How to Import Pharmaceuticals into Europe

Europe is one of the hardest pharmaceutical markets to enter and one of the most stable once you are in. The barrier is regulatory.

To import pharmaceuticals into Europe, three things must exist before a carton moves: an authorisation for the product, a company established inside the EU that owns it, and a licensed EU importer whose Qualified Person releases each batch. Non-EU manufacturers usually underestimate the third point.

How do you import pharmaceuticals into Europe? You need a marketing authorisation granted through the centralised, decentralised, mutual recognition or national route; an EU-established Marketing Authorisation Holder; and an EU importer holding a Manufacturing and Import Authorisation whose Qualified Person certifies every imported batch against EU GMP before release.

Who Regulates Pharmaceuticals in Europe
The Four Marketing Authorisation Routes
The CTD and eCTD Dossier
The EU-Established Marketing Authorisation Holder
Manufacturing and Import Authorisation
The Qualified Person and Batch Certification
EU GMP and Inspection of Non-EU Sites
API Requirements: Written Confirmation, CEP and ASMF
The Falsified Medicines Directive
Labelling, Leaflets and Braille
Pharmacovigilance Obligations
Batch Testing on Import
Customs Clearance Versus Regulatory Release
How to Import Pharmaceuticals into Europe: Step by Step
The United Kingdom After Brexit
Expert Tips
Common Mistakes
Frequently Asked Questions

Who Regulates Pharmaceuticals in Europe

The European Commission grants authorisations for centrally authorised products, turning the EMA’s scientific opinion into a binding decision.

The European Medicines Agency (EMA) coordinates scientific evaluation through committees such as the CHMP. It does not grant national authorisations.

National competent authorities (NCAs) are the working regulators in each member state, such as BfArM, ANSM and AIFA. They grant national authorisations, issue import licences and run GMP inspections.

The EDQM, under the Council of Europe, publishes the European Pharmacopoeia and issues Certificates of Suitability.

Day to day you deal with the NCA where your importer sits. See our overview of pharmaceutical regulatory authorities.

The Four Marketing Authorisation Routes

No medicine may be placed on an EU market without an authorisation, and the route is chosen before the dossier is written.

Centralised Procedure

One application to the EMA produces one authorisation valid across the EU and EEA. It is compulsory for defined categories, including biotechnology-derived products, advanced therapy medicinal products, orphan medicines, and products for areas such as cancer, HIV/AIDS, diabetes and neurodegenerative disease.

It is optional for new active substances outside those categories, and for generics of a centrally authorised product.

Decentralised Procedure (DCP)

Used when the product holds no EU authorisation anywhere and you want several member states at once. A Reference Member State (RMS) leads the assessment, Concerned Member States comment, and each issues its own authorisation.

Mutual Recognition Procedure (MRP)

Used when a national authorisation already exists in one member state. That state acts as RMS and others are asked to recognise its assessment.

Purely National Procedure

A single application to one NCA for one market, available where the product need not go centralised. It is often the cheapest first EU launch.

Comparison of the Four Routes

Route	Scope	Deciding Authority	Timeline Character	When to Use
Centralised	Whole EU plus EEA, one authorisation	European Commission, on EMA opinion	Longest, but one process for the whole market	Mandatory categories, new active substances, generics of centrally authorised products
Decentralised (DCP)	Selected states, simultaneously	Each NCA, coordinated by the RMS	Medium; assessment plus comment rounds	No EU authorisation yet, several countries at once
Mutual Recognition (MRP)	Further states, sequentially	Each recognising NCA	Shorter, the assessment exists	Extending a national MA you hold
National	One member state	That single NCA	Shortest and simplest	Single-country launch, or a step before MRP

Fees and national requirements differ, so confirm the current position with the NCA you intend to use.

