EU FMD: Get outsourcing before it’s too late!
In this article with European Pharmaceutical Manufacturer, Dexter Tjoa, director of Corporate Strategy, discusses why outsourcing is fast becoming the most logical choice for companies who have delayed developing appropriate solutions and what benefits an experienced CPO can bring to serialisation implementation.
As the European Falsified Medicines Directive (EU FMD) enforcement date draws closer, unprepared companies will most likely become reliant on outsourcing in order to achieve compliance. Time is simply too tight to be able to tackle the challenge of serialisation independently, especially since the task of complying with the new regulation has the potential to be extremely time-consuming and disruptive. However, engaging the support of a contract packaging organisation (CPO) can help to minimise these hurdles, with tried and tested lines, as well as access to expert knowledge making the process more straightforward, efficient and stress-free.
Common misconceptions
The main reason that many companies are now considering external serialisation solutions is simply because they have underestimated the scale of the challenge. Many are still struggling with understanding what is required and do not have the in-house expertise to tackle the implementation process. As such, they have misjudged the time and resource required to do so, not to mention the upfront investment involved in purchasing the necessary equipment.
Added value
The benefits of outsourcing should not be overlooked. Serialisation is not an entirely new concept for the pharmaceutical industry. In fact, regulations already exist in some markets, for example Turkey, where regulations have been in place since 2010.1As such, some CPOs will have long-standing experience of implementing both serialisation and aggregation projects. It is likely a contract packager will have overcome many of the common challenges before, and therefore their resources should be leveraged to navigate the hurdles and meet the regulatory deadline. From creating new packaging protocols to guiding companies in their connection to the EU Hub, the sooner a partnership is established, the sooner both teams can work through each stage together to reach an appropriate compliance solution.
Expertise will be invaluable in the coming months, not only to meet the February 2019 deadline, but also to ensure that costly ‘trial and error’ mistakes are avoided during the testing phases. A contract partner can relieve the pressure of potential downtime and enable ‘business as usual’ to resume as quickly as possible after implementation.
Managing expectations
However, outsourcing is no quick fix. While enlisting the help of an experienced partner with a tried and tested solution in place may help speed up the process, many underestimate the time scales involved in integrating new products onto packaging lines. In reality, it takes around four months for a new customer to be integrated with the packaging lines and systems, meaning time is of the essence with the six-month countdown now underway.
Four months allows for sufficient communication and approval cycles; however longer times might need to be allocated for customers who operate across multiple legislative markets, for instance a combination of EU and US. Managing the range of requirements and ensuring system integration across supply chain partners mean that, unfortunately, there is not a one-size-fits-all solution. Experienced and well-prepared CPOs are already in high demand, so it’s imperative that businesses approach potential partners as soon as possible.
Final thought
Companies who delay reaching out to a CPO run the risk of delays and depletion of stock. Estimated timelines are not a guarantee, and as the deadline gets closer, there is likely to be a bottleneck of companies looking for last minute solutions. Once a CPO reaches capacity, it will inevitably have to start pushing projects back and this means some companies run the risk of not becoming compliant at all. In short, the time to act is now.
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