The Breakdown: Russia Serialization Requirements

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 require serialization long by 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!

Russia Serialization Requirements

Selecting the Right Serialization Solution for You

Serialization solutions are not all created the same, and several factors must be taken into account when deciding which solution fits your needs.

Data integrity needs to be at the forefront of your decision making process. While nearly all solutions offer compliance and data validation, few provide continued data validation and verification after implementation. Continued data verification is immensely important, as errors do happen. Product master data needs to be accurate and aligned for an efficient and safe supply chain.  Having a serialization solution provider that works with you closely and catches errors before they get into the system or network is crucial.

A serialization solution provider needs be flexible for any product change processes that could create data inconsistencies between trading partners. Having a solution provider that works with all of your trading partners is important to create a system that meets all data and product standards.

Beyond data integrity – control, flexibility, trading partner connectivity, and scalability should all be key factors when picking a solution.

Most serialization and traceability software are built on cloud computing using either a multi-tenant or single-tenant architecture. Solution providers selling a multi-tenant architecture often over simplify this approach, selling it to their customers as a way to get automatic software upgrades with little or no effort. But, beware – these uncoordinated updates force customers into system upgrades with little or no coordination or consideration for their own system configurations. This can be incredibly disruptive to the customer and require revalidation and new system configurations. Conversely, single-tenant solutions give the customer control of when they implement updates, allowing them to upgrade at a time that is not only convenient for them, but allows them to ensure their configurations remain intact.

An effective serialization solution will also be flexible enough to fit all of your individual needs, while being scalable enough to cover all of your manufacturing and distribution needs. The solution should take into account what your systems require now and what they will require in the future as your company grows. Alongside flexibility and scalability, your solution should be connected to hundreds of other trading partners, allowing instant communication between network members and transmission of serialization and / or T3 data (transaction statement, transaction history, transaction information).

rfxcel’s solutions are built with our customers in mind. Our single-tenant architecture ensures that our solutions are flexible and scalable, all while ensuring our customers have complete control over their systems. We provide expert data monitoring to confirm that all of your products are properly serialized and traceable. Our solution uses over 100 data checks to verify your data and flags errors, giving you the time to fix issues before products ship.

The global supply chain never rests, and our global support and solution experts are available 24/7 to take your questions. Contact us today to learn more about our serialization and track and trace solutions or to talk with of our solution experts.

Serialization Solution

Unpacking the Pharmaceutical Serialization Process

Approaching pharmaceutical serialization is no easy task, but technology makes it infinitely more attainable.

 

While pharma companies are already required to have batch-level serialization, the upcoming deadlines – February 2019 for the Falsified Medicines Directive (FMD) and November 2018 for the Drug Supply Chain Security Act (DSCSA) – require unit level serialization. These deadlines are not far away, and failure to comply can mean harsh consequences for non-compliant companies. But, with all that is at stake, some companies have still not begun the serialization process.

 

Pharmaceutical serialization can be made easier through specialized software. However, implementation requires a careful approach, one that assesses the parts of your business that will be affected, and an understanding of requirements in the markets in which you will operate now and in the future.

 

The process of serialization affects more than just the manufacturing line, before implementing any serialization solution, executive leadership must address the importance of serialization and appoint a project sponsor to work directly with the solution provider. The project sponsor’s role is to champion the serialization effort, and work with the solution provider to create and manage a schedule that clearly identifies key tasks and implementation milestones. In addition to managing a schedule, it’s imperative that risks and mitigation plans are identified and tracked throughout the process. Having a plan in place to manage risks during implementation helps to avoid common pitfalls and gives priority to the concerns of both the customer and solution provider.

 

Although the process of serialization may be daunting, rfxcel’s serialization and traceability solutions and approach make the process more manageable. Our 60-day implementation plan is designed to quickly on-board your organization and establish connections with your trading partners in a repeatable fashion. Our approach provides your organization with a comprehensive and scalable solution that will meet compliance regulations today and in the future.

