In pharma, the customs declaration is rarely the bottleneck — until it is. A batch of insulin waiting on the tarmac for an incorrectly filled HS code, an MRI component stuck on a missing MDR declaration, or an API raw material falling out of validated temperature range due to delay in release. DouaneDoc has worked for years for pharmaceutical wholesalers, manufacturers and medical device companies and knows the additional requirements that rest on this sector: from Falsified Medicines Directive to MEB notifications.
What’s at play for Pharma & Healthcare
The pharmaceutical sector works under a double burden of regulation. In addition to regular customs formalities, there are sector-specific requirements from the Health and Youth Care Inspectorate (IGJ), the CBG/MEB, and at European level EMA. A pharmaceutical wholesaler needs a wholesale medicines license, must comply with Good Distribution Practice (GDP), and on import from third countries often also with GMP equivalence. For medical devices, MDR (2017/745) and IVDR (2017/746) apply with associated UDI and EUDAMED requirements.
On top of that comes ICS2 phase 3, which mandates Pre-Loading and Pre-Arrival data for air and sea freight from third countries — often with pharma-specific points of attention such as serial numbers and cold chain requirements. The Falsified Medicines Directive (FMD) requires unique identifiers (2D Datamatrix) to be actively decommissioned and reported on cross-border movements within the EU; on import from third countries this must align with the EMVS/NMVS system.
Finally there’s the operational side. Many shipments go under 2-8°C (chilled) or -20°C (frozen), sometimes even -70°C for ATMPs and mRNA products. Every release, every customs inspection and every change of carrier must fit within the validated time windows. An extra hour on the tarmac can mean a batch worth hundreds of thousands of euros gets rejected.
Documents Pharma & Healthcare often need
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Import declaration with license reference — Import declaration where your wholesale license, manufacturer license or MDR certificate is linked. We monitor that the right license holder is on the declaration.
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T1 transit from Schiphol to your GDP warehouse — Move under customs supervision at controlled temperature, without import VAT and duties already due.
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Certificate of Pharmaceutical Product (CPP) and GMP certificate — For both import (qualification of manufacturer) and export to third countries that require it.
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MEB notifications for parallel import — For parallel import of medicines registered in NL but coming from another EU country or third country.
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MDR/IVDR conformity declaration — Required for import of medical devices; we test whether the authorized EU representative is correctly listed.
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FMD decommissioning proof — For products leaving or re-entering the EU, including alignment with your QP.
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Export declaration for clinical trial material (IMP) — Often with sponsor’s EORI, linked to EudraCT number.
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CITES license — For some biologicals and raw materials of animal or plant origin.
How we serve Pharma & Healthcare
Our pharma flow is built around one principle: nothing sits idle because of a document. Specifically:
- Pre-clearance before arrival. As soon as the AWB or B/L is with us, we start the declaration. At landing at Schiphol or arrival in Rotterdam, the release is already ready — no waiting time on customs.
- 24/7 stand-by for urgent stockouts. A hospital pharmacy with a shortage cannot wait until Monday morning. Our on-call service picks up urgent pharma shipments on weekends too.
- GDP-aware document handling. We understand why a temperature logger and a batch record belong with the declaration, and ensure the digital file building aligns with your QMS.
- Direct line with IGJ and Customs Eindhoven (pharma team). For shipments under special licenses, we engage directly with inspectors.
- Integration with your WMS / SAP S/4HANA. For larger wholesalers we link our declaration workflow directly to your warehouse management — including lot, expiry and serial number transfer.
We work for both innovator pharma and generics, for wholesalers, for clinical research organizations (CROs) and for medical device importers. See our import declaration and T1 transit for operational details.
Frequently asked questions from Pharma & Healthcare
Are you allowed to declare for products under GDP?
Yes. The declaration itself is a customs action — GDP responsibility remains with you or your 3PL. We ensure the customs flow does not endanger your GDP: T1 under chilled transit, no unnecessary release, and release at the moment the truck is at your door.
How do you handle FMD decommissioning on returns?
For return imports or cross-border movements we ensure the declaration runs synchronous with your EMVS action. We don’t do the decommissioning ourselves — that remains with your QP — but we plan customs release so it’s watertight for inspection.
Can you clear urgent clinical trial materials on Saturday?
Yes, provided notified via our on-call line. For IMPs with EudraCT number we have a separate rush flow with direct integration to our NCTS and DMS access.
We import APIs from India — what extra do we need to arrange?
Active Pharmaceutical Ingredients need a Written Confirmation from the competent authority of the export country (equivalent to EU-GMP), unless the country is on the white list. We test this for every shipment and prevent a container from being held up due to a missing WC document.
Get started
Have an urgent pharma shipment or looking for a fixed partner for your GDP flow? Request a quote directly or get in touch. For stockout rush: call 088 088 2407 — we’ll pick it up.