With the deadline looming for the enactment of EU FMD and US DSCSA, Vikash Pushpraj, SVP, rfxcel, explains how consistency in achieving compliance is about much more than technology. Companies not yet set up for serialisation will need to adopt best practices and leverage the know-how of implementation experts in their methodology to go-live on time.
In February 2019, the Delegated Regulation to the Falsified Medicines Directive (FMD) comes legally into force in Europe, mandating Marketing Authorisation Holders (MAHs) to serialise individual medicine packs for authentication at the point of dispensation. But an even tighter deadline is just around the corner. This November, DSCSA requirements for package-level serialisation have finally come into play, midway through a 10-year roadmap for end-to-end traceability across the US supply chain. The question is: are you ready for it? And if you’re not, how can you get there before it’s too late?
The current landscape
Despite the proximity of the regulatory deadlines, suprisingly a number of companies have not yet established the infrastructure and processes required for serialisation.
The regulations have implications – and therefore active requirements – for the full gamut of stakeholders; manufacturers, brand owners, CMOs, third-party logistics providers (3PLs), wholesalers and dispensers. It’s therefore vital that pharmaceutical companies have a full understanding of the laws, requirements and the associated responsibilities of all parties in the partner network. Moreover, companies must map their entire supply chain operations to design systems that allow visibility, collaboration and agile workflow across a broad end-to-end process.
Serialisation and traceability require aligning processes and software to generate, capture, share and affix data related to products’ unique identifiers (UIs). This data must also be accessible to downstream trading partners. If the data isn’t in the system – or it isn’t accurate or reliable – products will not get through the supply chain, with implications for both profitability and patient care.
The best solutions fixate on data quality and integrity, routinely monitoring information as it flows through the system to detect human error, inaccuracy and duplication. Robust validation is essential to prevent erroneous data from entering the differing international data hubs, including EMVO, DAVA and other national databases. Alongside it, connectivity is key. Solutions must ensure data flows securely, end-to-end, across the supply chain, connecting all parties to a single version of the truth.
Urgency, Consistency and Planning in Implementation
Solutions have to be not only custom-designed, but they must also be securely implemented at speed and scale. The best partners will, therefore, deploy implementation teams spread across the globe to ensure 24/7 availability with expertise in setting standard artefacts, automating processes and applying industry best practices to ensure a consistent and planned approach. These ‘hyper’ care teams will mobilise Subject Matter Experts in multiple time zones to maintain continuous engagement and activity throughout the implementation process.
The deadlines for DSCA and FMD and compliance are rapidly approaching and companies that have not yet prepared for serialisation need to move quickly and urgently, but with care and precision.
It’s time to factor time management into serialisation.