Artesan, already ahead in the changeover to serialization
The year 2019 is approaching. The year pharmaceutical product serialization becomes mandatory. From 2019, no prescription medicines may be knowingly put to market without tamper-evident closures and serialization. Artesan was an early adopter of this challenge, with the aim to make the changeover for our customers as effective and affordable as possible.
We are meeting the challenge of serialization by fulfilling digital (coding) and analog (packaging) requirements.
|Software: PCE Level 3 System|
|Data-Matrix-2D-Code / GS1-Standard|
|Technical system: Mettler Toledo (Data-Matrix-Station + Tamper Evident)|
|German coding (PPN or NTIN)|
|French coding (CIP 13)|
|Turkish coding (ITS)|
|Korean coding (NTIN)|
|more available on request|
The Countdown to serialization has begun
From 9th February 2019, the Falsified Medicines Directive 2011/62/EU and the Commission Delegated Regulation (EU No. 2016/161) come into effect. From this point onwards, prescription medicines may only be brought into wholesale circulation throughout Europe if the packaging is stamped with an identifiable, individual serial number. Furthermore, the packaging must be clearly intact. Serialization is of existential importance for manufacturers and suppliers. Ultimately, it is the prerequisite for the sale of any medicines whatsoever. Seamless and reliable digital and analogue processes are therefore imperative here.
The main focus of serialization lies on the individualised serial number, which is linked to the respective manufacturing data (product identification GTIN/NTIN/PPN, use-by date as well as batch number). In this way a data matrix is created, which serves as a unique and fully traceable watermark. Accompanied by sealing labels on medicine packaging, it is possible to ensure that medicines are provably intact. This combination of digital and analogue serialization not only strengthens trust in the pharmaceutical companies’ products, but also provides doctors, chemists and patients as well as consumers with forgery and tamper-proof medicines.
We at Artesan offer you our comprehensive know-how for the serialization of your individual products. We have the most modern technologies for printing, packaging and labelling solutions at our disposal, as well as intelligent software systems for seamless serialization during production, ensuring safe, legally compliant pharmaceutical products.