Importing Medicines into Europe and Turkey: A Country-by-Country Guide (2026)

Last updated: 8 October 2026. Part of our region-by-region import guide series. Covers the European Union and EEA (as one system, with notes on how national markets differ, including the Baltic states), the United Kingdom, Switzerland and Turkey.

In Europe, the hard part isn't finding an importer. It's getting approved. The EU and EEA work as one system: you need a marketing authorisation, a holder established in the EU or EEA, and a qualified person who certifies every imported batch, usually after re-testing it inside the EU. The UK now runs its own system, but its International Recognition Procedure can turn an FDA or EU approval into a UK licence in 60 to 110 days. Switzerland can take foreign assessments into account under Article 13 of its Therapeutic Products Act. Turkey wants to inspect your plant itself, and it sets prices from the lowest price in five EU countries.

This guide walks through the region in plain language:

• The EU and EEA: the centralised, decentralised, mutual recognition and national routes, generic and biosimilar applications, QP release, API paperwork, safety features, tenders, and the reforms now on the way.
• Outside the EU: the United Kingdom, Switzerland and Turkey, each with its own regulator, import licence and special import route.

It's written for manufacturers exporting to Europe from China, India, Korea, the US and elsewhere, for European companies selling across the new borders, and for the importers, distributors and licence holders who work with them.

How the region works

The same doors exist here as everywhere else: register and sell, supply public tenders, or bring in an unlicensed medicine for a patient who needs it. But in Europe the first door is the one that matters most, and it's built differently:

• Full registration. Every market wants a CTD dossier. Our guide to CTD vs ACTD explains the format. The EU, the UK, Switzerland and Turkey all want the holder to be based locally.
• Abridged and reliance routes. The EU doesn't rely on foreign approvals. Instead, an approval in one member state can be recognised by others. The UK and Switzerland do rely on trusted regulators, including the EMA and FDA. Turkey has priority review for some products, but we found no route built on foreign approvals.
• Import is a quality step, not a trade step. In the EU and the UK, a licensed importer with a qualified person (QP) certifies each batch. Where there's no mutual recognition agreement, that usually means testing the batch again on arrival.
• Tenders and pricing are national. Hospital tenders, insurer contracts and price controls differ in every country, even inside the EU.
• Special import routes exist everywhere, but they're narrow: a doctor's request for one patient, tightly controlled.

The routes at a glance

The European Union and EEA

• Registration: there are four routes. The centralised procedure gives one licence for the whole EU and EEA. It's compulsory for biotech medicines, advanced therapies, orphan medicines and new active substances for cancer, diabetes, HIV, neurodegenerative, autoimmune and viral diseases. Everything else can go through the decentralised procedure (DCP, for a product not yet approved anywhere in the EU), the mutual recognition procedure (MRP, to extend an existing national approval) or a single national application. The applicant must be established in the EU or EEA.
• Generics, hybrids and biosimilars: Article 10 of Directive 2001/83/EC sets the rules. A generic (Article 10(1)) relies on the reference product's data and shows bioequivalence. You can file once the reference has been authorised for eight years, and sell after ten (eleven if a new indication brought a significant clinical benefit). A hybrid (Article 10(3)) adds studies when the product differs in strength, form, route or indication, or bioequivalence can't be shown. A biosimilar (Article 10(4)) adds the pre-clinical and clinical data needed to show it is similar to the reference biological.
• Centralised generics: a generic of a centrally authorised medicine gets automatic access to the centralised route. A generic of a nationally authorised medicine needs EMA's agreement first, on grounds of innovation or patient interest.
• Importing: bringing medicines in from outside the EU needs a manufacturing and import authorisation (MIA), the same licence a manufacturer holds. A QP named on it certifies each batch. For imports, the batch must be fully analysed again in a member state, unless an EU agreement with the exporting country lets the QP skip those controls.
• Mutual recognition agreements: the EU has GMP agreements with Australia, Canada, Israel, Japan, New Zealand, Switzerland and the US. They let regulators rely on each other's inspections and generally allow batch testing on import to be waived, though the scope differs by agreement. With the US, EU QPs have not needed to re-test covered human medicines since July 2019, provided they check the US controls were done. Vaccines, plasma-derived medicines and advanced therapies are outside the US agreement for now.
• APIs: active substances imported into the EU need a written confirmation from the exporting country's regulator that the plant's GMP is equivalent to the EU's. Countries on the Commission's list are exempt: Australia, Brazil, Canada, Israel, Japan, South Korea, Switzerland, Taiwan and the US. Your API also needs a CEP or an ASMF behind it. See our guide to CEP vs DMF vs ASMF.
• GMP/inspections: plants outside the EU are inspected by member-state inspectorates, unless an MRA partner's inspection is accepted.
• Safety features: under the Falsified Medicines Directive and Delegated Regulation (EU) 2016/161, prescription medicine packs, with some exemptions, carry a unique identifier and an anti-tampering device, checked against a verification system since 9 February 2019. The QP must confirm these are on the pack before release.
• Distribution: wholesalers need their own authorisation and must follow EU good distribution practice. Our GDP guide covers what inspectors check.
• Parallel import: independent traders can move an authorised medicine from one member state to another. For centrally authorised products, they need a parallel distribution notice from EMA first. Nationally authorised products follow each country's own parallel import rules.
• Public buying/pricing: pricing, reimbursement and tenders stay national. Hospital and insurer tenders follow the EU public procurement directive (2014/24/EU), which lets buyers weigh quality and supply as well as price. Some countries now reward supply security. Germany's 2023 supply law, for example, makes insurers' antibiotic tenders give weight to active-ingredient production in Europe. Our guide to tender sourcing explains how buyers score bids.
• Without registration: Article 5(1) of the Directive lets member states allow a medicine supplied against a bona fide unsolicited order from a doctor, for one patient under their care. Each country runs this differently. Our early access guide explains compassionate use and managed access.
• Watch out for: the batch re-testing cost and time if your country has no MRA, and the language. Every member state wants its own language on packs and leaflets, which is why multilingual packs are common.

