Art. 51(1) Directive 2001/83/EC
Every batch from a third country undergoes full qualitative and quantitative analysis in the EU before the Qualified Person certifies it.
View source ↗EU market entry · United Kingdom
From the UK into the EU market.
Since 1 January 2021, the UK has been a third country under EU pharmaceutical law. What used to be released in London now needs an importer, retesting and a Qualified Person in the EU. A&O handles the whole route.
- Manufacturing and import authorisation (MIA) under §§ 13 and 72 AMG
- EU retesting in our GMP-certified laboratory in Itzehoe
- EU marketing authorisation holder through the iMAH model
The route of a batch from the UK
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United Kingdom
Manufacturing and testing Recognised
GMP inspections are mutually recognised under the trade agreement.
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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 of every batch Handled by A&O
Full analysis in our GMP-certified laboratory.
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Efringen-Kirchen
QP certification Handled by A&O
UK release is no longer valid in the EU.
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EU and EEA
Market in 30 countries Destination
With a marketing authorisation holder in the EU.
Unlike the USA, no agreement waives retesting.
€9.0bn
of pharmaceutical products imported into the EU from the UK in 2025, third behind the USA and Switzerland.
Eurostat Comext, HS 302021
Since 1 January 2021, the UK has been a third country under EU pharmaceutical law.
European Commission and EMAEvery batch
from the UK needs full analysis in the EU. There is no agreement that waives this.
Art. 51 Directive 2001/83/ECIn short
What does a UK manufacturer need for the EU market since Brexit?
A marketing authorisation holder established in the EU or the European Economic Area, an importer with an import authorisation and a Qualified Person in the EU who certifies every batch. Every imported batch must be fully analysed in the EU.
The EU-UK Trade and Cooperation Agreement does recognise GMP inspections on both sides. Unlike the agreement with the USA, however, it contains no waiver of batch testing. If an active substance from the UK is itself imported into the EU, it also needs a written confirmation from the UK authority. For the finished product, the manufacturer's GMP certificate is what counts.
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 UK ranks third, but since Brexit every batch needs retesting in the EU.
- 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
Before and after
What changed with Brexit.
Drag the slider to the right to see what applied until the end of 2020. The dark side shows what applies today.
Marketing authorisation holder
Could be established in the UK.
Marketing authorisation holder
Must be established in the EU or EEA. UK holders had to transfer their authorisations.
Release
Certification by a UK QP was valid across the EU.
Release
A Qualified Person in the EU certifies every batch, under an EU import authorisation.
Batch testing
Testing in the UK was sufficient.
Batch testing
Every batch undergoes full qualitative and quantitative analysis in the EU.
API imports
Free movement within the single market.
API imports
A written confirmation from the UK authority is required: the UK is not on the EU list.
GMP inspections
One shared EU system.
GMP inspections
Mutually recognised under Annex 12 of the Trade and Cooperation Agreement.
How it works
From the UK batch to QP release in the EU.
This is the route today when a medicinal product from the UK enters the EU.
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01
MAH in the EU
If the authorisation is still held by a UK company, it must be transferred. A&O can take on the role as interim MAH (iMAH).
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02
Review documents
We review the manufacturer's GMP certificate, the quality agreement and the marketing authorisation documents.
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03
Import under our authorisation
The goods enter the EU under A&O's import authorisation under § 72 AMG.
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04
Retesting in Itzehoe
Our GMP-certified laboratory fully analyses every batch against the marketing authorisation.
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05
QP certification of every batch
Our Qualified Person certifies the batch. It can then 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.
Trade and Cooperation Agreement, Annex 12
The EU and the UK mutually recognise GMP inspections and GMP documents. The annex contains no waiver of batch testing.
View source ↗§ 72 AMG, EU GMP Annex 21
Since the UK became a third country, every commercial import from there needs a German or other EU import authorisation. Under Annex 21 of the EU GMP Guide, 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
Marketing authorisation holders must be established in the EU. UK holders therefore had to transfer their authorisations to establishments in the EU.
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 UK is not on the list of countries exempt from this. No confirmation is needed for an imported finished product.
View source ↗Art. 7(3) Protocol on Ireland/Northern Ireland, Regulation (EU) 2023/1182
Northern Ireland has a special status: batch certification by the Qualified Person of a manufacturer or importer established in Northern Ireland is recognised in the EU, as is batch testing carried out there. Medicines for the Northern Ireland market carry "UK only" and must not be moved into the EU.
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
Analytical Services
EU retesting of every batch in our GMP-certified laboratory in Itzehoe.
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Regulatory Affairs
Transfer of the authorisation to the EU and the iMAH model while you have no EU establishment.
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GMP and GxP Consulting & QA Support
Review of GMP documents, quality agreements and API written confirmations.
View this service
Frequently asked questions
What UK manufacturers ask us most often.
Is certification by a UK QP still valid in the EU?
No. Since 1 January 2021, the UK has been a third country. Every batch must be imported under an EU import authorisation and certified by a Qualified Person in the EU.
Do UK batches have to be retested in the EU?
Yes. Every imported batch undergoes full qualitative and quantitative analysis in the EU. The Trade and Cooperation Agreement recognises GMP inspections but does not waive batch testing. A&O carries out retesting in its own laboratory in Itzehoe.
Can the marketing authorisation holder stay in the UK?
No. The marketing authorisation holder must be established in the EU or the European Economic Area. If you have no EU establishment, A&O can take on the role as interim MAH (iMAH).
Do active substances from the UK need a written confirmation?
Yes. The UK is not on the EU list under Article 111b of Directive 2001/83/EC. Every imported active substance therefore needs a written confirmation from the UK authority that it was manufactured to EU-equivalent GMP.
Does a UK finished product need a written confirmation?
No. The written confirmation is only needed when the API itself is imported into the EU. For a finished product from the UK, the manufacturer's GMP certificate is what counts.
What applies to Northern Ireland?
Northern Ireland has a special status. If a manufacturer or importer established in Northern Ireland certifies a batch for the EU market, that certification is recognised in the EU, with no repeat certification and no retesting (Art. 7(3) Protocol on Ireland/Northern Ireland). Medicines for the Northern Ireland and Great Britain market, by contrast, carry the "UK only" label and must not be moved into the EU (Regulation (EU) 2023/1182).
Is there an agreement that will waive batch testing?
Not at present. The Trade and Cooperation Agreement only recognises GMP inspections. Until that changes, every UK batch needs retesting in the EU. We will update this page as soon as this changes.
Other countries of origin