Pharmaceutical Serialization

It’s Not Too Late for EMVO Onboarding with rfxcel

The European Union’s Falsified Medicines Directive (EU FMD) is just a few months away. On February 9, 2019 the law takes effect and those companies who aren’t serialized and traceable will not be able to sell their goods. The pressure of this deadline necessitates action – immediate action – but, according to a letter from the European Medicines Verification Organisation (EMVO) to all Marketing Authorisation Holders (MAHs), about 1500 MAHs have yet to begin the EMVO onboarding – a critical step in ensuring compliance with the FMD.

Pharmaceutical Journal, in their coverage, stated “only 841 companies have completed the first stage of connection: the signing of a participation agreement. Of those, only 106 companies have progressed to become fully connected to the production environment of the EU Hub.” So far, only 5 percent of all MAHs are fully compliant with the FMD.

The EMVO, in its letter and in previous letters, has stated that the onboarding process can take up to six months, and the last time to ensure no delays or complications would have been to start onboarding by June of 2018. June of 2018 has past, and unlike the US DSCSA, there has been no announced delays in the enforcement of the FMD.

What to do now:

Companies that haven’t begun the onboarding process should begin as soon as possible. The EMVO stated that it will not be responsible for any MAH that fails to complete onboarding or fails to begin the onboarding process on time. This places enormous pressure on companies to begin the onboarding process; as of now there is no guarantee that the onboarding process will be done by February 9, 2019.

Fortunately, onboarding with the EMVO is easier when MAHs choose the right solutions provider. rfxcel is pre-certified with the EMVO, allowing new onboarding partners to skip steps in the technical onboarding process. To ensure compliance by the FMD deadline you should begin the EMVO onboarding process immediately.

Connecting to the EMVO is critical for compliance with the FMD, but more integral is actually being able to serialize all products at a unit level with a 2D barcode including a batch number, expiry date, global trade item number (GTIN) and a randomized serial number. If your manufacturing line is not already prepared for serialization, then you have bigger problems than not having started the onboarding process for the EMVO. Companies that are not compliant by February 9, 2019 will likely be placed in a very inconvenient position – they must either send their finished goods to a CMO already compliant with FMD to serialize their products, or they must manufacture an excess and release their products before February. Our advice is to get started immediately. Perhaps you’ll have to use a combination of some or all of these approaches, but you’ll be closer to the finish line and compliance if you get started today.

The rfxcel Difference:

rfxcel is already pre-approved by the EMVO, allowing our customers to skip steps in the EMVO onboarding process. Beyond being able to provide an expedited onboarding process, we promise to provide our customers with a short implementation process, extensive data verification, a system that the customer is in control of, and straightforward pricing.

It is not too late to begin onboarding with the EMVO. Contact rfxcel today to learn how we can help you comply with the FMD.

EMVO Onboarding

rfxcel SNAP – A DSCSA Solution for Pharmacies

The Safeguard prescription drugs & protect consumers under the Drug Supply Chain Security Act (DSCSA) with rfxcel SNAP.

Enacted by Congress in 2013 and administered by the Food and Drug Administration (FDA), the DSCSA outlines steps to safeguard the public from counterfeit or adulterated drugs. Under the DSCSA dispensers / pharmacists are required to electronically track and trace certain prescription drugs as they enter their pharmacy. This is achieved through tracking and tracing T3 data (transaction history, transaction information, and transaction statement) generated at each step of supply chain from trading partners. The goal of the DSCSA is to have a fully electronic and interoperable system in place to track and trace prescription drugs by 2023.

