Category: blog

The Food Safety Modernization Act wants companies to proactively mitigate risk. Unit-level traceability is the logical next step

Leafy green producers had a terrible 2018.

According to the Centers for Disease Control and Prevention (CDC), E. coli outbreaks linked to romaine lettuce infected 272 people in 39 states and the District of Columbia; of these, 121 were hospitalized and 5 died.¹ Outbreaks linked to romaine from the same growing area also occurred in Canada. There was one recall, and both countries issued an advisory for all romaine.

Apart from the human toll, the cost of recalls can be staggering. A 2012 study by the Grocery Manufacturers Association (GMA) and the Food Marketing Institute concluded that the average direct cost of a recall in the United States was $10 million. In a separate study, GMA reported that 18 percent of surveyed multinational corporations had spent $30-$90 million on a single recall, and 5 percent had been involved in recalls with price tags topping $100 million.

Factor in indirect costs such as legal fees and damage to brand reputations and product categories — even entire industries — and it’s easy to see that recalls are a major problem.

During the romaine outbreak, Dr. Bob Whitaker, chief scientific officer at the Produce Marketing Association, advised the leafy greens industry to “ready traceback data.” This was an admission that the food industry had a long way to go to meet the demands of the modern supply chain, where accurate, granular, real-time product data is essential for mitigating emergencies and remaining competitive.

End-to-end, serialized, unit-level traceability is now the standard in the life sciences industry, where, like the food industry, a product’s purity and authenticity can be a matter of life and death. Similarly, serialization has the potential to increase the speed and accuracy of food safety investigations while reducing the scope and cost of recalls and product withdrawals.

Today, we can imagine a world where each bag of lettuce mixes or clamshell of berries has a unique identifier that can be tracked and traced from the exact picker and harvest plot through packing, casing, and palletizing, then on through distribution and retail — all the way to the consumer.

We can also envision empowering consumers to know everything about the pedigree of the exact item in their hand. What if they could scan your item at the store to ensure that it isn’t involved in a recall? What if you could message them after they took it home? What if you could tell them the item they’re holding had been scanned for foreign objects or tested for contamination that same day?

At last year’s Food Safety Consortium in Chicago, representatives from the CDC and U.S. Food and Drug Administration, presented on 2018’s first romaine outbreak, which began in April and appeared to be over by late June. As reported by Food Safety Tech, they identified several challenges, including:

• The production lot information disappears at the point of service.
• Having a commingled product hinders traceback.
• It takes time for authorities to review companies’ records.
• Packaging isn’t transparent about where the product was grown.

Let’s walk through a scenario in which people report getting sick after eating romaine lettuce from packs they purchased at a retail store. With serialization, the chain of events could look like this:

• Consumers who feel sick can report the package’s serial number by phone or perhaps through a link, sent by the retailer, that reads a 2D barcode and transmits the package’s unique number.
• All products from that harvest plot are immediately flagged, as the traceback goes all the way to the pickers/plots, then forward again to the actual items on the shelf — not just to a distribution center.
• With rich data from serialization, we know which items from the case are on the shelf and which are still in the case.
• As more data becomes available, authorities can pinpoint the issue, and only affected items are pulled from the shelf.

The benefits of serialization are great and costs are coming down. Consumers are interacting more with brands and expecting more data about products. Recognizing these realities — and in the ever-present context of the Food Safety Modernization Act — food companies should be looking to serialization and unit-level traceability to provide the data to safeguard their operations and thrive in the marketplace, today and in the future.

¹See CDC information from June 28, 2018, and January 9, 2019.

Serialization has transformed pharma. Food and beverage is next.

The pharmaceutical industry, spurred by global regulatory demands, has begun to transform itself by adopting unit-level traceability through serialization.

It has also responded to the ever-present threats of fraud, adulteration, and counterfeiting by working to make the supply chain a tightly controlled, transparent system. And, importantly, companies have begun to use the richer, timelier data that serialization creates to gain competitive advantages and increase market share.

The food industry is at a different type of crossroads, but it may lead to the same place. Innovative leaders are beginning to see serialization as a key tool to mitigate risk and drive growth; they are realizing that it empowers real-time track and trace and authentication, targeted product recalls, personalized marketing, and other critical operations.

