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Guides / Commercial medicines: UK to Poland · Updated 19 October 2026

Importing medicines from the UK into Poland: authorisations for businesses

Since the UK left the EU, medicines shipped from Great Britain to Poland are imports from a third country. For a business, that means an import authorisation, EU batch certification by a qualified person, a marketing authorisation covering Poland and, for onward sale, a wholesale permit, on top of the customs formalities.

Scope: commercial imports, not personal medicines

This guide is for businesses such as wholesalers, manufacturers and distributors that want to bring medicinal products from Great Britain into Poland to sell or supply them. If you are an individual carrying your own prescription medicines, the rules are completely different; see our guide to travelling between the UK and Poland with personal medicines instead.

For a business, the customs declaration is the easy part. The importation of medicines to the EU is controlled mainly by pharmaceutical law, and a consignment that clears customs can still not be lawfully placed on the Polish market if the right authorisations and batch release are missing.

Why the UK counts as a third country for medicines

The European Commission's notice to stakeholders on the UK's withdrawal and EU rules for medicinal products (revision of 13 March 2020, published by the European Medicines Agency) sets out the position. Since the end of the transition period, medicinal products shipped from the United Kingdom to the EU are imported medicinal products, and the requirements that apply to importers from any non-EU country apply to them. The notice also reminds businesses that goods shipped from the UK are subject both to fiscal controls (customs duties, origin, VAT) and to non-fiscal requirements such as batch release.

The notice deals with Northern Ireland separately. This guide covers goods leaving Great Britain.

Step 1: an import authorisation in the EU

Under Article 40(3) of Directive 2001/83/EC, as summarised in the Commission notice, Member States must make the import of medicinal products into their territory subject to an authorisation. The authorisation is granted only when the conditions in Articles 41 and 42 of the directive are met, for example the availability of a qualified person within the EU and a good manufacturing practice (GMP) inspection.

In Poland, the authority is the Chief Pharmaceutical Inspector (Główny Inspektor Farmaceutyczny, GIF). GIF's guidance explains that manufacturing or importing medicinal products requires a permit, the zezwolenie na wytwarzanie lub import produktu leczniczego, issued as an administrative decision under Article 38(2) of the Polish Pharmaceutical Law. Import in this sense means bringing medicinal products in from outside the EU, together with their storage, quality control for batch release and distribution.

Before deciding, GIF assesses whether the applicant:

GIF states that it issues the permit or a refusal within 90 days of the application, with the time limit paused while it waits for additional documents or explanations. Plan this into any launch timeline: an import permit is not something a customs agent can arrange on the day the goods arrive.

Step 2: qualified person certification and batch testing

Holding the permit is not enough for each shipment. According to the Commission notice, under Article 51(1) of Directive 2001/83/EC the qualified person of the manufacturing and importation authorisation holder must certify that each batch intended for the EU market was manufactured in accordance with EU GMP and the marketing authorisation.

The notice adds that each batch imported into the EU must undergo, on importation, a full qualitative analysis, a quantitative analysis of at least all the active substances, and any other tests or checks needed to ensure quality in line with the marketing authorisation, and that these requirements apply to medicinal products imported from the UK. Release decisions made only in Great Britain therefore do not replace EU batch certification.

Clearing customs in Poland does not mean a batch may be sold. Until the EU qualified person has certified it, treat imported stock as quarantined.

Step 3: a marketing authorisation that covers Poland

An import permit and batch release let you bring in and release a product; they do not by themselves allow it to be marketed. The Commission notice points out that marketing authorisation holders, and applicants for marketing authorisations, must be established in the EU, so a UK company cannot hold the authorisation itself.

For nationally authorised products in Poland, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) is responsible. URPL's guidance states that marketing authorisations are granted or refused by decision of the President of the Office, through the national, mutual recognition or decentralised procedure, and that authorised products are entered in the register of medicinal products authorised in Poland. Checking that register for the exact product, strength and pack is a sensible first step.

One route that some traders still expect to use is parallel trade. The Commission notice states that parallel trade of medicines sourced in the United Kingdom is in practice no longer possible since the end of the transition period, because EU rules on exhaustion of trade mark rights no longer apply to products placed on the UK market and authorisation terms will diverge over time.

Step 4: a wholesale authorisation for onward distribution in Poland

Distributing medicines within Poland is a separate regulated activity. GIF's guidance explains that a permit to operate a pharmaceutical wholesale business (hurtownia farmaceutyczna) is an administrative decision of the Chief Pharmaceutical Inspector under Article 74(1) of the Pharmaceutical Law. GIF decides after assessing whether the premises are suitable, normally within 90 days of the application, extendable in justified cases by no more than a further 60 days. The import permit and the wholesale permit cover different activities, so check which ones your business model actually needs.

The GB export side: MHRA licensing

The UK supplier has its own obligations. The MHRA's licensing guidance on GOV.UK says a wholesale dealer's licence is needed to sell or supply medicines to anyone other than the patient, and lists exporting medicinal products to EEA countries among the activities it covers. Licence holders must comply with good distribution practice (GDP) and pass regular GDP inspections. A manufacturer's licence is the relevant authorisation for manufacturing and assembling authorised medicinal products, including for export outside the EEA.

Before you sign a supply contract, ask the GB supplier which MHRA licence it holds and confirm it covers the activity. Separately from all of this, the consignment goes through customs formalities when it leaves Great Britain and when it enters the EU, covering duty, origin and VAT, as the Commission notice points out. Our guide on whether you need a customs broker explains who files what.

Checklist for an import of medicinal products into Poland

For the customs and logistics angle, Easy Clearance has a separate article on importing medicines from the UK into Poland. Always confirm the current regulatory position with GIF and URPL before the first shipment.

Related guides

Shipping regulated goods from the UK to Poland?

Easy Clearance is a UK–EU customs clearance agency handling import and export declarations, T1/T2 transit and UK–Poland removals. Its article covers the customs and logistics side of moving medicines from the UK to Poland.

Read the Easy Clearance article

Sources

General information, not legal, tax or customs advice. Rules change; confirm current requirements on gov.uk or with a registered agent before you ship.