Reference

Glossary

Definitions that say what the thing is, rather than what it stands for. The terms that show up in veterinary import documentation.

RegulatoryDocumentsQualityTradeTechnicalCommercial

ACTDRegulatory: The ASEAN Common Technical Dossier, used across several Southeast Asian markets. Structurally similar to the ICH CTD but with its own part numbering and national annexes.
APVMARegulatory: The Australian Pesticides and Veterinary Medicines Authority, which registers veterinary products for sale in Australia. New Zealand uses a separate ACVM regime under MPI.
CDSCORegulatory: The Central Drugs Standard Control Organisation, India's national drug regulator. State FDAs issue manufacturing and sale licences under the same legal framework.
CoADocuments: Certificate of Analysis. Test results for one specific batch against the finished product specification. If two batches share a CoA, something is wrong.
CoPPDocuments: Certificate of Pharmaceutical Product. A WHO-format certificate stating that a named product is licensed in the exporting country and made at a GMP-compliant site. The document most registration authorities will not proceed without.
CTDRegulatory: Common Technical Document. The five-module dossier structure used in the EU and many other markets. Module 1 is administrative, 2 summaries, 3 quality, 4 safety, 5 efficacy.
DIN / NNRegulatory: Drug Identification Number and Notified Number, the identifiers Health Canada assigns to authorised products. Both must appear on Canadian packs.
EudraGMDPRegulatory: The public EU database of GMP and manufacturing authorisations. If a supplier claims EU GMP, the certificate should be findable here.
Form 25 / Form 28Regulatory: Indian manufacturing licences under the Drugs and Cosmetics Act. Form 25 covers non-specified drugs, Form 28 covers specified categories including antibiotics and certain hormones.
Free Sale CertificateDocuments: Confirms a product is freely sold in its country of origin. Faster to obtain than a CoPP and accepted in its place in some markets, mostly for feed supplements and non-medicinal lines.
FSSAIRegulatory: The Food Safety and Standards Authority of India, which regulates feed supplements and pet food. A different legal regime from the drug licence, and buyers often ask for the wrong one.
GDPQuality: Good Distribution Practice. Governs storage, transport, traceability and prevention of falsified product entering the chain. The relevant standard for a distributor, as opposed to GMP for a manufacturer.
GMPQuality: Good Manufacturing Practice. Site-specific and dosage-form-specific. A certificate covering oral liquids says nothing about a sterile line at the same address.
HS codeTrade: Harmonised System code. The customs classification that determines duty. Most veterinary medicines fall under 3004, feed supplements under 2309. A mismatch between the code and the carton description is the most common cause of a customs hold.
IncotermsTrade: Standard trade terms published by the ICC that define who pays for and who risks each leg of a shipment. EXW, FOB, CFR, CIF and DDP are the ones that come up in this trade.
ISPM 15Trade: The international standard for wood packaging. Pallets must be heat treated and marked, and several markets reject consignments on unmarked wood alone.
MA / MAHRegulatory: Marketing Authorisation and its Holder. In the EU, UK, Canada and Australia the holder must be established locally, which is why an exporter cannot hold your authorisation for you.
MRLTechnical: Maximum Residue Limit. The highest concentration of a substance legally permitted in food from a treated animal. MRLs differ between jurisdictions, which is why withdrawal periods do too.
MOQCommercial: Minimum Order Quantity. Ask whether a quoted MOQ is the supplier's stock minimum or the manufacturer's batch minimum, because those two numbers are often ten times apart.
PIC/SQuality: Pharmaceutical Inspection Co-operation Scheme. A cooperation arrangement between inspectorates that drives mutual recognition. India is not a member.
POM-VRegulatory: A UK distribution category meaning prescription only, veterinarian. Related categories are POM-VPS, NFA-VPS and AVM-GSL, and the classification must appear on the pack.
Proforma invoiceCommercial: A preliminary invoice issued before the sale is finalised. Used to open a letter of credit, apply for an import permit and justify an advance payment.
RxRegulatory: Shorthand for prescription only. The exact classification varies by market, so a product that is prescription-only in one country may be over the counter in another.
SDSDocuments: Safety Data Sheet, in GHS format. Covers hazard classification, handling, storage and transport. Freight forwarders increasingly require it before accepting a booking.
Stability dataTechnical: Studies supporting the shelf life, run in a defined climatic zone. Zone II suits temperate markets, Zone IVa and IVb hot and humid ones. Indian plants routinely hold Zone IVb.
Telex releaseTrade: An electronic release of cargo that avoids couriering original bills of lading. Faster, and only available where your bank and carrier allow it.
VMDRegulatory: The UK Veterinary Medicines Directorate, which authorises veterinary medicines and accredits retailers.
Withdrawal periodTechnical: The time that must pass between the last dose and the point at which meat, milk, eggs or honey may enter the food chain. Market-specific, because it is derived from that market's MRL and dosing regimen.