Responsibilities of Dispensers Under the Drug Supply Chain Security Act (DSCSA)

Important Dates to Meet DSCSA Deadlines:

  • November 2017 – All lot level transactions should be electronic
  • November 2020 –Pharmacies/dispensers can only receive and engage with products that are encoded with a serial number and 2D barcode
  • November 2023 – All pharmacies/dispensers are required to have systems to support unit level traceability, enabling traceability back to point of origin

Under the DSCSA Dispensers Are Required To:

  • Electronically receive T3 data from authorized trading partners
  • Electronically store T3 data from all authorized trading partners for 6 years
  • Have a system in place to investigate and quarantine suspicious products, and then notify trading partners and the FDA of illegitimate or suspicious products
  • Generate T3 data for outgoing sales
  • Receive only products with serialized data encoded in a 2D barcode, by the year 2020

Meet DSCSA requirements with rfxcel SNAP

  1. Electronically connect with trading partners
    • SNAP electronically connects with your licensed and verified trading partners (primary wholesalers, secondary wholesalers, and manufacturers)
  2. Receive, store, and provide product tracing documentation
    • Accept and verify T3 product information (transaction history, transaction information, and transaction statement)
    • Store T3 data in an electronic format for 6 years or longer; in the event of an audit
    • Generate T3 data for outgoing sales and transactions
  3. Investigate and properly handle suspect and illegitimate drugs
    • Workflows that support the identification and quarantining of suspicious products
    • Electronic notification to the FDA and trading partners of illegitimate or suspect products

Contact rfxcel to learn more about SNAP our DSCSA solution for pharmacies and your obligations as a dispenser under the DSCSA.

DSCSA solution for Pharmacies Post

Serialization in Russia – Steps to Compliance

Serialization in Russia – Federal Law No. 425-FZ, signed by the President of the Russian Federation on December 28, 2017 and published on the following day, moved the country’s serialization deadline to January 1, 2020. With this move, the Russian government overrode the previous implementation date (January 1, 2019), providing pharma companies with more time to implement the legal requirements on serialization of drugs.

However, the serialization in Russia regulation is arguably the most complex centralized track and trace compliance regulation yet seen, and given that much of the detail is yet to be finalised, the industry is unsurprisingly being challenged by the timeframe.

So what are the details of the Federal Law, and how can pharmaceutical companies work towards compliance?

 

Federal Law No. 425-FZ

Under Law 425-FZ, in order to ensure effective quality control for pharmaceuticals and provide protection against fake and counterfeit medicines in Russia, a federal state IT system (the FGIS MDLP) is in the process of being set up in Russia to monitor the movement of pharmaceuticals from manufacturer to end user.

From January 1, 2020, pharmaceuticals manufacturers will have to put special identifiers on pharmaceuticals packaging that will enable the tracing of movements of pharmaceuticals from the manufacturer right up to the end user.

The specifications for these identifiers and the process for putting them on packaging is due to be published separately, while the details of the central system reporting system, which documents the key traceability events, their data structures and technical guidelines, are also still being finalized.  What is known is that it will be mandatory to report the date of every phase of each product – from manufacture through to dispensation. In addition, Russia will be one of the small number of countries globally where the aggregation of pharmaceutical products for tracking purposes is required.

Further complexity comes from the differing reporting and labelling requirements depending on the status of the pharmaceutical company in Russia. If the company is a member of GS1 Russia, a barcode, the serial number and the product code are compulsory. In the instance of aggregation, a GTIN, FEACN (customs) code and case serial number are also necessary. If an organization is a non-GS1 Russia wholesale organization, then the requirements are also to include a SSCC code on the package and a unique serial number for each case.

Other important changes have been introduced by Law 425-FZ. In order for pharmaceuticals and active pharmaceutical ingredients to be registered, details will now have to be submitted of the applicant and manufacturer’s registration as a taxpayer in their country of incorporation – they will need to show their tax ID numbers. The holders or owners of registration certificates for pharmaceuticals and the manufacturers of pharmaceuticals and active ingredients registered before January 1, 2018 will have to submit details of their registration as taxpayers by January 1, 2019 to the Federal Service for Surveillance in Healthcare, Roszdravnadzor.

 

Steps to Compliance

With MDLP currently in pilot and federal review of the initiative due imminently, any organizations who have yet to start their compliance project have little time left.

