Chestny ZNAK Archives - Page 2 of 2

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

Posted on February 12, 2021October 28, 2022 by rfxadmin

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 Pharma Serialization Update: “Notification Mode” Expedites Product Circulation

Posted on January 22, 2021August 16, 2023 by rfxadmin

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

Posted on January 22, 2021October 9, 2023 by rfxadmin

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

Posted on January 22, 2021October 9, 2023 by rfxadmin

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:

Milk and cream
Buttermilk, fermented milk products (e.g., curdled milk and cream, yogurt, kefir (a fermented milk drink)
Butter and other fats and oils made from milk, milk pastes
Milk whey and other dairy products not included in other groups
Dairy products for baby food
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:

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

rfxcel Continues Winning Streak in Russian Serialization, Track and Trace

Posted on July 15, 2020October 28, 2022 by rfxadmin

Once again, Russia’s Center for Research in Perspective Technologies (CRPT) has named rfxcel an official partner, this time for software and integration for dairy, bottled water, footwear, wheelchairs, tires, perfumes, bicycles, and light industry. We’re pretty excited about this. We had already been named an official software, integration, and tested solutions partner for medications. Our team in Moscow has worked hard to make us the leader in Russian serialization and track and trace for all industries; you should contact them if you have any questions about doing business in Russia.

The CRPT is a public-private partnership that manages Russia’s National Track and Trace Digital System, known as Chestny ZNAK. Our rfxcel Traceability System (rTS) works seamlessly with the system, including a Russian-language user interface that makes integration and startup much quicker.

Let’s take a quick look at what’s going on with the dairy and bottled water industries in Russia, and why we’re leading in Russian serialization and track and trace.

The CRPT and Russian Serialization/ChestnyZNAK “Experiments”

The CRPT follows best practices by conducting “experiments” — what we would call pilots — for products before the officially enter the ChestnyZNAK system. The pilot for dairy ran from July 15, 2019, to February 29, 2020; for bottled water, the pilot began April 1, 2030, and is scheduled to end March 1, 2021.

A pilot for bicycles wrapped at the end of May 2020, and a current one for wheelchairs is expected to end June 1, 2021. Pilots for children’s goods (e.g., baby food, clothing, toys, and games) and medical devices will apparently be announced soon.

Requirements for Dairy and Bottled Water

Russia’s supply chain regulations are notoriously strict. This is one reason being named an official CRPT partner is a feather in our cap: We’ve demonstrated that our solutions, particularly our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the requirements and ensure companies stay compliant.

We’re currently working on some other materials about the regulations for dairy and bottled water (and tires and other products), so check back soon to see those. In the meantime, however, here’s some basic information to tide you over.

Dairy

All products must be labeled with a DataMatrix code. The code must contain the following:

The goods code (14 numerical digits)
An individual serial number (13 digits) generated by the CRPT or a company’s economic agent
A verification key provided by the CRPT (4 digits)

According to the language in the regulations, companies may include an expiration date (6 characters for non-perishables, 10 for perishables), but that is not mandatory.

Product packaging mush have a 15×15 mm space for the codes. If a product has a cap, such milk in a PET bottle, the material and surface texture must be able to accommodate printing (e.g., ink or laser).

Bottled water

The regulations recognize six categories of bottled water. In addition to three unexplained “other” categories, these include:

Waters, including natural or artificial mineral, carbonated, free from sugar or other sweetening or flavoring substances. (The regulations also mention “ice and snow” under this category.)
Mineral and carbonated waters, including natural mineral waters:
Non-carbonated waters

The DataMatrix code must contain the same information as the codes for dairy. And like dairy, companies have the option to include other information, such as an expiration date or a minimum retail price.

Final thoughts

Our success with the CRPT is due to a lot of hard work and our commitment to designing the best solutions for Russian serialization, track and trace, aggregation, and compliance.

When Chestny ZNAK was enacted into law on December 29, 2017, we began honing our operations in Russia. About this time last year, we reported that we had doubled the size of our team in Russia; since then, it’s tripled in size. We’re one of very few supply chain solution providers with active implementations in Russia, and we’re working with more and more companies as our reputation grows.

