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The Secret to International Clinical Trial Shipments Clearing Customs

by Dan Polkowski

Does shipment success hinge on a person you may have never met?

An important member of your study team is a person you might never meet – it’s your registered importer, known formally as the importer of record (IOR).

When shipping study materials or medical equipment internationally, it is not unusual for them to get delayed in customs. The top two reasons why imports are stopped by country customs are:

1. Insufficient international paperwork

2. The registered IOR in country is not recognized

Many in the clinical study global logistics process find their study materials have been held in customs clearance because the party on the courier air waybill and pro forma invoice is not an in-country registered IOR. When this happens, customs agencies will place the import in a non-compliant status. That’s typically when clinical study teams turn the IOR status into a reactive process. This creates delays and inefficiency for all involved in the study. A proactive process is key.

The IOR provides a critical role in global clinical trial logistics success. Be proactive in your selection. Secure and vet a knowledgeable and resourceful IOR in each country months in advance of your actual export date. That’s how to eliminate customs clearance mayhem.

Your IOR needs to be compliant with the country’s import regulations, requirements and processes exclusively when importing various ancillary supplies, electronic and medical devices.

He or she needs to be able to translate the clearance documents when requested by country customs, perform formal clearance entry, and apply for licensure specific to commodities controlled by country government Ministry of Health and/or Ministry of Commerce. 

From the very beginning of study planning to delivery in country, open communication with all involved parties — pharmaceutical and contract research organization, exporter, courier, freight forwarder, importer, importer broker, and country customs — increases the outcome for optimum clearance and delivery.

Proactive global logistics planning in advance of shipping takes time, and this approach may seem like extra work. However, it is a much better option than having your trial supplies held by country import customs for days, weeks, and possibly months.

If you have questions about smoothing out the logistics process for your study, feel free to let us know. We’re happy to help.

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