Regulatory
Dossier support, and a clear line about what we cannot do
We supply the quality and manufacturing material that goes into a veterinary product dossier. We do not hold your marketing authorisation, and any supplier who says they will should be asked to put it in writing.
Who holds the authorisation
In the EU, the UK, Canada and Australia, the marketing authorisation holder has to be established in the country or region. That is written into the law, not a matter of preference. In the Gulf and most of Africa and Southeast Asia, the registration is held by a local agent or importer, usually the one with the import licence.
So the holder is you, or an agent you appoint. We sit behind that as the supplier of the product and the source of the manufacturing documentation. If a competitor tells you they will register a product in your name and hand you the authorisation, ask them which article of your national regulation permits that.
What we supply, module by module
| CTD module | Contents | Who provides it |
|---|---|---|
| Module 1 | Administrative and national requirements, application forms, proposed labelling | You or your regulatory agent |
| Module 2 | Quality, safety and efficacy summaries | Your regulatory agent, from our Module 3 |
| Module 3 | Quality: drug substance, drug product, specifications, methods, stability, container closure | Us, from the manufacturer |
| Module 4 | Safety: toxicology, residue studies, withdrawal period justification | Manufacturer where studies exist, otherwise literature-based |
| Module 5 | Efficacy: clinical and field trial data | Manufacturer where studies exist, otherwise literature-based |
The documents themselves
- Manufacturing licence, Form 25 or Form 28 under the Drugs and Cosmetics Act
- Current GMP or WHO-GMP certificate for the plant, with number and expiry
- Certificate of Pharmaceutical Product in WHO format, per product, per destination
- Free Sale Certificate
- Finished product specification and method of analysis
- Batch analysis data, typically three consecutive batches
- Stability data in the appropriate climatic zone
- Container closure system details and artwork proofs
- Safety data sheet in GHS format
- Batch-specific Certificate of Analysis on each shipment
Timelines by market
🇪🇺 European Union
12 to 24 months
CTD, Modules 1 to 5, electronic submission
🇬🇧 United Kingdom
10 to 18 months
CTD-format dossier via VMD portal
🇨🇦 Canada
12 to 24 months
NDS / ANDS, Health Canada format
🇦🇺 Australia & New Zealand
15 to 28 months
APVMA module-based application
🇦🇪 GCC & Middle East
8 to 18 months
CTD or ministry template, legalised documents
🌍 Africa
6 to 14 months
CoPP-led registration, often WHO format
🌏 Southeast Asia
8 to 16 months
ACTD / CTD hybrid
🌎 Latin America
10 to 20 months
Country dossier + legalised CoPP and FSC
Three mistakes that stall most first filings
Starting the dossier before checking the reference product. In markets with a generic pathway you need a named reference product that is authorised in that market. If none exists, the application is not a generic one and the data requirement changes completely.
Ordering the CoPP last. It is the slowest document and the one most authorities will not proceed without. Request it when you request the quotation.
Finalising artwork after production. Destination labelling rules cover language, the marketing authorisation holder block, batch and expiry format, withdrawal periods for food-producing species and often the registration number itself. Changing a carton after it is printed means reprinting. See packaging and labelling.
Common questions
What is a CoPP and why does it take so long?
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A Certificate of Pharmaceutical Product is a WHO-format certificate confirming that a product is licensed in the exporting country and that the manufacturing site complies with GMP. In India it is issued by the state licensing authority or CDSCO. Two to three weeks is normal, longer if your authority also wants it legalised by your embassy in New Delhi. Ask for it at quotation stage.
Can you provide a dossier in CTD format?
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We provide the Module 3 quality material from the manufacturer: specifications, methods of analysis, batch analysis, stability data, container closure information and the manufacturing licence. Assembling it into a complete CTD with Modules 1, 2, 4 and 5 is regulatory consultancy work, and you will want a consultant in the destination country who knows what that authority actually asks for.
Do I need stability data in a particular climatic zone?
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Yes, and it is the most common gap. The EU and Canada generally want Zone II data. Most of the Gulf, Africa and Southeast Asia want Zone IVa or IVb. Indian manufacturers routinely hold Zone IVb data because that is their home market, so filings into hot and humid destinations are usually straightforward and filings into Europe sometimes are not.
How much does registration cost?
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It varies enormously. Authority fees alone can run from a few hundred dollars in parts of Africa to well into five figures in the EU or Australia, before consultant fees. We do not charge for the dossier material on orders in progress, and we will tell you when we think the registration cost makes an order uneconomic.