December 2019 - rfxcel.com
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Brazil Track and Trace Requirements and Latest Updates

Brazil is the largest economy in Latin America. In May 2022, it will join Russia, the EU, and many other counties in mandating serialization in its pharma supply chain. Pharmaceutical companies manufacturing in or importing into Brazil are required to follow the regulations set forth in the National Medicine Control System (SNCM), as described in Law No. 13.410.

The SNCM was signed into law by the Brazilian Health Regulatory Agency (ANVISA) on December 28, 2016; it is the first step toward serialization implementation.

Here’s a rundown of the approaching Brazil serialization deadlines, the responsibilities of the Brazilian supply chain, and all the latest updates.

Original Brazil serializations deadlines

Brazil’s serialization requirements are being implemented in three stages. Stage 1 went into effect in September 2017, which marked the beginning of a 1-year pilot phase. Stage 2, lasting from September 2018 through May 2019, included a pilot review and the finalization of technical guidelines. Stage 3 was initially set for May 2019 to May 2022 and included unit-level serialization implementation.

In November 2019, reports stated there would be changes to these deadlines, which we will address later on in this piece.

Supply chain responsibilities

As of May 2022, every supply chain actor importing to or manufacturing in Brazil is responsible for capturing, storing, and exchanging important events electronically. This initiative was put into place to protect Brazil’s 190 million citizens against common problems in the drug supply chain, including counterfeit drugs and cargo theft.

The SNCM requires unit-level serialization, tracking and tracing products, and monitoring environmental conditions as products move through the supply chain. These serialization requirements state that every item must be visible at the unit level, and all products must have a list of the following specifications:

  • GS1 2D data matrix bar code that houses a Global Trade Item Number (GTIN)
  • ANVISA Medicine Registry Number
  • Unique serial number
  • Expiration date
  • Lot/batch number

Latest updates to the SNCM

As we reported in another recent blog post, updates to the SNCM were suggested in November (2019), raising concerns about compliance. The proposed changes stipulate that every pharma stakeholder should be able to serialize 25 percent of its products by October 2020 — a full 18 months earlier than the original deadline. (Other deadlines didn’t change: 50 percent by April 2021, 75 percent by September 2021, and 100 percent serialization and reporting by April 2022.)

We’re not sure what the ramifications will be — a 45-day public review is currently underway — but our Latin America team is monitoring the situation.

Final thoughts: rfxcel’s role in Brazil serialization

For 15 years, rfxcel has deployed its experience to help companies from Latin America to Russia increase supply chain visibility. We have fine-tuned our traceability software to help manufacturers operating in the Brazilian market achieve compliance.

We are prioritizing assisting Brazilian companies to prepare for the May 2022 deadline. Vinicius “Vinnie” Bagnarolli, rfxcel’s Director of Commercial Operations in Latin America, warns that even though the deadline is still far in the future, companies should start preparing for the shift now:

“SNCM requires pharma companies to do a lot of new things and adopt new behaviors. This includes implementing unit-level serialization, tracking and tracing products, and monitoring environmental conditions as they move through the supply chain. Companies will also have to submit detailed transaction data to the government. We want companies, distributors, and dispensers to know that we have the technical expertise and experience in Brazil to help them transition to SNCM. We are on the ground in Brazil; we are here to help.”

If you have questions or concerns about the SNCM or any other aspects of the pharma supply chain in Latin America, you can email Vinnie directly at vbagnarolli@rfxcel.com or contact us to set up an appointment. Also, check back for details about a webinar about these and other issues that Vinnie will host in December!

rfxcel’s Ultimate Guide to the 2020 Russian Track & Trace Requirements

On December 29, 2017, Russia signed Law No. 425-FZ into law. It was put in place to streamline the quality control of pharmaceuticals, protect against counterfeit medicines, and monitor supply and demand and expenditure. The law has been phased in over the past two years, and now we’re just weeks away from Russia’s serialization deadline.