But what is serialization, exactly? Simply put, it’s the process of creating a unique identifier or code for every item you sell, a package-level ID that can add up to four orders of magnitude (lot/batch, pallet, case, item) to your supply chain visibility in a single step. With serialization, each production batch is transformed from a jumble undifferentiated packs to individual, traceable units that have quality metrics and event attributes associated with their data. This data, from harvest information to each item’s unique journey to the consumer, is transparent and specific, not opaque and broad, which amplifies its power for decision-making, quality assurance, and a host of other uses.

The automotive industry, an early adopter of serialization, provides a nice analogy. Think of your car’s vehicle identification number (VIN). It is unique and trackable. When you buy a used car, you don’t use the VIN to learn about Ford Explorers generally; you use it to find out about the exact car you’re looking at — its history, its real-time condition, and so on.

This is the power of serialization. Knowing the unique story of the very item you’re holding in your hand. The idea that this clamshell of strawberries or container of tomatoes or can of soda may have a different story than the one next to it, even if they look identical.

In a lot-based system, the lot code provides only limited data. All the pallets, cases, and units share the same basic information, even if there are crucial differences among the individual items, such as the provenance of ingredients or harvest dates.

Product tracking can begin to fall apart as soon as shipments arrive at a distribution center. Pallets can be re-routed and cases can be disassembled and re-packed before units are shipped to fulfill orders.

With serialization, each input or movement can be recorded. When individual units are serialized, so are the case and pallet. Scanning the case or pallet provides data for all units inside and allows proper tracking as that case is assembled and disassembled. That’s how end-to-end traceability happens.

By tracking this “parent-child” relationship between pallet and case, and case and unit, it suddenly becomes possible to deal with challenging logistics, such as just-in-time inventory and targeted recalls.

The marketplace is inundated with providers who want to sell you vendor management software disguised as a traceability solution. Don’t be fooled. To deliver on current, emerging, and future demands, you must have granular, actionable data that you can access in real time. This kind of data is much more powerful than what most companies rely on today to protect their business.

Alas, despite the incredible — and demonstrable — value of serialization, many believe cost is a barrier to adoption. The truth, however, is that stringent pharma regulations in the United States, EU, and elsewhere are driving innovation, making serialization technology more affordable and reliable.

Furthermore, many forward-thinking food companies already have many of the pieces in place to take the next step. These include line systems, enterprise resource planning (ERP) software, and warehouse management systems (WMS), which make operations more accurate and efficient, and are the foundation upon which truly transformative change can be built.

Serialization is the essential step toward a modern supply chain. It can help ensure you are protected now and prepared for future challenges, from changes in regulation to an unexpected recall. Instead of playing catch-up tomorrow, the wise company will consider serialization today.

The Healthcare Distribution Alliance (HDA) assembled various pharmaceutical supply chain industry leaders at its Traceability Seminar, last month in Washington, D.C.

The 2018 seminar focused on the upcoming Drug Supply Chain Security Act (DSCSA) implementation milestones as well as innovative approaches and lessons learned as distributors, manufacturers and dispensers implement serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain.

The seminar educated the attendees with what to expect in the future as the industry approaches the final deadline and shared the available resources, tools and guidance on a range of traceability topics.

“For more than 15 years — from the advocacy stage through today — HDA has been a trusted partner for pharmaceutical traceability education,” said HDA Executive Vice President of Industry Relations, Membership and Education, Perry Fri. “Through our expertise, HDA is continuing to provide the pharmaceutical supply chain with opportunities, like the Traceability Seminar, to meet with a diverse group of professionals and DSCSA experts to share ideas, discuss important topics, seek out guidance and work toward common implementation goals.”

Real-time visibility in the supply chain is a strategic area of innovation at rfxcel. Within the seminar, rfxcel highlighted exactly how to overcome challenges and succeed when assessing, selecting, and installing an “extreme visibility” platform over the next few months.

“Our goal is to use this platform to have up-to-the-minute information on global events that could impact our supply chain, and provide this information to groups across the corporation.”