How national markets differ

One approval doesn't mean one market. Each country sets its own price, decides on reimbursement, and runs its own tenders and named-patient rules. Packs must be in the local language. Some countries cooperate to make supply easier:

• The Baltic states. Estonia, Latvia and Lithuania run a common Baltic package procedure. One reference agency handles approval of a shared pack for all three, under guidance first signed in 2005. They have also piloted electronic leaflets in place of paper ones for hospital-only medicines. For an exporter, that means one pack, one procedure and three markets.
• Centralised medicines still launch country by country. A centralised licence covers the EU, but you'll still need a price and reimbursement decision, a distributor and a pack for each market.
• Tender-heavy systems. In some countries, insurer contracts and hospital tenders drive off-patent supply. Read each tender's supply, stock and penalty terms before you price.

What's changing: the pharma package and the Critical Medicines Act

• The pharma package. The Council and Parliament reached a deal on the new EU pharmaceutical directive and regulation on 11 December 2025. The Council adopted its position on 28 September 2026. The Parliament must still give final approval, then the texts are published in the Official Journal, with transition periods before most rules apply. So as of October 2026 the current rules still apply.
• What it changes for generics and biosimilars. Baseline protection for new medicines becomes eight years of data protection plus one year of market protection, with extensions for some products. The Bolar exemption is widened, so preparing a generic, including for pricing and procurement tenders, doesn't infringe patents or SPCs, as long as nothing is sold while protection lasts. Law firm summaries say EMA's standard assessment falls from 210 to 180 days.
• The Critical Medicines Act. The Council and Parliament agreed a deal on 12 May 2026. It still needs formal adoption. When buying critical medicines, public buyers will have to apply resilience requirements, and they can reward supply made in the EU, including the share of the active ingredient made there. Five or more member states will be able to ask the Commission to buy jointly for them.

The United Kingdom

• Registration: the MHRA licenses medicines for the whole UK. Since 1 January 2025, under the Windsor Framework, licences cover Northern Ireland too, and EU centralised approvals no longer apply there. The MHRA compares its recognition timelines with a 150-day horizon for national assessment.
• Fast track/reliance: since 1 January 2024, the International Recognition Procedure (IRP) relies on approvals by the FDA, EMA and EU/EEA national agencies, Health Canada, Swissmedic, the TGA, HSA Singapore and PMDA Japan.
  • Recognition A: 60 days, for products approved by the reference regulator in the past two years with a matching, GMP-compliant manufacturing process.
  • Recognition B: 110 days with a clock stop, for products approved in the past five years, or where a trigger applies, such as an uninspected site or a first-in-class substance. The window was cut from ten years from July 2026.
  Generics, hybrids and biosimilars are in scope, but generics must cite a UK reference product. The applicant must be established in the UK or EU/EEA.
• Importing: a UK wholesaler can import QP-certified medicines from countries on the MHRA's approved list (the EU and EEA) under a wholesale dealer's licence, with a Responsible Person (import) checking each batch. From anywhere else, the importer needs a UK manufacturing and import authorisation, and a UK QP must certify the batch. The UK accepts batch testing done in the EU/EEA and in MRA countries (Australia, Canada, Israel, Japan, New Zealand, Switzerland and the US), with some exclusions.
• Packs: UK packs must say "UK Only". The UK's falsified-medicines verification system closed at the end of 2024, and EU-recognisable barcodes must be removed or covered.
• Public buying/pricing: in England, NHS England's Commercial Medicines Unit runs national frameworks for hospital medicines, including generics, branded medicines and biosimilars. Tenders are published on the UK government's Find a Tender service.
• Without a licence: unlicensed "specials" can be imported for individual patients. Importers use a wholesale dealer's licence for products from approved countries, or a manufacturer's specials licence for others, and must notify the MHRA before each import. Our guide to unlicensed medicines in the UK covers the full process.
• Watch out for: the EU now treats the UK as a third country. UK-made batches entering the EU are imports, and the UK isn't on the EU's MRA list.