While the details remain to be finalized, the federal government has already communicated that any further extension to the deadline is unlikely. Indeed, there is even the likelihood that serialization for certain “vital and essential” medicines may be enforced during 2019.

So what steps should you be taking now, to mitigate the risk of non-compliance, and in the worst scenario – not being able to trade?

  1. Establish a dedicated project team and project manager

Without executive buy-in and indeed buy-in across all organizational boundaries, there will no focus on the project and chances of success vastly reduced.

It’s vital that everyone across the business understands that without serialization, you will not be able to sell products in Russia after January 2020.

 

  1. Engage in a pilot phase

Building in a pilot phase can make a huge difference to the formal implementation. This is a chance for discussion and debate around functional requirements. It also allows to you properly explore your Master Data Management processes.

Serialization is all about data, so you should have a clear vision of the IT landscape and how the data will flow – from the point of manufacture all the way through to the point of dispensation, and the generation of the compliance report to the federal system.

 

  1. Think agile

Engage with a technology partner who will work in partnership with you to develop a system that can both bend to fit the yet-to-be-announced final details of the regulation, but also meet future requirements.

The best partner should be a recognised provider with experience, credibility and evidence that shows it can implement effectively within tight timeframes. A good partner will be committed to your success, keeping you abreast of fluctuating global regulations, and collaborating with you to customise solutions that adapt to changes in your business and the wider marketplace.

 

  1. Act now

Serialization is an initiative that has far-reaching implications across global boundaries and as such requires a full change management process. Again, the best partners will be able to support you through this, but only if you allow enough time to fully on-board them.

 

With global deadlines – DSCSA; FMD; and now Law 425-FZ – looming, it is perhaps unsurprising that pharmaceutical manufacturers and wholesalers feel under pressure from the mountainous task they face.

However, while certainly a challenge, your upcoming serialization in Russia does not have to be problematic.

For more information on how rfxcel can help with your serialization in Russia requirements, and to watch our “Serialization in Russia” webinar with Dmitry Freydin, Reckitt Benckiser, please contact us below to get full access to the webinar.

 

Serialization in Russia

FMD: Six months, Six thoughts

Today is exactly six months before the Falsified Medicines Directive (FMD) comes into force. On 9th February, 2019, more than thirty countries in the European Economic Area will have new rules for coding and verifying prescription medicines. We’ve had two-and-a-half years of the three year implementation window now: what conclusions can we draw and what recommendations can be made? Here are six short reflections.

  1. It will happen.

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. Will everything be ready by February? No, quite clearly not, especially at pharmacy level. That doesn’t mean the whole project will stop.

  1. It’s too late.

If you’re a marketing authorisation holder (MAH) and still need to convert production lines then it is too late to be ready. You have two options. You can make excess inventory, release it before February, and hope it lasts until your lines are ready, or you can send your finished goods to a contract manufacturer (CMO) for coding. Both inconvenient, but you’re still in business.

  1. It isn’t too late.

There is still time to get ready if you just need software to manage and report serial numbers (eg 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, then rfxcel can turn your enquiry into a contract within a week and have you implemented two months after that.

  1. Choose experience over price.

Saving a few thousand euros using unproven but cheap serialisation vendor is a false economy if you can’t sell or dispense products next February because they failed. 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.

  1. KISS

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). We can integrate our FMD solution with your planning software, warehouse system, dispensing software or your Apple Watch if you want to. We just don’t put those items 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.

  1. Adapt processes, train people.

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.

 

At rfxcel we can move quickly but time is very short. If you haven’t started your EMVO on-boarding, it’s not too late. If you don’t like your current solutions provider, it’s not too late to switch. rfxcel can help!

FMD Six months

What is Track and Trace for Pharmaceuticals?

What is track and trace for Pharmaceuticals? 

In the context of the pharmaceutical supply chain, track and trace refers to the process of determining a drug’s current and past locations. When track and trace is correctly implemented, a drug can be tracked throughout the supply chain and traced back up the supply chain upon return or recall.  

