Italy Regulatory Compliance

Journey towards EU FMD implementation

Looking back in 2019 the EU introduced the serialization system for pharmaceuticals and EU-FMD became mandatory for all countries in the European Union, except Italy, Greece, and Belgium. The granted extension for these three countries was set to be till 2025.

 

 

At the moment, Italy is still one of the few EU countries that have not yet required mandatory serialization of medicines. That will change next year since the complete serialization of RX drugs has been confirmed for 9th February 2025.

 

 

In the case of Italy, the main objective of the transitional period was to ensure sufficient conditioning time to facilitate a smooth transition from pre-existing labels like Bollino to labels up to GS1 standards.

 

 

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.”.

italy pharma track and trace

Current situation

Less than a month after NMVO’s establishment, in February was published the “Legge di delegazione UE”, 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 “Poligrafico dello Stato” 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

Serialization requirements are mandatory, including GS1 2D Data Matrix and anti-tampering device.

2D DataMatrix 

  • Global Trade Item Number (GTIN)
  • Expiry date
  • Batch/Lot
  • Serial number (SN)

Human-readable part

  • Global Trade Item Number (GTIN)
  • Expiry date
  • Batch/Lot
  • Serial number (SN)

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Italy Track & Trace compliance

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