FAQs – Antifraud stickers and tracebility

The antifraud sticker (“bollino ottico o farmaceutico”) is a tool ensuring the authenticity of the medicinal products on the Italian market. It is a support on a multi-layer adhesive paper, manufactured by the IPZS (Istituto Poligrafico e Zecca dello Stato, the State Printing and Mint Institute), containing all essential information for the identification of a medicine as well as each single pack. It is applied on the secondary packaging of pharmaceutical products.

They can be ordered via the IPZS website by the MA holder or a person delegated by the MA holder.

To present the request, IPZS should be provided with all information regarding the medicinal product for which the antifraud stickers are ordered. Together with information regarding the medicinal product, copy of the relevant publication in Official Journal of the Italian Republic should also be provided in order to check such information.

Antifraud stickers report the following information:

• MA code (identification code of human medicinal products, a number assigned by the Italian Medicine Agency – AIFA when authorising the marketing in Italy);
• Name and description of the medicinal product;
• Name of the MA holder;
• 9-digit progressive number assigned by the IPZS.

Decree of the Ministry of Health 30 May 2014 provides for a third code (Data Matrix) on the antifraud sticker, summarising all information included in the other two codes.

Drug traceability is a system dedicated to the control of the packs of medicinal products marketed in the Italian distribution system, consisting in the collection of information into a centralised database managed by the Ministry of Health.

Various competent authorities are involved in this system: AIFA, Ministry of Health and also police forces, like the NAS (Nucleo Anti-Sofisticazione, Anti-Counterfeiting Unit).

The data to be transmitted concern three flows.

• SFR, concerning the manufacturing waste, i.e. stickers that were broken/destroyed during the manufacturing process;
• MOV, regarding the handling of stickers or product packs (e.g. sales, thefts, returns);
• FAT, regarding the value of the supplies paid by the NHS in pooled data per MA/Customer logistic site, month and region of the customer. It is used for supplies of medicinal products only.

Traceability data are collected and sent via a file validated by electronic signature to the Ministry of Health, into a dedicated web portal.

Every user intending to transmit the data should apply for authorisation to the Ministry.

The database is fed by several stakeholders: manufacturing sites, distributors/wholesalers, depositories, MA holders when the secondary packaging or logistic site they use is located abroad, a preliminarily authorised user, delegated by the MA Holder.

In Europe, the drug traceability system is managed by Directive 2011/62/EU, the so called FMD (Falsified Medicine Directive) whose goal is to create a European standard identification system, allowing full traceability of pharmaceutical products in Italy. Data transmission takes place via a European hub, EMVS (European Medicines Verification System).

Italy is currently benefiting from a waiver until 2025 but shall comply with Directive 2011/62/EU.

However, all necessary consultations between the Ministry of Health, the Ministry of the Economy and Finance, the AIFA, and the IPZS are still ongoing, in order to try and save the specific features positively identifying our system and to consider a proposal for a further postponement of the regulation implementing process to be submitted at European level.