Pharma & ICS2: timely notification, cold chain preserved

Pharma importers face three specific challenges around ICS2: first, the pre-arrival data must be correct well before arrival, second, any delay at the border must not break the cold chain (typically 2–8°C or -20°C), and third, additional rules apply around Falsified Medicines Directive (FMD) serial numbers and the position of the license holder. Early and accurate delivery, pre-aligned cold routes, and clarity about who the declarant is — that’s the trinity for pharma import without Holds.

Why is pharma different?

Pharma formally falls under the regular customs regime, but three sector-specific factors make it complex:

1. Cold chain product imperative

Many medicines — vaccines, biologicals, mAbs, insulin, eye drops — must remain within a regulated temperature band during transport and storage (2–8°C for chilled products, -20°C for frozen, -70°C for mRNA vaccines). A Hold of several hours due to incomplete ICS2 data can spoil an entire shipment. According to GDP (Good Distribution Practice) Directive 2013/C 343/01, every deviation must be documented and assessed by a qualified person.

2. Falsified Medicines Directive (FMD)

The Directive 2011/62/EU (FMD) has required serial numbers (unique identifiers) on individual packages of prescription medicines since February 2019. Each package has a 2D barcode with product code, batch number, expiry date and serial number. On import this data is checked in the EMVS (European Medicines Verification System). ICS2 declarations must be consistent with the physical FMD data.

3. Marketing authorisation holder versus holder

In pharmaceutical chains there is a difference between:

• Marketing Authorisation Holder (MAH): the one bringing the product to market, often the manufacturer.
• Wholesale Distribution Authorisation Holder (WDAH): the wholesaler that physically imports and distributes.

For the customs declaration the WDAH is usually the declarant, but the owner of the goods can be the MAH. This has fiscal consequences for VAT, ownership and liability.

What changes with ICS2 for pharma?

ICS2 (see also our article on ICS2 phase 3) has been mandatory for all air freight since 1 March 2024 and since 2025 also for sea, road and rail. For pharma this means:

• House ENS must be ready before loading — typically 12–24 hours before departure in the country of origin.
• HS-6 or HS-8 codes mandatory; for pharma often chapter 30 (medicines) or 38 (diagnostics).
• Description must be specific: not “pharmaceuticals” but “monoclonal antibody, drug substance, lyophilized, 100mg vials”.
• Full addresses of consignor and consignee (no PO boxes).
• EORI numbers of all chain parties (see applying for an EORI).

With a Do-Not-Load (DNL) due to incomplete data, the pharma shipment cannot depart. With a Hold on arrival, the cool container or GDP-compliant box waits — and that’s where things go wrong.

How do you preserve the cold chain?

Before departure

• Work with GDP-certified forwarders that deliver data on time.
• Make agreements on maximum cut-off times: documentation 24 hours before loading complete.
• Use temperature loggers (Berlinger, Sensitech, Tive) with real-time monitoring.
• Have the carrier hold CEIV Pharma certification (from IATA): KLM Cargo, Lufthansa, Emirates SkyCargo, Singapore Airlines and others are CEIV-certified.

On arrival at Schiphol

Schiphol has a Pharma Gateway with dedicated cool dollies, GDP-compliant handling and short tarmac times. Working with handlers like dnata, Swissport (CEIV) or WFS shortens exposure time. With a Hold your shipment can be placed in a GDP-compliant container terminal — not on the standard cargo ramp.

Rule: pre-aligned Hold procedure

Coordinate with your customs broker what happens with a (temporary) Hold:

• Direct transfer to a GDP-compliant customs warehouse (e.g. Brocacef, Movianto, Mainfreight pharma)
• Real-time temperature notifications to the QA department
• If needed, fast physical inspection in a conditioned room

The declaration side in detail

EORI and declarant

The declarant of the import declaration must have:

• Valid EORI (NL or equivalent)
• WDA license or manufacturing authorisation (depending on role)
• GDP-compliant procedures for storage between arrival and delivery

HS classification

Pharma largely falls in chapter 30 CN:

For APIs (Active Pharmaceutical Ingredients) you can end up in other chapters — pay attention to exact tariff classification, because the rate and license obligations differ.

VAT and import reverse charge

Many pharma importers work with an article 23 license (VAT reverse charge mechanism), where VAT is not paid on import but reverse charged in the regular VAT return. This significantly improves cash flow. The application at the Tax Administration is a separate procedure alongside EORI and GDP.

Medicines Act and licenses

For import of medicines from third countries you deal with:

• Medicines Act and the CBG (Medicines Evaluation Board)
• IGJ (Health and Youth Care Inspectorate): supervision on WDA holders
• For narcotic drugs: CIBG/Bureau Medicinal Cannabis or opium license
• For veterinary medicines: CBG-MEB veterinary pillar

Common mistakes

1. Late documentation to the carrier

Production and QA only deliver batch certificates and invoices on the day of departure. The carrier must have filed the Master ENS hours earlier. Result: DNL and missed flight. Set a document cut-off of 36 hours.

2. Vague product descriptions

“Biologicals” or “drug product” triggers ICS2 flags. Write “drug product, IgG monoclonal antibody, sterile lyophilized, 100mg/vial, 10 vials/kit” — specific enough for risk assessment.

3. WDA holder not set up as declarant

Many pharma importers have a general forwarder make the declaration under their EORI, while the WDA license is on the end recipient. That doesn’t match the GDP chain and can lead to revocation of the WDA at IGJ inspection.

4. No backup with Hold

The shipment arrives, gets a Hold for inspection, but no GDP-compliant storage is directly available. Result: temperature deviation, batch quarantine or even destruction. Make a pre-agreed contingency plan with the customs warehouse holder.

5. Incorrect VAT processing

Pharma shipments without article 23 license lead to direct VAT payment on import (typically 9% or 21%). For a container of vaccines worth €2 million that’s €180,000–€420,000 cash flow impact. Plan the article 23 application timely.

6. FMD data not uploaded

WDAHs must upload serial numbers in the NMVS (Netherlands Medicines Verification Organisation, NMVO). Forgetting = unsellable product, despite correct import.

Get started

Pharma import without Holds and with unbroken cold chain is no matter of luck but of process design: complete data on time to the carrier, certified partners, pre-aligned Hold procedures and correct role distribution between MAH, WDAH and declarant.

DouaneDoc has years of experience with pharma import via Schiphol and Maastricht-Aachen. We work together with CEIV-certified handlers and GDP warehouses in the region. See our pharma sector page or request a quote.

Direct contact: 088 088 2407 or sales@aircargo.nl.