Key Deadlines

Adopting a phased approach, there are two key deadlines for different stakeholders: November 26^th 2018 is the widely acknowledged deadline for pharmaceutical manufacturers and repackagers. On November 27^th 2019, the DSCSA VRS deadline is enacted.  The wholesale industries must be compliant and only accept products that contain a serial number or product identifier, and they must verify this product identifier before they can go on to resell these goods. They must also be able to complete a validatable returns process.

To complete this process in specific regard to returned products that are saleable, the Verification Router Service (VRS) initiative was highlighted by the Healthcare Distribution Alliance (HDA) in its efforts to lead the industry in implementing the act.

Today, various solution providers, including rfxcel are in the process of providing a VRS.

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ABOUT RFXCEL

rfxcel is a supply chain track, and trace company within the Life Sciences industry, helping companies meet regulatory compliance requirements, protect the product and ascertain brand reputation. Thought leadership and experience since 2003, expansions to locations in the US, EU, India, Brazil, and Japan, and a leading stand-alone traceability solution, the company, enables people, businesses, and industries to protect end consumers and their products. This unique integrated software delivers better business outcomes and lowers overall costs.

ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

Serialization is much more than a rule to be obeyed – it’s a huge opportunity

Global pharma is teetering on the brink of a new world in which ground-breaking regulations impose strict serialization, traceability and verification obligations on the medicine supply chain. With deadlines for the adoption of DSCSA and FMD imminent it’s no surprise that companies are ramping up their efforts to assure regulatory compliance. Many businesses are adopting compliance-first (or indeed compliance-only) approaches that concentrate solely on ensuring they do the bare minimum to meet regulatory requirements. They’re ticking a box. The most proactive companies, however, have taken a different approach: they’re not ticking the box, they’re thinking outside of it – by focusing on quality and long-term value. It’s the right way to go. Here’s why.

Serialization is much more than a rule to be obeyed – it’s a huge opportunity for industry. But the possibilities will only emerge through a focus on quality right from the outset.

Key constituents of quality

Key to an effective serialization strategy is good technology, therefore the right partner and the best software is critical to success. However, the design, configuration and implementation of a system will ultimately be the difference between an approach that’s content with compliance and one that’s striving for added-value far beyond it.

The key phases of the adoption life-cycle typically include:

1. Defining requirements

This requires robust insight into regulatory requirements, the holistic needs of the market and, later in the development curve, the specific business needs of individual organizations. Clearly defined requirements outline the scope of the opportunity and provide the baseline for your approach. Getting them right is imperative.

2. Designing a solution

The development of core software requires continuous collaboration with a broad set of stakeholders to ensure the solution marries regulatory needs with recognizable industry processes and unique business characteristics. It also requires a full appreciation of the nuances of the medicine supply chain. It’s an iterative process.

3. Characterizing processes

Process characterization is an essential component of a quality-first approach. Stakeholders must have a deep understanding of the solution, how it operates and the areas where it may break. Only by understanding how individual components interact with each-other is it possible to build an optimal system where everyone has confidence in the data.

4. Validating processes

Hand-in-hand with characterization, achieving data quality requires robust validation of the processes established in the characterization phase. The best systems adopt ISPE’s GAMP 5 guidance for validation as a minimum.

5. Monitoring

Quality-led systems build in automated, ‘always on’ monitoring so that organizations can detect and respond to problems or anomalies quickly and effectively.

Success is ultimately contingent upon having an effective change control system that allows companies to modify and maintain the quality of both the processes and the data within the system. Fundamentally, serialization depends on having accurate, secure and accessible data – as well as appropriate processes that can reliably and transparently accommodate change.

The long-term advantages of serialization extend far beyond satisfying regulations. Serialization naturally introduces traceability to the medicine supply chain, but could also be used to provide added value for pharma, providers and, crucially, patients. From a patient safety perspective, in addition to providing reassurance around the authenticity of medicines, it can help also accelerate and improve the granularity of product recalls – benefitting wholesalers, pharmacists and patients.

This powerful data can inform marketing strategy, improve patient support and stimulate patient-centred innovation.

