EU-GMP import from India, assembled for your Qualified Person.
M Care partners with Indian manufacturing sites that have been inspected by an EU member-state authority and are listed on EudraGMDP. We supply the finished-dose product and the source-side dossier your MIA holder's QP needs to release the batch under Annex 16.
Annex 16, Annex 21, EudraGMDP. Three anchors, one import chain.
There is no EU-India Mutual Recognition Agreement for GMP. Import from an Indian site into an EU MIA holder therefore rides on EU member-state inspection of the manufacturing site, the importer QP's batch-release decision under Annex 16, and the Annex 21 controls on the import operation itself.
Annex 16 equivalence
The QP certifying a batch for the EU market must satisfy themselves the product was made to GMP equivalent to EU GMP. Where the manufacturing site has been inspected by an EU competent authority and the certificate sits on EudraGMDP, that evidence is the spine of the Annex 16 decision. Clause 1.7 covers the equivalence declaration the QP draws on.
Annex 21 scope
Annex 21 came into effect in 2022 and covers the importation of medicinal products into the EU. It sits with the MIA holder and the site performing the physical import, testing and release. M Care's side sits upstream of that: source-side manufacture, source-side documentation, source-side sampling under the importer's QP's direction.
EudraGMDP listing, site by site
EudraGMDP is the EU-wide public database of GMP certificates. Our partner sites hold current EU-GMP certificates for defined dosage forms, issued by BfArM (Germany), ANSM (France), AIFA (Italy), AEMPS (Spain), IGJ (Netherlands), HPRA (Ireland) or equivalent. The certificate is site- and scope-specific — we share the EudraGMDP reference before you commit to an enquiry.
Why an EU MIA holder phones the Mumbai desk.
Hospital oncology tender, Germany
A Landesapotheke or hospital group has won a regional cytotoxic tender and needs a second source at a price the licensed Germany brand will not match. The Indian partner site is EU-GMP inspected by BfArM or a Landesbehorde, the molecule sits in its dosage-form scope, and the tender importer holds the MIA. M Care assembles the source dossier for their QP.
AP-HP-type group, France
A French hospital-group purchasing central negotiates on behalf of multiple regional CHUs. ANSM inspection of the Indian site and a clean Annex 16 story are non-negotiable. Supplied into the group's nominated French MIA holder, who handles onward distribution inside France.
Ireland wholesaler, cross-Europe
An HPRA-licensed Irish MIA holder imports on behalf of hospital systems in Ireland and onward into the UK post-Brexit. The Indian site carries both an EU-GMP certificate on EudraGMDP and an MHRA inspection history, which lets one consignment cover two regulatory destinations.
Post-Brexit UK re-supply
A UK MIA holder needs an Indian source that is EU-GMP inspected, not only WHO-GMP. After Brexit the UK is a separate sovereign regulator, but sites on EudraGMDP inspected by an EU member-state authority remain recognisable to MHRA under current UK regulations. Supplied into the UK MIA holder's QP chain.
Everything your QP asks for before signing Annex 16.
Prepared at the Indian site, cross-checked by M Care's regulatory desk, and delivered electronically to your QP before the consignment departs Mumbai. Nothing arrives as a surprise.
EudraGMDP site reference
The inspection reference number for the Indian manufacturing site on EudraGMDP, the issuing EU competent authority, the inspected dosage-form scope, and the certificate expiry. Your QP looks this up independently; we share it up front.
Annex 16 equivalence data pack
The manufacturing-process consistency summary, the GMP equivalence narrative, and the deviation history that feeds clause 1.7 of Annex 16. Written so your QP can cite it inside the batch-release decision rather than re-author it.
Batch-specific CoA
HPLC assay, impurity profile per ICH Q3A/Q3B, water content, residual solvents per ICH Q3C, sterility and endotoxin as applicable. Signed by the manufacturer's authorised QC head with reference-standard and method-validation citations.
CoPP, WHO format
Certificate of Pharmaceutical Product issued by CDSCO in the WHO-recommended format. Apostilled at Indian MEA where the EU importer or the member-state authority has asked for legalisation.
FMD serialisation and tamper-evidence
Falsified Medicines Directive (Directive 2011/62/EU) compliant carton artwork with 2D DataMatrix barcode, product code, serial number, batch and expiry, and tamper-evident closure. Uploaded to the EMVS hub under the MAH's scheme before the pallet ships.
Cold-chain validated shipper report
Pre-shipment thermal qualification per shipper configuration, continuous temperature logging in transit, and on-arrival logger read-out. Excursion protocol agreed before dispatch, not written after the carton lands in Frankfurt or Schiphol.
Site alignment first. Then documents, sample, dispatch, release.
- Site alignment. Molecule, strength, dosage form, volume and destination EU member state. We match the enquiry to a partner site whose EudraGMDP listing covers that scope, and share the inspection reference so your QP can verify independently.
