EU-FMD Italy track and trace

[Blog] The serialization deadline for Italy is coming into force in 2025


The date of 9 February 2025 for the complete serialization of RX drugs in Italy has been confirmed.


Italy is 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. In 2019 the EU introduced the serialization system for pharmaceuticals, granting an extension period till 2025 for some countries including Italy.








Track and Trace Requirements


The requirements for Italy are not significantly different from those of the other EU countries. The “bollino” will be removed and the GTIN-Batch Number-Expiry Date – Serial Number – AIC Number will be printed with the relevant DataMatrix and Antitampering device.


For OTC/SOP drugs there will be a “light” approach with the removal of “bollino” and printing of GTIN-BATCH-EXPIRY-AIC NUMBER with related DataMatrix. The use of the anti-tampering device still needs to be clarified.


Marketing authorization holders will send serialization data to the European Hub – EMVO. The legislative decree is expected to be issued by the government.





Road toward Traceability


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.


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.





Pharmaceutical Landscape in Italy


Research marked a significant expansion of the pharmaceutical market in Italy regarding growth, trade, and investments. The Italy Pharmaceutical Market size is estimated at USD 37.70 billion in 2024 and is expected to reach USD 44.80 billion by 2029, growing at a CAGR of 3.51% during the forecast period (2024-2029). Based on the results, Italy has turned into one of the world’s leading pharmaceutical markets.


At the moment Prescription Drugs segment holds the largest share and is expected to do the same in the forecast period. The medicines in this segment are heavily regulated and the control will become even more stringent with the enforcement of EU-FMD.





SoftGroup follows the journey of Italy toward Track and Trace enhancement from the very beginning and our team is here to provide you with all the needed information. If you are going to face the challenges of enforcement of EU-FMD in Italy – do not hesitate and meet our experts >>