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Authorization enables the Frankfurt depot to ship to non-EU countries without filing EU paperwork
Marken (Research Triangle Park, NC), a leading express-delivery company for life sciences, has added a “customs-bonded warehouse” authorization to its Frankfurt depot. "With this certification, pharmaceuticals sent through a customs warehouse can now be shipped to non-EU countries as soon as the clinical trial is approved. This will obviously speed up delivery to the patients and investigator sites who are awaiting these clinical trial materials," according to Andrea Zobel, Marken's VP of global project management & feasibility.
The customs-bonded warehouse has similarities to what are commonly called free-trade zones, which allow for movement into and out of a country or region without customs clearance. According to the company (and a white paper available here), current EU regulations require a “qualified person” to certify that investigations medicinal products (IMPs) brought into the region are in compliance with good manufacturing practices before the products can be shipped within the EU. The QP process can necessitate substantial paperwork from the originating source (nominally, the trial sponsor). But EU locations like Frankfurt are an important transfer point for many clinical trial shipments whose destination is outside the EU. With the customs-bonded status (which requires an inventory management system that tracks the status and identification of the shipment), however, shipments destined for non-EU locations can be sent along. In addition, IMPs that are being repackaged or relabeled, for both EU and non-EU destinations, can be handled somewhat more efficiently, with QP management of the requirements of the destination.