Art. 51 Directive 2001/83/EC
Every batch from a third country is fully analysed in the EU and certified by a Qualified Person. An agreement with the country of origin can replace the analysis, not the certification.
View source ↗Services · EU market entry
Bringing medicinal products to the EU market.
Whichever country your medicinal product comes from, the EU market needs an importer with an authorisation, a Qualified Person for every batch and a marketing authorisation holder in the EU. Whether every batch is also retested depends on the country of origin.
Where does your product come from?
In short
What does a medicinal product from a third country need for the EU market?
Three things apply to every country of origin: a marketing authorisation with a holder established in the EU or the European Economic Area, an importer with an import authorisation and a Qualified Person who certifies every imported batch.
What differs by country is batch testing. Without an agreement, every batch is fully analysed in the EU. With a mutual recognition agreement that also covers batches, this retesting can be waived, for example for Switzerland and for the USA within the scope of the MRA. If an active substance is itself imported into the EU, it also needs a written confirmation from the authority of the country of manufacture, unless that country is on the EU list. For a finished product, the manufacturer's GMP certificate is what counts.
Regulations checked against the original sources on 19 October 2026
MAH in the EU or EEA
No marketing authorisation without an EU presence. A&O takes on the role as interim MAH (iMAH).
Import with partners
A partner handles physical importation. A&O holds the import authorisation under § 72 AMG that Annex 21 requires for QP certification.
Certification of every batch
A Qualified Person in the EU certifies every batch, even under an agreement.
Comparison
Countries of origin compared.
What applies to the main countries of origin at a glance. Import, an EU marketing authorisation holder and QP certification are required everywhere.
Country of origin
GMP inspection
Retesting of every batch
API imports
USANot for vaccines, plasma-derived products, ATMPs or investigational medicinal products.
Recognised
Waived
No confirmation
SwitzerlandRetesting applies if bulk comes from a third country.
Recognised
Waived
No confirmation
United KingdomInspections recognised, no waiver of batch testing.
Recognised
Required
Confirmation needed
ChinaAPI imports with confirmation from the provincial authority.
EU inspection needed
Required
Confirmation needed
IndiaAPI imports with CDSCO written confirmation.
EU inspection needed
Required
Confirmation needed
Other third countriesDepends on the agreement. The EU also has GMP agreements with Australia, Israel, Japan, Canada and New Zealand, with differing scope. We check this for your product.
The route of a batch into the EU
-
Country of origin
Manufacture to EU GMP Required
Shown by an inspection by an EU or EEA authority.
-
EU border
Import with partners Handled by A&O
Under A&O's import authorisation and that of our partner.
-
Itzehoe
EU retesting of every batch Handled by A&O
Full analysis in our GMP-certified laboratory.
-
Efringen-Kirchen
QP certification Handled by A&O
Only then is the batch placed on the market.
-
EU and EEA
Market in 30 countries Destination
With a marketing authorisation and an EU-based MAH.
This is the route for India, China and the UK, for example.
Where the EU sources its medicinal products
The USA and Switzerland together supply 70 per cent. For both, retesting can be waived; for all others, it cannot.
- 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
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. 40(3) Directive 2001/83/EC, § 72 AMG, EU GMP Annex 21
Importing medicinal products from third countries requires an authorisation, in Germany under § 72 AMG. Since 2022, Annex 21 distinguishes the site of physical importation from the site of QP certification; both need an authorisation.
View source ↗Art. 8(2) Directive 2001/83/EC, § 9(2) AMG
A marketing authorisation is only granted to an applicant established in the EU. Manufacturers from third countries need a company or partner in the EU or EEA.
View source ↗Art. 46b and 111b Directive 2001/83/EC
Imported active substances need a written confirmation from the authority of the country of manufacture, unless that country is on the European Commission's list.
View source ↗Frequently asked questions
What manufacturers from third countries ask.
Who may import medicinal products from a third country into the EU?
Only companies holding an import authorisation in an EU Member State, in Germany under § 72 AMG. Under Annex 21 of the EU GMP Guide, both the site of physical importation and the site of QP certification need one. A&O holds the authorisation for certification and has its own Qualified Persons; partners handle physical importation.
What is an MRA?
A mutual recognition agreement between the EU and a third country. It recognises GMP inspections and, depending on the agreement, also the manufacturer's batch certificates. EU retesting can then be waived. The EU has such GMP agreements with Australia, Israel, Japan, Canada, New Zealand, Switzerland and the USA.
What does the Qualified Person do for imports?
They certify every imported batch before it is placed on the market, ensuring it was manufactured to EU GMP and, where required, fully tested in the EU. This applies to every country of origin, even under an agreement.
Do we need an establishment in the EU?
The marketing authorisation needs a holder established in the EU or EEA. This can be your own EU establishment, a partner or, as an interim solution, A&O through the iMAH model.
What is an API written confirmation?
A confirmation from the authority of the country of manufacture that the active substance is made and supervised to EU-equivalent GMP. It is required when the API itself is imported into the EU, unless the country is on the European Commission's list, such as Switzerland or the USA. It is not needed for an imported finished product.