Our continued success with the CRPT, ChestnyZNAK, and Russian serialization boils down to the quality of our solutions and the knowledge and skill of our people, who have expertise in key areas of supply chain management and technology. They all speak Russian, of course, and they know the regulations inside and out. They understand how to meet our customers’ needs while ensuring they’re fully compliant with Russian serialization, aggregation, and supply chain compliance requirements.

Contact us today learn more about how rfxcel can help you with Russian serialization and the ChestnyZNAK regulations. And be sure to ask about our other track and trace and compliance solutions. Sure, we’re the leader in Russian serialization, aggregation, track and trace, and supply chain compliance solutions, but we can optimize any supply chain anywhere in the world. Ask us how!

rfxcel Takes Big Step as Leader in Russian Aggregation, Serialization & Supply Chain Compliance

Posted on April 17, 2020October 28, 2022 by rfxadmin

If you follow our blog or have seen our articles in industry journals, you know rfxcel is the leader in Russian aggregation, serialization, and supply chain compliance. Now we’ve taken another big step to cement our status: We’ve been named an official integration, software, and tested solution partner with Russia’s Center for Research in Perspective Technologies (CRPT).

This is big news for us, so let’s summarize how we got here and what it means.

The CRPT and Russian aggregation, serialization, and supply chain compliance

The CRPT is a public-private partnership that manages Russia’s National Track and Trace Digital System, known as Chestny ZNAK. To achieve integration, software, and test partner status, we had to show the CRPT that our supply chain software could fully manage and execute all aspects of Chestny ZNAK’s notoriously stringent compliance reporting processes. For example, here are some the requirements for pharma:

- A 2D barcode must be placed on all units; it must include a GTIN, serial number, a verification key, and a crypto code.
- All medications must be serialized, including over-the-counter medications.
- Different requirements for aggregations and batches.
- Supply chain members must report every change to individual batches.
- Foreign manufacturers may have to report up to 36 compliance events.

So, our Moscow-based team in Russia had a lot to prove when it met with a CRPT approval board in March. They presented a comprehensive demonstration of our signature full-stack solution, rfxcel Traceability System. They also answered technical questions and share examples of compliance reports.

After an internal evaluation, CRPT notified use that it had validated our solution and designated us as an official integration, software, and tested solution partner on its website. We look forward to working with companies in the pharma, food and beverage, consumer goods, and government industries to help the with Russian aggregation, serialization, and supply chain compliance.

Final thoughts

Our success with the CRPT was due to a lot of hard work and commitment to the Russian market. When Chestny ZNAK became law on December 29, 2017, we began honing our operations in Russia. In August 2019, we reported that we had doubled the size of our team in Russia; since then, we’ve tripled in size. As our CEO Glenn Abood said, “Today, we’re one of a very few supply chain solution providers with active implementations in the country, and we’re working with more and more companies as our reputation for ironclad compliance and supply chain management grows.”

Of course, we’re thrilled about our progress in Russia. It all boils down to the quality of our solutions and the knowledge and skill of our people, who have expertise in key areas of supply chain management and technology. They all speak the Russian, of course, and they know the regulations inside and out. They understand how to meet our customers’ needs while ensuring they’re fully compliant with Russian aggregation, serialization, and supply chain compliance requirements.

Contact us today learn more about how rfxcel can help you with Russian regulations. And be sure to ask about our other track and trace and compliance solutions. Sure, we’re the leader in Russian aggregation, serialization, and supply chain compliance solutions, but we can optimize any supply chain anywhere in the world. Ask us how!

Quick News: Russia Changes 2020 Serialization Deadlines for Footwear

Posted on March 11, 2020November 30, 2020 by rfxadmin

Leap Year brought significant change to the timetable for footwear serialization in Russia. Announced February 29, Government Resolution No. 860 gave companies a few extra months to comply with the regulations: Key deadlines were pushed back from March 1 to July 1.