In an effort to support track and trace for pharmaceuticals, serialization will be used to help identify a drug’s authenticity prior to sale, dispensing, return or recall. And, while a serial number provides a product with a unique identity, by itself, it is not enough to combat counterfeit, adulterated or expired medications from entering the drug supply chain. Serialized products must be supported by a number of other processes and data points, which are derived through track and trace. In the U.S. drug supply chain, those additional data points are supplied in the 3T data (transaction history, transaction statement, transaction information); and, in Europe those data points are aggregated into a master database, the European HUB (EU HUB) as well as country specific databases called National Medicines Verification System (NMVS). 

 

Are pharmaceutical track and trace regulations as commonly implemented as serialization requirements? 

Not every country with serialization requirements has track and trace requirements, but many countries are starting to implement track and trace paired with serialization to combat counterfeit, stolen or adulterated drugs. For instance, the U.S. is in the process of fully implementing the Drug Supply Chain Security act or DSCSA. The DSCSA details how the manufacturer must start the track and trace process through producing 3T data for drugs at the lot level. Every node within the supply chain from primary wholesalers and secondary wholesalers down to repackagers and dispensers must receive an electronic copy of the 3T data. They must also produce and add to the 3T data if they sell the product. Eventually, when all DSCSA requirements are fully implemented – recalled or returned drugs will be easily tracked back up through the supply chain.  

 

What happens if traceability is not implemented? 

In the U.S. and the E.U. companies that do not implement traceability procedures might face heavy fines, a bar on product launches, or loss of their drug licenses.  

The FMD should be seen as a significant business continuity risk. The law is very clear: no data or wrong data means no sale.  

In the U.S., wholesale distributors will not buy products that are not serialized or traceable, and manufacturers and repackagers run the risk of forfeiting their licenses if they do not serialize their products and initiate 3T. Finally, dispensers face similar risks if they accept and sell products lacking serial numbers and 3T data.  

The decision to track and trace products is no longer an option, it is a requirement for companies wanting to do business in the United States and Europe.  

 

To learn about Serialization, click here.

 

About rfxcel

Headquartered in the United States, rfxcel is the leading cloud-based provider of serialization, and track and trace solutions. For over fifteen years, rfxcel has provided reliable and affordable solutions to meet global serialization and compliance requirements. With rfxcel’s relentless commitment to customer success and continuous innovation, companies can meet today’s compliance requirements and tomorrow’s business challenges.

rfxcel is the number one managed cloud company for Life Sciences. Everything rfxcel offers is managed by rfxcel not the customers. That’s because rfxcel believes:

  • Commitment to customer success promises a prompt, full-service method of addressing customers’ serialization needs.
  • Economies of scale are nice — but economies of expertise are even more valuable. The highest performance and cost-efficiency come when you combine infrastructure with specialized expertise and the exceptional customer service that we call HyperCare
  • Every customer has easy access to engineers, project managers and experts to help with planning, architecting, building, and operations.

To learn more about track and trace for pharmaceuticals, contact rfxcel and speak to one of our specialists.

track and trace for pharmaceuticals

3 Months to DSCSA Serialization Enforcement

With only 3 short months to go, all manufactures and repackagers need to be ready for the FDA’s DSCSA serialization enforcement. Drugs sold in the United States must comply with the FDA’s Drug Supply Chain Security Act (DSCSA) deadline to have item-level serialization affixed or imprinted on unit-of-sale prescription drugs sold in the United States.   

On June 30, 2017, the FDA issued Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. This guidance informed supply chain stakeholders that the FDA would delay DSCSA serialization enforcement of product identifiers on prescription drug packages and cases until November 2018. This delay provided manufacturers additional time to put in place technology to generate product identifiers and avoid supply chain disruptions.

