From EU FMD compliance to Bollini-to-DataMatrix transitions — Jekson Vision delivers complete, hardware-and-software serialization for manufacturers supplying Europe, backed by engineers across Europe and 24×7 support.
Europe operates the most comprehensive pharmaceutical serialization framework in the world. The EU Falsified Medicines Directive — Commission Delegated Regulation (EU) 2016/161 — requires that every prescription medicine sold in the EU carries a tamper-evident Anti-Tampering Device (ATD) and a unique 2D DataMatrix code. Compliance means more than printing a code: each serial number must be uploaded to a National Medicines Verification System (NMVS) before product enters distribution, and decommissioned at the point of pharmacy dispensing.
| Country / Region | System | Status & Key Date |
|---|---|---|
| EU Member States (25) | EU FMD / EMVS / NMVS | MANDATORY since 9 February 2019. GS1 DataMatrix + tamper-evident ATD on all Rx packs. Serial numbers verified at point of pharmacy dispensing via national NMVS. |
| Italy | EU FMD + Bollini transition | DUAL-COMPLIANCE PERIOD: 9 Feb 2025 – 8 Feb 2027. Both Bollini labels and EU FMD DataMatrix permitted simultaneously. FULL EU FMD mandatory from 9 February 2027. Bollini system discontinued entirely from that date. |
| Greece | EU FMD / HMVS | MANDATORY from 7 February 2025. Hellenic Medicines Verification System (HMVS) fully operational. GS1 DataMatrix + ATD required. Previous EOF label system phased out. |
| Belgium | EU FMD | MANDATORY since 9 February 2019. Full EU FMD DataMatrix + ATD applies. Belgian vignette labels no longer required for new product. |
| United Kingdom | Windsor Framework / MHRA | Great Britain follows MHRA — separate from EU FMD. Northern Ireland: Windsor Framework from January 2025. Packs for NI supply must carry 'UK Only' label. EU FMD requirements disapplied for NI. UK operates independently from EMVS. |
| Russia / CIS | CRPT / MDLP / Chestny ZNAK | Separate crypto-code serialization requirement. GS1 DataMatrix + FEACN code + crypto signature. Full MDLP event reporting. Jekson has active deployments in Russia. |
If you manufacture or package medicines for the Italian market, the Bollini compliance timeline is the most operationally significant event in Europe right now.
The Bollino (plural: Bollini) is Italy's national pharmaceutical label, in use since the 1990s and operated by the Italian Medicines Agency (AIFA). Every medicine pack sold in Italy has historically required a tamper-evident Bollino sticker issued by the Istituto Poligrafico e Zecca dello Stato — the Italian state printing house. The label carries the Marketing Authorization number (AIC), product name, pack size, and a 1D barcode. Pharmacies detach it and submit it to the National Health Service as a reimbursement document.
Because the Bollino is a physical label issued by the state and purchased by manufacturers, packaging lines have always needed dedicated Bollini label handling, application, and inspection equipment built in.
Italy's EU FMD exemption expired on 9 February 2025. The Italian Council of Ministers simultaneously confirmed a two-year stabilization period:
During the stabilization period, manufacturers supplying Italy must run dual compliance on their lines — applying Bollini, printing and verifying DataMatrix codes, applying Anti-Tampering Devices, and uploading serial data to Italy's national verification system. Jekson's ST240 and ST250 are designed to handle this exact requirement.
Greece operated a similar pre-FMD label system — the EOF (National Medicines Organisation) label. As of February 2025, Greece is fully under EU FMD: GS1 DataMatrix + Anti-Tampering Device required, connected to the Hellenic Medicines Verification System (HMVS). For manufacturers shipping to Greece, requirements are now identical to the rest of the EU.
EU Delegated Regulation 2016/161 mandates two physical safety features on every in-scope prescription medicine sold in Europe:
A GS1 DataMatrix code printed directly on the carton, encoding:
The code must meet GS1 print quality Grade C or higher. It must be readable by high-speed vision cameras on the line and by pharmacy scanners at point of dispense.
Every in-scope pack must carry a physical Anti-Tampering Device — in practice a tamper-evident self-adhesive label applied across the carton closure. If the carton is opened, the label shows visible evidence of interference. The ATD is a physical hardware requirement: your line needs a label applicator integrated with your serialization system, not just a printer and camera. This is where Jekson's ST-series machines — the ST200, ST240 and ST250 — become the central equipment requirement for EU FMD compliance.
Jekson delivers a fully integrated hardware-and-software serialization ecosystem. Every component is developed and serviced in-house — one team, one service contract, one accountability.
A compact, high-speed serialization and tamper-evident system for pharmaceutical cartons. Serialization, Print and Inspect with positive and rejection verification. Designed to integrate seamlessly with existing cartoning machines.
The ST240 is built for the Italian and Greek markets. It handles serialization, tamper-evident label application, and — critically — the printing and inspection of Bollini and Vignette labels, making it the right machine for manufacturers navigating Italy's dual-compliance period through February 2027.
The ST250 is a compact, high-speed serialization and tamper-evident labelling system for pharmaceutical cartons, designed for integration into confined manufacturing lines. Its balcony architecture ensures easy access for operation and maintenance.
REETRAK is Jekson's proprietary serialization software, managing the full serial number lifecycle from generation through coding, verification, and rejection at line and site level. On European lines, REETRAK:
REESOURCE is Jekson's enterprise-level (L4/L5) traceability platform. For European compliance, REESOURCE handles:
While EU FMD does not legally mandate aggregation, supply chain partners and export markets increasingly require parent-child hierarchy data. Jekson's TS200 and TS201 aggregation stations automatically scan and verify cartons as they are packed into cases, build real-time shipper hierarchy data, and push it to REESOURCE — closing the loop from unit to pallet.
Serialization lines are not optional equipment. When your line stops, production stops and compliance gaps open. Jekson's service model is built around three commitments:
Round-the-clock remote technical support, every day of the year. Whether your line alarm fires at 3am or your NMVS connection throws an exception during a weekend production run, our helpdesk is available online 24 hours a day, 7 days a week, 365 days a year.
Jekson operates its own offices in Europe — Jekson SRL in Milan and Jekson Vision Ltd in Malta — with engineering capability available across European pharmaceutical manufacturing markets. Our engineers are Jekson-employed, not a third-party reseller network. They understand European compliance requirements and can be deployed on-site when remote support is not sufficient.
Jekson's REESERV programme offers structured Annual Maintenance Contracts covering hardware, software, and regulatory update management.
| Why | What It Means for You |
|---|---|
| Single-source hardware and software | ST-series machines, REETRAK, REESOURCE — all developed by Jekson. No third-party software layers. One team. One service contract. One accountability. |
| Bollini and Vignette handling | ST240 and ST250 are built to handle Bollini and Vignette labels — the right machines for Italian manufacturers navigating the dual-compliance period through February 2027. |
| 24×7 online support | Round-the-clock helpdesk means your EU FMD line never loses its support — regardless of time zone or day of week. |
| Engineers in Europe | Our own offices in Milan and Malta. Jekson-employed engineers, not a reseller network. |
| Multi-market from one platform | REESOURCE manages serial number lifecycles across EU, UK, Russia and beyond from a single enterprise platform — for manufacturers supplying multiple geographies from one site. |
| 25+ years, 700+ customers, 11,000+ installations | Experience across regulated markets globally. We have navigated DSCSA, Russia CRPT, EU FMD and emerging regulations — and we continue operating where others exit. |
| Retrofittable modular design | Existing packaging line? Our ST-series and aggregation stations integrate with your current cartoning equipment. No full line replacement required. |