A quality ambition

Ultimately, the success of your serialization efforts all comes down to ambition. The long-term, quality-first approach is underscored by a profound logic: compliance is a natural by-product of quality-driven objectives, but the reverse is seldom true. If the limit of your ambition is compliance, you may never achieve a quality solution. But if you’re unwavering focus is on quality… you’ll always be compliant. That’s why, when it comes to serialization, it makes sense not to just tick the box, but to think outside of it. Aim for quality – and you’ll be a serial winner.

ABOUT RFXCEL

rfxcel is a supply chain track, and trace company within the Life Sciences industry, helping companies meet regulatory compliance requirements, protect the product and ascertain brand reputation. Thought leadership and experience since 2003, expansions to locations in the US, EU, India, Brazil, and Japan, and a leading stand-alone traceability solution, the company, enables people, businesses, and industries to protect end consumers and their products. This unique integrated software delivers better business outcomes and lowers overall costs.

Over the last several years we’ve learned a thing or two about what separates a good or average system implementation effort from a successful solution implementation. Those that are great have a few things in common. Not surprisingly they all have great leadership, excellent communication and follow a plan.

In this blog, we’ll address some of the most critical steps to a successful solution implementation, and what we think is the recipe for success.

Selection is Everything

It’s very common for biotech and pharmaceutical companies to rely on solution providers for their serialization and compliance needs. Identifying and selecting the right solution provider is a lengthy and challenging process. The correct solution provider can mean successful long-term outcomes like supply chain optimization and cost savings, but choose the wrong solution provider, and your manufacturing lines could experience production and fulfillment issues or worse yet; they could come to a screeching halt.

Identify a Project Sponsor

While selecting right vendor is essential, it is just as important to identify the right internal project sponsor to work with the solution implementation team to communicate issues, risks, and status to their organization and work hand-in-hand with the vendor to resolve issues. The project sponsor is typically someone from within the business unit implementing the software, and they have overall internal responsibility and accountability for the success of the project. Finally, they ensure the solution provider delivers on the requirements identified in the Statement of Work or contract.

Create a Project Plan

It seems like a no-brainer, but often in haste to get started; project planning takes a back seat. A good solution provider will put together a project plan with activities and dates. The project sponsor should review the project plan with his /her internal team and make sure there are no issues. If there are dependencies, the project plan should reflect those dependencies.

Identify who will be responsible for updating the project plan and how often it will be updated and stick to it. Driving the schedule and activities helps to ensure implementation occurs on time – if the project plan deviates from the schedule – you’ll be able to communicate why and know the impact quickly.

Trading Partner Identification and Connection Requests

Identifying and alerting all trading partners before implementation not only helps the solution provider make quick work of onboarding trading partners, but also puts trading partners on alert for requests. Trading partners are busy too, and they work best when they know a request to connect is coming. Additionally, early identification of trading partners and their preferred method of connection identifies those with compatible systems and connections and those that do not. Knowing this will allow the implementation team to come up with strategies to address difficult connections and keep the project sponsor apprised of potential risks and issues.

Communicate the Status of Risks and Issues

One of the primary reasons system implementation projects fail is from lack of communication. Before implementation, it is wise to sit down with the project sponsor and solution provider’s leadership team to identify potential risks and issues.  For each risk assess the level of impact and outline a mitigation strategy. However, if a risk should ever become an issue, quickly elevate it to the project sponsor and leadership team. By the time a risk becomes an issue, it’s often too late to mitigate with little to no impact, so it’s best to have a plan to reduce risks to upfront and actively mitigate issues if they should occur.

Conduct Lessons Learned

It may sound cliché, but there is so much to be gained for both the customer and the solution provider by conducting a post-mortem or lessons learned. Even if implementation is a success, it is vital to document what went well. If the project was challenging, this step allows both parties to discuss what went wrong. If there are open issues, it will provide the vendor the opportunity to resolve it for the customer. A good solution provider will always work hard to resolve any issue and make sure things are right and fixed before handoff.

Summary

While there are more steps to any serialization implementation effort, at a minimum follow these, with them you’ll avoid common pitfalls, without them, you’ll experience unnecessary delays and certain difficulties.

