H.Essers prepares warehouse for European FMD

H.Essers prepares warehouse for European FMD

The new European FMD or Falsified Medicines Directive will take effect on 9 February. The directive issued by the European Union aims to prevent counterfeit medicines from entering the legal distribution chain. Linde Van Vlasselaer is Solution Design Engineer at H.Essers and assists our pharmaceutical customers in the adaptations that are necessary to comply with this directive, as well as in the interesting opportunities it may bring, to relieve the burden on our customers as much as possible.

“In concrete terms, according to the directive, each unit for sale at pharmacies must be given a unique code as early as its production,” Linde explains. “This unique label that the product will receive is then recorded in the EU database created for this purpose. To assist our customers in this rather complex approach, we are investing heavily in the construction of a new GMP area at our site in Genk. From there, we can support our customers in applying the unique codes if their production facilities are not yet equipped for this. In these spaces, we will apply the labels to the products, and thanks to the dedicated IT infrastructure, we will be able to scan the codes and upload them to the European database. In addition to these labelling activities, we can also apply other labels, such as prices or country-specific labels and the like, to both primary and secondary packaging.”

Decommissioning

“Even if products are no longer allowed to enter the European market – for example, if they will be sold in another country than initially intended or if the goods are damaged – we can handle the decommissioning. It is a convenient solution for customers, as it can be done at storage locations and no extra transport is needed.”

“In our new GMP areas, we will be working in two or three shifts depending on customer demand. Since in any one processing area only products and documents of one specific batch may be present, we will have both a preparatory and a processing area. This enables us to work on multiple orders in the preparatory space, which considerably reduces the turnaround time. The room is also air-conditioned for 15 °C to 25 °C, and is close to a zone suitable for storage at 2 °C to 8 °C. This allows for the labelling of goods that need to be kept cool. As you can see, we leave nothing to chance.”

Interested in more information? Contact Linde Van Vlasselaer, linde.vanvlasselaer@essers.com.

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