This quickly approaching deadline affects every component of the supply chain and puts into place some of the most — if not the most — aggressive compliance regulations in the world. Russian serialization requires the tracking of dozens of events throughout the supply chain, including commission/decommission, aggregation/disaggregation, and import/export. Without proper preparation, pharmaceutical companies operating in Russia or importing into Russia will fall behind and lose profits, if not be shut out altogether.

Here’s a rundown of the requirements and what you can do to be ready for 2020.

Upcoming Deadlines

December 31, 2019, is the final deadline for the serialization of all products being manufactured in or imported into Russia. It includes serialization, aggregation, and event reporting for all pharmaceuticals. It will require complete unit- and batch-level traceability. These requirements will apply to all medicines, including over-the-counter (OTC) drugs.

Track & Trace Requirements

Russia has enacted several strict track and trace requirements designed to prevent illegitimate medicines from entering its market, monitor financials, and guarantee the overall quality and safety of all pharmaceuticals.

These updated track and trace requirements include a Unique Product Identification consisting of a two-part crypto tail — a Global Trade Item Number (GTIN) and a serial number.

Manufacturers will be required to apply a 2D Data Matrix code to secondary and tertiary levels of pharmaceutical packaging, including OTC medicines. This 2D code must include:

  • GTIN/product code
  • Serial number
  • Verification key
  • Crypto code

Initially, the law mandated an 88-character crypto code, but that was cut to 44 characters in August 2019. This simplifies the process as businesses are rushing to comply by the deadline.

The new law also has strict aggregation requirements. Members of the supply chain must report all changes within individual batches. Every change made must be reported to the government. Reports must detail how much of the batch is together and the location of removed or displaced units.

rfxcel & Russian Serialization

rfxcel is helping pharmaceutical companies prepare for these quickly approaching deadlines. All supply chain participants must report tracing information to Russia’s centralized Federal State Information System for Monitoring Drug Circulation. rfxcel is helping to streamline this process.

As of August 2019, rfxcel has doubled the size of its workforce in Russia. Our Compliance Management (rCM) and Serialization Processing (RSP) modules are built to help our clients achieve and stay compliant in Russia.

Our local teams in Russia are working around the clock to help with implementation. Our Traceability System (rTS) is already being used in Russia to ease the compliance process for local companies. For assistance reaching compliance by the 2020 deadline, reach out to rfxcel today!

Visibility in a Digital Food Supply Chain Can Reduce Food Waste

Food waste is a huge problem in the food supply chain. A quick look at the statistics shows that good food is being wasted from one end of the supply chain to the other: on farms, during distribution, at stores, and in peoples’ homes.

The National Resource Defense Council reports that up to 40 percent of the food in the United States is never eaten. The financial statistics aren’t any better: According to ReFED, a nonprofit working to reduce U.S. food waste, American consumers, businesses, and farms spend $218 billion — 1.3% of the country’s gross domestic product — growing, processing, and disposing of food that’s never eaten. ReFED also says that, every year, 52 million tons of food goes into to landfills and 10 million tons is discarded or left unharvested on farms. Furthermore, the U.S. Department of Agriculture estimates that supermarkets lose $15 billion annually in unsold fruits and vegetables alone.

rfxcel is committed to helping reduce food waste — and increasing the food and beverage industry’s productivity and financial health — by improving supply chain visibility and enabling companies to harness the power of unit-level data in a digital supply chain. Let’s find out how we do this.

Making every product a “digital asset” in a digital supply chain

rfxcel is thinking about food waste differently. We believe that granular data about products at different hierarchies will reduce waste from the very beginning of the food supply chain. Our food and beverage solutions, including our MobileTraceability app and rfxcel Integrated Monitoring (rIM), create a digital supply chain that allows companies to turn every food product into a “digital asset.” Tracking these assets at different times (e.g., harvest, packaging, distribution) and levels (e.g., pallet, case, unit) reveals exactly what’s happening to it from the farm all the way to the checkout line. This creates opportunities to pinpoint where food waste may be occurring and to take action to stop it cold.

