EU FMD Compliance & EMVS Reporting for Pharmaceutical Companies

SoftGroup provides EMVO-certified EU Hub connectivity and EMVS reporting support for pharmaceutical companies, Marketing Authorisation Holders, and Contract Manufacturing Organisations.

Since the Falsified Medicines Directive first took effect in 2019, SoftGroup has connected pharmaceutical companies to the European Medicines Verification System and supported the operational reporting processes required to keep product, pack, and serial number data accurate across the product lifecycle.

For companies working across multiple markets, products, CMOs, and partner systems, EU FMD compliance is not only about the initial connection. It is about keeping reporting reliable every day.

What is EU FMD compliance?

The EU Falsified Medicines Directive introduced safety features for regulated medicine packs placed on the European market. These include a unique identifier, usually encoded in a 2D Data Matrix, and a tamper-evident feature on the pack.

For pharmaceutical companies, EU FMD compliance also means reporting product and pack information to the European Medicines Verification System, known as the EMVS, through the EU Hub.

In practice, compliance requires more than serialization at packaging-line level. It requires accurate product data, pack data, serial number lifecycle events, status updates, and reporting continuity across markets and partners.

This includes:

  • Product Master Data and Pack Data reporting
  • Serial number commissioning and decommissioning
  • Status events such as recall, export, withdrawal, and destruction
  • EU Hub / EMVS connectivity
  • MAH, CMO, and partner-system connectivity
  • EMVS alert visibility and investigation workflows
  • Ongoing data accuracy across products, batches, and markets

EU FMD does not end at go-live

EU FMD is often treated as a one-time technical connection. In reality, it becomes part of the company’s ongoing compliance and supply-chain operations.

Product data changes. Batches move through the supply chain. Serial numbers change status. Products are recalled, exported, destroyed, or decommissioned. CMOs and partners operate across different systems. EMVS alerts may need to be reviewed, investigated, and resolved.

That is why the real challenge is not only connecting to the EU Hub.

The challenge is keeping reporting accurate and operational over time.

SoftGroup supports pharmaceutical companies with the connectivity, system capabilities, and serialization expertise required to maintain reliable EU FMD reporting from day one and beyond.

customer feedback

What pharmaceutical companies tell us they need

“We need a single platform, we cannot manage multiple vendors across our markets.”
— Operations Manager, European pharmaceutical company

 

“We need reporting that keeps working as products, partners, and markets change.”
— European pharmaceutical company

 

Talk to an EU FMD expert

What continuous EMVS reporting involves

EU FMD reporting depends on several ongoing operational activities. SoftGroup supports these processes through proven EU Hub connectivity and serialization reporting expertise.

Product and pack information must be submitted to the EMVS and kept accurate when products, packaging configurations, markets, or operational requirements change.

SoftGroup supports the reporting and maintenance of Product Master Data and Pack Data required for EU FMD compliance.

Every regulated pack has a lifecycle. Serial numbers may be commissioned, decommissioned, recalled, exported, withdrawn, destroyed, or updated based on product movement and market activity.

SoftGroup supports serial number lifecycle reporting so companies can maintain accurate status visibility across products and markets.

SoftGroup provides EMVO-certified connectivity to the European Medicines Verification System through the EU Hub.

This gives pharmaceutical companies an established and certified route for EU FMD reporting, supported by live operational experience since the Directive first took effect in 2019.

EU FMD reporting often involves multiple stakeholders: Marketing Authorisation Holders, CMOs, contract packagers, distributors, logistics partners, and internal systems.

SoftGroup supports the connectivity needed to keep serialization and reporting flows aligned across partners and systems.

Serial number statuses need to remain visible and accurate throughout the product lifecycle.

SoftGroup supports status verification and reporting control, helping teams understand what has been reported, updated, or flagged.

EMVS alerts can indicate data inconsistencies, process issues, or reporting gaps that need investigation.

SoftGroup supports alert visibility and investigation workflows so pharmaceutical teams can respond with clearer context and better control.

Built for continuous EU FMD reporting

A successful EU FMD setup should not only work at implementation. It should continue to support daily operations as products, partners, markets, and reporting requirements evolve.

SoftGroup helps pharmaceutical companies maintain EU FMD reporting continuity by supporting:

  • EU Hub connectivity
  • EMVS reporting workflows
  • Product and pack data updates
  • Serial number lifecycle events
  • MAH and CMO connectivity
  • Multi-market reporting
  • Status visibility
  • Alert investigation workflows
  • Serialization and compliance operations

This makes EU FMD reporting easier to maintain across real pharmaceutical supply-chain complexity.

EU FMD reporting for Marketing Authorisation Holders

For Marketing Authorisation Holders, EU FMD compliance depends on accurate product data, reliable partner connectivity, and clear visibility over reporting activity.

The complexity increases when products are manufactured or packed by multiple CMOs, distributed across several European markets, or managed through different systems.

SoftGroup supports MAHs with the connectivity and reporting capabilities needed to maintain reliable EU FMD compliance across products, markets, and partners.

SoftGroup supports MAHs with:

  • EMVO-certified EU Hub connectivity
  • EMVS reporting across products and markets
  • Product Master Data and Pack Data reporting
  • CMO connectivity
  • Serial number lifecycle reporting
  • Status verification
  • Alert visibility and investigation workflows
  • Serialization and compliance operations support

For MAHs, the value is not only being connected. It is having a reliable reporting setup that can continue to work as the business changes.

EU FMD reporting for CMOs

Contract Manufacturing Organisations often support multiple MAH clients, each with its own products, markets, systems, and reporting expectations.

This creates operational complexity. A CMO may need to manage serialization and reporting flows for several customers, across multiple markets, with different partner systems and data requirements.

SoftGroup supports CMOs with EU FMD connectivity and reporting capabilities designed for multi-client, multi-market pharmaceutical operations.

SoftGroup supports CMOs with:

  • Serialization and EU FMD reporting workflows
  • Connectivity with MAHs and partner systems
  • Serial number lifecycle status management
  • EU Hub / EMVS reporting support
  • Reporting across multiple markets
  • Support for complex customer and product portfolios
  • Scalable serialization and compliance connectivity

For CMOs, the goal is to reduce reporting complexity while supporting customer requirements reliably.

When should you review your EU FMD setup?

Your EU FMD setup may already be live. But as your business changes, your reporting setup may need to be reviewed.

It may be time to review your EMVS reporting process if:

  • You have added new products or markets
  • You work with new CMOs or packaging partners
  • Your product data changes frequently
  • You receive recurring EMVS alerts
  • Reporting depends on manual checks or fragmented workflows
  • Internal ownership is unclear between Regulatory, QA, IT, and Operations
  • You are preparing for an audit or internal compliance review
  • Your current setup is difficult to scale across markets or partners

A structured review can help identify where reporting risks, operational gaps, or unnecessary complexity may exist.

Why pharmaceutical companies trust SoftGroup with EU FMD?

Proven since day one

SoftGroup has supported pharmaceutical companies with EMVS reporting since the Falsified Medicines Directive first took effect in 2019.

This is not a new or experimental route. It is an established EU FMD reporting capability used by pharmaceutical companies since the beginning of the Directive.

EMVO Certified connectivity

SoftGroup provides EMVO-certified connectivity to the European Medicines Verification System through the EU Hub.

This gives pharmaceutical companies a certified technical route for reporting product data, pack data, serial number lifecycle events, and status updates.

Built on pharmaceutical serialization expertise

SoftGroup has more than 22 years of experience in pharmaceutical serialization, aggregation, and traceability.

That experience matters because EU FMD reporting is not only a regulatory requirement. It is also an operational process connected to packaging, product data, partner systems, supply-chain activity, and quality workflows.

Trusted by pharmaceutical companies worldwide

SoftGroup supports 145+ customers across 43+ regulated markets.

Its EU FMD experience is part of a broader track record in pharmaceutical serialization, compliance connectivity, and Track & Trace operations.

Review your EMVS reporting setup