Belgium
USA trade laneBelgium is one of the world's largest exporters of pharmaceuticals. Vaccines, biologics, finished medicines and active ingredients leave Belgian plants every day, much of it by air through Brussels Airport (BRU) and Liège Airport (LGG), both with dedicated pharma handling, and a growing share by ocean from Antwerp. For US importers the rules changed in 2026: patented medicines now carry a Section 232 tariff, while generics remain excluded.
The cold chain itself is run by qualified partners, not by AGF staff. We arrange pharmaceutical shipments from Belgium through WCA partner agents there — AGF has no office in Belgium — and through airlines, airport handlers and packaging providers qualified for temperature-controlled pharma, and our licensed customs brokers file the entry with the FDA data the shipment needs. This guide is for licensed manufacturers, distributors and importers of record, not for personal imports.
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Shipping Pharmaceuticals from Belgium to USA
Most finished pharmaceuticals fly. BRU and LGG reach major US gateways in 1–2 days, and temperature-controlled shipments travel either in active containers that hold a set point (typically 2–8°C or 15–25°C) or in validated passive packaging sized to the route and the season, with data loggers recording the temperature end to end. Lane assessments and contingency plans — what happens if a flight is cancelled or the shipment is held at the border — are agreed before the first shipment, not during it.
Ocean is increasingly used for stable, less time-critical products: a temperature-controlled reefer from Antwerp reaches the US East Coast in roughly 10–14 days and the West Coast in 22–28 days, at a fraction of the air cost. Ocean pharma needs a validated set point, continuous power and monitoring, and a plan for the port and drayage legs, which is where temperature excursions usually happen.
- Air from BRU or LGG to US gateways in 1–2 days, in active containers or validated passive packaging
- 2–8°C and 15–25°C ranges, with data loggers end to end
- Ocean reefer from Antwerp for stable, less time-critical products
- Contingency plans agreed in advance for delays, holds and FDA examinations
What Drives the Cost
- Air versus ocean, and active container versus passive packaging
- The temperature range and the duration the packaging is qualified for
- Section 232 status — patented, generic or specialty product — and any agreement the importer holds
- FDA review time at entry, and storage at the correct temperature if the shipment is held
- Insurance for high-value, temperature-sensitive cargo
- Final-mile delivery by GDP-compliant carriers to your 3PL or distribution center
HS Codes and Duty Notes
Classification guidance only — duty rates change and depend on your exact product. Our licensed customs brokers verify every code before you commit to an order.
| HS Code | Products | Notes |
|---|---|---|
| 3004 | Medicaments in measured doses or retail packs | Most finished medicines have a free base rate. Patented products fall under Section 232 at 15% all-in for EU origin; generics are excluded at the time of review. |
| 3002 | Vaccines, blood fractions, immunological products, and cell and gene therapies | Biologics are regulated by FDA's Center for Biologics Evaluation and Research. Section 232 treatment depends on patent status and the specialty-product provisions — confirmed per product. |
| 3003 | Medicaments not in measured doses — bulk finished product | Bulk shipments for US packaging or fill-finish face the same FDA and Section 232 questions as finished packs. |
| 2933–2942 | Active pharmaceutical ingredients — heterocyclic compounds, hormones, antibiotics and other organic chemicals | Many APIs enter free under the tariff schedule's pharmaceutical appendix. APIs and key starting materials for patented medicines can fall under Section 232. |
Regulations and Compliance
Section 232 tariff on patented pharmaceuticals
Under a Section 232 proclamation of April 2026, patented pharmaceutical products — and the active ingredients and key starting materials for them — carry a tariff that, for products of the EU, is 15% all-in: the cap absorbs the normal duty rather than stacking on top of it. It has applied to most importers since 29 September 2026, and from 31 July 2026 to companies named in the proclamation. Generic medicines and biosimilars are excluded at the time of review, though the exclusion is due to be reassessed, and certain specialty products and companies with US onshoring or pricing agreements receive different rates. The applicable Chapter 99 provision must be reported at entry even where the rate is zero, so each product's patent status needs to be established before it ships.
The Section 301 measure on EU goods
Since 24 July 2026 most EU goods have paid their normal duty topped up to 10% in total under a Section 301 measure. Goods under Section 232 are not stacked with it, and several hundred tariff lines entered for pharmaceutical use are exempt. Which treatment applies is a line-by-line question our licensed customs brokers settle at quoting.
FDA drug registration, listing and approval
The Belgian manufacturer must be registered with FDA as a drug establishment, list its products and name a US agent, and the product must be approved under an NDA, ANDA or BLA, or otherwise lawfully marketed in the US. The entry carries the registration, listing and application numbers and the NDC. Unapproved products, and products from establishments on an FDA import alert, are held or refused.
Biologics, controlled substances and clinical supplies
Biologics such as vaccines and blood products are regulated by FDA's CBER and may be subject to lot release. Controlled substances need DEA registration and an import permit or declaration before they ship. Investigational products for US clinical trials enter under an IND, with their own labeling and documentation.
Good Distribution Practice and the cold chain
On the Belgian side, medicines move under the EU's Good Distribution Practice guidelines, which govern temperature control, qualified packaging and documentation. AGF arranges this through GDP-compliant partners — airlines, airport handlers at BRU and LGG, and packaging providers — and the temperature record travels with the shipment for your quality team's release decision.
DSCSA product tracing
Prescription drugs entering the US supply chain fall under the Drug Supply Chain Security Act, which requires serialized product identifiers and electronic transaction information exchanged between trading partners. The obligation sits with the manufacturer and the importer of record, and it should be confirmed before the first commercial shipment.
Door-to-Door Import Service
We start with the product: patent or generic status, temperature range, FDA registration, listing and application numbers, and any DEA or CBER requirement. With that settled, our partner agents in Belgium collect from the plant or distribution center under GDP conditions and route by air from BRU or LGG, or by reefer from Antwerp for stable products.
Our licensed customs brokers file the entry with the FDA data and the correct Section 232 or exemption reporting, and GDP-compliant partner carriers deliver to your US distribution center or 3PL, with the temperature record handed to your quality team.
Frequently Asked Questions
Are there tariffs on pharmaceuticals from Belgium?
How are temperature-controlled medicines shipped from Belgium to the USA?
Does a drug need FDA approval before it can be imported?
Can pharmaceuticals be shipped by ocean freight?
Pharmaceuticals is just one example. AGF ships whatever your business moves — on this lane and beyond. If your commodity isn't covered by one of our guides, tell us what you ship and we'll build the logistics around it.
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