Importing medicines & pharmaceuticals from the UK – GDP, customs documents and restrictions

Importing medicines and pharmaceutical products from the United Kingdom to Poland or other EU member states is one of the most complex logistics operations that importers have faced since Brexit. Pharmaceuticals are simultaneously subject to customs legislation, the pharmaceutical regulations of both the exporting and importing countries, Good Distribution Practice (GDP) requirements, and — for controlled substances — additional regulatory restrictions. Since the United Kingdom's departure from the European Union, medicine supply chains require full customs clearance at every border — both on export from the UK and on import into an EU member state. Additional requirements include the mutual recognition of GMP and GDP certificates, the need to hold appropriate import licences, and — for temperature-sensitive medicines — a documented cold chain throughout the entire transport journey. This article explains which documents are required, who must hold a GDP licence, what border controls for pharmaceuticals look like in practice, and what the most common pitfalls are when importing medicines from the UK to Poland.

Why is importing medicines from the UK more complex after Brexit?

Before Brexit, medicines moved freely between the UK and the EU within the single market — with no tariffs, no full border checks, and with mutual recognition of GMP and GDP certificates. Since 1 January 2021, the situation changed fundamentally:

• The UK and the EU have no Mutual Recognition Agreement (MRA) for GMP certificates — this means that medicines manufactured in the UK cannot automatically enter the EU market without an additional batch release by a Qualified Person (QP) located in an EU member state
• Every consignment of medicines from the UK to Poland requires full customs import clearance — with a customs declaration, HS code, customs duties and import VAT
• The importer in Poland must hold a manufacturing or import licence issued by GIF (the Chief Pharmaceutical Inspectorate) or — for wholesale distributors — a wholesale distribution authorisation
• For prescription medicines, additional restrictions on distribution and promotion apply

Who may import medicines from the UK to Poland?

Not every entity may legally import medicines into Poland. EU pharmaceutical law (Directive 2001/83/EC) and the Polish Pharmaceutical Law Act require:

Type of importer	Required authorisation	Issuing authority
Manufacturer importing for own production	Manufacturing authorisation covering import scope	GIF
Pharmaceutical wholesaler	Wholesale distribution authorisation	GIF / Chief Pharmaceutical Inspector
Parallel importer	Parallel import authorisation	Registration Office (URPL)
Marketing Authorisation Holder	Marketing Authorisation (MA)	European Commission or URPL

An ordinary commercial importer cannot place medicines on the market independently without the above authorisations. Breaching this requirement is a pharmaceutical offence carrying a custodial sentence.

GDP — Good Distribution Practice. What is it and who must comply?

GDP (Good Distribution Practice) is a set of standards governing how medicines must be transported, stored and distributed in order to preserve their quality and integrity. In the EU it is mandatory under Directive 2011/62/EU (the Falsified Medicines Directive) and the GDP Guidelines (2013/C 68/01).

Who must hold a GDP certificate?

• Pharmaceutical wholesalers distributing medicines
• Pharmaceutical brokers (commercial intermediaries who do not physically handle goods)
• Importers of medicines from third countries (including from the UK)
• Logistics companies handling temperature-sensitive medicines

What does GDP cover?

1. Quality management system (QMS) — documented SOP procedures
2. Temperature control — real-time monitoring during transport
3. Qualification of vehicles and containers — for temperature-sensitive medicines
4. Management of returns and complaints — an audit trail for every unit
5. Security and anti-falsification measures — authenticity verification (EMVO system in the EU)
6. Supplier audits — regular audits of manufacturers and logistics partners

In the UK, equivalent standards are regulated by the MHRA (Medicines and Healthcare products Regulatory Agency) — since 2021 the UK GDP framework has been an autonomous system aligned with EU GDP but administered independently.

Customs and pharmaceutical documents required when importing medicines from the UK

Importing medicines from the UK to Poland requires a complete set of documentation at two levels: customs and pharmaceutical.

