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Brazil ANVISA Update: Manufacturers, Distributors, and Dispensers Must Meet April 2022 Serialization Deadline

The Brazilian Health Regulatory Agency (ANVISA) has approved its final Normative Instruction (NI 100), meaning the April 28, 2022, deadline for meeting serialization, reporting, and traceability requirements is officially set in stone. Let’s take a look at what supply chain stakeholders can expect with Brazil ANVISA when the law goes into effect just six months from now.

Key Brazil ANVISA requirements for April 28, 2022

The pharma industry has been aware of the Brazil ANVISA requirements since December 2016, when the National Medicine Control System (SNCM) was signed into law (Law No. 13.410/2016), establishing serialization requirements and timelines for Brazil’s pharmaceutical supply chain.

There are three key requirements for April 2022:

  1. All prescription medicines must be serialized.
  2. All manufacturers and importers must have a “serialization plan” in the SNCM portal.
  3. All supply chain stakeholders must submit product event reports to the SNCM.

To meet serialization requirements, all products must have a GS1 2D Data Matrix barcode that houses a Global Trade Item Number (GTIN), a 13-digit ANVISA Medicine Registry Number, a unique 13-digit serial number, an expiration date (in the MM/YY format for human-readable form), and a lot/batch number (up to 20 alphanumeric characters).

The ANVISA Medicine Registry Number, serial number, expiration date, and lot/batch number make up the Unique Medicine Identifier (Identificador Único de Medicamentos), or IUM, which must be printed on every product. Compliant labeling might look something like this:

Brazil ANVISA IUM

For their serialization plans in the SNCM portal, manufacturers and importers must provide information about their relevant product lines and medicines. Furthermore, manufacturers must submit a serialization plan that includes all steps and actions they will take to become compliant by April 2022.

Final thoughts

What’s the most important takeaway for Brazil ANVISA? The clock is ticking and you have to be prepared. You should be coordinating with your supply chain partners. You should be registering your products with ANVISA. You should have access to the SNCM portal and be uploading the required reporting data.

You should also register for our “SNCM-ANVISA Serialization and Traceability Compliance” webinar on Wednesday, Nov. 17, 8:30 – 9:15 a.m. Eastern Time. Thiago Alegreti, director of our Latin American operations, will discuss the latest SNCM updates and let you know what you need to be doing to be ready for April 2022.

rfxcel has fine-tuned our traceability software to help manufacturers operating in the Brazilian market comply with the SNCM requirements, and we have an experienced team on the ground in Brazil that can help make sure you’re ready for the regulations. Register for the webinar and contact us today if you have any questions or want more information.

DSCSA 2023: Understanding DSCSA Authorized Trading Partners, Part 2

Welcome to Part 2 of our discussion about DSCSA authorized trading partners. The 10-year rollout of the U.S. Drug Supply Chain Security Act — the DSCSA — is scheduled to conclude on November 27, 2023, so now’s a good time to take stock of where we are and what to expect over the coming months.

As we said in Part 1, everybody’s talking about DSCSA authorized trading partners — manufacturers, wholesale distributors, repackagers, third-party logistics providers (3PLs), and dispensers. From now until November 2023, it’s really all about ensuring these supply chain actors are ready to comply with the regulations.

Remember, under the DSCSA, authorized trading partners may engage in transactions only with other authorized trading partners. In other words, if you’re not a DSCSA authorized trading partner, your access to the U.S. pharma supply chain will be severely restricted or denied altogether.

Below, we finish our discussion of DSCSA authorized trading partners by defining who qualifies as a repackager, a 3PL, and a dispenser.

Repackagers

Repackagers own or operate an establishment that repacks and relabels a product or package for further sale or distribution without a further transaction.

Generally, dispensers (specifically pharmacies) are not considered repackagers. By this definition, a dispenser/pharmacy only packs and labels a product for dispensation to a person who has a valid prescription for that product; they do not do “bulk” repackaging.

Repackagers are considered trading partners if they accept or transfer direct ownership of a product from or to a manufacturer, another repackager, a wholesale distributor, or a dispenser. To be a DSCSA authorized trading partner, repackagers, like manufacturers, must be registered with the U.S. Food and Drug Administration (FDA) in accordance with Section 510 of the Food, Drug, and Cosmetics Act (FD&C Act), “§360. Registration of producers of drugs or devices.”

