A Practical Guide to Importing Pharmaceuticals from Switzerland to the United Kingdom

Introduction

Importing pharmaceuticals from Switzerland to the United Kingdom combines regulatory rigour with logistical precision. Switzerland remains a global leader in pharmaceutical innovation, housing some of the world’s most advanced manufacturing facilities regulated by Swissmedic, while the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) upholds stringent oversight of all medicines entering the British market.

Since Brexit, the UK and Switzerland have reinforced their trading relationship through a Mutual Recognition Agreement (MRA) and a bilateral trade agreement, ensuring continued access to high-quality Swiss medicines. These agreements preserve preferential customs treatment, zero tariffs for eligible products, and mutual recognition of Good Manufacturing Practice (GMP) inspections and batch certificates. This alignment makes Switzerland one of the UK’s “approved countries,” simplifying pharmaceutical imports while maintaining full regulatory safeguards.

This guide explains the process, licences, documentation, and customs procedures required for importing pharmaceuticals from Switzerland into the UK — with a particular focus on how to file customs declarations efficiently using the Customs Declarations UK (CDUK) platform.

Understanding the Regulatory Framework

In pharmaceuticals, regulation precedes logistics. Before planning customs or transport, importers must ensure compliance with both Swiss and UK requirements.

Key Regulators:

• MHRA (UK) – Issues marketing authorisations, import and wholesale licences, and monitors pharmacovigilance.
• Swissmedic (Switzerland) – Licenses manufacturers and distributors and issues GMP/GDP certificates.

Mutual Recognition:
The UK–Switzerland MRA enables the UK to accept Swiss GMP inspection outcomes and Qualified Person (QP) batch certifications. This eliminates redundant re-testing, provided the product and manufacturer meet regulatory conditions.

Switzerland is also recognised as an “approved country” for active substances and batch testing under UK law, meaning imports from Swissmedic-approved facilities enjoy smoother entry into the UK supply chain.

Defining What You’re Importing

Before filing paperwork, clearly identify the product type and purpose:

• Finished human medicines (for commercial sale).
• Active pharmaceutical ingredients (APIs) for manufacturing.
• Investigational Medicinal Products (IMPs) for clinical trials.
• Unlicensed “specials” imported for individual patient needs.

Each category carries specific licensing and quality assurance requirements. This guide primarily focuses on finished human pharmaceuticals for commercial supply, though the principles broadly apply to other categories.

Verifying Marketing Authorisation and Licensing Requirements

Medicines imported for sale in the UK must hold a UK marketing authorisation (MA) issued by the MHRA, unless imported under exemption (such as unlicensed “specials”).

If the product already holds a UK MA:
You can import it under your Wholesale Distribution Authorisation (WDA(H)) or Manufacturer’s/Importer’s Authorisation (MIA), verifying the batch certificate from Switzerland.

If licensed only in Switzerland:
You may import it only under an unlicensed medicines route (for named patients) or apply for a UK MA if commercial supply is intended.

If for clinical trials:
You must hold a MIA(IMP) and a clinical trial authorisation from MHRA.

Securing the Required UK Licences

Manufacturer’s/Importer’s Authorisation (MIA)

A MIA is required to make, assemble, or import medicines. The MHRA inspects sites and requires a Qualified Person (QP) to oversee batch release. For investigational products, a specific MIA(IMP) is needed.

Wholesale Distribution Authorisation (WDA(H))

A WDA(H) is essential for importing and distributing medicines within the UK. This licence demands:

• A Quality Management System aligned with Good Distribution Practice (GDP).
• A designated Responsible Person (RP) responsible for GDP compliance.
• Secure facilities with environmental monitoring, traceability, and recall controls.

Many UK importers hold both MIA and WDA(H) to ensure complete compliance.

Confirming the Swiss Supplier’s Compliance

Swiss manufacturers and distributors must appear in the SwissGMDP database, confirming their valid GMP/GDP certification under Swissmedic. Importers should obtain:

• Up-to-date GMP/GDP certificates.
• Audit reports and quality agreements.
• Documentation proving serialisation and packaging compliance with UK labelling requirements.

Ensure the outer packaging carries English-language information and, from 2025, complies with the “UK Only” labelling standard under the Windsor Framework.