Here’s what happens with footwear serialization on July 1

Starting on July 1:

Production and import of unlabeled shoes is prohibited.
Wholesale and retail sale of unlabeled footwear is prohibited.
Transfer of information about production, importation, and wholesale and retail sales to Russia’s National Track and Trace Digital System (Chestny ZNAK) becomes mandatory.

We discussed Russia’s labeling requirements for footwear in a previous blog post. Read it here.

Two other changes in 2020

Resolution No. 860 also stipulated changes to deadlines concerning unlabeled footwear:

Unlabeled footwear purchased before July 1 may be imported until August 1. (The original dates were March 1 and April 1, respectively.)
Companies may label shoes made or acquired before July 1 until September 1, but only if they can document the date of manufacture or purchase. (The original dates were July 1 and September 1, respectively.)

And that’s that. Short and sweet — but significant in that companies who were not prepared have gained some much-needed time to ensure they’re in compliance.

Why you should choose rfxcel for Russian compliance, no matter what industry you’re in

rfxcel is the undisputed leader in Russia compliance. We’ve prepared for Chestny ZNAK since 2018. We’re one of the few providers with active implementations in the country. 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.

No matter how far along you are in your preparations to meet Chestny ZNAK requirements, we are who you need to talk to — even if you’re already working with another provider. Our powerful software ensures companies in any industry will remain compliant with Russia’s complex regulations while mastering their supply chains with end-to-end traceability and rich, actionable data mined right down to the unit level.

Email us today at russia@rfxcel.com to schedule a conversation with one of our supply chain experts in Moscow. We think you’ll be impressed when you learn more about our capabilities in Russia.

And be sure to read “Russia 2020: A Guide to Consumer Goods Supply Chain Compliance,” an easy-to-understand white paper that explains the fundamentals of the Russian legislation and puts it all in context.

Is It Time to Change Your Supply Chain Solution Provider?

Posted on February 28, 2020July 27, 2020 by rfxadmin

Is your supply chain solution provider dropping the ball? Is it doing everything it can to help you meet global compliance like EU FMD, U.S. DSCSA, and Russia Chestny ZNAK? What about serialization, traceability, environmental monitoring, safety, data analytics, and your other key needs?

If you operate a pharma supply chain in the EU, Russia, the United States — anywhere — think about this:

An effective supply chain is like an effective athlete. It’s fast. It works toward goals. It always plays by the rules. It uses data to innovate and improve performance. It communicates with its team members. It focuses on excellence 24/7. It wins the game.

But to optimize its potential, it needs an effective coach. That coach is your solution provider, and rfxcel wants you to know that we have a 17-year track record of serialization, traceability, and supply chain excellence in the pharma industry. So, if you’re thinking it’s time for a change because your current solution provider isn’t getting you the wins you want, we want you to take a look at us.

Here’s why.

You’ll be fast and work toward goals

When you work with rfxcel, you’re fast right out of the gate and focused on your business goals. Our preconfigured and pre-validated solutions simplify the implementation process, meaning you’ll have a fully validated production solution in under 30 days. We listen to what your goals are and configure your solutions based on your guidance. You review and approve the implementation. Plus, our solutions are available in a variety of languages, which speeds implementation and boosts ease of use because people can work in their native language.

You’ll always “play by the rules” — you’ll always be compliant

rfxcel has the most comprehensive compliance reporting solution for your regulatory requirements. With us, you never have to worry if you’re compliant, no matter where you’re doing business. To illustrate, consider what we do for our pharmaceutical clients:

We deliver iron-clad global compliance: EU Falsified Medicines Directive (FMD); U.S. Drug Supply Chain Security Act (DSCSA); Russia’s National Track and Trace Digital System (Chestny ZNAK); India Drugs Authentication and Verification Application (DAVA); plus all regulations in China, South Korea, Brazil, Saudi Arabia, Turkey, and more.
We’ve sponsored pilots with U.S. Food and Drug Administration and the Brazilian Health Regulatory Agency (ANVISA)
We’ve processed more than 3 billion transactions and serial numbers.
The Top 6 pharma manufacturers in India have selected us as their solution provider.

