Importing Medicines from the UK to Poland 2026 – GMP, Licences and Customs

Categories of pharmaceutical products from the UK

Before beginning the import process it is essential to correctly classify the product. Each category is subject to different regulations and requires different documents:

GMP requirements – Good Manufacturing Practice

A GMP (Good Manufacturing Practice) certificate is a mandatory requirement for importing any medicinal product from the UK. The certificate confirms that the manufacturing site meets European pharmaceutical manufacturing standards (Directive 2003/94/EC, Eudralex Vol. 4).

After Brexit the United Kingdom became a third country from the EU's perspective. This means:

• GMP certificates issued by the MHRA (Medicines and Healthcare products Regulatory Agency) must be recognised by the EMA or the relevant national authority
• Every batch of a medicine imported from the UK must be re-tested and released by a QP in the EU
• The GMP certificate must be current (valid for 3 years from the last inspection)

The currency of a GMP certificate can be verified in the EudraGMDP database (European Medicines Agency) or directly through MHRA.

Import authorisation – GIF and the procedure

An importer of medicinal products must hold a manufacturing/import authorisation issued by the Chief Pharmaceutical Inspectorate (GIF) under Article 38 of the Polish Pharmaceutical Law. The authorisation specifies, among other things:

• Scope of activity (types of products)
• Warehouse locations (must comply with GDP — Good Distribution Practice)
• Designated responsible persons (Qualified Person)

Procedure for obtaining the authorisation:

1. Submit an application to GIF with technical documentation
2. GIF inspection at the importer's premises
3. Decision within up to 90 days
4. Annual fee to maintain the authorisation

Time to obtain the authorisation: 3–6 months with complete documentation.

Qualified Person (QP) – role in imports from the UK

Every importer of medicinal products from a third country (including the UK after Brexit) must designate a Qualified Person (QP) — a qualified individual responsible for certifying each imported batch. The QP must:

• Hold the qualifications required by Directive 2001/83/EC (typically a pharmaceutical degree + minimum 2 years of experience)
• Be employed by the importer or acting under a contract
• Sign the batch release certificate for each batch before it is placed on the EU market
• Confirm that each batch complies with the marketing authorisation requirements and GMP

For small importers designating an in-house QP can be costly. An alternative is to outsource QP services to specialist pharmaceutical companies — so-called "QP as a Service".

Border controls – pharmaceutical inspection

At the EU border, medicines imported from the UK may be subject to inspections by the pharmaceutical inspectorate. In Poland inspections are conducted by the Pharmaceutical Inspectorate (WIF/GIF) in cooperation with the National Revenue Administration (KAS).

Inspections may cover:

• Document verification (import authorisation, GMP certificates, analytical certificates)
• Checking transport conditions (temperature, humidity — especially cold chain)
• Sampling for laboratory testing (may extend the release time by 7–21 days)
• Labelling and packaging check (language, legally required information)

Cold Chain – temperature-sensitive medicines

Biological medicines, vaccines, insulins and many other preparations require transport under controlled temperature (most commonly +2°C to +8°C or -20°C). Importing such products from the UK involves additional requirements:

• Temperature loggers — continuous recording throughout the entire transport journey
• Validated cold chain — from the manufacturer to the warehouse in Poland
• Contingency procedures — documented plan for handling refrigeration failures
• GDP for temperature-controlled medicines — specific storage requirements

Failure to maintain the cold chain results in the entire batch being rejected by the QP and the goods having to be destroyed.

Medicines vs dietary supplements – key legal distinction

The boundary between a medicine and a dietary supplement is the subject of numerous legal disputes in Poland. The key distinction:

Products from the UK sold as dietary supplements imported to Poland require only a notification to GIS and compliance with food requirements. No GIF authorisation or manufacturer GMP certificate is needed.

Customs clearance costs for medicines and pharmaceuticals

Importing medicines and pharmaceutical products is a specialist clearance procedure requiring additional documentation and verification. Easy Clearance service fees: from £150 to £400. Indicative price range — exact quote after document submission.

Factors driving the higher clearance cost include:

• The need to verify the GIF import authorisation before lodging the declaration
• HS classification of pharmaceutical products (Chapter 30) — requiring knowledge of pharmaceutical law
• Possible licence/permit codes in the customs declaration
• The need to coordinate with the pharmaceutical inspectorate for first-time imports

Duty rates on pharmaceutical products (HS Chapter 30) are typically 0% for most medicines under the WTO Pharmaceutical Agreement. VAT is 8% for medicines and pharmaceutical raw materials in Poland.

FAQ — Importing medicines and pharmaceuticals from the UK

Can I import medicines from the UK as a private individual?

Private individuals may bring medicines from the UK solely for their own personal use, in quantities consistent with personal consumption (typically up to a 3-month supply). Commercial import of even a single package of medicines without a GIF authorisation is illegal and carries sanctions. Prescription medicines brought in personally may not be sold.

Are GMP certificates issued by MHRA recognised in Poland?

As an EU member state Poland applies EU law. MHRA (UK) GMP certificates are generally recognised provided the manufacturing site appears in the EU EudraGMDP database. However, since Brexit every batch of a medicinal product imported from the UK must be re-certified by a QP in the EU — recognition of the GMP certificate alone does not replace this procedure.

What is the HS code for medicines and pharmaceuticals?

Pharmaceutical products are classified mainly in Chapter 30 of the HS: 3001 (glandular products and extracts), 3002 (sera, vaccines, blood products), 3003–3004 (medicaments for internal or external use), 3006 (pharmaceutical preparations). Active pharmaceutical ingredients (APIs) may be classified in other chapters depending on their chemical composition (e.g. Chapter 29 — organic chemistry). Correct HS assignment requires specialist knowledge.

Official sources

• GIF — Chief Pharmaceutical Inspectorate of Poland
• URPL — Office for Registration of Medicinal Products
• MHRA — Medicines and Healthcare products Regulatory Agency
• EudraGMDP — GMP certificate database — EMA, 2026