Using rfxcel technology at every node of your supply chain, companies can “load” their products with rich data. For example, you can add information about critical tracking events and specific product attributes. This creates an all-important product pedigree that can aid in stopping food waste by reducing spoilage, monitoring shelf life, and making sure the value of every food product is optimized.

Supply Chain Visibility Means Less Food Waste

The important result of a digital supply chain with digital assets is supply chain visibility. And frankly, the food and beverage industry needs to improve supply chain visibility. If you can see deeply into every aspect of your supply chain, you’ll have the “intel” to fight food waste. With the full unit-level life cycle of a product at your fingertips, you can connect with whenever you want, including to see if it has sold, when it expires and “best by” dates — even if you can connect it to post-consumer and secondary markets.

And there’s an added benefit for food and beverage companies: With digital assets in a fully digitized food supply chain, you can wring every last bit of value out of every product. First, rfxcel validates all your data so you know it’s accurate, timely, and compliant. From there, the opportunities are virtually limitless. Use your data for data analytics. Use it to communicate with consumers. Use it to boost your bottom line and secure your brand.

rfxcel wants you to see deeply into every aspect of your operations — and we have the technology to do it. Our solutions offer much more than the mere Who, What, When, Where, Why, and How about products. Contact us today to learn more about decreasing food waste and increasing value through visibility in a digital food supply chain.

Everything You Need to Know About the Russian Serialization Requirements

THIS WEBINAR ENDED. YOU CAN ACCESS THE RECORDING BELOW.

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This webinar will cover the full scope of the serialization requirements in Russia, including all mandatory labeling requirements for 2019 and 2020.

In recent years, the serialization landscape has undergone drastic changes, with a number of new regulations coming into force. This has drastically impacted operations for many pharmaceutical companies.

There are still new changes on the horizon, with one of the most complex regulations quickly approaching from Russia.

By 2020, all pharmaceutical companies distributing in Russia must have complete unit and batch level traceability.

Considering the length of time needed to implement changes, if companies want to be compliant in time for the deadline and continue their current distribution strategy they must prepare now.

Over the course of this webinar, Mark Davison, Vice President of International Business at rfxcel will share:

  • Insight into the full scope of the serialization requirements in Russia
  • The mandatory labeling requirements to meet in 2019 and 2020
  • What you need to do now in order to be compliant by the deadline

You will walk away with answers to key questions, such as:

  • How should I prioritize efforts for each drug line to ensure compliance?
  • How should you navigate the new reporting system?
  • How can you best manage the complexities of this serialization project?

To limit the impact on your distribution strategy when this regulation comes into force, use this webinar to kick-start your preparations and understand how these changes will affect you.

About Mark Davison:

Mark Davison is the Vice President of International Business for rfxcel. He is a leading traceability and digital health expert, specializing in the Internet of Things (IoT), traceability, and blockchain solutions. The author of “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”, Mark specializes in global health and big data issues that affect key industries such as pharmaceuticals, food/beverage, and fast-moving consumer goods (FMCG). His expertise lies heavily in serialization, supply chain security, patient safety, and government policy. He resides in the United Kingdom.

 

Please fill out the form below to get access to the webinar recording.

Russian serialization requirements

Brazil Pharma Update: SNCM Changes, ANVISA, and Supply Chain News

Our team in Brazil has been busy. Very busy. Led by Vinicius “Vinnie” Bagnarolli, rfxcel’s Director of Commercial Operations in Latin America, they’ve been speaking at conferences, following developments at the Brazilian Health Regulatory Agency (ANVISA), tracking implementation of Brazil’s National Medicine Control System (SNCM), and advising pharma supply chain stakeholders.

Let’s take a look at the latest from Brazil.

