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Europe Regulatory

Europe Regulatory Requirements

 
Regulatory Agency
  • European Commission / European Medicines Agency (EMA)
  • National Competent Authorities (each Member State)
  • European Medicines Verification Organisation (EMVO) / National Medicines Verification Organizations (NMVOs) – for repository and verification system operations.
Regulation Name Directive 2011/62/EU – Falsified Medicines Directive
Commission Delegated Regulation (EU) 2016/161 (Safety Features) These rules together define serialization and verification of safety features on medicines packaging across the EU/EEA
Compliance Dates Mandatory application of safety features: 9 February 2019 for most prescription medicines.
Longer national transition periods (e.g., specific state allowances) expired with full EU rollout completed in 2019
Applies to Prescription medicinal products for human use (with some minor “white list/black list” exceptions).
Certain non‑prescription medicines at higher risk may also be included per Delegated Regulation lists.

Secondary Packaging

 
Barcode Symbology GS1 2D DataMatrix (ECC200) mandatory on secondary/saleable units.
Barcode Content Encodes the “Unique Identifier” consisting of:
  • Product code (GTIN)
  • Unique Serial Number
  • Batch/Lot number
  • Expiry date
  • Optional: national reimbursement/identification number if mandated.
Serial Number Randomization Yes — must be generated with negligible guessability per FMD requirements (probability < 1/10 000).
Serial Number Reuse Not permitted — must remain unique per pack for specified retention period
Human Readable Expiry Date Format Expiry must be printed in human‑readable format on packaging adjacent to the DataMatrix where feasible
Barcode Data Encoding Standardized GS1 application identifiers and ISO/IEC 15418 syntax required
Product Code Notes GTIN must be globally unique and conform to ISO/IEC 15459 where applicable
Free Samples must be marked? FMD does not explicitly exempt free samples; safety features apply to packs placed on the EU market per regulation and national adoption.

Tertiary Packaging

 
Barcode Symbology Not mandated by FMD for serialization at tertiary packaging level.
Barcode Contents Not required under EU FMD for tertiary; GS1 logistics labels used commercially at company discretion.

Aggregation Data Capture

 
Parent-Child Mapping Aggregation Capture? Not mandated; optional for supply‑chain efficiency

Data Exchange

 
Send Unit Data to Government Repository? No separate “government repository” — data is uploaded to a central EU Hub and propagated to National Medicines Verification Systems (NMVS) operated by NMVOs.
Send Unit Data to Third-Party Repository? Not regulated (central system is the EU Hub/NMVS network).
Send Unit Data to Trading Partner? Not mandated under FMD — internal commercial data sharing optional.
Send Aggregation Data to Government Repository? No aggregation requirement in EU FMD.
Send Aggregation Data to Third-Party Repository? Optional (internal use).
Send Aggregation Data to Trading Partner? Optional (internal use).

Authentication

 
Who Offers Data Repository for Authentication? European Hub (operated via EMVO) and connected national systems (NMVS) in each EU Member State
Manufacturers Must Register Shipments in Repository? Yes — serialized pack master data and serialization data must be submitted to the EU Hub/NMVS network prior to supply chain entry.
Downstream Trading Partners Must Authenticate on Receipt? Yes — pharmacies and authorized dispensers must verify the unique identifier at point of dispense and decommission the serial in NMVS. Wholesalers may perform risk‑based verification.
Downstream Trading Partners Must Authenticate on Shipment? Not mandated under FMD — verification and decommissioning occur at dispense and in risk‑based checks.

Government Reporting

 
Manufacturer Activity Reported? Yes — serialized pack data and master data.
Downstream Trading Partner Activity Reported? Partial — decommissioning events and verification queries are recorded in NMVS data stores..
Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

Disclaimer

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

About Kevision Systems

Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.

For Further Information, please contact our Compliance Team at info@kevision.in

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