+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Drug traceability, all subjects involved

Tracciabilità del farmaco in Italia

Drug traceability is a relevant and delicate aspect of pharmaceutical management.

In fact, it allows unique identification of every single drug pack, protecting manufacturers from frauds, patients from dangerous counterfeiting and the public revenues from any damage.

Moreover, it is essential to monitor the supplies of medicinal products to hospital and pharmacies, and to have full picture of the trend of drug consumptions in our country.

Finally, it is a fundamental tool for pharmacovigilance, as it allows the awareness on all medicinal product packs handled and present in the market.

Drug traceability in Italy

In Italy, drug traceability is based on the presence of an antifraud sticker on the outer packaging of the drugs, including two barcodes (in the upper and lower part of the sticker) together with a datamatrix. These include all information on the drug.

Other information are also printed on the sticker, such as the name of the marketing authorisation holder and of the product, and the marketing authorisation (MA) number. It is also characterised by a unique number, actually assigning a numbering to each pack, that is attributed by the IPZS charged with the task of printing them.

Through this unique identification system, it is mandatory to transmit to a Central Database the data regarding the drug traceability, from manufacturing up to distribution.

These data include:

  • the “SFR” production waste (the stickers’ scraps and those correctly applied during the manufacturing process);
  • the flow “MOV”, including a great amount of events, such as the drug sale, theft, loss etc. and,
  • the flow “FAT”, regarding the economic values of the sales intended for the NHS (National Health System) facilities.

This Central Database is therefore fed by the various stakeholders of the distribution chain: manufacturing sites, wholesalers/depositories, MA holders or any suitable personnel delegated by them (outsourced activity), that can take care of the whole drug cycle.

The serialisation in Europe

At European level, the drug traceability system is managed through Directive 2011/62/UE, so called FMD (Falsified Medicine Directive), whose goal is to create a standard identification system allowing a full traceability of pharmaceutical products in Europe.

Data transmission is performed by manufacturers via the European hub EMVS (European Medicines Verification System), in turn enriching the national database, NMVS.

Italy is currently enjoying a waiver until 2025, being equipped with its own validated and functioning traceability system.

However, some discussions are taking place between the Ministry of Health, the Ministry of Economy and Finance, the AIFA and the IPZS, in order to make attempts to preserve the specific and positive aspects of our traceability system, and evaluate a proposal on a further postponement of the regulation implementing process for Italy, to be submitted to the European authorities.

Written on 23/01/2023 by: Alessia del Duca and Giordana Mastrosanti