October 23-24: Pharma Logistics & Cold Chain 2019 Conference, São Paulo

Vinnie was a featured speaker on Day 1, talking about the importance of following supply chain best practices to prepare for the SNCM. He also reviewed the processes, technologies, and machinery that will help companies be ready for the future, including our signature rfxcel Traceability Solution (rTS) platform, our rfxcel Integrated Monitoring (rIM), which can track more than a dozen environmental factors in real time, Supply Chain 4.0, and blockchain.

Another hot topic was Resolution 304 (RDC 304). Released September 19 and set to take effect in March 2020, it provides for good practices in distribution, storage, and transport of medicines. It’s guided by Article 7 of the SNCM, which states that the acquisition of medicines from distributing companies other than the registration holders is permitted only if the cargo is traceable through the SNCM.

We also attended an SNCM roundtable with ANVISA, GAESI, and SINDUSFARMA. GAESI does R&D in automation technologies for ports, airports, logistics, and cargo track and trace; SINDUSFARMA is a syndicate of pharma products in the State of São Paulo. GAESI’s Vidal Melo shared his observations about the one-year SNCM pilot  phase and stressed that the environment for connecting and sending data already exists in Brazil. Members of SINDUSFARMA made multiple requests to extend the final SNCM deadline, but ANVISA reps said they make no changes to the 36-month timeline (April 29, 2019–April 29, 2022).

November 7: Engineering and Technology Seminar for the Traceability of Strategic Medicinal Products and Supplies (SETRM 2019), São Paulo

GAESI organized and hosted this conference to explore changes in drug supply chain traceability scenarios and promote interaction and communication among government agencies, academia, and pharma companies. People also discussed opportunities to boost Industry 4.0 in the pharma sector using solutions stakeholders have adopted to meet SNCM requirements.

The conference gave Vinnie and our team an excellent opportunity to hear feedback from two companies that participated in the SNCM pilot, Janssen and Boehringer Ingelheim. Both said that SNCM was here to stay and that the industry had to be ready for the April 2022 deadline regardless of how complex the undertaking might be — something we’ve been saying all along. Representatives from ANVISA also attended, but they did not have any revelations for the attendees. They confirmed that the pilot phase was over and that the pharma industry shouldn’t expect any major changes to the legislation, especially concerning deadlines.

But …

November 12: A Major Change to SNCM?

Public Consultation No. 747 was released five days after the SETRM conference. It established the “minimum limits of manufactured drugs packaging and related deadlines for the beginning of transmission of the movement of data to the SNCM.” In a major change to the implementation timeline, it stipulates that every pharma stakeholder should be able to serialize 25 percent of its products by October 2020. This is a full 18 months earlier than the original deadline. (Other deadlines didn’t change: 50 percent by April 2021, 75 percent by September 2021, and 100 percent serialization and reporting by April 2022.)

We’re not sure what the ramifications will be — a 45-day public review is currently underway — but Vinnie and the whole Latin America team is monitoring the situation. They’re also sticking with the advice they’ve been giving since the SNCM was announced: Start preparing now!

Final thoughts

One more noteworthy thing happened in November: The SNCM won an Abril & Dasa Medical Innovation Award. Curated by Saúde Magazine in Brazil, it recognizes projects and medical professionals that make a difference in the scientific, clinical, and healthcare areas. Winners are chosen by popular vote among a scientific jury.

This laudable recognition comes 30 months before the SNCM goes into full effect. This may seem like a long time, but companies have to act now to be ready to comply. The changes are complex, but implementing best practices now will ensure you’re ready for the future and will also bring immediate value to your bottom line.

As Vinnie puts it, “rfxcel is ready to provide guidance on how to best approach the changes that are coming. The unique software capabilities we’ve developed over the past 15 years have helped companies around the world meet stringent compliance requirements, safeguard their supply chains, and expand their markets. I want to talk with you about best practices, how to prepare for SNCM, and the future of our pharma supply chain.”

