Art. 51(1) Directive 2001/83/EC
Every batch from a third country undergoes full qualitative and quantitative analysis in the EU. A waiver requires an agreement, which does not exist with India.
View source ↗EU market entry · India
From India into the EU market.
There is no mutual recognition agreement between India and the EU. Every batch is therefore fully tested in the EU and certified by a Qualified Person. A&O handles import together with its partners, plus retesting in its own laboratory and release.
- Manufacturing and import authorisation (MIA) under §§ 13 and 72 AMG
- GMP-certified laboratory in Itzehoe for retesting every batch
- Qualified Persons under § 14 AMG on our own team
The route of a batch from India
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India
EU GMP evidence for the site Required
Inspection by an EU or EEA authority; a WHO-GMP certificate is not sufficient.
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EU border
Import with partners Handled by A&O
Under A&O's import authorisation and that of our partner, with GMP evidence under § 72a AMG.
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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
Only then is the batch placed on the market.
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EU and EEA
Market in 30 countries Destination
With a marketing authorisation and an EU-based MAH.
No step is waived, which makes having them all with one provider all the more important.
€2.94bn
of medicinal products imported into the EU from India in 2025, making India the sixth-largest supplier outside the EU.
Eurostat Comext, HS 307
countries have a GMP mutual recognition agreement with the EU. India is not one of them.
EMA, international agreementsEvery batch
from India is fully analysed in the EU before it is placed on the market.
Art. 51 Directive 2001/83/ECIn short
What does an Indian manufacturer need for the EU market?
Evidence that the site operates to EU GMP, usually through an inspection by an EU or EEA authority. In addition, an importer with an import authorisation, full analysis of every batch in the EU and certification by a Qualified Person. The product must be authorised, with a marketing authorisation holder established in the EU or the European Economic Area.
If an active substance from India is itself imported into the EU, it also needs a written confirmation from the Indian authority CDSCO, because India is not on the EU list of countries with equivalent supervision. For the finished product, the manufacturer's GMP certificate is what counts. A WHO-GMP certificate does not replace any of these requirements.
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
India ranks sixth. Without a mutual recognition agreement, every batch is retested 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
Ready-to-ship check
Ready for your first shipment?
Tick what you already have. The ring shows how far along you are, and below it you can see what is still missing and who at A&O can help.
How it works
From the Indian batch to QP release in the EU.
This is the route when a medicinal product from India enters the EU for the first time. Most of the work happens before the first shipment; after that, every batch follows the same rhythm.
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01
Review site and documents
We review the EU GMP certificate, inspection reports and quality agreement and prepare an on-site audit where needed.
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02
Transfer methods to the laboratory
Our laboratory in Itzehoe takes over specifications and test methods so that retesting runs smoothly for every batch.
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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
Retesting of every batch
Full analysis against the marketing authorisation, with a certificate of analysis.
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05
QP certification
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.
Art. 46b and 111b Directive 2001/83/EC
Imported active substances need a written confirmation from the authority of the exporting country. India is not on the list of exempt countries; in India, CDSCO issues it.
View source ↗§§ 72 and 72a AMG
Import requires an import authorisation and a certificate or official attestation that the country of manufacture applies recognised GMP standards. Under Annex 21, the site of physical importation and the site of QP certification each need an authorisation: A&O holds it for certification, a partner handles physical importation.
View source ↗Art. 111 Directive 2001/83/EC
Manufacturers in third countries are also inspected by EU authorities. The result is recorded as a GMP certificate in the European database EudraGMDP.
View source ↗EU-India Free Trade Agreement
Negotiations were concluded on 27 January 2026; the agreement is not yet in force. It does not change GMP, retesting or release.
View source ↗What A&O takes on
Everything from one provider, with names and faces.
Analytical Services
Method transfer and retesting of every batch in our GMP-certified laboratory in Itzehoe.
View this service
QP Batch Release
Import together with our partners and certification of every batch by our Qualified Persons.
View this service
GMP and GxP Consulting & QA Support
Preparation for EU inspections, audits and review of API written confirmations.
View this service
Regulatory Affairs
EU marketing authorisation and the iMAH model if you have no MAH in the EU.
View this service
Your experts for this route
Frequently asked questions
What Indian manufacturers ask us most often.
Do batches from India have to be retested in the EU?
Yes. There is no mutual recognition agreement between the EU and India. Every imported batch is therefore fully analysed in the EU before a Qualified Person certifies it. A&O carries out retesting in its own laboratory in Itzehoe.
Is a WHO-GMP certificate enough for the EU market?
No. Imports into the EU are based on EU GMP. A WHO-GMP certificate replaces neither a GMP inspection by an EU or EEA authority, nor retesting, nor certification by the Qualified Person.
Do active substances from India need a written confirmation?
Yes. India 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 Indian authority CDSCO that it is manufactured and supervised to EU-equivalent GMP.
Does a finished product from India need a written confirmation?
No. The CDSCO written confirmation is only needed when the API itself is imported into the EU. For a finished product from India, the manufacturer's GMP certificate is what counts, even if the API comes from India.
How does a site obtain an EU GMP certificate?
Through a GMP inspection by an EU or EEA authority, usually initiated via the importer. The certificate is entered in the EudraGMDP database. A&O prepares the site with a gap analysis and audit.
Does the EU-India Free Trade Agreement change this?
Not the requirements. Negotiations were concluded on 27 January 2026 and the agreement is not yet in force. According to the European Commission, all imports from India remain subject to the EU's strict health and safety rules.
Other countries of origin