The CTD and eCTD Dossier

Every route uses the Common Technical Document, submitted electronically as an eCTD. Its five modules are:

Module 1 — Regional administrative information. Forms, product information, packaging mock-ups, MAH and site details, and the QP declaration for active substance sites. This module is EU-specific and the one first-time applicants most often get wrong.
Module 2 — Summaries and overviews. Quality overall summary plus non-clinical and clinical overviews, read first by assessors.
Module 3 — Quality. Chemistry, manufacturing and controls for the active substance and finished product, including specifications, methods and stability studies.
Module 4 — Non-clinical study reports. Pharmacology, pharmacokinetics and toxicology.
Module 5 — Clinical study reports. For generics, usually a bioequivalence study.

Generics do not need full Modules 4 and 5, but Module 3 is assessed just as strictly.

The EU-Established Marketing Authorisation Holder

The Marketing Authorisation Holder must be established in the European Union. A manufacturer outside the EU cannot hold the authorisation directly.

That leaves three options: set up an EU legal entity, partner with an EU company that holds the MA and buys from you, or contract a regulatory service provider to act as MAH. Whoever holds it controls the market position and carries the legal duties for quality, variations, pharmacovigilance and recalls.

Manufacturing and Import Authorisation

A Manufacturing and Import Authorisation (MIA) lets an EU site manufacture medicines or import them from outside the EU. It is granted by the NCA where the site sits.

Third-country medicines must enter through a site whose MIA covers importation for the relevant dosage forms. That importer quarantines the consignment, arranges testing, and presents the batch to its Qualified Person.

MIA holders are inspected and listed in EudraGMDP, the public EU database of authorisations, GMP certificates and non-compliance statements. A wholesale distribution authorisation is a different licence and does not permit import from outside the EU.

The Qualified Person and Batch Certification

The Qualified Person (QP) is a named individual employed by the MIA holder who meets defined education and experience criteria.

For each batch imported from outside the EU, the QP certifies that it was made and checked in line with EU GMP and the marketing authorisation. No certification, no release.

Certification is a personal legal act, which is why an EU importer audits your site and reviews batch records closely.

A QP declaration is also required at dossier stage, confirming that active substance sites, including third-country ones, work to GMP standards equivalent to the EU standard, normally after an audit of the API site.

EU GMP and Inspection of Non-EU Sites

EU GMP applies wherever the product is made, so a site in Asia is held to the same standard as a site in Belgium. Non-EU sites named in an authorisation can be inspected by an EU authority. A satisfactory inspection produces an EU GMP certificate published in EudraGMDP; a serious failure produces a published non-compliance statement that usually stops supply immediately.

Where a mutual recognition agreement exists, inspection outcomes may be recognised rather than repeated. See our guide to GMP, WHO-GMP, EU GMP and US FDA.

API Requirements: Written Confirmation, CEP and ASMF

Written Confirmation

Each consignment of imported API must generally arrive with a written confirmation from the competent authority of the exporting country. It confirms the API was made to standards equivalent to EU GMP, that the site is inspected regularly, and that findings are shared with EU authorities.

A short list of countries assessed as having an equivalent framework is exempt, as is a site holding a valid EU GMP certificate. The Commission maintains that list and it changes, so confirm your country’s status.

CEP

A Certificate of Suitability to the monographs of the European Pharmacopoeia is issued by the EDQM. It confirms the relevant monograph adequately controls your substance as you make it, replaces much of the active substance data in a dossier, and is portable across customers.

ASMF

The Active Substance Master File is the alternative, with an Applicant’s Part shared with the finished-product applicant and a Restricted Part seen only by the authority. It works like a Drug Master File elsewhere. Use a CEP where a suitable monograph exists, and an ASMF for substances outside the pharmacopoeia.

The Falsified Medicines Directive

Under the Falsified Medicines Directive, prescription medicines in scope carry two safety features on the outer packaging:

A unique identifier in a 2D data matrix, holding the product code, a randomised serial number, batch number and expiry date, plus a national reimbursement number where required.
An anti-tampering device that visibly shows whether the pack has been opened.