3PLs

The DSCSA defines a 3PL as an “entity that provides or coordinates warehousing or other logistics services with regard to a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.”

3PLs are considered trading partners if they accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. Returns processors and reverse logistics providers are considered 3PLs. There are two reasons for this:

  1. They provide other logistics services for other trading partners in a facility they own, rent, or lease.
  2. They do not take ownership of the product and do not direct the sale or disposition of the product.

Generally, brokers, solution providers, common carriers, and logistics or administrative services contractors are not considered 3PLs because they don’t provide or coordinate warehousing and don’t accept or transfer direct possession of the product. These stakeholders do not have to be licensed.

To be a DSCSA authorized trading partner, 3PLs must have a valid license under state law or FD&C Act Section 584(a)(1), “National Standards for Third-Party Logistics Providers,” in accordance with Section 582(a)(7), “Requirements, Third-party logistics provider licenses”, as amended by the DSCSA and in compliance with reporting requirements under Section 584(b).

Dispensers

To be considered a dispenser, you must meet one of three criteria:

  1. You’re a retail pharmacy, a hospital pharmacy, or a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor.
  2. You’re a person legally authorized to dispense or administer prescription drugs.
  3. You’re an affiliated warehouse or distribution center of a dispenser under common ownership and control that does not act as a wholesale distributor.

A dispenser is considered a trading partner if they accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or another dispenser. To be a DSCSA authorized trading partner, a dispenser must have a valid state license.

Generally, veterinarians are not considered dispensers, per FD&C Act Section 512(a)(5).

Final thoughts

The table below summarizes everything we’ve laid out above and in Part 1 of our DSCSA authorized trading partners series. It’s adapted from an August 2017 FDA publication.

As you’re reading, remember that all of our stakeholders are considered to be trading partners if they accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. To be an DSCSA authorized trading partner, however, they must meet the criteria explained in the table.

There’s one last installment of our “DSCSA 2023” series coming soon. In it, we’ll talk about the key requirements for 2023 and the future of traceability in the pharma supply chain. While you’re waiting for that, take a moment to check out our webinars, white papers, pharmaceutical compliance solutions, and other resources about the DSCSA. If you feel inspired, contact us to schedule a demo to see our solutions in action.

DSCSA Authorized Trading Partners

DSCSA Authorized Trading Partners

New Russian Serialization Pilot for Biologically Active Food Additives

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 beyond 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.

So, when we heard about the Russian serialization pilot for biologically active food additives, we thought it was time to update our white papers for 2021. There have been a lot of changes over the last year. Deadlines have changed. Other pilots have ended. Requirements and process have evolved. We’re including all the latest information from Chestny ZNAK and providing much greater detail about products and requirements.

The papers — including Russian versions — be ready soon. We’ll let you know when they’re available. In the meantime, our 2020 white papers are still online. You can also visit our website for more information about our solutions for Russian compliance and contact our team in Moscow directly.

rfxcel Enters into Acquisition Agreement with Antares Vision Group

The combination of rfxcel’s industry-leading traceability software platform and Antares Vision’s solutions for intelligent track and trace will create significant value for customers.

Reno, Nevada, Feb. 19, 2021 (EINPRESSWIRE). rfxcel, a global leader in digital supply chain traceability solutions, today announced that it had entered into an acquisition agreement with Italy’s Antares Vision Group, a leading global provider of intelligent track and trace, inspection, and smart data management solutions for the life sciences and food and beverage sectors.

rfxcel CEO Glenn Abood said the agreement marked the start of an expansive era for the company he co-founded with Chief Strategy Officer Jack Tarkoff in 2003. “This is an exciting new chapter for rfxcel,” he said, “a time for the company and our customers to look to the future.

“Becoming part of Antares Vision Group will give us new ways to strengthen our relationships with our customers and provide them with enhanced solutions as they do their important work in the life sciences, food and beverage, consumer goods, and government industries. Plus,” Abood continued, “the integration of our companies’ capabilities will enable us to drive into new markets and geographies as the undisputed leader in supply chain track and trace solutions. It really is a ‘win-win’ for our global teams and our customers.”