While product identifiers—commonly referred to as serialization—is the backbone of the DSCSA, it is just one of many requirements. Each node within the supply chain, from manufactures all the way down to dispensers, must meet a unique set of DSCSA requirements. These unique requirements have presented new challenges to companies of all sizes within the drug supply chain. Recently, many of those challenges came to light at a Healthcare Distribution Alliance (HDA) meeting, in which industry leaders exchanged their experiences and the many challenges that still lie beyond the November 27, 2018 serialization deadline.

 

How rfxcel is helping companies get ready for DSCSA serialization enforcement:  

The November 2018 deadline accelerates the need for rfxcel’s traceability solution. In order to achieve full compliance, members of the supply chain including manufacturers and wholesalers all the way down to dispensers need collaborative technologies that track and trace a product, no matter the maker or origin, throughout the supply chain. The DSCSA details how the manufacturer must start the process of tracing a product by producing the transaction history, transaction information, and a transaction statement of the individual batches and units. This information is then passed to each actor within the supply chain to continue the drug history. Serialization is the crux of the effort allowing for the eventual tracing back up the supply chain for returns and recalls.

rfxcel understands the intricacies of the supply chain and how easily a business can be consumed by compliance efforts. This is why rfxcel closely partners with customers to understand their business strategy and objectives without losing sight of regulatory compliance. This is achieved through establishing a clear project structure, open lines of communication, collaboration, approved technical requirements, and a ‘Gold Release’ implementation effort that does not disrupt business operations.

‘Gold Release’ Implementation Plan: 

Larger pharmaceutical companies have been doing serialization for over 15 years. Even still, many of these companies had to adjust to the DSCSA serialization enforcement requirements. In late 2016, a number of these large pharmaceutical companies wrote to the FDA indicating they were facing challenges meeting the serialization deadline. The FDA wisely determined that if these large companies were having issues meeting the deadline, then smaller companies must be having similar issues. The FDA agreed to delay the deadline by one year establishing a new deadline of November 27, 2018.

Based on the issues many companies were having, rfxcel created an express on-boarding plan to expedite pharmaceutical companies’ compliance with the DSCSA. Dubbed the ‘Gold Release,’ rfxcel developed templates and compliance modules for rapid compliance implementation. The ‘Gold Release’ is a repeatable process that enables deployment events to occur faster and trouble free, providing a simple approach to meet compliance while controlling costs and minimizing business impact.

Supported with collaboration:

Historically, while the pharmaceutical supply chain has worked in a stove-piped fashion, traceability paired with the requirements of the DSCSA requires total collaboration across the industry. In that spirit, rfxcel leads collaborative efforts with working groups and classes among industry partners. Transparency and ongoing collaboration ensures that customers are able to learn and implement successful track and trace efforts. For example, rfxcel educates members on current and potential regulatory requirements, how to on-board new trading partners, and how serialization works.

Full-service approach:

Many small pharmaceutical companies face challenges with DSCSA serialization enforcement including master data management and data exchange with contract manufacturing organizations and wholesalers. rfxcel designates teams across the globe ready to support the entire serialization and track and trace process.

Regardless of size of the company, rfxcel will always find the most cost effective and easy to use solution to comply on time and build business value beyond compliance. When developing the supply chain strategy, rfxcel considers regulations like the DSCSA, and any global differences in associated product descriptions with related literature and support materials.

Awareness and understanding of guidelines and regulations for the serialization of pharmaceuticals products are critical. This awareness includes compliance with regulations (current and planned) that ensure the authenticity, safety, and security of the product.

 

About DSCSA:

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The goal is to  protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain.

 

About rfxcel

Headquartered in the United States, rfxcel is the leading cloud-based provider of serialization, and track and trace solutions. For over fifteen years, rfxcel has provided reliable and affordable solutions to meet global serialization and compliance requirements. With rfxcel’s relentless commitment to customer success and continuous innovation, companies can meet today’s compliance requirements and tomorrow’s business challenges.

rfxcel is the number one managed cloud company for Life Sciences. Everything rfxcel offers is managed by rfxcel not the customers. That’s because rfxcel believes:

  • Commitment to customer success promises a prompt, full-service method of addressing customers’ serialization needs.
  • Economies of scale are nice — but economies of expertise are even more valuable. The highest performance and cost-efficiency come when you combine infrastructure with specialized expertise and the exceptional customer service that we call HyperCare
  • Every customer has easy access to engineers, project managers and experts to help with planning, architecting, building, and operations.