If you have questions or concerns about the SNCM or any other aspects of the pharma supply chain in Latin America, you can email Vinnie directly at vbagnarolli@rfxcel.com or contact us to set up an appointment. Also, check back for details about a webinar about these and other issues that Vinnie will host in December!

 

What’s Happening with the DSCSA? Year-End Reflections with Herb Wong, rfxcel’s VP of Marketing & Strategic Initiatives

We sat down with Herb Wong, our VP of marketing and strategic initiatives, to get the skinny on what’s going on with the Drug Supply Chain Security Act (DSCSA). Herb has been leading rfxcel’s Verification Router Service (VRS) pilot with the U.S. Food and Drug Administration (FDA), and has been involved with VRS testing and ensuring readiness for the November 27 DSCSA deadline. Here’s what he had to say.

The FDA announced on September 23 that it did “not intend to take action against wholesale distributors” that do not meet the DSCSA salable returns verification requirement before November 27, 2020. How does this affect rfxcel and the industry?

The FDA said the reason for the delay was to allow more time for production levels of testing. The VRS network is the lynchpin to enabling saleable returns. Based on our FDA pilot effort to test the readiness of the VRS network, we think this was a prudent step. Although individual VRS providers have tested their systems and have performed testing with each other, more testing is needed. Despite the enforcement delay, rfxcel and other VRS providers remain committed to meeting the original November deadline; however, the additional time will allow us to further verify the VRS network in a production environment. This will surface new issues not seen in a non-production testing environment.

I’ll just add that rfxcel is the pharma industry’s thought leader on VRS and the longest-tenured track and trace provider in the life sciences. Of course, we immediately addressed the FDA’s announcement on our blog.

What types of issues have you observed during the FDA pilot testing?

In October, we published a draft copy of our interim findings at the Healthcare Distribution Alliance’s (HDA’s) Traceability Seminar in Washington, D.C., and provided our final interim report to the FDA shortly afterwards. You can get a copy of the full interim report here, but here two findings that stood out for me:

First, connections: Approximately 40–50 percent of VRS test targets could not be tested during the pilot period due to connection issues. This was much higher than anticipated and was largely due to different providers moving to Quality Assurance (QA) environments for final testing. Resolution of these connection issues will not happen quickly. If this occurs when we are in a full production mode, then this can disrupt the network.

Second, for VRS providers that could be tested, all passed the positive test case of a valid Product Identifier. When we started testing various negative test conditions, we started to see variations. The most notable was how some providers responded to an invalid lot date. All providers detected this, but not everyone could reply with an error that identified that a failure was due to an incorrect date. This will be problematic for distributors because it will make it harder for them to troubleshoot failed verifications.

You mentioned that you were at the HDA Traceability Seminar (October 21–23). How did attendees respond to the DSCSA timelines?

At this point, most pharmaceutical supply chain participants have selected solution providers to help meet DSCSA requirements. Attendees were focused on gathering any new information from the FDA and understanding the readiness of solution providers to meet the next stage of the DSCSA, as saleable returns require a level of interoperability that is new to the network. After the Traceability Seminar, the HDA was asked “to reconvene the VRS Task Force for discussing the industry scale-up over the period of enforcement discretion.” rfxcel will be working further with the HDA and others to ensure that we put the extra time provided by the FDA to good use.

How are solution providers responding to the DSCSA timelines?

I already mentioned that all solution providers have committed to meeting the original November deadline. However, going beyond that simple statement, I have observed a renewed commitment by providers to ensure that we work collectively to ensure what we can meet the increased interoperability requirements required for VRS (i.e., saleable returns).

To give two examples, SAP reviewed our FDA pilot test cases and provided feedback that greatly improved the clarity of the testing. They have also provided test data that allows rfxcel to test readiness of their network. Furthermore, Chronicled/MediLedger provides a blockchain implementation of VRS that gives an additional nuance to our testing approach. I was invited to their headquarters, where we sat down and shared our testing approaches and agreed to work together to ensure proper coverage. These are just two examples, but we have received positive responses from many other providers.

