By the PharmaTradz BD Team. Published October 2026.
CoPP stands for Certificate of a Pharmaceutical Product. It is an official certificate, issued by the medicines regulator of the exporting country in a format set by the World Health Organization, that tells the importing country's regulator three things about a specific product: whether it is authorised for sale in the exporting country, whether it is actually on the market there, and whether the factory that makes it is regularly inspected and complies with GMP. For most importing countries without the resources to inspect foreign factories themselves, the CoPP is a central document in registering an imported medicine.
Where the CoPP comes from
The CoPP belongs to the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, which WHO member states have used for decades. The idea is simple: the regulator that knows the product and the factory best, the one in the exporting country, vouches for them in a standard format that every other regulator can read. Because it follows the WHO model, a CoPP looks broadly the same whether it comes from India, the EU, the United States or elsewhere.
What a CoPP says
| Section | What it covers |
|---|---|
| Product details | Name, dosage form, the active ingredient(s) and their amount per unit dose; the full list of excipients is usually attached |
| Importing country | The country the certificate is issued for |
| Licensing status | Whether the product holds a marketing authorisation in the exporting country, with its number and the name of the holder |
| Marketing status | Whether the product is actually on the market in the exporting country (yes, no or unknown). If it is not authorised there, the certificate states why: not required, not requested, under consideration, refused or withdrawn |
| Manufacturer and GMP | The manufacturing site, whether the regulator inspects it periodically and whether it complies with WHO-recommended GMP |
| Product information | Whether the approved product information (such as the summary of product characteristics) is attached |
The "not authorised or not marketed at home" case comes up often with products made purely for export. A CoPP can still be issued, but the importing regulator will see that the product is not sold at home, and some regulators treat that as a reason for closer review.
CoPP, WHO-GMP certificate and Free Sale Certificate
These three are often requested together and sometimes confused. A WHO-GMP certificate covers the manufacturing site and confirms it meets WHO GMP. A CoPP covers a specific product made at that site, and also states its licensing and marketing status. A Free Sale Certificate simply confirms that a product may be freely sold in the exporting country; it is used more for food supplements, cosmetics and devices than for medicines, although some markets ask for it as well.
How CoPPs are issued in India
In India, WHO-GMP certificates and CoPPs are issued jointly by the Central Drugs Standard Control Organisation (CDSCO) and the State Licensing Authorities, usually after a joint inspection of the site. A product must hold a valid manufacturing licence before a CoPP can be issued for it, and certificates are revalidated over time. Many importing countries also ask for the CoPP to be legalised by their embassy or apostilled, so build that time into your registration plan.
What importers should check
First, make sure the CoPP is addressed to your country and describes exactly the product you are registering: the same strength, the same composition and the same manufacturing site as your dossier. A CoPP for a different strength or a different site does not help.
Next, look at the licensing and marketing status. A product that is authorised and marketed in the exporting country is the straightforward case; if it is export-only, be ready for questions.
Check that it is recent. Many regulators and tender authorities want a CoPP issued within the last year or two, and some specify the exact period.
And confirm it is genuine. A CoPP should carry the issuing authority's details and certificate number, and if in doubt you can ask the issuing authority to confirm it. Our guide to verifying a pharmaceutical supplier covers the red flags.
Where it fits in a registration
The CoPP sits alongside the dossier (usually in CTD or ACTD format), the GMP certificate and batch documents such as the Certificate of Analysis. Our guides to CTD and ACTD and to starting a pharmaceutical import business show how the pieces fit together, and our import guides by region list what each country asks for.
More document explainers
The documents in a supplier's quality pack work together. See also what a DMF (Drug Master File) is, how to read a Certificate of Analysis, GMP vs cGMP and what a WHO-GMP certificate is and how to check one.
How PharmaTradz can help
Tell us the product and the country you are registering in, and we will tell you which manufacturers can provide a CoPP addressed to that country, together with the GMP certificate and dossier. Our dossier licensing and registration service and documentation and quality pack are built for exactly this, or you can send us an RFQ.
Frequently Asked Questions(FAQs)
What is the full form of CoPP?
CoPP stands for Certificate of a Pharmaceutical Product, a certificate in the WHO format issued by the exporting country's medicines regulator for a specific product.
Who issues a CoPP?
The medicines regulator of the exporting country. In India, CoPPs are issued jointly by CDSCO and the State Licensing Authority, usually after a joint inspection of the manufacturing site.
What is the difference between a CoPP and a WHO-GMP certificate?
A WHO-GMP certificate covers the manufacturing site. A CoPP covers a specific product made at that site, and also states whether it is licensed and marketed in the exporting country.
Can a CoPP be issued for a product made only for export?
Yes. The certificate then shows that the product is not authorised (or not marketed) in the exporting country, with the reason authorisation is lacking, and the importing regulator may review it more closely.
Does a CoPP need to be legalised?
Many importing countries require legalisation by their embassy or an apostille. Check the destination's rules early, because it adds time to registration.
