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Customs Clearance Pharma and Life Sciences

We clear your medicines, active substances (APIs), excipients and medical devices: we file in ATLAS, check the import licence under §72/72a AMG, coordinate with the QP for release per EU GMP Annex 16, align GDP-conformant with your logistics partner, and clarify dual-use and sanctions questions on programme deliveries. You send us the pre-advice and shipping documents; you receive customs-conformant declarations with an unbroken cold chain - from Emmerich am Rhein, right next to the pharma hubs on the Lower Rhine and in Venlo.

AEOAEO-certified
decadesindustry expertise
EU+NL/BE/DE access

What pharma clients get from us

We link customs to medicines law, GMP/GDP logistics, tax law and - where needed - export controls. We hold your goods under customs supervision until the QP releases them per EU GMP Annex 16, we secure the cold chain during physical examination, and we verify the AMWHV licence before every API import. You send us the pre-advice and accompanying documents; we deliver a prioritised ATLAS filing, pre-arrival pre-clearance and tight forwarder coordination - so your regulatory process does not stall at the border.

Trust anchors at a glance

GMP
Cold-chain & temp logging
EU-GDP
Distribution-practice compliant
AEO-C
Authorised Economic Operator

Typical pharma customs scenarios

  • We clear active substances (APIs) from India and China for further EU processing - we check your AMWHV licence and the CEP/EDQM certificate before every shipment.
  • We handle finished medicinal products from the USA, Switzerland and Japan and hand them over under customs supervision to your QP for release per EU GMP Annex 16.
  • We manage re-import constellations within the EU - Union goods on the customs side, flanked by us on the medicines-law side.
  • We clear clinical trial samples and IMPs carrying BfArM/PEI authorisation and we respect your storage and record-keeping rules.
  • We export medicines to non-EU countries - including WHO programme deliveries and humanitarian aid; we screen every shipment against EU sanctions lists.
  • We check CE documentation, the notified body and the EUDAMED entry per MDR Art. 13 / IVDR on every import of medical devices and IVDs.
  • We move lab supplies, reagents and biosamples through customs - including Category B dangerous goods, dry-ice handling as ADR Class 9 / UN 1845, and ATA Carnet for equipment.

GMP, GDP and QP release at the customs interface

We coordinate ATLAS clearance and the QP process so your goods enter free circulation only after QP release per EU GMP Annex 16. We hold the shipment under customs supervision in a GDP-approved warehouse - typically under a customs warehousing authorisation per UCC Art. 240 - while your QP pulls samples and reviews the batch documentation. You give us the release signal; we transfer to free circulation in ATLAS. This eliminates double handling and removes the recall risk that arises when defects are detected after market entry.

Import licence under AMG and AMWHV

We verify before the first filing whether your licence under §72 AMG (medicines) or §72a AMG in conjunction with AMWHV (active substances) covers the planned import - in NRW this licence is typically issued by Bezirksregierung Köln. We check whether the non-EU country's GMP equivalent (e.g. US FDA, Japan PMDA) is recognised and whether a CEP from EDQM exists for your API. You send us the licence and the GMP/CEP certificate; we cross-check before departure. If a prerequisite is missing, we stop the shipment before arrival - preventing rejection or seizure at the border.

Temperature-controlled supply chains

  • We pre-clear cold-chain shipments (2-8°C, deep-frozen, dry ice) before arrival so that customs controls do not interrupt your cold chain.
  • We archive data loggers and validation documentation alongside the customs declaration - you have the complete GDP audit trail in one place.
  • When an inspection is ordered, we escalate immediately to the competent Hauptzollamt, demonstrate GDP relevance and shift the inspection to the cooled warehouse rather than the port.
  • We declare dry-ice shipments correctly as ADR Class 9 / IATA UN 1845, including ENS filing and transport marking.

Dual-use pharma and embargo programmes

We screen every pharma and biotech export to non-EU countries against Dual-Use Regulation 2021/821 - toxins, biological agents, pathogens, bioreactors and fermentation plants appear on the Annex I lists. We match list position against destination country and apply for BAFA authorisation where required. For embargoed countries (Russia, Belarus, Iran, Syria, North Korea) we additionally check person-related and sectoral sanctions. For humanitarian programme deliveries we assess the applicability of the medical exception and document your end-use declarations completely and audit-proof.

Medical devices under MDR and IVDR

We support you as importer of medical devices and IVDs through your MDR Art. 13 / IVDR obligations. We verify CE marking and the declaration of conformity on import, cross-check the notified body against the EUDAMED entry, flag missing UDI markings and stop shipments where a classification risk is apparent - for example a Class III device without a notified body - before you place them on the market.

Pitfalls we avoid

  • Market entry without QP release despite ATLAS clearance - we hold your goods under customs supervision in the bonded warehouse until QP release is confirmed.
  • Cold-chain break during port inspection - we shift the inspection to the cooled warehouse before this can happen.
  • Sanctions risk on Russian or Belarusian API sources - we screen your procurement chains against EU lists.
  • Wrong HS Chapter 30 classification - we distinguish cleanly between finished medicines, nutrient solutions and diagnostics so you pay the correct duty rate.
  • Medical devices from the UK without an EU authorised representative - we verify before arrival whether placing on the market holds after the Brexit transition.
Request pharma clearance Talk to us: 02828 9039920

Frequently asked questions

We hold your goods in a customs warehouse (authorisation UCC Art. 240) or in temporary storage under customs supervision while your QP performs batch testing and issues the release per EU GMP Annex 16. You send us the release confirmation; we immediately transfer to free circulation via ATLAS. This prevents goods from entering the market that would later have to be recalled.
The licence under §72 AMG (medicines) or §72a AMG (active substances) must be held by you as importer - it is a medicines-law licence and cannot be delegated. Before the first import we verify whether your existing licence covers the non-EU manufacturer, the dosage form and the distribution route, and we support your application documentation towards the competent Bezirksregierung.
We escalate immediately to the competent Hauptzollamt, demonstrate GDP relevance and the cold-chain requirement, and request that the inspection is carried out at your consignee's cooled warehouse or a GDP-approved service provider - not at the port. In practice this is achievable for pharma shipments when we engage early. We store the escalation pattern per importer and apply it automatically on every inspection order.
We screen your suppliers against EU person/entity lists and sectoral restrictions. Pharma mostly falls under the medical exception, but dual-use components - certain reactor parts, fermentation equipment - are explicitly listed under Dual-Use Regulation 2021/821 and are not covered by that exception. You send us supplier data and an end-use declaration; we cross-check and document the exception grounds in an audit-proof manner.
MDR Art. 13 obliges you as importer to verify CE marking and declaration of conformity, affix your importer data to the product and register the import in EUDAMED. Your US manufacturer needs an EU authorised representative. We check CE documentation, UDI marking and classification on import and stop shipments with recognisable defects before you place them on the market.
Yes. We clear IMPs with trial-sample designation - they qualify as medicinal products under AMG but require ethics-committee and federal-authority approval (BfArM, PEI) instead of a regular marketing authorisation. You send us the study-protocol reference and approval numbers; we coordinate with the QP of your sponsor site and observe the special rules on storage and record-keeping.
We charge a flat fee per declaration, with surcharges for cold-chain escalation, sanctions screening, EUDAMED support and pre-clearance. For recurring API imports we agree volume-based flat fees with a prompt response commitment. You send us a volume and frequency profile; we return a non-binding quote as soon as possible.