EU FMD: After the deadline

Following the enforcement of the EU Falsified Medicines Directive (FMD) in February 2019, serialisation is a legal requirement for pharmaceutical products. Designed to enhance the security of the manufacture and delivery of pharmaceutical products distributed in the European market, the FMD requires safety features, such as unique identifiers (UI), on all medicines. Manufacturers are also obliged to use new equipment and software to comply with the new requirements for data exchange and compliance reporting in a bid to prevent counterfeit drugs reaching patient possession.

So, six months after the FMD deadline, how has Recipharm standardised a serialisation solution and returned to ‘business as usual’? What were the main challenges faced in the industry in the years of planning and operational upheaval?

Standardising serialisation capabilities

Building a serialisation solution across all packaging lines is a very time-consuming process. Alongside training of personnel and implementing new line equipment, companies also needed to select and introduce the appropriate hardware and software capable of transferring and storing data. Serialisation has meant that new digital processes have been introduced into the pharmaceutical supply chain and this requires more communication and connections between supply chain partners.

Recipharm implemented a three-year programme in order to ensure that it was prepared in advance of the FMD deadline. Due to its complexity, the taskforce was designed to enable staff across all departments to understand the impact of the serialisation programme and manage the implementation process. With serialisation impacting all areas of a business, it is important for businesses to align processes and infrastructure across all facilities. Recipharm adopted a holistic approach and decided to create a standard serialisation solution (that would meet the requirements of the regulation to ensure customer compliance) in order to effectively handle the process and minimise layers of complexity.

Despite Recipharm’s preparedness, this was not the case across the entire industry. Unfortunately, many other CDMOs and marketing authorisation holders (MAH) did not meet compliance in time for the deadline as they failed to recognise and identify how complex implementing a serialisation solution would be.

Preparing for serialisation

In preparation for the FMD regulation, Recipharm invested EUR 40 million into equipment and technology for serialisation compliance, starting in 2016.  In order to prepare for any disruption, Recipharm anticipated a reduction in overall equipment effectiveness (OEE) in the short-term period after the FMD deadline. In order to minimise problems and allow time for testing, serialisation capabilities were established across all facilities in advance of the deadline. This allowed manufacturing processes to be improved and gave enough time to measure and improve OEE before serialisation became a mandatory requirement. As such, there have been no problems encountered with regards to customers and their products during the transition period. In addition, as an extension of serialisation preparations, a post-implementation programme was established to facilitate improvements and efficiency across the organisation.

A primary challenge for CDMOs in meeting serialisation compliance was the onboarding of customers. Companies were unable to control the readiness of customers in this time, meaning that many were working at different stages in their serialisation journey; it was not a uniform experience. In a bid to manage resulting complexities, Recipharm gave customers access to consultants to help them with their compliance.

While data exchange presented additional problems for the industry, employing TraceLink’s Life Sciences Cloud enabled Recipharm to remove complexities and connect with customers and other supply chain partners through just one connection. By operating in the same network as customers and stakeholders, all parties could cooperate within a shared space and exchange data more seamlessly. This coupled with other strategies employed throughout the transition period, has meant that 95% of customers have been successfully onboarded.

EU vs US requirements

Serialisation requirements differ from country to country. Under the Drug Supply Chain Security Act (DSCSA) in the US, manufacturers are required to label prescription medicine packages with a product identifier, serial number, lot number and expiration date. Additionally, the US is set to make unit level traceability, including aggregation, mandatory from 2023.

Aggregation isn’t currently mandated in Europe, however it is something that companies may want to invest in and implement due to its potential benefits, including improved supply chain efficiency and enhanced traceability. While implementing aggregation as an extension to a serialisation solution entails greater cost and a complex process, the benefits far outweigh the challenges. There is also a strong likelihood that other markets will emulate these measures and so preparing early stands organisations in good stead for when this is the case. 

Next steps

Following the creation of a robust serialisation solution, manufacturers should now consider how they can futureproof their offerings. With many uncertainties surrounding the future of serialisation, pharmaceutical companies should consider how different markets may evolve regulations and the direction that the legal landscape is moving towards. This will help manufacturers to quickly adapt and respond to legislative reforms, as well as maximise supply chain efficiencies.

Going forward, manufacturers are likely to concentrate on efficiency to ensure that a high level of productivity and performance is maintained. They should also focus on the lessons learned and make sure that software updates are installed in order to uphold legitimacy.

If you’re looking to find out more about navigating through the pharmaceutical serialisation landscape, we can help.

Find out more about our serialisation solution.