Switzerland

• Registration: Swissmedic authorises medicines. The applicant needs a Swiss address, registered office or branch, and a Swiss licence to manufacture, import or wholesale.
• Fast track/reliance: under Article 13 of the Therapeutic Products Act (TPA), Swissmedic takes into account the results of a foreign authority's assessment when the product is authorised in a country with comparable control. Swissmedic publishes the list of these countries. Its published list has named the EU/EEA, the US, Canada, Japan, Australia, New Zealand and Singapore. The dossier must be identical to the one the foreign authority approved, with its final assessment reports. For an EU decentralised approval, the reference member state's report is enough. Hybrids need a Swiss-authorised reference product, and biosimilars must meet extra criteria. If the conditions aren't met, Swissmedic moves the file to its normal procedure.
• Work-sharing: Swissmedic belongs to the Access Consortium with Australia, Canada, Singapore and the UK. Its work-sharing schemes for new active substances, biosimilars and generics let one dossier be reviewed by several members together.
• Importing: anyone importing medicines commercially needs a Swissmedic licence, granted after an inspection. In principle, only Swiss-authorised products can be imported. Switzerland has a GMP mutual recognition agreement with the EU.
• Public buying/pricing: reimbursed medicines are listed on the Specialties List, with prices set after a comparison with similar treatments and with prices abroad. They're reviewed every three years.
• Without authorisation: healthcare professionals can import non-authorised medicines in limited cases under the medicinal products licensing ordinance.
• Watch out for: the law is changing. On 19 June 2026, the Federal Council opened a consultation, running until 16 October 2026, on a simpler authorisation route for medicines approved by comparable regulators. It would also let wholesalers and importers temporarily bring in non-authorised medicines during shortages.

Turkey

• Registration: TİTCK, the Turkish Medicines and Medical Devices Agency, licenses medicines under the Licensing Regulation published on 11 December 2021, which aims to align with EU Directive 2001/83/EC. The applicant must be based in Turkey and file a CTD dossier. Evaluation takes 210 days from acceptance, not counting clock stops. Generics face a six-year data exclusivity period.
• Fast track/reliance: priority evaluation exists for some products. We found no route that shortens review because of an FDA or EMA approval.
• GMP/inspections: this is the big one. Since 1 March 2010, imported products have needed TİTCK's own GMP inspection of the foreign plant, and a pending inspection can hold up a licence. TİTCK's foreign-site guidance was updated in September 2025. It offered a one-time file-based review, using a recent PIC/S inspection report, for sites never inspected that applied by 31 December 2025. TİTCK has been a PIC/S member since 1 January 2018.
• Public buying/pricing: a Presidential Decision of 12 March 2026 sets the rules.
  • Reference countries: a communiqué of 29 August 2026 names France, Spain, Italy, Portugal and Greece. The reference price is the lowest ex-factory price there, or a lower one in the country of batch release or import.
  • Euro rate: prices are converted at a fixed euro value, set at 65% of the previous year's average rate. For 2026 it's 29.1164 lira from 1 April.
  • Generics: priced at up to 60% of the reference. Higher rates of 80%, 75% and 70% apply over three years for some high-priced first generics.
  Reimbursement is a separate decision by the Social Security Institution (SGK).
• Without a licence: under TİTCK's foreign medicine supply guidance, a doctor applies through the e-prescription system for a named patient, and TİTCK approves each case. Supply runs through approved suppliers, which include the Turkish Pharmacists' Association (TEB). The foreign source must be the manufacturer, licence holder or a wholesaler licensed by an ICH member authority, the MHRA or the TGA. Medicines supplied this way are tracked in the national drug tracking system (İTS).
• Watch out for: localisation pressure. Since 2016, Turkey has linked reimbursement of some imported products to local production. A WTO arbitration award in July 2022, in a case brought by the EU, found the measure discriminatory. Check the current position for your product with a local partner.