- QP-facing document pack. Source dossier drafted: CoA template, CoPP, GMP certificate, Annex 16 equivalence narrative, ICH Q7 declaration where your MIA holder needs the API story too. Shared electronically for QP review before any physical sample moves.
- Sample and stability. Pre-production sample to your MIA holder for in-house analytical verification. Stability data per ICH Q1A shared in parallel. If your QP wants a witness audit of the Indian site, we co-ordinate dates, visas and auditor access.
- Batch dispatch. Cold-chain validated shipper where applicable, FMD-compliant serialised cartons, continuous temperature logging, apostilled paperwork. Airway-billed into the MIA holder's nominated EU warehouse, not a broker yard.
- QP batch release. On-arrival logger read-out, physical identification check, sampling per your MIA holder's SOP, and the Annex 16 batch-release decision signed by your QP. M Care remains on call for any post-arrival query that needs source-side confirmation.
EU-GMP import — the specifics.
Are your Indian partner sites EU-GMP inspected?
Specific partner sites in our roster hold current EU-GMP certificates issued by EU member-state authorities — BfArM (Germany), ANSM (France), AIFA (Italy), AEMPS (Spain), IGJ (Netherlands) or HPRA (Ireland), depending on the site. Each certificate is dosage-form and scope specific, and each is listed on EudraGMDP. Before you commit to an enquiry we share the EudraGMDP reference number for the specific site so your regulatory affairs or QP can verify it independently. Not every site in our 80-plus partner network is EU-inspected — we route EU-GMP enquiries only to those that are.
Do you hold your own MIA?
No. An MIA (Manufacturing and Importation Authorisation) is issued by an EU member-state authority to a company physically operating on EU soil. M Care is an Indian exporter. The MIA sits with your import-side partner — the German, French, Italian, Spanish, Dutch or Irish company that physically receives, tests and releases the product inside the EU. We supply product and source-side documentation into that MIA holder's supply chain; we do not hold or claim to hold an EU MIA ourselves.
What does the importer's QP need from your end?
Everything that lets the QP sign Annex 16 without re-inventing evidence. That is: the EudraGMDP reference for the inspected site, the Annex 16 clause 1.7 equivalence narrative, a batch-specific CoA, the WHO-format CoPP, the ICH Q7 declaration where the API story matters for the MIA holder, FMD-compliant carton artwork, and the cold-chain validation pack per shipper. Supplied electronically before dispatch and physically in the consignment.
Is the EU-India GMP MRA applicable here?
No. The EU operates Mutual Recognition Agreements for GMP with the USA, Japan, Switzerland, Canada, Israel, Australia and New Zealand. There is no EU-India MRA. Import from an Indian site into the EU therefore relies on two routes: EU member-state inspection of the Indian site with the certificate listed on EudraGMDP, or the Annex 16 clause 1.7 equivalence declaration where your QP has audited the site themselves. The first route is the one we built our EU-facing roster around.
What changed with Annex 21 in 2022?
Annex 21 of the EU GMP Guide came into effect in 2022 and clarified the responsibilities of MIA holders who import medicinal products into the EU. It covers receipt, testing, release and onward distribution on EU soil. It sits with your side of the chain, not ours. What it means for M Care is that the source-side documentation has to be crisp enough to support your MIA holder's Annex 21 obligations — batch records, equivalence declarations, deviation histories — and that our partner sites understand the audit trail Annex 21 expects.
What's the lead time for batch-release-ready documentation?
The source dossier for a stock molecule from an EU-inspected partner site can reach your QP within 5 to 10 working days of the enquiry. Made-to-order batches where the site has to schedule manufacturing run 8 to 14 weeks door-to-door, including FMD serialisation, stability verification and Annex 16 equivalence pack preparation. Urgent medical-need single-patient supply has moved in under three weeks with QP pre-alignment.
How is FMD serialisation handled?
Cartons are printed with a 2D DataMatrix barcode carrying product code, serial number, batch number and expiry date, plus a tamper-evident closure, per Directive 2011/62/EU. The serial numbers are uploaded to the European Medicines Verification System (EMVS) hub under your Marketing Authorisation Holder's scheme before the pallet ships. Where M Care's Indian partner is not the MAH, we co-ordinate with the MAH's serialisation contractor so the upload lands on time.
What happens if a site's EU-GMP inspection expires?
We stop routing new batches from that site to EU destinations until the inspection is renewed. EudraGMDP listings carry validity windows, typically three years from inspection, and our roster manager tracks each site's expiry six months ahead. Open supply contracts get proactive notice so your MIA holder can either wait for re-certification, switch to a sister site on the EudraGMDP list, or rely on an Annex 16 clause 1.7 equivalence route where the QP has audited the site recently. Nothing ships to the EU on an expired certificate.
An MIA holder, a tender, an Indian site that needs to clear your QP. That's the conversation.
Molecule, destination member state, volume and target QP release window. We come back with a site on EudraGMDP, an equivalence story your QP can sign under, and a landed price to your warehouse.