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Arvato ready for tighter US drug rules

[ December 14, 2023   //   ]

German-owned supply chain company Arvato says it is prepared for tighter US drug requirements under the Drug Supply Chain Security Act which stipulates that pharmaceutical products must be electronically traceable at all times at package as well as batch level.

Medicine packs can be fully verified electronically via a specific serial number and a track-and-trace system.

Arvato says that with the FDA’s global influence, and the overseas footprint of many US drugs firms, it expects this to have an impact on Europe in the future and is already ready for the new requirements.

While a requirement for packaging to carry the Global Trade Item Number, serial number, batch number and expiry date, encoded in a 2D matrix code has been in force throughout the EU since 2019, the new US legislation also requires creation of an aggregation structure as a prerequisite for an import permit, showing which package is in which shipping unit and on which pallet, data which must be transmitted electronically to the consignee in advance.

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