Marchesini Group and SEA Vision: ready-to-use serialisation technologies
Technological compliance with drug traceability regulations sees the Group as a key player, providing integrated solutions and rapid responses for the achievement of objectives.
The inter-ministerial decree, implementing the so-called FMD Decree, which introduces the new drug serialisation system in Italy, in line with Delegated Regulation (EU) 2016/161, officially came into force on 28 January 2025. Italy benefited from a multi-year dispensation that postponed the mandatory adoption of measures under the Falsified Medicines Directive (FMD). Today, our country is called upon to conform to European standards in the fight against counterfeit medicines and for the protection of public health.
The drug identity card
The key element in this transformation is the Data Matrix code, a unique identifier that enables traceability at every stage of the distribution chain. This electronically readable two-dimensional code contains a set of information coded according to the international GS1 standard. The following are identifiable on the inside: product code; unique serial number; batch number; expiry date and marketing authorisation number issued by AIFA, the Italian Medicines agency.
No more tampering with packages, with ATD
In addition to the Data Matrix, the new system, in operation in Europe since 2019, also includes an anti-tampering device (ATD) for packs and a new type of security sticker that only bears a serial number, different from the one on the Data Matrix. All the information is then collected in a national database, managed by AIFA and the Ministry of Health, where the serialised codes are registered and verified. After an initial test phase in which the Italian national system will be connected to the European EMVO hub, serialisation will be fully operational from February 2027.
Marchesini Group's integrated solutions – Sea Vision
To deal with the transition brought about by serialisation, pharmaceutical companies must equip themselves with systems able to generate, print, verify and transmit serialised codes, with the aim of making the pharmaceutical supply chain more secure, transparent and digital. A key role in this process will be played by Marchesini Group's solutions which can be integrated with SEA Vision systems to offer a fast, flexible and comprehensive response to achieve these goals. Labellers such as the BL-A415 are designed to manage the serialisation process by printing the Data Matrix and applying the labels, while SEA Vision's comprehensive software manages the entire serialisation and aggregation process, including integration with ERP systems and the NMVO Italia database. As a multinational company that exports worldwide, the Group has gained the know-how and experience necessary to support Italian companies in this complex transition required for compliance with European standards.
