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.

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.

On December 28, 2017, President Vladimir Putin signed Federal Law No. 425-FZ, establishing a path to serialization in the Russian supply chain. When the law was published the following day, it delayed the country’s serialization deadline from January 1, 2019, to January 1, 2020. Pharma companies now had an extra year 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 finalized, 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.

2. 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.

3. 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 recognized 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.

4. 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.

Final thoughts

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.

To learn more about Russian Pharma Compliance click here.

Today is exactly six months before the Falsified Medicines Directive (FMD) comes into force. On 9^th 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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!