A little more about Russia Chestny ZNAK

rfxcel is the leader in Russian compliance. We’ve been prepared for the country’s strict regulations since 2018, a year before they began rolling out. We’re one of few providers with in-country implementations. Over the last year, we tripled our workforce in Russia. That Moscow-based team provides our customers, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting and assuring ongoing compliance. So, if you want to do business in Russia, rfxcel is your best choice for total supply chain compliance, optimization, and support.

You’ll use data to improve performance and innovate

Our full-stack rfxcel Traceability System software platform is one solution for your entire supply chain, enabling comprehensive serialization capabilities, true end-to-end traceability, compliance reporting, Internet of Things (IoT)-enabled environmental monitoring, and analytics from anywhere in the world. It can comprise up to eight discrete solutions that work in concert to harmonize, optimize, automate, and monitor virtually every aspect of your operations.

In other words, you will have around-the-clock access to rich, actionable data about everything in your supply chain, right down to the unit level. This is data you can use to improve performance, innovate your operations, and engage with consumers. Furthermore, our solutions support all industry and customized data formats, and we offer secured connections to exchange and manage/transform data.

You’ll connect and integrate with all your trading partners

With rfxcel, you’ll never be out of touch with your trading partners, no matter where they’re located. Thousands of companies are already connected to our network, which means almost instantaneous integration and communication across common trading partners. Our systems enable secure connections to exchange information, so your communications are always safeguarded. Most important, we have more than 70 data verifications that prevent bad data from entering your system. No garbage in means no garbage out.

You’ll get rfxcel’s world-class service and 24/7 support

Our industry-leading service doesn’t end after you’ve signed your contract and your system is implemented. Customer satisfaction is our No. 1 priority. We want you to be happy with our service, support, and products at all times.

Final thoughts

rfxcel is the coach you need to achieve peak supply chain performance. If your solution provider isn’t operating at this level, it’s probably time to think about switching teams. We deliver from one end of your supply chain to the other, whether it’s laboratory to patient, farm to table, or factory to retailer to point of purchase. We will help you meet compliance requirements and make your partners and customers happy. If your current provider isn’t delivering what you need, you need to contact us today.

Exploring Track and Trace for Pharmaceuticals: A Complete Guide

Posted on August 3, 2018August 10, 2023 by rfxadmin

Track and trace for pharmaceuticals lets you pinpoint any item’s current and past locations in your supply chain in real time. It’s a powerful tool that no pharma company can do without, especially as more and more regulations mandate track and trace capabilities and specific requirements for recording and sharing supply chain data.

We’ve been doing track and trace for pharmaceuticals for 20 years, longer than any other solution provider serving the industry, and we thought now was a good time to revisit the fundamentals as part of our ongoing discussion about the pharma supply chain, evolving technologies, and regulatory compliance. Let’s take a look.

What is track and trace?

Track and trace is the ability to see everything in your supply chain.

Tracking means you’re able to see where something is now and where it is heading (e.g., a factory, a warehouse, a pharmacy or hospital). That “something” can be a pallet of items, individual boxes on that pallet, and the individual items inside each box.

Tracing means you’re able to see where an item has been and who has handled it (e.g., the date and time it arrived at a warehouse and when it was shipped to its final destination).

What is a track and trace system for?

A track and trace system comprises components that work together to ensure efficient product identification, data management, and communication. These components are crucial for accurate, real-time visibility and effective management throughout the supply chain. A track and trace system usually utilizes specialized software combined with product labeling, particularly barcodes (e.g., 2D DataMatrix codes) as unique identifiers, to achieve these capabilities.

What is track and trace for pharmaceuticals?

When designed and implemented correctly, a track and trace system for pharmaceuticals does exactly what its name promises. It tracks a drug, a vaccine, a medical device — anything in any configuration — as it moves forward through the supply chain and traces backward to reveal where it has been in the supply chain, all the way back to the individual ingredients or components that combined to create it.

