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In less than a year the 6-year extension period for FMD (Falsified Medicines Directive)ย implementation in Italy and Greece will end. After this date, the FMD 2011/62, the European directive on falsified medicines, will come into force in both countries. Here is an overview of the current situation in Greece and Italy, accompanied by information about the concrete requirements.
Greece
The Greek NMVO (National Medicines Verification Organization) has been established and regulatory measures have been initiated, as it is planned to be fully operative by the deadline in February 2025.
To provide detailed information to the Greek stakeholders, EMVO organized a workshop last year. Regarding the technical details and information for onboarding to the EMVS, EMVO plans a separate workshop in cooperation with Greek NMVO in Q2/Q3 of 2024.
Under discussion between Greek stakeholders stays the topic of the incorporation of parallel traders and wholesalers.
Italy
At the beginning of 2024, the National Medicines Verification Organization Italy was established and since then it has monitored the next legislative steps and supports the upcoming institutional discussions. Italian NMVO is “working on an action plan, including a change to the national legislation which will have to provide for the removal of Bollino from all medicines packs. In the meantime, the Italian Ministry of Health maintains ongoing communication with the EU Commission regarding the Italian implementation roadmap.โ.
Less than a month after NMVO’s establishment, in February was published the โLegge di delegazione UEโ, provided certain obligations concerning the implementation of the new system in Italy:
- Government is tasked with issuing, within twelve months, one or more legislative decrees to detail the existing legislation to comply with the obligations arising from EU FMD;
- For this purpose, progressive measures will be adopted to make the unique identifier and the anti-tampering security feature affixed on medicine packaging, by 9 February 2025;
- Through a specific agreement, the NMVO-Italy member companies, will engage the services of the โPoligrafico dello Statoโ for the establishment of the national archive.
The NMVS will have to be connected to the Italian National Health Platform (NSIS) that will remain functional for reimbursement and market surveillance purposes (among other tasks).
Barcode Requirements
GS1 standards are required to be used in both Greece and Italy.
For Greece – GS1 2D Data Matrix + anti-tampering device; 2D Data Matrix must include:
- Global Trade Item Number (GTIN)
- Serial number (SN)
- Batch/Lot number
- Expiry date
Notes: A fifth data point – a national reimbursement number โ is under ongoing discussion.
For Italy – GS1 2D Data Matrix + anti-tampering device; 2D Data Matrix must include:
- Global Trade Item Number (GTIN)
- Serial number (SN)
- Batch/Lot number
- Expiry date
Notes: A fifth data point – a national reimbursement number โ is under ongoing discussion
The countdown has begun and it is expected for 2024 to be full of updates, changes, and challenges. To make the process smooth, we will continue tracking down the journey of Greece and Italy on the road of EU FMD implementation and share with you all important information.
Sources:
