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:

Who may import medicines from the UK to Poland – authorisations and registers

Since Brexit the United Kingdom is a third country, so bringing medicines in from the UK is an import within the meaning of the Polish Pharmaceutical Law. The required authorisation depends on the company's role in the supply chain:

The manufacturing or import authorisation is issued for an indefinite period once the State Pharmaceutical Inspectorate has found that the company has suitable premises and equipment and employs a Qualified Person (Art. 39(3)). As a rule, an importer may distribute the imported medicines only to pharmaceutical wholesalers and to hospitals, i.e. healthcare entities providing round-the-clock inpatient services (Art. 42(1)(2)).

Operating without the required authorisation carries criminal penalties: carrying on manufacturing or import of medicinal products without an authorisation is punishable by a fine, restriction of liberty or imprisonment from 3 months to 5 years (Art. 125(1)), and placing a medicine on the market without a marketing authorisation by up to 2 years' imprisonment (Art. 124).

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:

• The EU–UK Trade and Cooperation Agreement (Annex TBT-2 on medicinal products) provides for mutual recognition of the outcomes of GMP inspections carried out by the other party; this does not replace batch certification by a QP in the EU
• 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 — confirm the exact validity period for the specific inspection with GIF/MHRA, as this can vary

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. Fee payable on submitting the application for the authorisation or for its amendment (Art. 41(4)); the authorisation is issued for an indefinite period (Art. 39(3))

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:

• Meet jointly the requirements of Art. 48(1) of the Pharmaceutical Law: a master's-level degree in one of the disciplines listed in the Act (e.g. pharmaceutical sciences, chemical sciences, biotechnology), knowledge of the required subjects (including chemistry, pharmaceutical analysis, pharmacology, pharmaceutical technology), at least two years' work experience at an authorised manufacturer or importer (qualitative and quantitative analysis and quality-control testing), and the Polish language skills needed to perform the duties
• 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".

What exactly the QP certifies when importing from a third country

Under Art. 48(3)(2) of the Pharmaceutical Law, for an imported product the Qualified Person must ensure that each batch has undergone, in Poland, a full qualitative and quantitative analysis (at least of all active substances) and the other tests necessary to ensure quality in line with the marketing authorisation. The QP may waive these tests if they were carried out in the exporting country and, after checking with GIF, the product's country of origin is on the list of countries with which the EU has made arrangements ensuring GMP requirements at least equivalent to those of the EU (Art. 48(6)). Before a batch is released to the market, the QP certifies in a register that it meets these requirements (Art. 48(7)).

The EU–UK Trade and Cooperation Agreement (Annex TBT-2 on medicinal products) provides for mutual recognition of the outcomes of GMP inspections, but it does not replace batch certification by a QP in the EU, which Polish law requires.

GDP – Good Distribution Practice: who must comply

GDP rules are set out in the European Commission Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01), which replaced the guidelines published in March 2013. For an importer in Poland the duty also follows directly from the statute: for the distribution of manufactured or imported medicines it must apply Good Distribution Practice requirements (Art. 42(1)(8) of the Pharmaceutical Law).

• Pharmaceutical wholesalers – anyone carrying out wholesale trade must hold a wholesale distribution authorisation and apply the GDP guidelines
• Importers – for the distribution of imported medicines (Art. 42(1)(8))
• Brokers – they do not physically hold medicines, so the premises requirements do not apply to them, but they are subject to registration and the other rules for wholesale distributors apply to them accordingly (Chapter 10 of the guidelines)
• Transport companies – they work under a contract with the distributor that covers the requirements for outsourced activities (Chapter 7); the carrier must be made aware of the transport conditions for the consignment (point 9.2)

The guidelines cover, among other things, a written quality system, temperature and environment control at the storage site, qualification and validation of equipment and processes, qualification and approval of suppliers, recall procedures, handling of falsified medicines, transportation and outsourced activities.

Border controls – pharmaceutical inspection

Customs clearance of the goods is carried out by the customs authorities of the National Revenue Administration (KAS). Pharmaceutical supervision of the importer is exercised by the State Pharmaceutical Inspectorate, which may inspect the places of import, check documentation and take samples of medicinal products for quality testing (Art. 42(1)(6) of the Pharmaceutical Law).