The Antares Vision Group will leverage rfxcel’s capabilities and signature rfxcel Traceability System (rTS) software suite to help customers accelerate their transition toward digital and sustainable supply chains characterized by full transparency and visibility. Together, the companies will provide a full stack, end-to-end digital supply chain solution that will optimize and streamline customers’ operations while providing complete end-to-end visibility, from product ingredients and raw materials to the end customer experience.

rTS is a digital supply chain visibility platform comprising up to eight discrete solutions that work in concert to harmonize, optimize, automate, and monitor virtually every aspect of supply chain operations, including serialization, regulatory compliance, Internet of Things (IoT)-enabled monitoring, and raw materials and finished goods traceability. rfxcel also offers a Mobile Traceability app that extends the power of rTS to users at every node of the supply chain, from remote fields and warehouses to retail outlets.

Emidio Zorzella, chairman and CEO of Antares Vision, said he and co-founder Massimo Bonardi were “delighted” about the agreement with rfxcel. “Demand for traceability and serialized products and services has increased significantly over the last few years,” he said, “and this transaction accelerates our ability to offer best-in-class propositions in all our key reference sectors, life science and food and beverage. We look forward to welcoming the management and employees of rfxcel to the Antares Vision Group and working together to serve our customers across the world.”

Abood added that both companies shared the same goals and Antares Vision would help rfxcel accelerate its plans. “The rfxcel management team is delighted to join with Antares Vision to offer customers the most complete end-to-end solution for track and trace on the market today.”

For more information about the acquisition agreement or the companies’ solutions, contact Herb Wong, rfxcel’s vice president of marketing and strategic initiatives, at hwong@rfxcel.com or 925-824-0300.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

About Antares Vision

Listed since April 2019 on the AIM Italia market of the Italian Stock Exchange, Antares Vision Group guarantees the protection of products, people and brands through inspection systems for quality control, track and trace solutions for anti-counterfeiting and supply chain transparency, smart data management tools for maximized efficiency and digitalization of the supply chain, from the point of production to the end consumer. The Antares Vision Group is active in the life science sector, including the pharmaceutical, medical device, and hospital segments, as well as in other industries, including, primarily, food and beverage, cosmetics, and in consumer-packaged goods. The Group reaches over 60 countries worldwide with complete and flexible solutions, hardware, and software, with related services: it has five offices in Italy (Brescia, Parma, Piacenza, Latina and Vicenza), 15 foreign branches (Germany [2], France [2], USA [3], Latin America [2], India, Russia, Hong Kong, China, Croatia, and Serbia), three Innovation and Research Centers (Italy) and a worldwide network of more than 40 partners. With the 20 years of experience in vision technologies of the two founding partners, the Antares Vision Group is the supplier of 10 of the 20 leading pharmaceutical companies in the world (by turnover), with more than 25,000 inspection systems, which ensure everyday product safety and quality, 6,500 quality controls, and more than 3,500 serialization modules on lines installed all over the world. With the aim of continuing and supporting the growth and development strategy, during 2019, Antares Vision finalized participation agreements with T2 Software, a Brazilian company specialized in smart data management solutions, and Orobix, an Italian company leader in artificial intelligence services, and acquired 100 percent of FT System, leader in control and inspection in the beverage sector. In 2020, Antares Vision acquired 82.83 percent of Tradeticity, a Croatian company specialized in software management of traceability and serialization processes, 100 percent of Convel, an Italian company specialized in automated inspection machines for the pharmaceutical industry, the assets of Adents High Tech International, a French company specialized in software for serialization and traceability, and 100 percent of Applied Vision, a global leader in inspection systems for glass and metal containers in food and beverage. In 2019, Emidio Zorzella and Massimo Bonardi won the Ernst & Young “Entrepreneur of the Year” award for innovation. For more info: www.antaresvision.com.

rfxcel Ready to Help Dairy Industry Comply with Russia’s 2021 Serialization Regulations

rfxcel’s track and trace solutions ensure companies operating in Russia’s dairy market can comply with dairy serialization regulations being rolled out in 2021

Reno, Nevada (Feb. 11, 2021). rfxcel, the global leader in digital supply chain traceability solutions, today announced that it was prepared to ensure companies operating in Russia’s dairy market could comply with serialization regulations being rolled out in 2021.

