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Europe and the United States have taken a leading role in the fight against counterfeit medicines. Their priority is to ensure consumers’ right to receive authentic medications through regulations aimed at medicine safety.
In 2013, the FDA (Federal Drug Administration) introduced the UDI (Unique Device Identification) system for pharmaceutical coding. The UDI codes for medical devices require the identification of each medical device throughout the entire supply chain. To comply, manufacturers of medical devices and their suppliers must mark each product with a unique identifier (UDI code) composed of four data points according to FDA labeling: product code, serial number, batch number, and expiration date.
This information must be included within a barcode or a datamatrix code dedicated to pharmaceuticals. The identifying number must be visible on the package and readable by both humans and optical scanners.
In Europe, the anti-counterfeiting directive that took effect in February 2019 implemented the serialization process for pharmaceutical products along with data aggregation. Unique identification is mandated for all prescription medicines, along with a tamper-evident device to ensure packaging integrity.
This guarantees the inviolability of the packaging and the authenticity of the product, enabling pharmaceutical tracking in case of adverse events to protect consumer safety.
Zanasi inkjet printer and marking systems are designed with a flexible approach, allowing their integration into the complex pharmaceutical track-and-trace process, including drug marking. Thanks to these marking systems for pharmaceuticals, medication traceability is possible.
Through collaboration with qualified and certified partners, we provide comprehensive solutions consisting of a serialization station and related data aggregation management.
The complete station can be divided into individual modules. Marking systems can be integrated within these modules to interact with the devices they contain, ensuring precise, readable coding on various types of substrates and pharmaceutical packaging.