Inspections may cover:

• Document verification (import authorisation, GMP certificates, analytical certificates)
• Checking transport conditions (temperature, humidity — especially cold chain)
• Sampling for laboratory testing
• Labelling and packaging check

Tariff classification and narcotic drugs

Medicines are classified in Chapter 30 of the Combined Nomenclature (pharmaceutical products, headings 3001–3006). TARIC shows the duty rates and non-tariff measures for each code, so the code should be checked before the customs declaration is lodged.

Narcotic drugs and psychotropic substances follow a separate regime: they may be imported only after, for each consignment, an import permit issued by the Chief Pharmaceutical Inspector and an export permit issued by the authorities of the exporting country have been obtained (Art. 37(3) of the Act on Counteracting Drug Addiction). Bringing narcotic drugs into a customs warehouse is prohibited (Art. 37(8)).

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.

What the GDP guidelines say about temperature-controlled transport

• The storage conditions specified by the manufacturer or on the outer packaging must be maintained throughout transport (point 9.2) – the temperature range follows from the product itself, not from a universal table
• For temperature-sensitive products, qualified equipment is used: thermal packaging, temperature-controlled containers or vehicles (point 9.4)
• The choice of packaging takes into account, among other things, expected external temperature extremes, the maximum transport time including transit storage at customs, and the qualification status of the packaging and the validation status of the shipping containers (point 9.3)
• A deviation such as a temperature excursion or product damage must be reported to the distributor and the recipient, and a procedure for investigating and handling such cases should be in place (point 9.2)

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: see easyclearance.pl/pricing.html. 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 medicinal products authorised for marketing (Annex 3 to the VAT Act, item 14); for other products, including active substances, the rate depends on classification.

Duty and VAT – what TARIC and the VAT Act confirm

According to TARIC (as at 19 October 2026), for subheading 3004 90 (medicaments, other) the third-country duty rate is 0% and the preferential rate for the United Kingdom is also 0%. For such a code, proof of origin does not reduce the duty because it is already zero. For other codes, e.g. active substances, check the rate and any preferences in TARIC for the specific code.

The 8% VAT rate applies to medicinal products authorised for marketing in Poland under the Pharmaceutical Law and to those holding an authorisation issued by the Council of the EU or the European Commission (Annex 3 to the VAT Act, item 14). For other products the rate depends on classification – check the VAT Act or podatki.gov.pl.

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?

The EU–UK Trade and Cooperation Agreement (Annex TBT-2) provides for mutual recognition of the outcomes of GMP inspections carried out by the other party. This does not remove batch certification, however: under Art. 48 of the Pharmaceutical Law every batch of an imported product must be released by the importer's QP in the EU.

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.

Who releases a batch of medicine imported from the UK for sale in Poland?

The importer's Qualified Person (QP) certifies the batch. Under Art. 48 of the Pharmaceutical Law the QP ensures that each batch of an imported product has been tested in Poland (unless the conditions for waiving the tests are met, after checking with GIF) and certifies this in a register before the batch is released to the market.

To whom may an importer supply a medicine brought in from the UK?

As a rule, an importer distributes imported medicines to pharmaceutical wholesalers and to hospitals, i.e. healthcare entities providing round-the-clock inpatient services (Art. 42(1)(2) of the Pharmaceutical Law), applying Good Distribution Practice requirements.

Does a transport company have to meet GDP requirements?

The GDP guidelines place the obligations on the distributor that commissions the transport: the contract with the carrier covers the requirements for outsourced activities, and the carrier must be made aware of the transport conditions for the consignment. In practice the carrier must be able to maintain and document the required conditions, e.g. temperature.

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
• Pharmaceutical Law – consolidated text, Dz.U. 2026 item 612 (ISAP, in Polish)
• Act on Counteracting Drug Addiction, Dz.U. 2023 item 1939 (ISAP, in Polish)
• VAT Act – consolidated text, Dz.U. 2026 item 1263 (ISAP, in Polish)
• Guidelines on Good Distribution Practice 2013/C 343/01 – EUR-Lex
• TARIC – European Commission