Contact rfxcel for information how to meet your serialization, traceability and compliance requirements. rfxcel is a company committed to innovation and affordability in delivering best-in-class track and trace to Life Sciences across the globe.

 

No Leniency for Wholesale: Start Preparing Now to Meet the DSCSA VRS Deadline

The DSCSA VRS deadline is one of the most important milestones the pharmaceutical industry needs to meet. The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013, in doing so amending the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs.

Title II of the bill, the Drug Supply Chain Security Act (DSCSA) is designed to establish requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. It outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed. This will enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect consumers.

Adopting a phased approach, there are two key deadlines for different stakeholders: November 26th 2018 is the widely acknowledged deadline for pharmaceutical manufacturers and repackagers; however, given that the FDA has already pushed this deadline back once by a year (from November 2017), the second deadline is unlikely to be met with similar lenience.

On November 27th 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. Essentially the VRS community consists of a third-party routing service, comprising requestors, responders, VRS providers, and a governance body to help manufacturers and distributors work together.

Under the proposals, the responders – ie. the manufacturers –  are responsible for providing repository connectivity information to the VRS and providing appropriate responses to the requesters’ (ie. the wholesale distributors) verification requests by matching the product identifier received from the requester with the product identifier in their repositories.

This level of collaborations requires tools for manufacturers and distributors need to work together. And these tools require testing – in minutiae.

Today, various solution providers, including rfxcel are in the process of providing a VRS. By the end of Q2 2018, industry testing is expected to start. The industry testing will consist of two rounds of testing, where there will be updates and modifications to the VRS specification to accommodate learning’s from the first test. Final revisions and refinements of the VRS will go in place with the final report published by the end of Q4 2018. Therefore, the VRS is expected to be available in early 2019, in readiness for the November deadline.

Lessons learned

However, as mentioned, it’s unlikely that the FDA will be lenient with this second deadline. It is therefore important to be aware that the duration of the testing depends on a lot of different things. It is going to be dependent on the readiness of your trading partners to start testing, and be determined by the quality of the data you received. You will need to expect some problems and be able to account for that within your schedule.

Analysing the recent HDA meeting back in February, we have put together our top tips to ensure you meet the upcoming DSCSA deadline:

  • Start talking with your providers, NOW! If you haven’t started implementing solutions yet or looking into your options, this is the perfect time to start.
  • If you are selecting vendors, make sure you understand the level of service provided by these providers. Everyone has a different way of managing the implementation process, so it’s not all the same.
  • Understand the total cost of ownership or the total cost of implementation. Make sure you have resources in the budget for that so you’re not surprised when the project starts.
  • We recommend that engage your trading partners to mutually understand the impact of your plans. This is probably the most important phase that you’ll need to go through. Your trade partners have different schedules, they may have different commitments to other customers that they are exchanging information with. So as part of this, make sure you understand the proximity exchange and make sure you reach out to your key suppliers in time.
  • Finally, the HDA does require continued testing implementation regarding serialized items. Make sure that you schedule ample time to test the implementation. Run through the proper test cases with your trade partners as part of the on-boarding process.

To learn more about the DSCSA VRS deadline and rfxcel’s VRS pilot project please contact us.

 

Legal Note *We are very familiar with the DSCSA requirements and the DSCSA implementation we are not familiar specific trading partners or contracts or business requirements. As a result we do recommend that you have them all reviewed by your legal team to make sure that DSCSA law and DSCSA VRS deadline might apply for your specific situation.

DSCSA VRS deadline