What this means for exporters in India, China, Korea, Europe and the US

For every exporter

• Find your holder first. All four systems need a locally established applicant. Many exporters license their dossier to a European company. Our guide to out-licensing a dossier explains how those deals are priced.
• Choose the EU route by footprint. Use the DCP for a multi-country launch, the centralised route where it's compulsory or the reference was centrally authorised, and a national filing to test one market.
• Plan for batch release. Without an MRA, budget for an EU or UK importer with a QP, re-testing on arrival and the time that takes.
• Use one approval to unlock the next. An EU approval feeds the UK's IRP and Switzerland's Article 13 route.
• Get your stability data right. Our guide to ICH stability guidelines covers what assessors expect.

For exporters in India

• Every batch is re-tested. India has no MRA with the EU, so imported batches are fully analysed in the EU, or in the UK or an approved country for the UK market.
• APIs need written confirmation. India isn't on the Commission's exempt list, so each EU-bound API shipment needs a written confirmation from the Indian regulator.
• Expect inspections. EU member-state inspectors and TİTCK both inspect plants in India. An EU GMP certificate helps in the UK and Switzerland, but Turkey still wants its own.

For exporters in China

• Same paperwork as India: written confirmations for APIs, EU re-testing of finished batches, and member-state or TİTCK inspections.
• Watch the resilience rules. The Critical Medicines Act and national rules such as Germany's antibiotic tenders reward supply made in Europe. For critical medicines, partnering with an EU finished-dose maker may keep you in the bid. See our China vs India API comparison for how buyers weigh the two.

For exporters in Korea

• APIs are easier. South Korea is on the EU's exempt list, so Korean APIs don't need a written confirmation.
• Finished products still need testing. Korea isn't an EU MRA partner, so EU and UK importers re-test batches.
• Biosimilars are the natural fit. The EU's biosimilar route under Article 10(4) is mature, and an EU approval then supports UK and Swiss filings.

For exporters in Europe

• The UK and Switzerland are a short step. Your EU approval opens the IRP and Article 13, and the UK accepts EU QP certification and batch testing.
• Going the other way is harder. UK-made batches entering the EU need an EU importer, QP and testing, and UK API makers need a written confirmation from the MHRA.
• Turkey needs separate plans. EU plants still need a TİTCK inspection, and your EU prices in France, Spain, Italy, Portugal and Greece will set your Turkish ceiling.

For exporters in the US

• The MRA saves real time. EU QPs don't need to re-test covered US-made human medicines, and US APIs need no written confirmation.
• FDA approval travels. It's a reference approval for the UK's IRP and a comparable-control approval for Swissmedic. It doesn't shorten review in the EU or Turkey.
• Named-patient routes matter. Newer US medicines often reach patients before they're licensed here, through the EU's national routes, UK specials and Turkey's foreign medicine supply.

Ready to source for your market?

• Licence holders, importers and tender bidders in Europe, the UK, Switzerland and Turkey: post your sourcing RFQ. Our RFQ guide shows what to include, and our dossier licensing and registration service can help with EU, UK, Swiss and Turkish files.
• Hospitals and patients needing an unlicensed medicine: submit an RFP for named-patient import. Our named-patient import guide compares the routes.
• Manufacturers looking to supply the region, whether finished products, APIs or dossiers for licensing: list your company and products so buyers and licence holders can find you.

This guide summarises public regulations and official sources as of October 2026. The EU pharma package and the Critical Medicines Act are not yet in force, and Swiss and Turkish rules are changing. Confirm current requirements with the regulator or a local regulatory partner before acting.

