Art. 51 Directive 2001/83/EC, § 17(3) AMWHV
The Qualified Person certifies every imported batch. Retesting in the EU can be waived where an agreement such as the MRA with the USA is in place.
View source ↗EU market entry · USA
From the USA into the EU market.
Your FDA inspection counts in Europe too, but the EU market needs three more things: an importer with an import authorisation, a Qualified Person who certifies every batch, and a marketing authorisation holder established in the EU. A&O provides all three.
- Manufacturing and import authorisation (MIA) under §§ 13 and 72 AMG
- Qualified Persons under § 14 AMG on our own team
- GMP-certified laboratory in Itzehoe for EU retesting
The route of a batch from the USA
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USA
Manufacturing and testing Recognised
The FDA GMP inspection is recognised in the EU.
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USA
Batch certificate Required
Signed by the manufacturer, for every batch.
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EU border
Import with partners Handled by A&O
Under A&O's import authorisation and that of our partner.
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Itzehoe
EU retesting Waived
The MRA replaces retesting in the EU.
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Efringen-Kirchen
QP certification Handled by A&O
Every batch, even under the MRA.
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EU and EEA
Market in 30 countries Destination
With a marketing authorisation and an EU-based MAH.
One step fewer than for most third countries: retesting is waived.
€43.6bn
of pharmaceutical products imported into the EU from the USA in 2025, 37 per cent of all imports from outside the EU.
Eurostat Comext, HS 302019
Since 11 July 2019, the EU and the USA have fully recognised each other's GMP inspections for human medicines.
EMA, MRA Q&AEvery batch
still needs certification by a Qualified Person in the EU, even under the MRA.
Art. 51 Directive 2001/83/ECIn short
How does a US manufacturer bring a medicinal product to the EU market?
With three building blocks: an EU marketing authorisation whose holder is established in the EU or the European Economic Area, an importer with an import authorisation, and a Qualified Person who certifies every imported batch before it is placed on the market.
The mutual recognition agreement (MRA) between the EU and the USA makes this much easier: FDA GMP inspections are recognised, and for products within its scope that were manufactured and tested in the USA, EU retesting can be waived. Vaccines, plasma-derived products, ATMPs and investigational medicinal products are among those not covered. Batches of vaccines, plasma-derived products and ATMPs are retested in the EU.
Reviewed on 23 October 2026 by
Dr. Olaf Mundszinger
Qualified Person (QP) under § 14 AMG
Regulations checked against the original sources on 19 October 2026
Where the EU sources its medicinal products
The USA is the largest country of origin and one of only two among the top six where retesting can be waived.
- 1 USA €43.6bn No retesting within MRA scope
- 2 Switzerland €39.0bn No retesting within MRA scope
- 3 United Kingdom €9.0bn Every batch retested
- 4 China €5.4bn Every batch retested
- 5 South Korea €5.3bn Every batch retested
- 6 India €2.9bn Every batch retested
EU imports of pharmaceutical products (HS 30) from outside the EU, 2025. Source: Eurostat Comext, as of October 2026
MRA checker
What the MRA covers, and what it does not.
Select your product type. You will see straight away whether the FDA inspection is recognised and whether EU retesting can be waived.
Finished product
FDA GMP inspection
Recognised, the EU does not inspect twice.
EU retesting of each batch
Can be waived if manufactured and tested in the USA, with the manufacturer's batch certificate.
Release in the EU
The Qualified Person certifies every batch, relying on the batch certificate.
Biotech product
FDA GMP inspection
Recognised for authorised therapeutic biotech products.
EU retesting of each batch
Can be waived under the same conditions.
Release in the EU
QP certification of every batch.
Active substance (API)
FDA GMP inspection
Active substances and intermediates are covered.
EU retesting of each batch
No written confirmation from the FDA is needed: the USA is on the EU list under Art. 111b.
Release in the EU
The finished product manufacturer tests the API in line with EU GMP.
Vaccine
FDA GMP inspection
Human vaccines are currently not covered.
