Implementing the Falsified Medicines Directive with Arvato

The serialization of prescription medicines is mandatory in the EU since February 9, 2019 to prevent counterfeit drugs from entering the legal supply chain. All affected medicines that will be put into circulation from this key date onwards must carry a so-called unique identifier (2D data matrix code incl. serial number) on the folding box, which must, in addition, be sealed with an anti-tampering device. To produce millions of randomised, alphanumeric serial numbers, apply them to the drugs packaging and include the data when tracking goods movements will require special machines, powerful IT systems and intelligent processes. Arvato can offer both the necessary hardware and suitable software solutions and processes to enable the distribution of medicines in line with the FMD requirements, thereby facilitating end-to-end verification. 

The manufacturing process: more than just a code on packaging

Arvato is very well prepared for serialization requirements: The healthcare site in Harsewinkel has its own machine to print and seal folded boxes. Using an interface to Arvato’s Corporate Serialization Database (CSDB), serial numbers can either be obtained by manufacturers or generated on their behalf and transmitted automatically to our own production line in a GMP-compliant production facility together with the production order. Once the folding boxes have been printed and sealed, the serial numbers are either notified back to the customer or uploaded to the relevant national verification system on their behalf via the EU hub.

With this service, Arvato offers customers the opportunity to serialise pharmaceutical products at short notice and without high investment ( late-stage finishing/postponement ), thereby complying with the FMD requirements within the EU as well as the increasing global requirements relating to the protection of medicines against counterfeiting.  

The handling process: more than just scanning a barcode

The Falsified Medicines Directive will also result in far-reaching changes regarding the logistics involved in the distribution of prescription drugs and the underlying processes. While the serial numbers will not be verified until the medicines are handed over to patients, the upstream process stations in the supply chain must also record the codes to ensure appropriate status management in the national verification systems. Arvato offers its customers a number of logistics concepts that are geared to satisfy the serialization requirements, in some instances even exceeding them and including aspects of aggregation, for instance. Arvato has an additional machine that generates labels for aggregation on shipment boxes and pallets, which provide information about the entire content of the shipment unit with a single scan. Aggregation is already a requirement in many countries outside the EU. Due to the years of experience in handling serialized products gained by other Arvato divisions, the Healthcare Unit can fall back on powerful IT as well as intelligent processes that already exist. This makes business processes more efficient.

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Also interested in IT Solutions?

Arvato’s own Corporate Serialization Database (CSDB) is an optimum IT solution for your serialization management. Acting as a Certified Gateway Provider, Arvato generates serial numbers for the folding boxes and transmits them to the national verification systems (e.g. “SecurPharm” in Germany) via the EU hub. This allows pharmacies to determine whether medicines are real and verified and thus can be sold or not. Many national verification systems in Europe already rely on Arvato’s IT expertise.

Arvato’s serialization experts thus cover the entire supply chain in the healthcare segment, from postponement to logistics handling to the verification system. 

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Jens Wagner

Jens Wagner

Project Manager Strategic Projects