In one corner of the world, an elderly patient anxiously waits for medication for her congestive heart failure. In another, an outbreak of a contagious, deadly virus may threaten the lives of thousands, unless those all-important vaccine shipments arrive in time. The global pharmaceutical market is critically important and thriving as a result, but it’s important to remember that this complex sector has many pain points. From a distribution standpoint, errors during the customs clearance process may impair your ability to ship and deliver pharmaceutical supplies on time and in good condition.
Customs clearance problems can have a range of far-reaching effects. First, there’s a risk of penalties if the correct information isn’t provided upfront. Pharmaceutical products are complex products and the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) work hard to make sure that that the products do not violate customs law. “If the FDA identifies issues with the importer of record, or even the manufacturer, they have broad authority to take action,” says Courie Dennis, Brokerage Operations Manager at UPS Supply Chain Solutions.
There’s also the risk to the product when shipments of certain medications are delayed. “UPS Healthcare believes in the It’s A Patient, Not A Package® philosophy. There is a person waiting for your product,” says Gregory Tompsett, Division Manager at UPS Supply Chain Solutions. Many pharmaceutical supplies are time and temperature-sensitive, potentially increasing the risk of spoilage if customs clearance issues arise.
So, what types of problems occur for pharmaceutical distributors? What factors are most likely to cause problems with customs clearance? One important issue might be when an importer does not comply with the FDA process.
A second scenario, may be when an importer fails to supply all of the correct details needed for customs clearance. The FDA has visibility into the process and a lack of correct detail may result in delays, or ultimate refusals of your shipments. As Dennis puts it: “Data integrity is an important part of a timely FDA clearance. When information transmitted by the broker is not consistent with the FDA’s records, the electronic entry process could potentially be halted. When FDA personnel have to manually make an admissibility decision, the transaction could be delayed and you could experience detentions, exams, or entry refusals”.
Variances in customs regulations across countries can make the customs clearance process increasingly complex. If you’re not prepared to deal with these challenging regulatory issues, the consequences can be stark. We understand how difficult that can be. Follow the steps below to help optimize your chances of a faster customs experience, so your time-sensitive products can arrive exactly where they need to go, when they need to be there.
1. Streamline your documentation process
“Clear and precise documentation is the backbone of the importing process. Missing or incorrect information is usually the crux of issues we face,” explains Tompsett. Because the complexity and level of detail is so significant, a streamlined documentation process is probably the most crucial element of the export/import customs process.
An experienced logistics provider with experience in the area of FDA requirements related to pharmaceutical supplies, such as UPS, can help make sure that your documentation information is not only correct, but timely provided to the FDA. “UPS typically is proactive in terms of making those documents available to the FDA,” notes Dennis. In addition, UPS has document imaging technology which can help to streamline your documentation process even more effectively.
2. Improve visibility around your inbound and outbound shipments
When it comes to customs clearance, proactive, real-time visibility is critical. Reacting to any roadblocks as they happen can help to minimize delays, especially for pharmaceutical supplies when shipping out of a country or territory. Fortunately, UPS services like UPS Quantum View® and Flex® Global View tracking and visibility tools offer a wide range of benefits around the export/import customs process. Tompsett puts it like this: “Everything in the import and supply chain business is about having good information. Quantum View and Flex Global View technologies provide you with real-time information at a granular level so that you can make informed decisions on how to pivot, change, and re-plan as things crop up.” tracking and visibility tools
3. Confirm that all the required documents are included
Although it sounds simple, it’s important to make sure that all required forms and documents are included with your shipment. Commercial invoices—the primary documents for importation control—are always required, while certificate of origin forms may be necessary when dealing with countries that require them. “When certificate of origin applies, it’s very important,” says Tompsett.
4. Get advice from an international trade expert
Working with an international trade specialist can help to reduce the risks of export/import customs issues. “UPS recognized that there was a need for a higher level of trade consulting, and that’s why we acquired one of the most well-respected trade management services groups in the industry: STTAS. They are a world-renowned resource for import trade issues and are able to handle a variety of complex and out-of-the-box situations,” says Tompsett.
By working with an international trade expert, working proactively to ensure that you’re aligned for clearance, and boosting visibility around shipments, medical supply distributors can help to optimize conditions for a quicker customs clearance process, and help make sure that your pharmaceutical supplies get to where they need to go on time and in good condition. Find out more about how UPS customs services can help pharmaceutical distributors cross borders.
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