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Author

Dan Polkowski

Dan Polkowski

Dan is export compliance manager for Imperial’s printing and global fulfillment team. He has managed global logistics and export compliance for over 25 years. Dan currently assists Imperial's team members and clients with his technical knowledge, subject matter expertise and training regarding a wide range of global trade topics. He analyzes the export/import regulations to over 115 countries, provides compliance risk justification for company and clients regarding each country’s import regulations and complexities, and provides global management of client clinical study print materials, ancillary, electronic and medical device commodities.

    Paper Plane flying around the globe. Around the world travelling by plane, airplane trip in various country. Planet Earth. Travel and tourism concept
    Site Materials & Logistics

    Importer of Record for Clinical Trials

    by Dan Polkowski September 7, 2023
    written by Dan Polkowski

    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.

    Business man point to people with many business person or working staff. Target customer or Human resource, head hunter concept. Global business target that can reach many people.

    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-on–deck with the IOR, the IOR’s broker, shipping courier, and customs all working together to resolve the import requirements.

    A man on his cell phone dealing with importer of records issues

    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.

    September 7, 2023 0 comment
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  • Ancillary Trial Supplies and Equipment

    COVID-19 Brings Pressure Testing to Ancillary Supplies and Equipment

    by Dan Polkowski May 4, 2021
    by Dan Polkowski May 4, 2021

    Managing ancillary supplies and equipment in clinical trials is complex, and strict import regulations make it a tough challenge. When the COVID-19 pandemic threw the world into the unknown, the global supply chain fell apart. In the blink of an eye, world trade came to a…

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  • Ancillary Trial Supplies and EquipmentBusiness Insights

    Clinical Trial Logistics: Here’s How to Clear Customs

    by Dan Polkowski May 1, 2019
    by Dan Polkowski May 1, 2019

    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…

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  • Ancillary Trial Supplies and EquipmentBusiness Insights

    Pre-approval communications prior to export: Why are they so important?

    by Dan Polkowski May 3, 2018
    by Dan Polkowski May 3, 2018

    The best way to answer this question is with the catchphrase a chain is only as strong as its weakest link.  After 25 years of managing global clinical trial studies for clients, I cannot emphasize enough how much this phrase relates to the global distribution…

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  • Ancillary Trial Supplies and Equipment

    Shipping Globally? Who is Your Importer of Record?

    by Dan Polkowski February 8, 2018
    by Dan Polkowski February 8, 2018

    Planning to export an ancillary supply or a medical device? Get ready for some bureaucratic red tape. Country governments take compliance with their import and export laws and regulations seriously. If a violation occurs, the in-country importer of record could find itself facing fines, penalties,…

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  • Business InsightsSite Materials & Logistics

    7 Caveats to ‘Just Ship It’, Part 2

    by Dan Polkowski June 1, 2017
    by Dan Polkowski June 1, 2017

    If you think logistics isn’t your business, think again… Logistics processes are not just for logistics personnel – they should be understood by everyone involved in the process in order to avoid thousands of dollars in delays and fines. Here’s my quick take on how…

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  • Site Materials & Logistics

    7 Caveats to ‘Just Ship It’, Part 1

    by Dan Polkowski June 1, 2017
    by Dan Polkowski June 1, 2017

    If you think logistics isn’t your business, think again… I often hear the phrase: “I provided you an address, just ship it, what’s the big deal?” Logistics processes are not just for logistics personnel – they should be understood by everyone involved in the process…

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  • Business InsightsSite Materials & Logistics

    2 Tips for Shipping Your Clinical Supplies Internationally

    by Dan Polkowski May 15, 2017
    by Dan Polkowski May 15, 2017

    Shipping clinical study supplies internationally is an art and a science. Customs departments add an unsympathetic layer of bureaucracy – if paperwork and preparations aren’t in line with the country’s regulations, you can expect headaches that will add costly delays that could impact your study’s…

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  • Site Materials & Logistics

    5 Countries with Challenging Import Regulations

    by Dan Polkowski March 14, 2017
    by Dan Polkowski March 14, 2017

      Shipping Study Supplies Internationally: How to Avoid Customs Delays in these Five Challenging Countries Shipping study supplies internationally is a challenge, even for the experts.  I have found In my 20+ years of global logistics experience that the shipping requirements of five countries consistently…

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Imperial Clinical Research Services Blog

Imperial is a global leader in clinical trial solutions and support, specializing in study and site print materials, ancillary trial supplies and equipment, clinical trial translation management, and clinical trial patient engagement.

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