The countdown is on: Important considerations around the nearing EU FMD enforcement date
Earlier this month (9 August) we passed the six-month time point before all companies in Europe will be expected to comply with the falsified medicines directive (FMD).
With concerns about readiness in the industry still rife, we discuss the looming enforcement date and some tips on how to best prepare in the time that is left with some of the major players in the field…
Dexter Tjoa, director Corporate Strategy, Tjoapack
Now, with just six months until the EU FMD enforcement date, time is very short for companies who are considering outsourcing as an alternative to implementing a serialisation solution in-house. Four months is typically required for sufficient communication and approval cycles to take place and for products to be fully integrated on to contract providers’ lines. Keep in mind this time may not include any extra time required to adapt solutions for customers with multiple regulatory market requirements, for instance the US and EU.
There is no one-size-fits-all solution, but experienced contract packaging organisations (CPOs) are ideally placed to tailor solutions and ensure compliance for their customers. This also means that they are in increasingly high demand. It is, therefore, vital for businesses to approach potential partners now to ensure EU FMD compliance ahead of the deadline. Companies who delay reaching out to a CPO may run the risk of delays and depletion of stock. Estimated on-boarding times are not guaranteed and businesses need to ensure adequate time for testing a solution before February 2019.
Daniel Tedham, managing director, Wasdell Manufacturing a division of the Wasdell Group
There are now just six months until the EU FMD comes into force and the state of readiness across the industry remains a concern.
As the deadline draws closer, one of the biggest risks to serialisation programmes is the availability of equipment. Delivery lead times will inevitably get longer in the last-minute rush and it is likely that some companies will struggle to acquire the necessary equipment on time.
Of course, preparing for serialisation is not just a case of installing new equipment. Teams need to be trained and new processes need to be introduced across entire businesses. Time for testing needs to be factored into the implementation period to ensure a seamless transition post-February 2019.
Packaging components must be carefully considered too. For example, cartons must have unvarnished areas added to cater for new lines of text such as GTIN, batch number, expiry dates, serialised data and 2D matrices. Tamper evidence measures also add additional complexity, for example, will they be covert or overt?
It is these complexities, together with the tight timings, that are leading many companies to outsource to experienced partners with tried and tested serialisation capabilities. Now is the time to act, as these partners’ resources are already in high demand as the deadline approaches.
Brian Daleiden, vice president of Industry Marketing, TraceLink
The 9thAugust marked the six-month countdown to the EU FMD compliance deadline. With such limited time left, it is essential that businesses prioritise the on-boarding of partners, complete European Medicines Verification Organisation (EMVO) OBP applications and related National Medicines Verification Organisation (NMVO) agreements, connect to and verify integrations with the European Hub, and validate their end-to-end EU compliance solutions.
At FutureLink Munich 2018, more than 200 pharmaceutical and healthcare executives from 100 unique companies were polled on a range of topics relating to serialisation and the EU FMD. Just 12% of FutureLink poll respondents said they had completed end-to-end testing with at least one NMVO. It has become clear through insights gained from numerous early adopters who have been working towards EU compliance since early 2016 that managing the product coding, master data, serialisation and compliance data for products in the European market is much more complex than it appears at first glance.
In an announcement on 6thAugust,*EMVO stated that only 106 of the EU’s 2000-plus pharmaceutical companies have completed the EMVO on-boarding process and developed their connection to the EU Hub production environment to be compliant with the FMD. EMVO reiterated that pharmaceutical companies could take several months to complete all of the business and technical steps to complete EMVO on-boarding.
Given that this on-boarding process, internal design of all technical and operational touch-points needed for EU compliance, and connecting IT systems to the EU Hub across multiple data transactions can be challenging, businesses that aren’t using a pre-validated solution have a lot of work to do in a very short timeframe. Businesses that have opted for point-to-point connections with CMOs and 3PLs have created additional layers of complexity and are at risk of failing to meet the deadline.
More worryingly, around 50% of the EU market are still to decide on their serialisation supplier. These are mostly small companies that are dispersed across Europe with resource and budget constraints that make serialisation exponentially more challenging.
As these companies make decisions that will dictate their readiness for the February 2019 FMD deadline, they will have to rely on support from providers that can deliver cost-effective, turnkey solutions.
TraceLink, for example, has developed FMD Express to meet this demand. FMD Express is a complete, easy to implement and use solution. It uses purpose-built templates and compliance modules to allow smaller manufacturers to define and manage master data, on-board partners, and integrate with the EU Hub through a single, secure connection.
Leveraging solutions such as this will be the optimal approach for underprepared pharma businesses as they push for FMD compliance.
*https://emvo-medicines.eu/news/announcement-emvo-notice-of-on-boarding-on-time/