Contact us today to learn more about our approach to successful solution implementation, serialization and our track and trace solutions.

Russian Federal Law No. 425-FZ, the law requiring serialization in Russia, gives pharmaceutical companies until January 1, 2020 to be fully compliant. This means pharmaceutical companies have less than a year and a half to comply with the most complex serialization requirements to date – without the Russia Serialization requirements fully established and written. 

What We Do Know: 

While it is unknown how the requirements for serialization in Russia may change over the next year, pharma companies who wish to sell their products in Russian markets cannot rely on there being another delay for the deadline. To ensure they can sell in Russia, companies must start to prepare for Russia serialization now. 

The requirements that have been put forth by the Russian government are some of the most complex serialization requirements yet. Currently, companies who wish to sell their products in Russia after January 1, 2020, need to make sure their products are traceable at a unit and a batch level from the creation and packaging of the product to the dispensing of the product. Beyond unit-level traceability, Russia has many requirements surrounding the aggregation of a product. Russia will require special reporting and documentation surrounding the disaggregation and aggregation of units and batches. 

While many serialization requirements for other regions – such as the EU FMD or the USA DSCSA – require only prescription medication to be serialized and traceable, Russia’s regulation requires all medication to be serialized and traceable, including over-the-counter medications. This is a major departure from the global status quo, and a departure that producers of over-the-counter medications are not prepared for. 

What Pharma Companies Need to Do: 

Companies that have not  started preparing for Russia serialization need to start immediately. The uncertainty surrounding the final regulations means that pharma companies need to be prepared for anything – their serialization solution needs to be agile and flexible.  

Due to the comprehensiveness and complexity of the serialization requirements, companies need to be able to produce the type of data Russia will require, as well as be able to produce serialization data for all of their products, including over-the-counter products. Companies that have not yet started converting their production lines need to do so immediately if they wish to sell in Russia. 

Contact us below to learn more about Russian serialization requirements and how rfxcel can help you meet them in time.

The food industry is undergoing massive changes. Consumer behaviors are changing the way food companies’ source and manufacture foods. A growing amount of food dollars are looking to brands that can make – and validate – claims of local, organic, sustainable and a host of other value-added food attributes. In this environment, companies operating in the food and beverage industry need to have deep insight into their supply chains to compete. Companies that don’t know what’s happening to their products in the global marketplace are at risk, and their supply chains aren’t the assets they should be.  

Digital, end-to-end serialized traceability originally developed and deployed across the global pharmaceutical industry to fight fraud and counterfeiting, provides an essential tool in winning the food game in the new food economy. End-to-end serialization helps to ensure that companies are protected today, and ready to adapt to the challenges of tomorrow. 

Serialization is the process of creating a unique identifier or code for every item sold. Some estimate that serialization can add four orders of magnitude to supply chain visibility in a single step. How? Well, once products are serialized a batch is no longer just thousands of undifferentiated packs, but single, traceable items that have quality metrics associated with their data. Data about the product starting with harvest through its journey to consumer can be tracked at every stage of the supply chain.  

Serious leaders in the food and beverage industry understand that item-level traceability is the future and are beginning to take advantage of what it has to offer. Importantly, the costs for implementing serialization solutions are coming down at the same time the benefits are becoming indispensable. 

FIGHT FRAUD AND COUNTERFEITS 

Food companies rely on brand promises to drive consumer loyalty, but Food Fraud – including mislabeling and brand counterfeiting – costs businesses $30-$40 billion a year globally. Counterfeiting in high-value products like specialty foods and spirits costs brand value. By labeling products with a unique code, consumers can validate the authenticity of products. Serialization helps to ensure that returned products are authentic, allowing for retailers or distributors to put items back on the shelf with confidence.  

REDUCE IMPACTS OF CONTAMINATION OR ADULTERATION 

No matter the rigor of food safety protocols, product recalls due to contamination or adulteration are still possible. However, by serializing each product, the size and scope of any recall can be reduced. Each item has a unique identifier that is put into a case which has its own unique identifier. When these cases are loaded onto a pallet, the pallet receives another unique number. By creating and following these parent-child relationships through aggregation and then de-aggregation and distribution, targeted, surgical recalls become possible, ensuring that only impacted product is pulled, while allowing for a safe product to stay on the shelf. 