Customs documents

Document	Description
Commercial Invoice	With goods description, HS code, customs value, Incoterms
Packing List	Detailed packaging breakdown, item counts, weights
SAD / Import Declaration (CDS)	Customs declaration filed in the UK CDS (Customs Declaration Service) or TARIC (PL)
Proof of Origin	Required to claim zero duty rates — EUR.1 certificate or invoice declaration (where TCA applies)
Transport documents (CMR/AWB/B/L)	Waybill / bill of lading

Pharmaceutical documents

Document	Description
Certificate of Analysis (CoA)	Quality test results for each batch — issued by the manufacturer
Batch Release Certificate	Confirmation of batch release by a Qualified Person (QP) in the EU or UK
Marketing Authorisation (MA)	Marketing Authorisation — must be valid in Poland/EU
GDP Certificate	Confirmation of GDP certification for the importer/wholesaler
Import Licence / GIF authorisation	Required for importers
Temperature log	For cold chain medicines — a continuous temperature record throughout transport
MSDS / SDS	Safety data sheet for hazardous substances

Cold chain — transporting temperature-sensitive medicines

Biological medicines, vaccines, insulin, certain oncology products and in-vitro diagnostics require transport under controlled temperature conditions. Standard temperature ranges are:

Class	Temperature	Examples
Frozen	–80°C to –15°C	mRNA vaccines, plasma
Refrigerated	+2°C to +8°C	Insulin, conventional vaccines, biologics
Controlled room temperature	+15°C to +25°C	Most tablets and capsules
Ambient temperature	No control required	Non-temperature-sensitive goods

For cold chain medicines, the documentation must include: qualification of the transport packaging (IQ/OQ/PQ), a continuous temperature record throughout transport (data logger), a temperature report on arrival, and a procedure for handling deviations (temperature excursion).

Every deviation from the permitted temperature range must be assessed by the QP — and may result in the destruction of the entire batch.

Border control of pharmaceuticals — what does customs check?

When importing medicines, customs authorities focus on several key aspects:

1. Tariff classification (HS code) — medicines are classified under CN chapters 3001–3006. Incorrect classification may result in additional duty or VAT being demanded, and in extreme cases, the seizure of the goods.
2. Customs value — medicines moved between related parties (e.g. manufacturer to own distributor) may be subject to detailed transfer pricing scrutiny.
3. Importer authorisation — customs may require the importer to produce the GIF licence or manufacturing authorisation.
4. Prohibition on importing controlled substances without authorisation — narcotics (HS 2939) and psychotropic substances require authorisation from the Chief Sanitary Inspector (GIS) and a separate customs procedure.
5. Labelling — medicines placed on the EU market must carry labels in Polish (or the official language of the destination country).

Duty rates and VAT for medicines imported from the UK

Under the UK–EU Trade and Cooperation Agreement (TCA) of 2021, medicines may benefit from a zero tariff rate, provided the rules of origin are satisfied. This means that if a medicine is manufactured in the UK (rather than merely repacked or relabelled there), a 0% rate can be applied.

Scenario	Duty rate	Notes
Medicine manufactured in the UK (rules of origin satisfied)	0%	EUR.1 certificate or invoice declaration required
Medicine from the UK but manufactured outside the EU/UK	0–6.5%	Depends on HS code and the actual country of origin
Pharmaceutical active substance (API)	0–6.5%	Most APIs benefit from zero duty in the EU

VAT on medicines in Poland: medicines with a Marketing Authorisation carry a reduced rate of 8% VAT. Pharmaceutical substances, food supplements and medical devices — the rate depends on classification.

Common mistakes when importing pharmaceuticals from the UK

Based on Easy Clearance's experience, the most frequent issues are:

• Missing or out-of-date CoA for the imported batch — analytical certificates must match the batch numbers shown on the commercial invoice
• QP batch release performed by a person in the UK — after Brexit, a UK-based QP may only release batches for the UK market. A separate release by a QP in an EU member state is required for the EU market
• Expired import licence — GIF licences have a defined validity period and must be renewed
• Missing origin declaration on the invoice — required in order to claim the zero TCA duty rate
• Incorrect HS code — e.g. classifying food supplements as medicines or vice versa