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Antifraud stickers and traceability of medicines: in Italy still until 2025

Drug serialisation is a tool to improve product safety, ensure patients’ health and prevent frauds.

As of February 2019 all Countries shall comply with the new European serialisation system, with the sole exception of Italy, Belgium, and Greece that – already having a drug traceability system in place to monitor drug supply and distribution – were granted a time extension until 2025.

More specifically, in Italy article 40 of Law 1st March 2002 no. 39, provides for the set-up of a central Database at the Ministry of Heath, collecting all manufacturing and supply data of numbered stickers for medicinal product and recording any transaction of the single packs.

Article 40 establishes that all actors of the pharmaceutical chain – from the manufacturers up to the final users (pharmacies opened to the public, health centres authorised to use medicines, primary care units, and drug disposers) – are bound to file and transmit the product code and identification number (sticker progressive numbering) of each pack and the corresponding destination to this database. Those who receive the product are in turn bound to file its code and identification number.

The Decree of the Ministry of Health of 15 July 2004 has established the setup of this database defining the relevant guidelines to implement the theoretical models defined by Law 39/2002, and has specified “all medicinal products for human use marketed in Italy” as the field of application.

Based on this new regulation, each Pharmaceutical company holding MAs in Italy shall apply a specific antifraud sticker on each pack. This will report the name of the MA holder, the name of the product, the progressive number of the sticker, the MA number, and the description of the packsize.

The sticker also includes two barcodes (an upper and a lower barcode), and a datamatrix, including the information of the two barcodes (MA code in base 32 sticker’s batch number).

All this allows to make the national pharmacovigilance program more effective and to provide an accurate overview of the consumption of medicines, and consequently, to develop a prescription system ever more suited to the need of consumers.

Written by: Ersilia Fiorentino