Tracking lets pharmaceutical manufacturers keep tabs on every item in their supply chains as they are distributed. Its many benefits include optimizing operational efficiency and speed in the manufacturing process. It also protects against theft and diversion; monitors products in transit to help ensure they remain safe and environmentally stable; and prevent counterfeit, adulterated, or expired medications from entering the supply chain.

Traceability lets you follow the trail of anything in your supply chain. It is a key component in supply chain visibility and transparency. Its many benefits include fast and accurate recall management capabilities, brand protection, accurate inventory management, and building consumer/patient confidence.

Serialization for track and trace pharma

Track and trace for pharmaceuticals relies on a deliberate combination of technologies and processes. Its “building block” is serialization, which endows a product with a unique identity that allows it to be tracked and traced 24/7 and authenticated at any time (e.g., prior to sale, at dispensing, upon return, or during a recall).

Serialization also lets pharma companies “configure” their products to meet government regulations, many of which specifically mandate track and trace capabilities and related data requirements.

For example, the U.S. Drug Supply Chain Security Act (DSCSA) will require full serialization of the U.S. pharma supply chain on November 27 of this year (2023). Among other things, the law stipulates that a unique product identifier (PI), such as a barcode, must be placed on certain prescription drug packages, and that pharma companies must provide detailed information about a drug and who handled it each time it’s sold. (See below and read more about these and other requirements here.)

In Europe, a product’s data points are aggregated into a master database, the European HUB (EU HUB), as well as country-specific databases called the National Medicines Verification System (NMVS). In Russia, it’s the National Track and Trace Digital System (Chestny ZNAK).

Are track and trace regulations as common as serialization requirements?

Not every country with serialization requirements has track and trace requirements; however, regulators in many countries are starting to pair track and trace with serialization to achieve their goals, which include combating counterfeit, stolen, or adulterated drugs.

For example, as we said above, the DSCSA will require pharmaceutical stakeholders provide detailed information — transaction information (TI) and transaction statements (TS) — about a drug and who handled it each time it’s sold. Stakeholders at every node of the supply chain — from wholesalers to repackagers and dispensers — must receive an electronic copy of this data. They must also produce and add to the data if they sell the product.

Note: The DSCSA currently requires a third piece of data called the transaction history (TH). This is an electronic statement with the TI for every transaction going back to the manufacturer. However, TH will not be required after the November 2023 deadline.

Global compliance for track and trace in pharmaceuticals

In the pharmaceutical industry, track and trace systems are crucial for maintaining product integrity, combating counterfeit medications, and ensuring patient safety. To address these concerns, regulatory authorities worldwide have implemented stringent compliance requirements for track and trace in pharmaceuticals. Key aspects of global compliance requirements include serialization, product identification/authentication, traceability, electronic reporting to regulators, and electronic data-sharing among trading partners.

For more information about what countries require for track and trace for pharmaceuticals, check out our Global Compliance page. The regulatory landscape is constantly changing, so it’s the wise company that takes the time to keep up with requirements, changes, and deadlines.

Final thoughts: track and trace for pharmaceuticals

Track and trace for pharmaceuticals is no longer an option: It is a requirement for companies wanting to do business in key markets such as the United States, Europe, Russia, Brazil, the Middle East, Asia — virtually everywhere in the world. Put simply, not having a modern track and trace system is a huge risk.

As we said in our introduction, we’ve been doing pharmaceutical track and trace for 20 years. We were founded on the principle of making the pharma supply chain safer and protecting consumers through track and trace.

Today, we offer the industry’s most powerful track and trace solution. And now, as part of Antares Vision Group, we are confident that we offer the world’s most comprehensive solution for end-to-end supply chain track and trace connectivity. From L1 to L5, we have the hardware and software solutions that deliver all the benefits of track and trace for pharmaceuticals — or any product category.

Contact us today to talk to one of our supply chain experts or to schedule a demo of our award-winning Traceability System for the pharmaceutical industry. We want to make your supply chain your most valuable business asset.