EU retesting of each batch
Retesting in the EU, plus official control authority batch release (OCABR).
Release in the EU
QP certification of every batch.
Plasma-derived product or ATMP
FDA GMP inspection
Currently not covered.
EU retesting of each batch
Retesting in the EU.
Release in the EU
QP certification of every batch.
New since October 2025: EU authorities may, case by case, also rely on FDA inspections of sites outside the USA.
How it works
From the US plant to QP release in the EU.
This is the typical route when an authorised medicinal product from the USA enters the EU for the first time.
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01
Marketing authorisation and MAH
No marketing authorisation without a holder established in the EU. A&O takes on this role as interim MAH (iMAH) until you have an establishment in the EU or a partner.
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02
Review manufacturer and documents
We review GMP status, FDA inspections and the quality agreement, and establish what is recognised under the MRA.
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03
Import with our partners
A partner handles the physical import, under A&O's import authorisation and that of our partner, with the manufacturer's batch certificate.
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04
Retesting where required
Products outside the MRA are fully tested to EU requirements in our GMP-certified laboratory in Itzehoe.
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05
QP certification of every batch
Our Qualified Person certifies every batch. Only then may it be placed on the EU market.
Route check
Which steps does your product need?
A few clicks and you will see your route into the EU market. It does not replace advice, but it shows what we should talk about.
The legal framework
What the regulations require.
EU-US MRA, Sectoral Annex on GMP
Mutual recognition of GMP inspections, fully operational for human medicines since 11 July 2019. Vaccines, plasma-derived products, ATMPs and investigational medicinal products are among the products currently excluded.
View source ↗§ 72 AMG, EU GMP Annex 21
Even under the MRA, imports from the USA remain third-country imports. Under Annex 21, both the site of physical importation and the site of QP certification need an authorisation. A&O holds the import authorisation for certification; a partner handles physical importation.
View source ↗Art. 8(2) Directive 2001/83/EC, § 9(2) AMG
A marketing authorisation may only be granted to an applicant established in the EU. In Germany, only a pharmaceutical company based in the EU or EEA may place medicinal products on the market.
View source ↗Art. 46b and 111b Directive 2001/83/EC
Imported active substances need a written confirmation from the authority of the exporting country. The USA is on the list of countries for which this is not required.
View source ↗What A&O takes on
Everything from one provider, with names and faces.
QP Batch Release
Import together with our partners and certification of every batch by our Qualified Persons.
View this service
Regulatory Affairs
EU marketing authorisation and the iMAH model if you do not yet have an MAH in the EU.
View this service
Analytical Services
EU retesting in our GMP-certified laboratory in Itzehoe, for everything outside the MRA.
View this service
Frequently asked questions
What US manufacturers ask us most often.
Is our FDA inspection recognised in the EU?
Yes, for products within the scope of the MRA. EU authorities recognise FDA GMP inspections and do not inspect twice. This has applied to human medicines since 11 July 2019. Vaccines, plasma-derived products, ATMPs and investigational medicinal products are among the products currently excluded.
Do US batches have to be retested in the EU?
Not if the product falls under the MRA, was manufactured and tested in the USA, and every batch comes with a batch certificate signed by the manufacturer. The Qualified Person can then waive retesting. For vaccines, plasma-derived products and ATMPs, retesting is still required.
Is a Qualified Person in the EU still needed under the MRA?
Yes. Under Article 51 of Directive 2001/83/EC, a Qualified Person certifies every batch before it is placed on the EU market. The MRA replaces the testing, not the certification.
Can a US company be the marketing authorisation holder in the EU?
No. The marketing authorisation holder must be established in the EU or the European Economic Area. Companies without an entity there can appoint A&O as interim marketing authorisation holder (iMAH).
Will the new EU pharmaceutical package change this?
The reform of EU pharmaceutical law is not yet in force. It will replace Directive 2001/83/EC, and article numbers will change. We will update this page as soon as the new rules apply.
Other countries of origin