Mandatory serialization of cheeses and cottage cheese and ice cream and food ice is set to begin on June 1, 2021. These are the first dairy products required to be serialized in Russia’s National Track and Trace Digital System, known as Chestny ZNAK. Companies were allowed to begin labeling these goods as early as January 20, but the regulations will not go into full effect until June.

Furthermore, dairy products with a shelf life of more than 40 days and fewer than 40 days are required to be serialized beginning September 1 and  December 1, respectively. The regulations apply to several product categories, including milk and cream, buttermilk and fermented milk products, and dairy products for baby food.

rfxcel CEO Glenn Abood said the company had been preparing for the dairy regulations since an industry pilot was announced in 2019. “The long and short of it is that we’re always prepared to help companies in any industry navigate Russia’s strict and complex regulations,” he said. “We committed ourselves to being the leader in Chestny ZNAK compliance when the system was created a little more than four years ago, and our team in Moscow has followed its rollout, the evolution of the regulations, and the pilots for different industries, including dairy. We knew what was coming, so we’re ready to go.”

The dairy pilot ran between July 2019 and the end of 2020. During that time rfxcel earned official partner status in 10 of the 11 industries for which the Center for Research in Perspective Technologies (CRPT), which operates Chestny ZNAK, had chosen partners. It also tripled the size of its Moscow-based team and continues to be one of only a few solutions providers with active implementations in Russia.

Abood said the CRPT designations and success of the Moscow team had solidified rfxcel’s status as the leader in Russian compliance. “We’ve taken our rfxcel Traceability System, which includes solutions for serialization and compliance, into Russia and enabled companies in the pharmaceutical and consumer goods spaces meet deadlines, adapt to changes, stay compliant, and keep their supply chains moving. It’s been quite exciting, actually, and we’re looking forward to helping dairy companies have the same kind of success.”

Enacted by Federal Law No. 425-FZ on December 29, 2017, Chestny ZNAK was designed to protect consumers by keeping fake and substandard products out of the market. As envisioned, by 2024 it will transform the Russian supply chain and affect virtually every industry, from pharmaceuticals to baby food.

To learn more about rfxcel’s operations in Russia and its solutions for dairy, pharma, consumer goods, and other industries, contact Vice President of Marketing and Strategic Initiatives Herb Wong at hwong@rfxcel.com and visit rfxcel.com.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

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.

Modernizing Food Recall Management

“Recall” is the one word food companies never want to hear. But recalls are a fact of life, so it’s the wise manufacturer, wholesaler, and retailer that prepares for the inevitable. What does it take to have fast, effective food recall management? The short answer is that you need to modernize your supply chain so you can act quickly based on high-quality data. Let’s take a look.

“Modernize” is today’s food and beverage buzzword

The Food Safety Modernization Act (FSMA) has been in effect for almost a decade, so modernizing the food and beverage supply chain isn’t a new idea. Designed to improve the security and safety of the U.S. food supply, FSMA focused on preventing food-borne pathogens across the food system. It also encouraged companies to be proactive instead of reactive when it comes to food safety — including how they deal with food recall management.

Now, the U.S. Food and Drug Administration (FDA) has ratcheted up its food safety efforts. On April 30, 2019, it announced the New Era of Smarter Food Safety, which it describes as “a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.” To be rolled out over the next decade, it’s “also about simpler, more effective, and modern approaches and processes.”

In other words, more modernization that builds on FSMA. The “ultimate goal is to bend the curve of foodborne illness in this country by reducing the number of illnesses.”

Then, in July 2020, the Administration released the “New Era of Smarter Safety Blueprint” that

“ … outlines achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. It outlines a partnership between government, industry, and public health advocates based on a commitment to further modernize our approach to food safety.”

The Blueprint also includes a Food Traceability Proposed Rule (formal title: “Requirements for Additional Traceability Records for Certain Foods.”) It would implement Section 204(d) of FSMA, with requirements 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.” The list includes fruits and vegetables, fish, shellfish, cheeses, nut butters, eggs, herbs, and ready-to-eat salads.

