FAQs – Antifraud stickers and tracebility
Although Directive 2011/62/EU (Falsified Medicines Directive) and Regulation (EU) 2016/161, introducing European harmonised measures to fight medicinal product falsification have become effective, in Italy the use of antifraud stickers is still provided for. Italy has in fact obtained a timeline extension until 2025, as a system to monitor possible frauds is already in place.
It is a tool ensuring the authenticity of the medicinal products marketed in Italy. It is a label on water-marked multi-layer adhesive paper, manufactured by the Istituto Poligrafico e Zecca dello Stato (State Printer and Mint), containing all essential information for the identification of a medicinal product and each of its packs.
They are a tool against counterfeiting and are used to identify univocally each single pack of medicine entering the Italian distribution chain.
They can be purchased from the “Istituto Poligrafico e Zecca dello Stato” (State Printer and Mint). There are several related activities, such as for instance the registration in the “Portale Unico Valori” (Securities portal), the data check and the taking on of responsibilities before the printing.
The sticker is considered as integral part of the secondary packaging.
“Drug Traceability” indicates the registration of the handling of all single packs of medicinal products by all stakeholders involved in the production chain: from manufacturing, to the intermediate (warehouses and wholesalers) and final (pharmacies, hospitals, para-pharmacies, etc.) distribution, up to the disposal of expired and unusable medicines.
The data involved in the detection concern:
- the supply of numbered stickers as per the Decree of Health of 30 May 2014 (by the Istituto Poligrafico e Zecca dello Stato – IZPS);
- the handling of the single packs of medicinal products for human use to be marketed in Italy via the detection of the product code and the identification number present on the packs;
- the value, per homogeneous therapeutic category, of the supply of medicinal products to the facliities of the National Health Service.
The transmission of traceability data occurs through the creation of a XML file, generated by specific software.
The XML files should be digitally signed and sent to the Ministry of Health through a dedicated platform.
Wasted stickers and any handling are transmitted by the logistic site carrying out the stocker application (or handling). If the sticker application occurs at a foreign site, or if the MA Holder takes advantage of the faculty of transmitting the data, this is responsible for the transmission.
The people responsible for the transmission (RdT) and the MA transmission responsible people (RdT AIC for human medicines only) that carried out the registration into the system and are associated to logistic sites for which they are appointed are authorised to the transmission to the Central database.
