Market
Exporting veterinary medicines to European Union
EMA + national competent authorities sets the rules here, under Regulation (EU) 2019/6. Expect 12 to 24 months for a new registration, and plan the supply chain and the filing in parallel rather than one after the other.
Requirements at a glance
Documents you will need from us
- Certificate of Pharmaceutical Product in WHO format, per product. Request it at quotation stage, since it is the slow one.
- Current GMP certificate for the manufacturing site, with number and expiry
- Free Sale Certificate
- Finished product specification and method of analysis
- Batch analysis for three consecutive batches
- Stability data in the climatic zone your authority recognises
- Container closure details and print-ready artwork proofs
- Safety data sheet in GHS format
- Batch-specific Certificate of Analysis with every consignment
What each of those proves, and how long it takes to obtain, is on the documentation library.
Labelling
QRD template, local language, MA holder block, withdrawal periods.
Get artwork reviewed by someone inside European Union before it goes to print. The mandatory text block is the part that causes trouble, because fitting it onto an existing carton sometimes forces a larger pack, and that in turn changes the shipper carton count and the freight quote. Full detail on packaging and labelling.
Getting goods there
Sea freight from Nhava Sheva (JNPT) or Mundra is the normal route for volume. Air freight from Nagpur (NAG) or Mumbai (BOM) for samples, urgent replenishment and anything on the cold chain. Transit times by destination are on the logistics page.
What to watch for in European Union
Three things, in the order they usually bite. First, whether an import permit is needed per consignment rather than once per product, because that changes your reorder cycle permanently. Second, whether your authority wants documents legalised, which adds two to four weeks each time. Third, whether the stability data your manufacturer holds matches the climatic zone your regulator recognises. Indian plants routinely hold Zone IVb data, which suits hot and humid markets and does not always satisfy temperate ones.
None of this is a regulatory opinion. It is what we see on shipments, and it is a starting point for a conversation with a consultant who practises in European Union. Ask us and we will tell you which ones our other customers there actually use.
Common questions
Can I import veterinary medicines into European Union without registering them?
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Generally no, not for commercial sale. Some territories allow limited import under a special or named-patient style permit, for research, for a government programme or where no registered alternative exists, and those permits are issued per consignment. Treat unregistered commercial import as not available and work from there.
Does the registration have to be held locally in European Union?
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EU-established MA holder or QPPV required. We supply the product and the manufacturing documentation behind it; the authorisation itself sits with you or your appointed representative.
What language does the label have to be in for European Union?
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QRD template, local language, MA holder block, withdrawal periods. Artwork has to be finalised and reviewed locally before production, because a reprint after the fact costs weeks.
How long does registration take in European Union?
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12 to 24 months from a complete dossier in our experience, and the phrase doing the work there is "complete". Most delays come from an incomplete Module 3, missing stability data in the right climatic zone, or a Certificate of Pharmaceutical Product that was requested too late.