What does modernization mean for food recall management?

It’s clear that FSMA and the New Era of Smarter Food Safety have recalls in mind when they mandate modernization or propose procedures to attain it. However, with or without the influence of regulations, rules, blueprints, and lists, modernization boils down to two things for food recall management: digitization and traceability.

A digital supply chain with end-to-end traceability delivers speed and high-quality data, the most crucial aspects of food recall management. Digitization — eliminating the physical paper trail in favor of a cloud-based management system — enables end-to-end traceability, and end-to-end traceability means you have rich, actionable data available in real time so you can find products quickly, make informed decisions, and act with authority and assuredness.

Digitization and traceability also expediate food recall management because they allow you to easily share information with your trading partners and regulators. If you’re a manufacturer or wholesaler, you’ll keep retailers up to date so they can take the recalled product off the shelves. Consumers benefit too, because they’ll get recall alerts and know to return the product or dispose of it as instructed.

Modernizing food recall management also helps mitigate the very things that can trigger a recall in the first place, such as poor visibility into the supply chain, lack of accountability, or an insufficient safety culture. Indeed, it’s up to companies to fix such shortcomings internally through training and establishing safety protocols, but digitization and traceability will carry and facilitate safety across the entire supply chain.

For instance, you can attach critical tracking events (CTEs) and key data elements (KDEs) to every product’s digital profile, creating an indelible provenance you can trace up and down the supply chain. You’ll see where a product has been, where it is (or is supposed to be), and where it’s going. During a recall, you can “reach into” your supply chain and extract the product quickly.

Final thoughts

As we move into 2021, F&B companies have absolutely no excuses to put off modernizing their supply chains and recall management systems. A poorly handled recall can result in catastrophic financial loss and cause irreparable damage to your reputation. And companies that don’t modernize will likely find themselves pursued by regulators, ostracized by trading partners, shunned by consumers, and, ultimately, out of business.

rfxcel can help. Our award-winning Traceability System (rTS) is the basis of a modernized, digital supply chain with fully customizable and scalable solutions that yield complete end-to-end traceability. It is the foundation of a digital supply chain and a successful food recall management system that operates with surgical precision.

For example, our Serialization Processing (rSP) solution assigns every product a unique digital ID that lets you locate affected products quickly, remove them from circulation, and record and verify that every recalled item was destroyed. Furthermore, rSP generates last-mile data that helps you identify the source of outbreaks and their scope for better consumer safety efforts.

Coupled with rSP, our Raw Materials Traceability (rRM) and Finished Goods Traceability (rFG) solutions build a digital supply chain that aids food recall management by maintaining a validated, traceable pedigree for every product. Track the transformation of raw materials into finished goods with total forward and backward traceability. Track lot to unit or unit to lot all the way to the consumer. Attach key data to every critical tracking event digitally. And if there’s a recall, see how exposed you are and respond rapidly by notifying affected customers and trading partners and changing the disposition of all units/lots to “RECALL” to prevent them from being included in any ship event. You can also use your data to aid investigations.

Contact us today to speak with one of our F&B supply chain experts. They’ll give you a short rTS demo that will show you how an rfxcel digital supply chain with end-to-end traceability will modernize your operations and optimize your food recall management.

Russia Chestny ZNAK Track and Trace: A Refresher Course

Russia is in the midst of creating the world’s most ambitious — and strict — supply chain track and trace system. Its National Track and Trace Digital System, known as Chestny ZNAK (and sometimes translated as Honest SIGN or Honest BADGE), is on track to be fully operational in 2024. Chestny ZNAK track and trace requirements are tough, and they’ll cover virtually every type of product you can imagine.

No matter what role you play in the supply chain, you have to understand how the system works and what the regulations mandate. Let’s examine Chestny ZNAK track and trace, from its origins to what it requires.

The origins of Chestny ZNAK track and trace

On December 29, 2017, Russian President Vladimir Putin signed Law No. 425-FZ, officially inaugurating the Chestny ZNAK track and trace system. Its goal is to streamline quality control, protect against counterfeits, and monitor supply and demand and expenditure. The regulations cover 12 product categories: medicines, furs, footwear, bottled drinking water, tires, tobacco, dairy, wheelchairs, bicycles, light industry, perfumes, and photo cameras and flashbulbs.