GENERATE SAVINGS FROM THE SUPPLY CHAIN  

Getting accurate, real-time data about a product’s disposition is the driver behind the informed decision making that will allow tomorrow’s winners to leverage item-level traceability for competitive advantages. 

That visibility enables a better understanding of the product flow to improve logistics and transportation efficiency, including reverse logistics, and quicker and better decisions for demand forecasting and production planning.  

Being able to see exactly where products are and how long they have been there can reduce losses due to shrink, out-of-stocks and other ills of inaccurate/incomplete inventory. Companies can identify exact locations of bottlenecks in production or key QC points of failure.  Any issues from customers or even consumers can be traced back to the individual item. Just-in-time inventory can become a reality. 

CREATE OPPORTUNITIES TO NUTURE BRAND LOYALTY 

As end-to-end digital traceability becomes the expectation of consumers, serialization will open the door to unlocking the potential of innovative food brands eager to connect with their customers in new and powerful ways.   

By leveraging the unique code on each pack, marketers can use specified incentives and targeted digital messaging to connect with consumers. Companies can talk to consumers to communicate specific messages about ingredients, provenance, harvest date and other relevant information that can help build trust, including handling/testing data for the very item in hand. Couponing, incentives and other brand messages can build brand loyalty and provide targeted incentives to keep consumers coming back – the key to brand development.  

Serialization has become the primary requirement in the pharmaceutical industry, and well-known companies leverage the benefits of item-level track and trace. The leaders in the food industry can realize many of these same benefits. As we’ve seen in other markets, it’s only a matter of time before the benefits of serialization become indispensable.  

The Falsified Medicines Directive (FMD) imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. By February 2019, Marketing Authorisation Holders (MAHs) will need to start uploading serialisation codes for almost all their prescription medicines to the European Medicines Verification Organisation (EMVO) hub for authentication with pharmacists at the point of sale. Those that can’t will simply be unable to sell their products in Europe.

More than thirty countries in the European Economic Area will have new rules for coding and verifying prescription medicines. Despite the significance of the regulation, there are some pharmaceutical manufacturers – and many pharmaceutical dispensers, including community and hospital pharmacies – who have yet to put a strategy in place to assure compliance.

The introduction of serialisation, designed to ensure the authenticity and traceability of individual medicines, promises to improve patient safety and create exciting opportunities for digital health. However, failure to comply with the EU regulation that mandates it means you cannot legally ship your product. No code, no trade. And those in the driving seat are MAHs. We’ve had two-and-a-half years of the three-year implementation window: now, what’s left to do?

Its key to mention, that those of you waiting for Brussels or Brexit to cancel FMD are wasting your time. Even if there is a delay, FMD is not going away and the UK is tied to it until at least Dec 2020.

It is clear that not everything will be ready by February 2019, especially at Pharmacy level, but that doesn’t mean the whole project will stop.

Therefore, rfxcel have put together their top tips to rapidly implement a cohesive serialisation solution.

Simple FMD projects work best.

Only make system linkages you need. Usually (for manufacturers) that means MAH to CMO and MAH to EMVO. For distributors and dispensers it means to your national system (NMVO). While it would be possible to integrate your FMD solution with your ERP software, warehouse system, dispensing software – even your Apple watch if you want to – right now the focus should be entirely on the critical path for FMD compliance. Starting with a standalone approach as part of a roadmap to deeper integration is the best balance of risk and ROI.

Spend money on those that matter.

For every euro spent on vendor technology, several euros need to be spent on your own people and processes to bend them into shape. Don’t skimp on this bit. Pack-level traceability changes everything all along the supply chain. If people carry on with old ways of working your FMD project will fail: expensively.

Experience outweighs the price.

Saving a few thousand euros using unproven, but cheap serialisation vendors, is a false economy if you can’t sell or dispense products by next February. It is too late for home-made solutions or inexperienced me-too suppliers. Competition means that prices are already pretty keen amongst the market leaders. Don’t chase the last cent.

