EnglishFrenchGermanItalianPortugueseRussianSpanish

Keys to a Successful Solution Implementation Effort

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.

Successful Solution Implementation

Act Sooner than Later to Prepare for Russia Serialization

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.

Act Sooner than Later to Prepare for Russia Serialization

Item-Level Traceability Can Transform Food Businesses

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.  

 

food traceability

Serialisation Requirements: Why risk it? FMD is not going away! Are you ready?

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.

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 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!

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