Serial numbers go to the European Medicines Verification System, connected to national systems. Pharmacies and hospitals decommission packs at dispensing; wholesalers verify on a risk basis.

Agree who generates serial numbers and handles failed scans before packaging artwork is finalised.

Labelling, Leaflets and Braille

Labelling is a country-level obligation even when the authorisation is EU-wide.

Outer packaging, immediate packaging and the leaflet must appear in the official language or languages of the member state where the product is marketed, and the text must be approved in the dossier.

The medicine’s name, with strength where relevant, must appear in Braille on the outer packaging, and the MAH must supply the leaflet in formats suitable for blind and partially sighted patients on request. Readability testing forms part of the application.

Pharmacovigilance Obligations

The MAH appoints a Qualified Person Responsible for Pharmacovigilance (QPPV), who must reside and operate in the EU and be contactable at all times. Some member states also require a national contact person.

The MAH maintains a Pharmacovigilance System Master File (PSMF), which authorities can request or inspect. Adverse reaction reports go to EudraVigilance within set timelines, alongside periodic safety update reports and risk management plans.

Batch Testing on Import

Medicines manufactured outside the EU are normally subject to full qualitative and quantitative analysis inside the EU, covering at least the active substances plus the other tests needed to confirm compliance with the authorisation. That means an EU laboratory and time before release.

Mutual recognition agreements with certain third countries can waive re-testing where the agreement covers the product type. They are scope-specific, so assuming a waiver you do not have will strand a consignment.

Customs Clearance Versus Regulatory Release

Customs clearance is a fiscal and border procedure covering tariff classification, duties, VAT and import formalities.

Regulatory release happens only when the QP certifies the batch after documentation review and any required testing. Only then may product go to wholesalers, pharmacies or hospitals.

Between the two, the consignment sits in quarantine at the importer’s site, under cold chain handling if needed.

How to Import Pharmaceuticals into Europe: Step by Step

Define the product and target markets. Molecule, strength, dosage form, member states.
Choose the authorisation route. Centralised, DCP, MRP or national.
Appoint or establish the EU MAH.
Secure the API position. Obtain a CEP or prepare an ASMF, and confirm written confirmation status.
Prepare the eCTD dossier, with Module 1 built for the target member states.
Arrange the QP declaration for the API sites, usually after an audit.
Contract an EU importer holding a suitable MIA, verified in EudraGMDP for your dosage form.
Prepare the manufacturing site for GMP inspection.
Submit and manage the assessment, answering questions within the clock.
Finalise artwork. National language text, Braille, anti-tampering device and 2D unique identifier.
Set up serialisation and pharmacovigilance. Verification system, QPPV and PSMF.
Ship with the full export documentation set — Certificates of Analysis, batch records, temperature data and API documents.
Clear customs, then quarantine at the importer’s site.
Test and certify. Import testing where required, then QP certification and release.
Distribute and maintain. Variations, renewals and safety reporting continue for the product’s life.

The United Kingdom After Brexit

The MHRA grants its own marketing authorisations, and EU centralised authorisations do not automatically apply. The UK runs national routes of its own, including procedures that take account of approvals by trusted regulators elsewhere, plus its own importer licensing, QP requirements and pharmacovigilance obligations.

Northern Ireland arrangements are governed by the Windsor Framework, with supply organised on a UK-wide basis under MHRA authorisation. The detail has moved more than once, so confirm the current position with the MHRA.

Expert Tips

Verify your importer’s MIA in EudraGMDP before signing anything. A licence covering only secondary packaging will not let them import your product.
Settle the API position first. A CEP or well-built ASMF removes the biggest source of deficiency letters in generic applications.
Treat the QP audit as a project, not a visit. Prepare data integrity evidence, change control and deviation history.
Lock artwork early. Braille, language text and serialisation all constrain layout, and reopening it after approval means a variation.
Write the QP’s document expectations into the supply agreement, and model the import testing cost per batch. Missing paperwork is the usual reason a batch waits in quarantine.