Sources

• Applying for EU marketing authorisation (EMA)
• Procedural guidance: application for marketing authorisation, MRP and DCP (CMDh, Heads of Medicines Agencies)
• Directive 2001/83/EC on the Community code relating to medicinal products for human use (EMA copy)
• Directive 2001/83/EC, Article 51 on qualified person controls (legislation.gov.uk)
• Generic and hybrid applications (EMA)
• Generic and hybrid medicines (EMA)
• Mutual recognition agreements (EMA, updated June 2026)
• Importation of active substances: listing of third countries (European Commission)
• Falsified medicines (European Commission)
• Parallel distribution (EMA)
• Directive 2014/24/EU on public procurement (EUR-Lex)
• Substitute insurers award antibiotic contracts to European producers (Pharmazeutische Zeitung, May 2024)
• Baltic package procedure (Estonian State Agency of Medicines, February 2023)
• Baltic ePIL project for hospital-use medicines (Estonian State Agency of Medicines, November 2021)
• Pharma package: Council and Parliament reach a deal (Council of the EU, December 2025, updated March 2026)
• Voting result on the pharmaceutical regulation, document 13737/26 (Council of the EU, 28 September 2026)
• Council of the EU adopts pharma package (RAPS, October 2026)
• EU Council adopts new EU pharma package (Matheson, 2026)
• The EU pharma package: how close is it to becoming law? (Setterwalls, May 2026)
• Critical medicines act: Council and Parliament reach provisional deal (Council of the EU, May 2026)
• New rules for critical medicines in the EU (Council of the EU)
• EU Critical Medicines Act: political agreement reached (McCann FitzGerald, May 2026)
• International Recognition Procedure (MHRA, updated September 2026)
• MHRA's International Recognition Procedure goes live from 1 January 2024 (MHRA)
• Windsor Framework agreement on the supply of medicines in Northern Ireland explained (MHRA, March 2025)
• Wholesalers' and manufacturers' guidance following the Windsor Framework (MHRA)
• List of approved countries for authorised human medicines (MHRA)
• Acting as a Responsible Person (import) (MHRA)
• Import a human medicine (MHRA, January 2025)
• Commercial Medicines Unit (NHS England)
• NHS national framework for generics housekeeping and supply chain resilience products (Find a Tender, 2025)
• Questions and answers on Art. 13 TPA (Swissmedic, March 2026)
• List of countries with comparable control of medicinal products (Swissmedic)
• Access Consortium (Swissmedic)
• Therapeutic Products Act, Article 10 (Lawbrary)
• Life sciences Switzerland 2026 (Bär & Karrer, April 2026)
• Revision of the Therapeutic Products Act: Federal Council wants to strengthen medicines supply (Swiss Federal Council, June 2026)
• Amendment of the Therapeutic Products Act 3b (Federal Office of Public Health)
• The Turkish pharmaceutical industry's regulatory landscape (CBC Law via Legal 500, March 2023)
• New regulation on the licensing of medicinal products for human use (Paksoy, January 2022)
• Medicine licensing process and TİTCK legislation (Geçmez Hukuk, February 2026)
• GMP inspections of foreign manufacturing sites, guidance version 10 (TİTCK via TİSD, September 2025)
• Turkey becomes a PIC/S member (Esin Attorney Partnership, October 2017)
• Decision 11031 on the pricing of human medicinal products (Official Gazette text via Alomaliye, March 2026)
• Decision on the pricing of human medicinal products published (Moroğlu Arseven, April 2026)
• Communiqué on the pricing of human medicinal products (Official Gazette text via Alomaliye, August 2026)
• Guidance on supply of medicines from abroad, revision 14 (TİTCK, August 2024)
• Foreign medicines must be registered in the drug tracking system (Sözcü, February 2023)
• The future of Turkish pharma localisation: the EU dispute (PharmaBoardroom, November 2021)
• EU wins WTO case against Turkey on pharmaceutical products (KPMG, July 2022)

Frequently Asked Questions(FAQs)

Is one EU approval valid in every EU country?

A centralised approval is valid across the EU and EEA. Decentralised and mutual recognition approvals cover only the countries you name. Either way, price, reimbursement, packs and distribution are still handled country by country.

Do imported medicines have to be re-tested in the EU?

Usually, yes. A qualified person must certify each imported batch after a full analysis in a member state. Where the EU has a mutual recognition agreement with the exporting country, such as the US, Switzerland or Japan, that testing can be waived for covered products.

Can an EU or FDA approval speed up a UK licence?

Yes. The MHRA's International Recognition Procedure relies on approvals from the EMA, EU/EEA agencies, the FDA and other reference regulators. It takes 60 days under Recognition A or 110 days under Recognition B.

Has the EU pharma package come into force?

Not yet. As of October 2026, the Council has adopted its position, but the Parliament must still give final approval before the texts are published. Most new rules then apply after transition periods. The Critical Medicines Act is also still awaiting formal adoption.

How are medicine prices set in Turkey?

Under a March 2026 decision, the reference price is the lowest ex-factory price in France, Spain, Italy, Portugal and Greece, converted at a fixed euro rate. Generics are priced at up to 60% of the reference, with higher rates for some first generics.