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On February 9th2016, Mr. Juncker, president of the European Union, signed the Delegated Act to the Falsified Medicines Directive (FMD). From that moment on, all EU member states had to incorporate this Delegated Act in their national legislation. Pharmaceutical companies had three years to implement the Delegated Act (often referred to as FMD) in their production processes
The objective of the FMD is to prevent falsified medicines, which may contain ingredients of bad or toxic quality, or in the wrong dosage, get access to the market. The answer to this is packing all prescription drugs in such a way that pharmacies can easily verify the authenticity of a drugs package and check whether the seal is broken. On each folding box for prescription drugs, a unique, random, serial number is printed and every box is sealed. All packed serial numbers are reported to a European database, when medicine batches are released to the market. The pharmacist checks the status of the serial number in the database and changes it to ‘issued’ when the product is issued to patients.
In order to implement an easy way of verifying the serial number status, a 2D barcode with the product code and serial number are printed on the folding box. When issuing the pack to a patient, the pharmacist simply scans the barcode and his computer system verifies the pack status and records the issue. Likewise wholesalers are required to sample verify the status of received medicines in a similar way, so falsified drugs are prevented from entering the distribution channels.
The introduction of the FMD required Basic Pharma Manufacturing to migrate from in-line printing the batch number and expiration date to printing more data and a 2D barcode and to apply a tamper evidence provision. This required investments in software (for the management of the serial numbers) and production equipment for printing and sealing the folding cartons. In addition all artwork had to be checked and adapted to accommodate the seal and the extra print.
The software selected to manage the serial numbers (Arvato’s CSDB*) communicates with our customers and with the European database. It connects our ERP system with our production lines, so that production orders get random serial numbers. These numbers can be requested automatically from and supplied by our customers, but with CSDB we can also generate these numbers as a service to our customers.
Since initiation of the project last year, we worked hard on the acquisition and implementation of new serialisation equipment for our packing lines (Wipotec-OCS TQS machines) and the software we licensed from Arvato. Visitors, who knew our packaging department before the project took off, will hardly recognise this department now. New machinery and equipment is already in full production for inline printing of boxes with lot number and expiration date. We expect to deliver our first FMD compliant production batches by the end of the summer, this year.
The transformation of the packaging department was not possible without the effort of all our people, especially the packaging operators. They had to adapt to new and more complex equipment, new procedures and new work instructions. Now we are fine-tuning the systems and procedures still require everybody’s attention, but we are ready to comply with the FMD in time, where many of our customers and colleague manufacturers are struggling to meet the EU-determined deadline.
Being ready to comply with the FMD does not mean we are ready with the project. We are now working, together with our customers, to connect the computer systems and to set up the collaboration with each individual customer. Per customer we have to determine and implement how to work with serial numbers, what and when to report, etc. With some customers, we are still working on the artwork changes, with other customers we have already tested the software and connections.
There is still much work to do, but Basic Pharma Manufacturing is fully confident to be ready for the FMD in time.
*CSDB in this context means: Corporate Serialisation Data Base