You still have some time.

There is still some time to get ready if you just need software to manage and report serial numbers (e.g. to the European Medicines Verification Organisation, EMVO) or if you’re a downstream distributor or pharmacy needing to verify and decommission packs. If you haven’t started, but can make quick decisions and take standard options, ACT NOW, and you could have your software implemented within the next few months.

Take action before regulators remove your right to trade.

The fact remains that many companies are still some distance from being fit for purpose. The complexities of serialisation mean that a failure to act now could make it extremely difficult to complete implementation in time for the FMD deadline, or at least to guarantee a seamless end-to-end process.

Moreover, with the fees for registering with EMVO and other affiliate repositories increasing, the internal costs of your project will inevitably rise the longer you wait. However, the biggest price of non-compliance will be your inability to ship product. So why risk it?

Contact us below to learn more about serialisation requirements and how rfxcel can help you meet them in time.

Russia’s latest serialization regulations give pharma companies until 2020 for complete unit and batch level traceability. Originally the law – Federal Law No. 425-FZ – was to be complied with by 2019, but was pushed back by a year. While this extra year is certainly helpful to pharma companies, given the complexity of Russia serialization requirements, it still may not be enough time for pharma to prepare.

The Regulations:

Like the EU FMD or the US DSCSA, Russia serialization requires a 2D barcode on all individual units, with a GTIN, serial number, batch number, expiration date. However, Russia serialization also requires a Foreign Economic Activity Common Nomenclature (FEACN) code encoded on all 2D barcodes.

Additionally, Russia Federal Law No. 425-FZ requires serialization on all medications – including over the counter (OTC) medications, and also outlines special requirements regarding aggregation and separate serialization requirements for batches. While each individual unit must be serialized and a 2D barcode must be placed on the box or bottle, each batch must also be serialized with a 2D barcode placed on the box.

Aggregation will require individual members of the supply chain to report every change in individual batches. Reports must be produced around each individual change made to a batch and each member of the supply chain must report how much of the batch is left together, and where the removed units went.

Manufacturers shoulder most of the reporting responsibility under Russia serialization requirements, and foreign manufacturers have an even more rigorous set of requirements. Foreign manufactures can expect to have to report up to 36 different compliance events – for reference, the FMD only has a maximum 7 compliance events.

Much like the FMD, Russia serialization will be centralized through a database called the Federal State Information System for Monitoring Drug Circulation (FSIS MDC). Manufacturers will be expected to onboard with the FSIS MDC and report all serial numbers and batch numbers to the centralized system.

Finally, there are cryptography requirements in the system, and for the codes, that are unique to Russia.

Russia may have special requirements before the deadline:

While all prescription and OTC serialization and traceability are required by 2020, Russia also holds two lists of crucial and expensive medicines that require serialization before the 2020 deadline. The first are medications used to treat a list of diseases, including hemophilia, cystic fibrosis, and multiple sclerosis, which are rare and expensive to treat. The second includes medications considered vital and essential. Both potentially require serialization before 2019.

Conclusion:

Russia’s complex serialization and traceability regulations will be a challenge for all pharma companies. Manufacturers need to act now to be compliant by the January 1, 2020 deadline. Unlike regulations in other parts of the world, Russia requires the complete serialization and traceability of OTC medications. Manufacturers who produce OTC medications need to make sure that their manufacturing lines are ready. Companies who have yet to start converting their lines need to start now.

Under Russia serialization requirements there will not only be more compliance events, but there is also a heavy emphasis on aggregation. Batches will be serialized just as individual units are with multiple compliance events around aggregation and disaggregation.

The rfxcel promise:

rfxcel is the leading provider for worldwide traceability solutions. Since 2003, our solutions have helped pharma companies achieve global compliance. rfxcel recently announced our solutions module for Russia. With our 60 day, end-to-end implementation plan, rfxcel is ready to help you complete all serialization and traceability requirements, while also providing you with the business value you need.

For more information on serialization and traceability in Russia, click here.

We have Russian-speaking experts, based in Russia, as part of our European team.

Contact rfxcel today to see how rfxcel’s Russia compliance solution can help you!