Chestny ZNAK is run by the Center for Research in Perspective Technologies (CRPT), a public-private partnership akin to the European Medicines Verification Organization. Its principal partner, with a 51 percent stake, is business giant USM, which 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.

What are the requirements?

Chestny ZNAK track and trace regulations are arguably the strictest in the world. Companies that do not comply face fines and other penalties, including “deprivation of liberty” (prison), and can in essence be banned from doing business in Russia.

The requirements vary by industry, and deadlines and labeling requirements have changed, but the fundamentals have remained constant: serialization, aggregation, unit- and batch-level traceability, crypto codes, and electronic reporting and records management.

Products must be marked with 2D Data Matrix codes with an 85-character alphanumeric sequence that contains at least four groups of information: a Global Trade Item Number (GTIN), a serial number, a verification key, and a verification code (i.e., crypto code). Furthermore, the owner of goods must create a Universal Transfer Document (UTD) at the moment of ownership, then transfer it to the CRPT.

The crypto codes are an important part of Chestny ZNAK track and trace. At first, every code had to have 88 characters, but a federal decree in August 2019 that amended the procedure for applying drug labelling codes cut the requirement to 44 characters. The CRPT issues the codes, which only authorized representatives can request/receive. rfxcel is an approved partner of the CRPT; more on that below.

For the pharma sector, it’s prudent to note that Chestny ZNAK track and trace requires over-the-counter (OTC) drugs to be labeled, scanned, and recorded in the system. This is a significant departure from the EU Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA).

These are the broad strokes of the Chestny ZNAK track and trace regulations. There are other requirements — such tracking products with Universal Transfer Documents (UTDs), which must be sent to the CRPT when ownership of goods changes — but we won’t get into those here.

How does it work?

Chestny ZNAK track and trace is a five-step process that calls for complete traceability all the way to consumers. Let’s walk through these steps.

First, the CRPT sends the manufacturer, wholesaler, retailer, or importer — referred to as “economic agents” in the regulations — a unique digital code for every product that must be affixed to the packaging. Only a CRPT-authorized representative can request codes. Every product is logged in Chestny ZNAK’s catalogue of marked goods.

In the second “logistics” step, the digital code becomes an immutable “passport” that legitimizes the product at every step of the supply chain. Every transfer of ownership must be recorded.

Next, the product arrives at the location where it will be sold or dispensed. The receiver scans the item, Chestny ZNAK receives a transfer confirmation, and it’s ready for sale.

Fourth, the product is sold or dispensed. The seller is required to have a point-of-sale cash register, a system connected to the internet that typically includes a touchscreen, a scanner to read 2D Data Matrix codes and other codes, a credit card scanner, and a printer. The product is scanned at checkout and the cash register reports to Chestny ZNAK that “the code has left circulation.” If the scanned data doesn’t match what’s in the catalogue of marked goods, the product is counterfeit or otherwise illegitimate and cannot be sold.

In the last step, the consumer takes over and becomes the final supply chain quality control checkpoint. Using the Chestny ZNAK app for smart devices, described as “your main assistant for product quality tracking and counterfeit detection,” a person scans the 2D Data Matrix code on the product and gets instant access to rich information directly from Chestny ZNAK. If a scan reveals a “violation” — meaning the product is counterfeit or not in compliance with marking regulations —  consumers can report it directly to the CRPT. They can also send questions about how the app works and suggestions to improve it

Here, we want to point out that the Chestny ZNAK track and trace app reminds us of our own MobileTraceability app, only for consumer use. Both can show the date, time, and place of production, the expiration date, and details about the product’s journey from the farm or factory to the store. Our MobileTraceability app is a powerful tool for track and trace in any industry. Check out our short video about how it works in the food and beverage supply chain.

