The Falsified Medicines Directive (FMD) introduces pan-European measures to prevent counterfeit medicines from entering the supply chain
Companies that sell medication in the European Union have a deadline of 9 February 2019 to comply with the the regulation, which broadly mandates for serialisation, compliance reporting and verification.
According to the directive, manufacturers must create unique identifiers on each unit level pack that is carried within a 2D data matrix barcode, and in human readable text on the package; this is composed of a product code, serial number, national reimbursement number (where required), batch number and expiration date.
There are more than 50 similar pieces of similar legislation worldwide and there have been some notable issues with implementing compliant solutions throughout the pharma sector — notably in the US where active enforcement of its track and trace law was delayed by a year as the industry was simply not ready for the deadline.
With the FMD deadline now only a year away, Manufacturing Chemist spoke to businesses across the pharma industry to get their perspective on what challenges the sector is facing as the deadline looms.
This Friday, 9 February, marks exactly one year until the EU FMD goes into effect.
As we saw in the Global Drug Supply, Safety and Traceability Survey, which painted a clear picture of the pharma sector's readiness for serialisation regulations, there still remains — worryingly — an uncomfortably large number of businesses that simply aren't ready.
The survey found that one third of pharma companies do not feel prepared for EU FMD and 46% of CMOs have not yet started to prepare for the FMD requirements.
With the FMD deadline now only a year away, this lack of readiness should be activating companies through the industry. There remains a lack of understanding of the complexity and resource intensiveness of serialisation.
The implementation process is almost entirely new and lot of uncertainty remains when it comes to understanding what is really needed to comply with different markets.
One of the biggest problems is that many companies think that vendors have sufficient amounts of delivery capacity and that later implementation will lead to lower costs. However, the reality is a stark contrast.
A serialisation programme typically takes 6–9 months to implement, meaning businesses looking to make the February 2019 FMD deadline should be starting their projects by the end of Q1 in 2018 at the latest.
For businesses yet to start their serialisation projects, it is vital that they specify any required third-party support, the total internal resource needed and the level of collaboration with partners that will be required for successful implementation and act immediately.
The huge volumes of data that will be generated and shared across the industry is perhaps the greatest challenge.
Serialisation creates the need for a connected supply chain and those companies that leverage existing multitenant networks can take advantage of multiple, seamless connections with their partners.
At this stage in the industry's serialisation journey, risk mitigation is more important than ever.
That is why we strongly believe that working with well-established, experienced partners, with the capability to expedite trade partner connections through an extensive network, are fundamental to serialisation success both in the short-term to ensure compliance and in the long-term to help realise the benefits of a truly connected supply chain.
Although the US FDA gave many businesses a welcome reprieve, by extending the deadline, the EU's pharma industry is not likely to be as lucky.
The deadline for compliance with the EU's Falsified Medicines Directive (FMD) is now less than a year away. Now, more than ever, pharmaceutical manufacturers need to make serialisation a priority.
If they are yet to begin their serialisation programmes, then they may find themselves facing an uphill battle to meet the deadline.
More problematic is the timeframe for selecting, delivering and validating line systems. Some vendors are currently proposing timescales of more than 12 months to deliver line systems that will now take implementation beyond the EU deadline.
Serialisation is not a task that can be completed overnight and the repercussions of missing the deadline will have a significant detrimental impact on the success and longevity of a business.
Companies that fail to comply with the regulations risk everything from production downtime to the loss of business to more prepared companies in key markets.
More proactive businesses should begin reviewing processes and exploring the opportunities to improve productivity and, in some instances, achieve a competitive advantage as part of their serialisation programme.
The one-year countdown will come as a welcome milestone for the well-prepared as they position their offering as not only being compliant, but more efficient than their competitors.
The time scales associated with serialisation have been discussed at length. Although a year may sound like a long time, it's a very short space of time to implement a lot of changes.
This challenge is no longer isolated to contract manufacturers; their customers are also starting to feel the pressure.
Marketing authorisation holders (MAHs) who have outsourced requirements need to start finalising packaging artwork to create space for barcodes and ensuring they're set up to report data into the EU repository.
It is vital that companies start to consider the impact beyond their lines at this point. As the deadlines loom closer contract manufacturers will become increasing busy onboarding new customers who are unprepared.
This means there is likely to be longer lead times for implementing changes. Customers can no longer hold out until the last minute without incurring hurdles at a later date.
Even with the deadlines so close, many marketing authorisation holders (MAHs) have still not selected a level four system that will allow them to store serialisation data and even less have started the onboarding process to the European Medicines Verification System (EMVS).
Onboarding to the EMVS takes time and, beyond this, companies need to think about connecting to the relevant National Medicines Verification Organisations (NMVOs), meaning time is tight.
The European Medicines Verification Organisation increased the fee for onboarding to the EMVS in January 2018 and this will increase again in June 2018, which is an incentive for companies to act sooner rather than later.
Realistically, if companies do not start onboarding until after June 2018, they will probably not be ready until the February 2019 deadline or later leaving no time to test their solution.
As a CDMO, we have started to encourage our customers to onboard sooner rather than later to ensure a smooth transition come the deadlines.
We are also exploring ways to offset the costs of introducing a level four system for companies with only a couple of SKUs as cost remains a major barrier for many when it comes to implementation.
With slightly more than a year to go until the deadline, the EU FMD remains a challenge for the pharmaceutical industry.
Cost remains a huge hurdle for many companies when it comes to implementing the necessary software and hardware for serialisation.
As a result, small and mid-sized pharma companies are looking to outsource their serialisation requirements.
It is important that those looking for a reliable outsourcing partner do not underestimate product transfer and data exchange integration timelines.
Generally speaking, 3–4 months, depending on complexity, is a realistic timeframe to ensure a CPO can take the necessary steps to ensure a successful transfer and serialisation integration. This is still considerably shorter than an in-house implementation project, which can easily run 12–18 months given current supplier lead times.
In addition, the European Medicines Verification Organisation (EMVO) recently published an announcement that the end of June 2018 should be considered the last opportunity to start onboarding to the EU hub and ensure timely implementation.
However, many companies have yet to select a level four and level five software provider, either because of the associated cost or the complexity of implementation.
Employing a third-party solution provider such as Meditraq can help companies to navigate these hurdles and enables companies to ensure the safe and secure storage and exchange of serialisation data.
In short, the next few months are crucial for companies looking to outsource serialisation.
Selecting appropriate partners to ensure compliance is important but companies should also look beyond the February 2019 deadline to see how these partners can help optimise their supply chain management given these new data requirements.
The EU's Falsified Medicines Directive (FMD) deadline is looming larger than ever and although the CDMO and CMO players in the EU are slightly behind the US in terms of conversion, we are beginning to see an increase in pick up in terms customer interest and site audits during the last 16 months.
The most active segments appear to be those in speciality, injectable and biologic products, but it is vital that pharma manufacturers across the sector now fully engage in their implementation projects.
Lead times to readiness are often longer than expected because of issues with equipment availability and the increasing scarcity of expert resources both inside respective organisations, and externally when third-party suppliers, consultants and vendors in the industry are in high demand.
Ultimately, it is crucial that patients are protected from falsified medicines and recalled products and it is imperative that companies, if they haven't already done so, begin their preparations for this regulation in earnest and bear in mind the scale and cost of the task ahead.