You mentioned blockchain, which we all know is an industry buzzword. Did you observe any issues or opportunities with interoperability?

rfxcel has been investing in blockchain technologies and interoperability, so it was not an issue with blockchain providers. We expect seamless connectivity to continue, and we are in active discussions with blockchain providers to deepen our commitment to the technology.

To learn more about rfxcel’s FDA VRS pilot or our other leading-edge supply chain track and trace solutions, contact Herb directly at hwong@rfxcel.com and visit our website.

PMA Fresh Summit Convention + Expo Roundup

rfxcel’s Food and Beverage team attended the PMA Fresh Summit last month in Anaheim, California. From October 17-19, we talked about the latest in food production, distribution, and marketing, and how companies that harness supply chain data will win the future. Here’s a rundown of the key takeaways!

1. New product innovation aimed at specific segments

Focusing on consumer interests and personalizing experiences continue to gain traction with food and beverage companies. For example, the ketogenic — or “keto” — diet has piqued the industry’s interest. It limits foods that are high in carbohydrates, such as sugar, bread, and pasta, in favor of foods with higher fat and protein content, such as meat, fish, cheese, eggs, and nuts. Leafy greens (e.g., spinach, kale, chard, collards) are also okay on keto.

2. Cauliflower and nuts make a (gluten-free) splash

The industry is taking notice of gluten — or, more precisely, a lack thereof. Producers are taking a commodity, cauliflower chief among them, and making it a value-add raw material to cater to brands making gluten-free products. Consumers want alternatives to traditional wheat- and flour-based products such as bread, pasta, rice, and snacks. Foods with rye and barley are also no-no’s in a gluten-free diet. We’re talking whole grains (e.g., quinoa, brown rice, oats), fresh fruits and veggies, red meat, poultry, seafood, plant-based proteins (e.g., legumes, nuts, seeds), and traditional soy foods such as tofu and edamame. Cauliflower rice has been grabbing headlines lately, and nut crusts have also become very popular.

3. Functional ingredients are trending

A functional ingredient is a bioactive compound typically recovered through separation, purification, or concentration techniques. Medium-chain triglyceride (MCT) oil is a popular example. It’s made from coconut or palm kernel oil, is easy to digest, and the body readily turns it into usable energy. Today, it’s added to smoothies, bulletproof coffee, and salad dressings. Look for functional ingredients to continue to gain steam as consumers see them as nutritional must-haves.

4. Using supply chain data to make business better

rfxcel is all about the data, so we were very excited to exhibit our latest track and trace innovations, which work together to yield real-time validated data at the unit, case, pallet, and lot levels.

We ran a live demo of our Integrated Monitoring (rIM) solution, which works with any sensor and gives users an array of super-rich data, from cut-to-cool time to in-transit conditions on land, sea, and air. We brought our improved MobileTraceability app along to show how it captures and reports on data when and where it happens and builds trust by empowering consumers to validate a product’s provenance. And, of course, we showcased our signature Traceability System (rTS), which has been empowering supply chain excellence since 2003.

Visitors to our booth saw how our solutions harness mobile technology and the Internet of Things (IoT) for the most complete view of production and distribution. Growers can collect and report accurate data from the field. All trading partners have access to high-quality, real-time data — including data from sensors — that they can use to improve operations and customer experiences. It’s too much to get into here, but check out our short video to see some of what we can do!

Conclusion

As consumers demand more diet-specific products and diverse raw materials and functional ingredients continue to enter the supply chain, you need to proactively manage risk and traceability/visibility. If you’re looking for supply chain solutions that yield the data you need and can adapt to industry trends, look no further than rfxcel. It doesn’t matter which consumers you need to reach or how you need to configure and track your supply chain. From keto devotees and gluten-free consumers to people who just want to know where their produce was grown, we’ve got you covered. Contact us today to book an appointment.