Customs and Trade Procedures

Preferential Tariffs and Origin

Pharmaceuticals originating in Switzerland benefit from zero customs duty under the UK–Switzerland Trade Agreement, provided proof of origin accompanies the import.

Acceptable proofs include:

• An origin declaration on the invoice, or
• A formal EUR.1 certificate issued by Swiss authorities.

Maintain origin evidence for at least four years for HMRC audits.

VAT Treatment

Most prescription medicines are zero-rated for VAT, though import VAT must still be declared. VAT-registered importers can use Postponed VAT Accounting (PVA) to avoid paying at the border, reporting it instead in their VAT return.

Transport and Logistics

Medicines must travel under GDP-compliant conditions, typically temperature-controlled between 2–8°C or 15–25°C. Use validated cold-chain packaging and data loggers. If transiting the EU (via France), the shipment should move under a T1 transit procedure to maintain customs control until arrival in the UK.

Filing Customs Declarations Using Customs Declarations UK

The Customs Declarations UK (CDUK) platform offers a streamlined, compliant solution for submitting import declarations to HMRC’s Customs Declaration Service (CDS) — a critical step in the import process.

Using CDUK, importers can:

• Input all required data in guided, plain-English workflows.
• Enter importer/exporter details, shipment value, Incoterms, and origin.
• Reference supporting documents such as invoices, origin proofs, and licences.
• Automatically validate data to catch missing or inconsistent entries.
• Submit electronically and receive an instant Movement Reference Number (MRN) from HMRC.

All declarations are securely archived in the CDUK system, supporting HMRC audits and internal compliance checks. The platform also aligns customs data with ENS (Entry Summary Declarations), reducing the likelihood of delays at ports.

Learn more at Customs Declarations UK – Import Declarations.

End-to-End Import Flow

A compliant Swiss–UK pharmaceutical import typically follows this sequence:

1. Pre-contract stage:
   • Verify both parties’ credentials and licences.
   • Confirm product authorisation and quality agreements.
2. Pre-shipment:
   • Agree on Incoterms (DAP, FCA, or DDP).
   • Prepare export and import documentation.
   • Verify cold-chain transport arrangements.
3. At the border:
   • Swiss exporter completes export clearance.
   • UK importer or broker files the CDS declaration via CDUK.
   • Preferential duty and VAT accounting are applied.
4. Post-import:
   • Inspect goods, verify temperature records, and hold in quarantine until QP release.

Distribute under GDP standards to authorised customers.

Special Cases and Considerations

Unlicensed “Specials”

These medicines may be imported for specific patient needs but only by companies holding both MIA and WDA(H) licences. The importer assumes responsibility for quality and traceability.

Parallel Imports

These involve sourcing a medicine already authorised in the UK from another country and repackaging it for local sale. Parallel importers must obtain MHRA authorisation and comply with packaging and labelling rules.

Controlled Drugs

Imports of controlled substances require additional Home Office import licences. Ensure the correct licence accompanies the shipment and declare it on the customs entry.

Practical Risk and Compliance Controls

To maintain regulatory assurance and prevent disruption:

• Keep complete import documentation (invoices, licences, declarations, quality certificates).
• Maintain digital archives for at least six years.
• Align ENS data, CDS entries, and shipment invoices to avoid discrepancies.
• Review supplier GMP compliance annually.
• Ensure GDP training for all staff handling pharmaceutical imports.

These controls reduce inspection risk and build long-term supply chain reliability.

Conclusion

Importing pharmaceuticals from Switzerland to the United Kingdom is a disciplined process rooted in mutual regulatory trust, preferential trade treatment, and robust quality assurance. With Switzerland’s recognition as an approved country and the UK’s pragmatic approach to mutual recognition, the process can be efficient when managed correctly.

By verifying marketing authorisations, maintaining GMP/GDP compliance, and filing accurate customs declarations through the Customs Declarations UK platform, importers can achieve predictable timelines, avoid unnecessary costs, and maintain full audit readiness.

With the right systems in place, Swiss–UK pharmaceutical imports continue to represent one of the most stable and compliant international supply routes in the post-Brexit era.

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