{"id":70595,"date":"2023-09-07T17:07:17","date_gmt":"2023-09-07T17:07:17","guid":{"rendered":"https:\/\/www.imperialcrs.com\/blog\/?p=70595"},"modified":"2023-09-19T21:53:01","modified_gmt":"2023-09-19T21:53:01","slug":"importer-of-record-for-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.imperialcrs.com\/blog\/imperial-graphics\/importer-of-record-for-clinical-trials\/","title":{"rendered":"Importer of Record for Clinical Trials"},"content":{"rendered":"<h3 class=\"p1\"><b>Avoiding<\/b><b> <\/b><b>\u201cCustoms<\/b><b> <\/b><b>Chaos\u201d in Clinical Trials<\/b><b> <\/b><b>Means<\/b><b> <\/b><b>Working<\/b><b> <\/b><b>Closely<\/b><b> <\/b><b>with<\/b><b> <\/b><b>Your<\/b><b> <\/b><b>Importer<\/b><b> <\/b><b>of<\/b><span class=\"s1\"><b> Record<\/b><\/span><\/h3>\n<p class=\"p1\">Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the <a href=\"https:\/\/www.imperialcrs.com\/blog\/2018\/02\/08\/shipping-globally-importer-record\/\"><span class=\"s1\">importer of record<\/span><\/a> (IOR) for clinical trials. <span class=\"s3\">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.<\/span><\/p>\n<p class=\"p1\">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.<\/p>\n<p class=\"p1\">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.<\/p>\n<p><iframe loading=\"lazy\" title=\"Understanding the Vital Role of Importer of Record in Clinical Research Distribution\" width=\"1170\" height=\"658\" src=\"https:\/\/www.youtube.com\/embed\/f-OAEYs7eQg?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" allowfullscreen><\/iframe><\/p>\n<h2><\/h2>\n<h2 class=\"p3\"><span class=\"s3\"><b>Communication Is Part of The Plan<\/b><\/span><\/h2>\n<p class=\"p3\">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.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-70626 size-medium alignright\" src=\"https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-300x200.jpeg\" alt=\"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.\" width=\"300\" height=\"200\" srcset=\"https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-300x200.jpeg 300w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-1024x683.jpeg 1024w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-768x512.jpeg 768w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-585x390.jpeg 585w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-263x175.jpeg 263w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records.jpeg 1080w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p class=\"p3\">To eliminate your study team<span class=\"s3\"> finding itself <\/span>running around in circles, it is vital to engage in early planning and communications<span class=\"s4\"> with <\/span>your<span class=\"s3\"> in-country <\/span>IOR. This greatly reduces the likelihood of customs chaos. As the owner of<span class=\"s3\"> the items being shipped (<\/span>clinical study<span class=\"s3\"> and site <\/span>print materials, ancillary trial supplies and equipment, electronic and medical devices,<span class=\"s4\"> etc.), <\/span>it is your responsibility to:<\/p>\n<ul>\n<li class=\"li1\"><em>Make it a priority to understand the role of your IOR.<\/em><\/li>\n<li class=\"li1\"><em>Give your service providers access to and knowledge of your assigned registered IOR.<\/em><\/li>\n<li class=\"li1\"><em>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.<\/em><\/li>\n<\/ul>\n<p class=\"p3\">Medical ancillary supplies, electronics, and medical devices are regulated commodities, and the IOR\u2019s 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.<\/p>\n<p class=\"p3\">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.<\/p>\n<h2><\/h2>\n<h2 class=\"p6\"><b>What Happens When There\u2019s an Issue?<\/b><\/h2>\n<p class=\"p3\">What happens when a shipment is<span class=\"s3\"> <a href=\"https:\/\/www.imperialcrs.com\/blog\/2019\/05\/01\/clinical-trial-logistics-requires-the-right-importer-of-record\/\"><span class=\"s1\">held<\/span> <span class=\"s1\">by<\/span> <span class=\"s1\">country<\/span> <span class=\"s1\">customs agencies<\/span><\/a><\/span>? It becomes all-hands-on<span class=\"s3\">&#8211;<\/span>deck with the IOR,<span class=\"s3\">\u00a0<\/span><span class=\"s3\">the <\/span>IOR\u2019s broker, shipping courier, and customs all working together to resolve the import requirements.