Is the market ready for the Falsified Medicines Directive (FMD)? IN YOUR VIEW, HOW FAR DID INDUSTRY PROGRESS IN 2018 IN TERMS OF READINESS FOR FMD?
WHAT HAVE THE GREATEST CHALLENGES BEEN IN MEETING THE FMD REQUIREMENTS?
WHAT’S YOUR ADVICE TO MARKETING AUTHORISATION HOLDERS UNPREPARED FOR THE REQUIREMENTS?
JEAN-MARIE AULNETTE: The European Medicines Verification Organisation (EMVO) provides an update on the readiness of the pharma industry in Europe – and still, less than three months out, not all pharmaceutical companies have completed the EMVO on-boarding process and developed their connection to the EU Hub production environment. This process can take up to six months and any businesses that aren’t well underway face a significant risk of not being ready in time.
DANIEL TEDHAM: For contract manufacturers and packagers, one of the main challenges of implementing serialisation was installing and validating the sophisticated coding and detection equipment required. It was also vital to ensure that the software systems put in place are capable of supporting multiple client and country serialisation coding requirements. Companies have also had to consider a number of necessary changes to packaging components. Artwork templates had to be reworked and redesigned to incorporate these requirements, which added a layer of cost and complexity that some businesses hadn’t factored into their preparations.
DANIEL TEDHAM: Any company that is not close to validating a solution must look to outsource serialisation requirements to third-party contract partners. Some manufacturers that do not count packaging as a core competency took this route at an early stage to offset some of the costs of buying and installing new hardware, as well as ensuring the right IT infrastructure was in place and training staff. Ultimately, this has allowed them to negate the production downtime required to equip lines. These factors make the outsourcing approach an appealing option, and as the deadline looms, this is likely to become more prevalent.
STAFFAN WIDENGREN: The reality is that there are still some companies that will not meet the regulatory deadline. This is particularly the case for smaller organisations that were unable to invest the necessary time and resources into preparing for the FMD. For these companies, outsourcing their serialisation requirements will be the only option.
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PIETER VERCRUYSSE: The most obvious FMD challenge is the varying market demands that one solution must cater for. Many companies supply products to a global marketplace and each country’s legislation differs slightly. There is not a one-size-fits-all solution to serialisation requirements, so companies have had to develop adaptable solutions that can be customised when necessary. Cost has also been a barrier for some companies. The upfront investment required to equip lines and to introduce the necessary IT infrastructure to manage and exchange the data that will be generated is huge. This, added to the cost of training staff and the time required to adequately try and test lines, means for many small and midsized players, implementing a solution inhouse has simply not been a viable option.
PIETER VERCRUYSSE: For those companies that are further away from finalising a solution, the sensible decision at this stage is to look to third party providers who can support them with a compliant solution. However, the onboarding process also takes time, so the sooner companies approach contract providers the better.
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The end goal for the industry should be the implementation of full track and trace systems that work collaboratively across the global marketplace
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