale cash registers connected to the internet.)
  • September 1, 2022: Using Universal Transfer Documents (UTDs), stakeholders must transmit information on the sale and withdrawal of goods.

And for products with a shelf life of more than 40 days:

  • December 1, 2023: Unit-level serialization Each product’s unique identification code must be indicated in the UTD.

Mandatory labeling will not apply to the following products:

  1. Baby food for children under 3 and specialized dietary therapeutic and preventive food
  2. Products packed in a non-industrial manner/method in retail organizations
  3. Products with a net weight of 30 grams or less
  4. Products produced or imported into Russia as advertising/marketing samples not intended for sale
  5. Products to be exported outside the EAEU
  6. Products for sale in duty-free shops
  7. Products being stored by manufacturers (i.e., not intended for distribution)
  8. Products acquired under a transaction, information about which constitutes a state secret

Final thoughts

As the leader in Russia dairy serialization solutions, rfxcel knows the regulations can be a challenge to decipher. To help, we offer useful resources online, like this refresher course and white papers and webinars that explain the requirements.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia dairy serialization is to talk with us directly. Consider our credentials:

  • We’re an official integration, software, and tested solution partner with the CRPT.
  • We’ve demonstrated that our solutions, including our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Russia dairy serialization requirements and ensure you stay compliant.
  • rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.
  • We’ve prepared for Russia dairy serialization and Chestny ZNAK since 2018.
  • We’re one of the few providers with active implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting.

Contact us today learn more about how we can help you with Russia dairy serialization and 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 the complex regulations.

Food Traceability: What’s the Latest for 2021?

As we all know, the pandemic has revealed shortcomings in the supply chains of virtually every industry. And though the vaccine supply chain has dominated headlines over the last several months, food traceability has been top of mind for companies and governments alike since the earliest days of COVID-19.

Let’s take a look at the state of food traceability — what it is, how it works, and its future as we kick off 2021.

What is food traceability?

The U.S. Food and Drug Administration (FDA) defines food traceability as “the ability to follow the movement of a food product and its ingredients through all steps in the supply chain, both backward and forward.”

That’s a spot-on definition, but we’d like to add a few things. First, food traceability in 2021 means you can follow your products in real time. Yes, you can see where they’ve been and know where they’re going, but you can also see where they are right now. And with powerful tools like our rfxcel Integrated Monitoring (rIM) solution and Mobile Traceability app, you’ll have access to real-time information about environmental conditions (e.g., temperature, humidity, light, tilt, and shock) and location.

With this rich, actionable data, your food traceability capabilities expand exponentially. Not only can you take immediate action if there’s an environmental concern — a temperature excursion, for example — but you can course-correct if your vehicle is approaching a traffic jam or encountering other obstacles or delays. You can also tap data to combat theft and make recalls more efficient. (We wrote about modernizing food recall management late last year; check it out here.)

The other thing we’d like to add to the FDA’s definition is that, today, food traceability should be occurring in a digital supply chain. If you’re still pushing paper in 2021, it’s time for you to contact us and start thinking about upgrading to a digital supply chain powered by the rfxcel Traceability System (rTS). Our award-winning platform will transform your supply chain and how you use it. From ingredients to finished goods, rTS will bring state-of-the art food traceability to your operations.

Furthermore, rTS turns every one of your products into a “digital asset” that you can use to nurture and protect your brand and engage consumers. Complete food traceability, starting at the harvest and ending in your customers’ homes, builds an ironclad product provenance and a compelling story you can promote and share. Today’s consumers, especially with the health and safety of their families foremost in their minds, are demanding more from brands — more information, more transparency, more quality, more interaction. As we wrote last fall, food traceability is creating a new kind of “consumer kingdom,” and it’s a digital supply chain that’s making it possible.

Food traceability: An FDA priority

In “Modernizing Food Recall Management,” we talked about the FDA’s New Era of Smarter Food Safety. Announced in April 2019, it’s “a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.”

Then, in July 2020 the Administration released the “New Era of Smarter Safety Blueprint,” which included a Food Traceability Proposed Rule designed to “help the FDA rapidly and effectively identify recipients of foods on its Food Traceability List to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.”

Next, to ring in 2021, the Administration on January 12 “made clarifying edits” to the Food Traceability List and published a FAQ for the Food Traceability Proposed Rule.

The Food Traceability List contains the foods that have additional traceability recordkeeping requirements per the Proposed Rule. The January 12 edits did not add or remove items from the list; instead, the FDA changed the descriptions of some commodities. For example, “fresh” was added to several fruits and vegetables “to clarify the scope of those commodities.” Revisions also clarified what cheeses fell under the category of “cheeses, other than hard cheeses.” See the FDA’s four-page memo for all the changes.

The FAQ for the Food Traceability Proposed Rule addresses questions the Administration has received about the Proposed Rule. Its primary goal is “to assist stakeholders who are considering providing feedback during the comment period, which has been extended until February 22, 2021.” If you want to submit a comment or review the comments that have been submitted, go to regulations.gov (Docket ID: FDA-2014-N-0053).

Final thoughts

Companies and governments around the world have been compelled to re-examine the security, efficiency, and resilience of their supply chains. Food traceability is vital to public health and safety, so it should rightfully remain a top priority.

rfxcel was founded on the principle of helping consumers know where products come from and being able to confirm that they’re safe and legitimate. With rfxcel’s Traceability System, Integrated Monitoring, Mobile Traceability app, and other solutions for food traceability, you’ll increase food quality and safety, modernize and improve recall management, optimize inventory tracking, and improve every aspect of customer service and interaction.

In other words, food traceability in a digital supply chain from rfxcel will ensure you’re doing everything possible to safeguard your customers, your brand, and your bottom line. No matter where you do business — the United States, Europe, Asia, South America, the Middle East — we can help make sure you’re ready for whatever 2021 (and beyond) has in store. Contact us today to arrange a demo.