Customer Story
The Challenge
Our customer, a global CMO, asked us to process serialization data, as their packaging process did not allow this. Our job was to process their encrypted data in our printing press and convert the result of the serialization process back into another encrypted file format.
The Solution
Faubel set up an SFTP server to securely transfer the serialization data. Special software was coded to process the pharmacist's encrypted file. The reformatted serialization data was then applied to a single-layer label in the printing press. The mandatory data stored in the 2D DataMatrix code, such as expiry date, batch number, serial number, and article number, were displayed in plain text on the label. During printing, the printed image was checked for legibility and grading by a 100 percent camera inspection. The software then rewrote the serialization control protocol into the encrypted file format supplied by the pharmacist.
Counterfeit Prevention
In February 2019, the EU Falsified Medicines Directive (FMD) 2011/62/EU was introduced: the first legally binding and Europe-wide measure to curb counterfeit medicines. Pharmaceutical manufacturers were required to affix a code on the outer packaging for identification purposes and a tamper-evident code proving the integrity of the packaging. This code contains mandatory information such as the manufacturer's name, expiry date, batch number, article number, and serial number. In the U.S., the Drug Supply Chain Security Act (DSCSA) requires all prescription drug packaging to carry a unique product identifier by November 27, 2023.
Suspicious Cases
The FMD provides a 10-day window after an alert appears to the entity where the prescription drugs were initially dispensed (pharmacy, hospital, physician's office, amongst others), asking it to clear the alert and then reactivate the products concerned in the Europe-wide FMD database (the European Medicines Verification System, EMVS) as legally marketable products.
Illegal Medicines
As a measure against illicit trafficking in counterfeit and misused medicines and doping products, Europol conducted Operation Shield III between April and October 2022. Over 10.5 million drugs worth over 40 million euros were seized during this operation, which involved police and customs authorities from 28 countries (19 EU Member States and nine third countries). The total market for counterfeit medicines is estimated to be worth $200 billion and is growing by 20 percent every year ̶ twice as fast as the legal pharmaceutical market.
If you wish to know more about the EU Anti-Counterfeiting Directive 2011/62/EU, visit the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices) website for more comprehensive information.
Further details on Operation "Shield III" are summarized on Europol News.
