Importer of Record for Clinical Trials

by Dan Polkowski
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Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record

Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials. The IOR is the person or entity responsible for ensuring that the goods brought into the country are imported in adherence to the laws and regulations of the importing country.

To prevent delays in your clinical study shipments, proactive planning and selection of the IOR are critical to success. An experienced and knowledgeable IOR is vital to bring visibility, compliance, and control to the customs clearance process.

The complexity of the role of the importer of records for clinical studies varies from country to country, and restrictions can be inconsistent. For example, in some regions and countries, only the pharmaceutical company, contract research organization, or sponsor can act as the IOR. In other global regions, the IOR can be a third party.

Communication Is Part of The Plan

A careful review and verification of documents allow a more streamlined process for customs clearance and reduces, even eliminates, the likelihood that customs will stop the shipment during the clearance process.

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To eliminate your study team finding itself running around in circles, it is vital to engage in early planning and communications with your in-country IOR. This greatly reduces the likelihood of customs chaos. As the owner of the items being shipped (clinical study and site print materials, ancillary trial supplies and equipment, electronic and medical devices, etc.), it is your responsibility to:

  • Make it a priority to understand the role of your IOR.
  • Give your service providers access to and knowledge of your assigned registered IOR.
  • Have a strong link in the relationship among the owner of goods, IOR, shipper, courier, and customs broker by informing your in-country IOR of the products you are exporting.

Medical ancillary supplies, electronics, and medical devices are regulated commodities, and the IOR’s involvement with customs clearance will be required. Each country has its own import rules based on commodity type. Your in-country IOR should have knowledge of the specific import rules.

For example, electronics and medical devices will require import licenses/permits in place prior to the goods arriving in the destination country. If these key factors are ignored, efficiency becomes impossible. Timely customs clearance and final door delivery will not be achieved.

What Happens When There’s an Issue?

What happens when a shipment is held by country customs agencies? It becomes all-hands-ondeck with the IOR, the IOR’s broker, shipping courier, and customs all working together to resolve the import requirements.

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There are over a hundred reasons why customs stops and holds an import, and the IOR assists with those clearance discrepancies. To reduce customs clearance issues, it is best practice to have open communication prior to

export with the IOR in the country, owner of goods, exporter, shipper, and courier service.

Prior approval communications before export provide a more streamlined approach to the clearance process. Supporting a copy of the proforma/commercial invoice document (which contains detailed information about the goods and the parties involved) with the IOR is key to your success.

Here Are Some Examples of Why Customs Will Hold Imports in Their Country:

  1. The proforma/commercial invoice document does not support the IOR’s tax identification number (TIN). For example, if the TIN is not on the commercial invoice document or if the TIN does not match what customs has on file in its registry, customs will request the IOR to support their valid TIN.
  2. Customs needs more information and asks the IOR:
    • Why are the goods are coming into the country?
    • What will the goods be used for?
    • Who will be using the goods?
  3. Customs asks the IOR to translate the invoice into their local language.

Open communication in the planning of your study all the way to the final delivery location is vital. This allows for enhanced efficiency and significantly lowers your risk across the entire clinical supply chain process. All this helps reduce delays for timely and efficient door-to-door service for your clinical study materials.

I told you it is complex! For some plain talk about IOR, check out my recent chat with Dan McDonald. You can watch it below.

The Imperial Advantage

With over 45 years of experience in clinical trials, and shipping expertise to 125 countries, Imperial understands the many challenges and complexities of global distribution and working with importers of record for clinical trials. Contact us for help.

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