EU FMD: What are the next steps post serialization?

Now that the deadline has passed, our panel of industry experts discuss where to focus your attention

On 9th February, the European Union’s Falsified Medicines Directive 2011/62/EU came into force. The aim of this regulation is to improve the security and delivery of medicines throughout Europe by introducing new requirements on manufacturers. Manufacturers must now apply two safety features to all new packs of prescription medicines; a unique identifier and an anti-tampering device.


The Challenge of Serialization

Although these may seem like simple requests, it has been a time-consuming process for many to select suitable software and hardware and then ensure the process has been integrated across all product lines. The process is only effective if it is consistently enforced but this is difficult to guarantee when facing such significant change.

Three core issues have emerged for many companies, these are; packaging redesign, manufacturing lines and the additional data burden.

Much of the packaging and artwork for medicine packs has had to undergo a re-design. Cartons have needed larger, unvarnished areas to accomodate the batch number, expiry dates and serialized data. Anti-tampering devices also add new level of complexity to packaging. To facilitate these changes companies have also had to consider whether they will seek out a late stage serialization solution or adapt their current processes. With the new serialization changes, much more data can be captured on a product and companies also need to understand how to handle and utilize this influx of information.


Looking forward: The impact of aggregation

Aggregation is not a requirement of the EU FMD regulation, although many see the potential benefits it may bring. Dexter Tjoa, director of corporate strategy at Tjoapack, believes that those who have implemented suitable processes “should now look towards the future and begin preparing for the next rounds of developments and change”. Aggregation will be a requirement in the US from 2023 and it is likely that regulators may look to explore or expand such requirements. As Dexter notes “early preparation for these kinds of changes will put companies in a much stronger position if they come to pass”.

Daniel Tedham, managing director at the Wasdell Group, is in agreement; “by starting to consider potential changes sooner rather than later, companies will ultimately be able to respond more quickly to any new legislation and minimize the impact on their operations”. If companies become complacent, they may miss out on the opportunity to get ahead of regulatory developments and will not benefit from new efficiencies.

As Daniel points out,  by enhancing supply chain traceability “aggregation can allow for improved inventory management control and a sophisticated product recall system”. Establishing parent-child relationships across the three tiers of packaging will give companies far more control in the process of verifying their batching without fully unpacking them. This can be a key time saver at all stages of the process.

Aggregation does require additional costs though so it is important to consider how effective the change will be within your process and what benefits it will bring.



Jean-Marie Aulnette, vice president of EMEA sales at TraceLink, believes that “eventually, the industry will move to a state where serialization is business as usual” with companies searching for greater efficiencies in their manufacturing relationships.

Jean-Marie aptly points out that “to date, the collective pharma industry has been very focused on the costs associated with serialization and is yet to see its potential”. With the deadlines for both the DSCSA and the FMD passing, we will now see many focusing their attention on how to make the most of their investment.