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Clinical Trial Logistics: Here’s How to Clear Customs

by Dan Polkowski
International Clinical Trial Shipments Clearing Customs

Updated: July 11, 2022

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. In global logistics, the top two reasons imports are stopped by country customs are:

1. Insufficient international paperwork

2. The IOR supported by the pharmaceutical company or contract research organization client is not recognized as a registered importer by the in-country customs agency

Why is your international clinical trial shipment in customs hold?

Many in the clinical study global logistics process find their study materials placed in customs clearance hold 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 is 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 for customs clearance and delivery.

The registered IOR in-country 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.

Requirements for IORs

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

He or she needs to be able to translate the clearance documents when requested by country customs, assist with formal clearance entry, and apply for licensure specific to commodities controlled by the country government Ministry of Health, Ministry of Commerce, FDA, or Consumer Product Safety Commission. 

Get everyone on the same page

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 clinical trial logistics process feel free to let us know. We’re happy to help.

For more global logistics information, check out our blog on the clinical trial supply chain.

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