Pharma Serialization 2.0: What the EU-FMD Revision Means for IT and Supply Chains

5 min read

Since 9 February 2019, pharmaceutical serialisation has been mandatory across the EU. Every pack of prescription medication now carries a 2D data matrix code and a tamper-evident seal, with data fed into the European Medicines Verification System (EMVS). Six years on, the European Commission is working on a revision of the Falsified Medicines Directive. What’s emerging is less a break with the past than a tightening of the rules—with tangible consequences for manufacturers’ IT and supply chain architecture.

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The FMD was adopted in 2011, refined in 2016 by Delegated Regulation 2016/161, and has been operational since 2019. The revision process launched by the European Commission in 2024 through a public consultation doesn’t aim to replace the system but to improve data quality and forge closer links with initiatives like the European Health Data Space. For IT leaders, this means the infrastructure is already in place—data points are just getting denser.

What the FMD revision will change in practice

In 2023, the European Commission proposed a revision of pharmaceutical legislation, launching a public consultation in 2024 on supply chain security and anti-counterfeiting measures. The Falsified Medicines Directive (FMD) is one of several key components in this package. What emerges from the consultation documents and accompanying statements by the European Medicines Agency (EMA) can be distilled into three major shifts.

First, a push for higher data quality. The current FMD requires only basic data to be reported to the hub: product code, serial number, batch number, and expiry date. The discussion now centres on structured supply chain events—meaning notifications for when a batch leaves the manufacturer, arrives at a wholesaler, or undergoes repackaging. This isn’t a new type of data, but a shift toward finer granularity.

Second, tighter integration with the European Health Data Space and supply chain transparency initiatives like the Critical Medicines Act. The goal? If a medicine faces shortages and needs tracking, the path from the European Medicines Verification System (EMVS) to aggregation dashboards should be far more direct than it is today.

Third, harmonisation of national hubs. The consultation raises the question of whether data schemas and interfaces should be centrally defined in future. For manufacturers operating across multiple markets, this would simplify compliance—but only if their systems can adapt to a standardised schema.

The regulatory roadmap

The FMD didn’t appear overnight. To understand this revision, you need to look back at the journey since 2011.

What manufacturers’ IT needs to adapt now

Operational serialization systems have been in place at nearly all manufacturers since 2019. The question isn’t whether a production line can encode, but how resilient the data chain is—from the packaging process through the Level-4 repository to the national hub.

In a standard setup, a Level-4 solution like SAP ATTP or TraceLink acts as the central serialization repository. ATTP integrates with SAP S/4HANA, while TraceLink is often chosen for heterogeneous ERP landscapes or extensive CMO networks, offering EU hub connectivity as a managed service. Both meet today’s FMD requirements as standard.

The new workload stems less from additional features and more from what lies beneath the surface: master data governance (are product codes and GTINs consistent?), EDI connections to wholesalers, interfaces for batch release from MES and QMS, and aggregation at pallet and shipping levels. When audits demand extra events, these transitions become the bottlenecks.

Standard Suite or In-House Development?

For mid-sized companies, the architecture question resurfaces time and again: Is the in-house solution from 2019 still sufficient for the next expansion phase, or is it time to switch to a standard suite?

Serialization is no longer just a compliance checkbox. If you treat the audit as a mere add-on to your existing track-and-trace solution, you’re building a system that will need replacing by 2028.

The reliable decision-making line rarely follows company size—it’s determined by the number of production sites, CMO partners, and target markets. The more fragmented the network, the more expensive in-house development becomes once audits demand additional data points.

Where Mid-Sized Companies Get Stuck

Discussions with IT leaders at mid-sized manufacturers reveal a recurring pattern. Line integration works, hub uploads run smoothly, and verification alerts are managed. The real pain point lies further downstream: in the data pipelines connecting serialization information with the rest of the business.

Common gaps include inconsistent master data between ERP, MES, and Level-4 solutions. Batch information that only partially automates from QMS releases into the serialization chain. EDI routes to wholesalers that still process shipping notices via CSV or PDF. And a repository that serves the EU Hub but can’t deliver clean analytics on batch and serial number histories when regulators come knocking.

When the FMD audit expands to include structured supply chain events in the coming years, these are the exact points that will break. Companies operating without master data governance today will face manual rework for every new data point tomorrow. The proposed EHDS integration won’t simplify the picture—it assumes manufacturers already know which data they have in good order.

Key Data Points in the Discussion

The consultation responses and position papers from EFPIA, generic medicines associations, and the European Medicines Verification Organisation (EMVO) repeatedly highlight several recurring themes. These aren’t finalised changes but indicate the direction in which discussions are heading.

First, structured shipping events along the wholesale distribution chain. Currently, the manufacturer reports when a product is placed on the market, and the pharmacy reports when it’s dispensed. In between, the EMVS is blind. The discussion now includes at least aggregation reporting at pallet and carton level to enable faster access to stock data during recalls and shortages.

Second, a cleaner link to supply chain transparency regimes. The Critical Medicines Act aims to keep track of critical active ingredients and finished products across Europe. Those already required to maintain batch-level origin data could eventually feed this information into the serialisation repository—provided master data hygiene is up to scratch.

Third, closer integration with the European Health Data Space. For medicines, this doesn’t mean verification data will end up in patient records. Instead, the focus is on aggregated consumption and stock data, which authorities and secondary-use research should be able to access in a structured way. The FMD infrastructure is a logical source for this.

How Costs Are Shifting

The initial FMD investments between 2016 and 2019 often ran into six-figure to low seven-figure sums per site for many manufacturers—covering line equipment, Level-3 cameras, Level-4 repositories, hub connections, and validation. Ongoing operations are significantly cheaper but still typically land in the mid-six-figure range annually, depending on setup and product portfolio.

A revision reshapes this structure in two key ways. For standard suites, additional data points usually arrive via release upgrades, covered under maintenance contracts—the real work lies in customising and validating the new configuration. For in-house developments, the effort falls entirely on the company and scales with the number of integrations and markets. Depending on the expansion level, this can push ongoing costs noticeably higher.

The strategic question for mid-sized IT leaders, then, isn’t so much whether a standard suite makes financial sense, but when to adopt it. Those starting in 2026 and allowing two years for migration will meet the next FMD expansion stage with a robust platform. Those who wait until the delegated acts are finalised risk running into the classic bottlenecks: licence negotiations, integrator capacity, and audit scheduling.

What this means for the next 24 months

Panic isn’t the right approach. The FMD infrastructure is in place, and standard suites are delivering. Audits will come with lead times that allow for planning. What makes sense now is an honest inventory: Which data points currently pass through the serialization repository, which only partially, and which not at all? Where are the EDI and ERP interfaces fragile?

If you carry out this inventory thoroughly, you’ll have a realistic foundation to decide in two to three years whether your existing solution can hold up with minor adjustments—or whether the revision is the moment when switching to a standard suite makes more sense than another in-house release.

As of April 2026, no final deadlines for extended FMD data points have been set. Those who use this time to consolidate master data, EDI routes, and repository connections will enter any potential expansion phase with a robust foundation instead of patchwork.

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