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 timeline. Here are two tips that will help you rise to the global challenge.
Establish a clear process
My top recommendation is to create a well-defined process that is agreed to by all parties well in advance of making any shipments. It is easy for misconceptions about roles and responsibilities to cause confusion and delays, so the larger the number of parties involved in the clinical study, the greater the need for the sponsor to make the process as transparent and seamless as possible.
Understand the role of the importer of record
The importer of record (IOR) is a legal entity with several responsibilities: It ensures the imported goods comply with its country’s laws and regulations, it files completed duty entry and associated documents, and it pays assessed import duties and other taxes on the goods.
However, some countries allow delivery duty paid (DDP) transactions, where the IOR in country isn’t responsible for paying clearance charges – instead, they are billed to the owner of goods in the U.S.
The identity of the IOR varies from country to country; in Argentina, Brazil, China, and Russia, for example, the sponsor is the only entity allowed to assume the role of the IOR.
In other countries, the IOR can be a third party in country, such as a clinical research organization or a distributor.
That’s why it is important to understand the specific nature of the IOR in every country where you will be shipping your clinical study materials. In some cases, this will form part of a tax strategy and the IOR will be able to reclaim taxes paid on behalf of the sponsor. (There is an exception when the charges are paid through DDP terms as mentioned above, since the charges are billed to the shipper or owner of goods in the U.S., and not paid by the IOR in country.)
There is much more to consider when shipping supplies internationally. But these two concepts — establishing a clear process and understanding the role of the IOR — are the framework that will support the successful export of your clinical study supplies into countries around the world.
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