Common Mistakes

Assuming a wholesaler can import from outside the EU. Only an MIA holder can, so the consignment stalls.
Treating customs clearance as market release. Supplying uncertified stock is a regulatory breach.
Filing weak Module 3 data. Quality deficiencies generate the longest question rounds.
Ignoring written confirmation for APIs. The consignment is held while documents are chased, consuming shelf life.
Setting up pharmacovigilance after approval. Findings against the QPPV or PSMF can threaten the authorisation itself.

Frequently Asked Questions

Can a non-EU company hold an EU marketing authorisation?

No. The Marketing Authorisation Holder must be established in the European Union. A manufacturer outside the EU can incorporate an EU entity, partner with an EU company that holds the authorisation, or contract a regulatory service provider to act as MAH. The choice matters commercially, because the holder controls the market position and answers for quality, variations, pharmacovigilance and recalls.

What is a Manufacturing and Import Authorisation?

An MIA is the licence allowing an EU site to manufacture medicines or import them from outside the EU, granted by the national competent authority of the member state where the site is located. Third-country medicines must enter through an MIA holder, which quarantines the consignment, arranges required testing and presents it to a Qualified Person. A wholesale distribution licence does not allow import.

Do I need a Qualified Person to import pharmaceuticals into Europe?

Yes. Every MIA holder must have at least one Qualified Person, and the QP must certify each batch imported from outside the EU before it can be released. Certification confirms the batch was made and checked in line with EU GMP and the terms of the marketing authorisation. It is a personal legal act recorded in a register, which is why QPs audit third-country sites closely.

What is written confirmation for imported APIs?

It is a document from the competent authority of the exporting country confirming the active substance was made to standards equivalent to EU GMP, that the site is inspected regularly, and that findings are shared with EU authorities. Imported API consignments generally need it. A short list of countries with an equivalent framework is exempt, as is a site holding a valid EU GMP certificate.

What safety features does the Falsified Medicines Directive require?

Prescription medicines in scope carry two features on the outer packaging. The first is a unique identifier in a 2D data matrix containing the product code, a randomised serial number, batch number and expiry date, plus a national reimbursement number where required. The second is an anti-tampering device showing whether the pack has been opened. Identifiers are decommissioned at dispensing.

Does every imported batch need testing again in Europe?

Usually, yes. Medicines manufactured outside the EU are normally subject to full qualitative and quantitative analysis within the EU, covering at least the active substances and the other tests needed to confirm compliance with the marketing authorisation. Mutual recognition agreements with certain third countries can waive this where the agreement covers the product type. Confirm coverage and price the testing in.

Is customs clearance the same as regulatory release?

No, and confusing them causes real problems. Customs clearance is a fiscal and border procedure covering classification, duties, VAT and import formalities. Regulatory release happens only when the Qualified Person certifies the batch after documentation review and any required testing. A consignment can be fully cleared by customs and still be illegal to sell, sitting in quarantine at the importer’s site.

Does the United Kingdom follow EU medicines rules after Brexit?

No. The UK operates its own system under the MHRA, with its own marketing authorisations, manufacturer and importer licences, Qualified Person requirements and pharmacovigilance obligations. EU centralised authorisations do not automatically apply, so a separate UK application is needed. Northern Ireland arrangements are governed by the Windsor Framework, with supply organised on a UK-wide basis under MHRA authorisation. Confirm current requirements with the MHRA.

Final Thoughts

The dossier, the MAH structure, the importer relationship and the QP audit all sit on the critical path, so treat regulatory work as the project rather than paperwork attached to it.

Start with the API position and the importer, and confirm current requirements with the relevant national competent authority.

Discuss Your Sourcing Requirements

If you are planning to import pharmaceuticals into Europe, or need an API supply partner that can support an EU filing, speak with our pharmaceutical experts. Share your molecule, target member states and volumes for a realistic timeline.

How to Import Pharmaceuticals into Europe: A Market-Entry Guide

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