Final thoughts

If you follow our blog or read our news, you know rfxcel is the leader in Chestny ZNAK track and trace compliance. That’s a bold statement, but we think we have the facts to back it up:

  • We’re an official integration, software, and tested solution partner with the CRPT. We’ve demonstrated that our solutions, particularly our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Chestny ZNAK track and trace requirements and ensure companies stay compliant.
  • rTS works seamlessly with Chestny ZNAK track and trace, including a Russian-language user interface that makes integration and startup much quicker.
  • We’ve prepared for 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 Chestny ZNAK track and trace. No matter how far along you are in your preparations to meet the requirements, 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.

 

DSCSA Saleable Returns Verification Requirement: Just the Facts

Note: On October 23, 2020, the FDA delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The Drug Supply Chain Security Act (DSCSA) is transforming every aspect of the U.S. pharmaceutical supply chain. The law has many parts, but today we’re focusing on the DSCSA saleable returns verification requirement, one of its key mandates. Let’s jump right in.

First, what is the DSCSA?

The DSCSA went into effect on November 27, 2013. It is actually Title II of the Drug Quality and Security Act (DQSA) and calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies).

The goal of the DSCSA is to facilitate product tracing in the pharmaceutical supply chain and, ultimately, promote patient and consumer safety and ensure the authenticity of products. Non-compliance is “prohibited … and subject to enforcement action under the [Federal Food, Drug, and Cosmetic Act].” In a nutshell, if you’re out of compliance, you’re out of business.

What is the DSCSA saleable returns verification requirement?

Millions of pharmaceutical products are returned for resale every year in the United States. These are known as “saleable returns.” Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. In other words, every returned drug has to be vetted — declared as safe and legitimate — before it can be sold again. This is accomplished by verifying the drug’s PI, which has four components: a Global Trade Item Number (GTIN), a unique serial number, a lot ID, and an expiration date.

The DSCSA saleable returns verification requirement for distributors was originally scheduled to take effect on November 27, 2019; however, as we discussed in a previous blog post, the FDA in late September 2019 announced that it did “not intend to take action against” wholesalers that did not meet the requirement before November 27, 2020. This 1-year postponement gave pharma supply chain stakeholders more time to prepare to comply.

Of course, November 27, 2020, is only a few months away. Are you going to be ready? More on that below.

How does the DSCSA saleable returns requirement work?

The easiest way to understand the DSCSA saleable returns requirement is to think of the U.S. pharma supply chain as having only two members: wholesalers and manufacturers. And the law requires them to talk with one another about returned drugs. Here’s what we mean.

To meet the DSCSA saleable returns verification requirement, a wholesaler must initiate a verification request (to a manufacturer) to verify the returned products before it can resell them. The manufacturer that receives that request must provide a verification response within 24 hours. This is why wholesalers are called requestors and manufacturers are called responders.

The 24-hour deadline, however, doesn’t meet business realities. Why? Because, as we mentioned above, millions and millions of drugs are returned every year. The volume is just too great. Therefore, wholesalers need manufacturers to provide verification responses almost instantaneously — at the sub-second level, not in a few minutes, let alone an entire day.

Enter the Verification Router Service (VRS).

The VRS and the DSCSA saleable returns verification requirement

VRS is a huge topic, and to get into the details is outside the scope of what we’re talking about today. Put simply, the VRS enables the rapid, secure exchange of data between requestors and responders to meet the DSCSA saleable returns verification requirement.

The Healthcare Distribution Alliance (HDA) is the driving force behind the VRS, which facilitates the “talk” between wholesalers (requestors) and manufacturers (responders) to verify every drug. Here, a third member joins the DSCSA saleable returns “family”: A solution provider that enables the verification requests to be routed between wholesalers and manufacturers.

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

Final thoughts

rfxcel is the industry thought leader in the DSCSA saleable returns verification requirement and the VRS. Not only did we extend testing of VRS, we implemented a VRS pilot program for the Food and Drug Administration. We’re applying our expertise in supply chain track and trace, serialization, and compliance solutions to help the pharma industry prepare for November.

And we can help you too. Contact us today to talk with one of our supply chain experts and see how our award-winning rfxcel Traceability System can ensure you comply with the DSCSA saleable returns verification requirement — and meet all your other supply chain needs.

CONTACT US TO SEE THE VRS SOLUTION AND FDA TEST RESULTS: