EU FMD Compliance

European Union Safety Features and EMVS Verification System

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Global Regulations

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Labelling

Products are required to display information in writing.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Aggregation

The packaging hierarchy of products is required to be identified and documented.

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Central repository

The traceability documentation is required to be centralized in a unique system.

Summary

The European Union enforces serialization and pack verification under the Falsified Medicines Directive (2011/62/EU) and Delegated Regulation (EU) 2016/161. All prescription medicines must carry a serialized 2D DataMatrix and an anti-tampering device.

EU FMD is a verification-based model using the European Medicines Verification System (EMVS), supported by national repositories (NMVS).

Manufacturers and MAHs must upload both serialization data and product master data (PMD) before releasing products to the market.

Labelling Requirements 

Each prescription pack must include a GS1 DataMatrix with:

  • GTIN (Product Code)
  • Serial Number
  • Batch/Lot Number
  • Expiry Date
  • National Reimbursement Code (when required)

Additionally:

  • Anti-Tampering Device (ATD) is mandatory.
  • Human readable data must match the DataMatrix.
  • Aggregation is not required under EU FMD.

Regulatory Timeline 

  • 2013 – EMVO established to build EMVS.
  • 2016 – Delegated Regulation EU 2016/161 published (technical specs).
  • 2019 February 9 – Full go live:
    • Serialization mandatory
    • ATD mandatory
    • EMVS/NMVS verification and decommissioning active ‍
    • PMD and serial upload required before market release
  • 2019 onward – Refinement and country-specific clarifications.

Reporting Requirements 

EU FMD focuses on verification and pack status, not full EPCIS movement reporting.

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For Manufacturers / MAHs

EMVS Requirements Table
Requirement
Description
Product Master Data (PMD)
Product-level attributes must be uploaded to EMVS before any serials can be uploaded. This includes GTIN, product name, strength, form, packaging, market authorization details, etc.
Serialization Upload
All serial numbers for released packs must be uploaded to EMVS.
Batch / Lot Upload
Batch-specific attributes as required by EMVO.

For Supply Chain Actors

NMVS Operations Table
Operation
Description
Verification
Pack is checked in NMVS at key points (e.g., wholesale returns, pharmacy).
Decommissioning
Pack status changed to supplied, destroyed, exported, sample, etc.
Recommissioning
Allowed in limited scenarios if pack never left the physical control of the same entity.
Destruction / Write-off
Serial decommission with a valid reason code.

Operational Timelines for Industry 

  1. Onboard as MAH and manufacturing sites with EMVO and NMVS.
  1. Upload Product Master Data (PMD) for each GTIN-market combination.
  1. Upload serial data (product packs) to EMVS.
  1. Release serialized, ATD-protected product to market.
  1. Wholesalers perform risk-based verification.
  1. Pharmacies and hospitals verify and decommission at dispensing.
  1. Handle returns and recommissioning as per national guidelines.

Reporting Hub

  • Central system: EMVS, managed by EMVO.
  • Country-level systems: NMVS in each EU/EEA market.
  • MAHs upload:
  1. Product Master Data (PMD)
  1. Serialization Data (Serial Uploads)
  • Wholesalers, pharmacies, and hospitals verify and decommission packs through NMVS.

Aggregation Requirements 

  • Not required for EU FMD.
  • No regulatory reporting of parent-child SSCC hierarchy.
  • Some companies use aggregation internally for logistics but it does not interact with EMVS/NMVS.

Common Errors to Avoid 

  • Missing or incomplete Product Master Data, blocking serial uploads.
  • GTIN-product mismatch between label and PMD.
  • Serial not uploaded before distribution.
  • Missing or damaged ATD (treated as suspect).
  • Decommissioning by the wrong NMVS or after the allowed window.
  • Attempting to use EU FMD like a full track and trace system (it is not).

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LSPedia didn’t just provide software; they ensured we were fully compliant. Anytime we had questions, the LSPedia team knew DSCSA inside and out and guided us step by step. That level of expertise made a huge difference during audits. Thanks to their expert team our audit was smooth and successful

Hussein Salman
Lead Pharmacist, Pioneer Pharmacy Services

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LSPedia shows a constant commitment to improvement; whether it's their support or their product...they're always leveling up. The support team provides consistently thorough follow-up and clear, articulate communication. the support we receive represents a meaningful step up in service and is genuinely appreciated.

Zac Sweeny
EPCIS Data Encoder,Capital Wholesale Drug
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