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-70625 alignright\" src=\"https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-clinical-trials-1-300x200.jpg\" alt=\"A man on his cell phone dealing with importer of records issues\" width=\"288\" height=\"192\" srcset=\"https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-clinical-trials-1-300x200.jpg 300w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-clinical-trials-1-1024x683.jpg 1024w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-clinical-trials-1-768x512.jpg 768w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-clinical-trials-1-780x516.jpg 780w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-clinical-trials-1-585x390.jpg 585w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-clinical-trials-1-263x175.jpg 263w, https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2023\/09\/importer-of-records-clinical-trials-1.jpg 1080w\" sizes=\"auto, (max-width: 288px) 100vw, 288px\" \/><\/p>\n<p class=\"p7\">There are over a hundred reasons why customs stops and holds an import, and the IOR assists with those clearance discrepancies.<span class=\"s4\"> To reduce customs clearance issues, it is best practice to have o<\/span>pen communication prior to<\/p>\n<p>export with the<span class=\"s4\"> IOR in the country, <\/span>owner of goods, exporter, shipper, and courier service.<\/p>\n<p class=\"p7\">Prior approval communications before export provide a more streamlined approach to the clearance process. Supporting a copy of the <a href=\"https:\/\/www.trade.gov\/pro-forma-invoice\"><span class=\"s1\">proforma\/commercial invoice<\/span><\/a> document (which contains detailed information about the goods and the parties involved) with the IOR is key to your success.<\/p>\n<h3><\/h3>\n<h3 class=\"p7\">Here Are Some Examples of Why Customs Will Hold Imports in Their Country:<\/h3>\n<ol>\n<li class=\"li1\">The proforma\/commercial invoice document does not support the IOR\u2019s 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.<\/li>\n<li class=\"li1\">Customs needs more information and asks the IOR:\n<ul class=\"ul1\">\n<li class=\"li1\"><em>Why are the goods are coming into the country?<\/em><\/li>\n<li class=\"li1\"><em>What will the goods be used for?<\/em><\/li>\n<li class=\"li2\"><em>Who will be using the goods?<\/em><\/li>\n<\/ul>\n<\/li>\n<li class=\"li1\">Customs asks the IOR to translate the invoice into their local language.<\/li>\n<\/ol>\n<p class=\"p1\">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.<\/p>\n<p class=\"p7\">I told you it is complex! For some plain talk about IOR, check out my recent chat with <a href=\"https:\/\/www.imperialcrs.com\/blog\/author\/dmcdonald\/\"><span class=\"s1\">Dan McDonald<\/span><\/a>. You can watch it below.<\/p>\n<h2 class=\"p1\"><b>The Imperial Advantage<\/b><\/h2>\n<p class=\"p10\">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.<span class=\"s3\"> <a href=\"https:\/\/www.imperialcrs.com\/contact\/\"><span class=\"s6\">Contact us<\/span><\/a> for help.<\/span><b><\/b><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Avoiding \u201cCustoms Chaos\u201d 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&hellip;<\/p>\n","protected":false},"author":8,"featured_media":70624,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[41],"tags":[395,408,50,119,398,401,396,405,397,410,333,399,404,393,394,407,400,411,402,406,403,409],"class_list":["post-70595","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-imperial-graphics","tag-clinical-study-shipments","tag-clinical-supply-chain","tag-clinical-trials","tag-communication","tag-compliance","tag-contract-research-organization","tag-customs-clearance","tag-customs-issues","tag-global-distribution","tag-imperial","tag-import-license","tag-import-regulations","tag-import-rules","tag-importer-of-record","tag-ior","tag-local-language-translation","tag-pharmaceutical-companies","tag-shipping-expertise","tag-sponsor","tag-tax-identification-number","tag-third-party-ior","tag-timely-delivery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Importer of Record for Clinical Trials - Imperial Clinical Research Services Blog<\/title>\n<meta name=\"description\" content=\"Learn about the crucial role of the Importer of Record (IOR) for clinical trial shipments. 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