EU-Switzerland agreement, Annex 1 Chapter 15
Mutual recognition of GMP inspections, manufacturing authorisations and batch certificates. The manufacturer's certificate is accepted without re-control at import.
View source ↗EU market entry · Switzerland
From Switzerland into the EU market.
The agreement between Switzerland and the EU spares your batches retesting. What it does not spare you: an importer with an EU import authorisation, a Qualified Person who certifies every batch and a marketing authorisation holder in the EEA. A&O provides all of this, together with our import partners.
- Manufacturing and import authorisation (MIA) under §§ 13 and 72 AMG
- Qualified Persons under § 14 AMG on our own team
- EU marketing authorisation holder through the iMAH model
The route of a batch from Switzerland
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Switzerland
Manufacturing and testing Recognised
The Swissmedic GMP inspection is recognised in the EU.
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Switzerland
Batch certificate Recognised
Recognised without re-control at import.
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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 agreement replaces retesting in the EU.
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Efringen-Kirchen
QP certification Handled by A&O
For every batch, relying on the Swiss certificate.
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EU and EEA
Market in 30 countries Destination
With a marketing authorisation holder in the EEA.
The shortest route into the EU market: the Swiss certificate replaces retesting.
€39.0bn
of pharmaceutical products imported into the EU from Switzerland in 2025, a third of all imports from outside the EU.
Eurostat Comext, HS 302002
Since 1 June 2002, the EU and Switzerland have mutually recognised GMP inspections and batch certificates.
EMA, MRANo retesting
for batches manufactured in Switzerland entering the EU. QP certification still applies.
EU-Switzerland agreement, Chapter 15In short
What does a Swiss manufacturer need for the EU market?
A marketing authorisation holder established in the EU or the European Economic Area, as Switzerland is not part of the EEA. In addition, an importer with an EU import authorisation and a Qualified Person who certifies every batch.
The mutual recognition agreement spares the retesting: the Swiss manufacturer's batch certificate is recognised at import without re-control. This applies to products manufactured in Switzerland. If bulk or intermediate product comes from a third country, the batch is 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
Switzerland is the second-largest country of origin. Thanks to the agreement, retesting is waived, but release in the EU is not.
- 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
When the agreement applies
When the agreement spares you retesting.
Whether your batches enter the EU without retesting depends on where they are made. What counts is the bulk, not the packaging.
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No retesting
Manufactured in Switzerland
The batch certificate is recognised without retesting. The Qualified Person in the EU certifies on that basis.
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No retesting
Only API or packaging from a third country
The product still counts as Swiss, so retesting is waived.
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Retesting in the EU
Bulk or intermediate from a third country
The agreement does not apply. Every batch is retested in the EU.
How it works
From Switzerland into the EU market.
This is the route when a medicinal product manufactured in Switzerland enters the EU. Retesting is waived; the other steps remain.
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01
MAH in the EEA
A Swiss company cannot be the marketing authorisation holder in the EU. A&O takes on the role as interim MAH (iMAH).
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02
Quality agreement and certificates
We agree batch certificates, documents and communication between your Responsible Person and our QP.
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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.
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04
QP certification
Our Qualified Person certifies every batch, relying on the Swiss batch certificate.
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05
On the market in the EU and EEA
The market is then open in all 30 countries.
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.
Art. 51(2) Directive 2001/83/EC, § 17(3) AMWHV
Under the agreement, testing in the EU can be waived. The Qualified Person still certifies every batch and records it in a register.
View source ↗EMA questions and answers on the Swiss MRA
If bulk or intermediate product comes from a third country, the agreement does not apply and the batch is retested in the EU. API or packaging from third countries does not change this.
View source ↗§ 72 AMG, EU GMP Annex 21
Switzerland is part of neither the EU nor the EEA. Every commercial import from there therefore needs an 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; 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
Switzerland is on the list of countries with equivalent API supervision. Swiss active substances need no written confirmation.
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, relying on the Swiss batch certificate.
View this service
Regulatory Affairs
EU marketing authorisation alongside your Swissmedic authorisation and the iMAH model as MAH in the EEA.
View this service
Analytical Services
Retesting in Itzehoe when bulk or intermediate product comes from a third country.
View this service
Frequently asked questions
What Swiss manufacturers ask us most often.
Do Swiss batches need retesting in the EU?
No, if the product was manufactured in Switzerland. Under the mutual recognition agreement, the manufacturer's batch certificate is recognised at import without re-control. If bulk or intermediate product comes from a third country, the batch is retested in the EU.
Is a Qualified Person in the EU still needed?
Yes. The EU importer's Qualified Person certifies every batch, relying on the Swiss batch certificate. The batch must have been imported into the EU for this. A&O handles certification, a partner the physical import.
Can a Swiss company without an establishment in the EU be the marketing authorisation holder?
No. Switzerland is a member of EFTA but not of the European Economic Area. The marketing authorisation holder must be established in the EU or EEA. A&O can take on the role as interim MAH (iMAH).
Is a Swissmedic authorisation valid in the EU?
No. The EU market requires its own marketing authorisation, nationally or centrally via the EMA. The agreement covers GMP inspections and batch certificates, not marketing authorisations.
Does the new Switzerland-EU package change anything?
The package was signed on 2 March 2026 and is not yet in force. According to the Swiss Federal Council, the principles of the mutual recognition agreement remain unchanged; it is only to be updated regularly in future.
Other countries of origin
