What a certificate of pharmaceutical product (COPP) is and when you need one

A certificate of pharmaceutical product, usually shortened to COPP or CPP, is one of the most requested documents in international medicine supply. Regulators use it to rely on another country's assessment, tender agencies use it to screen bidders, and importers use it to show that a product comes from a known, inspected source.

This guide explains where the COPP comes from, what it says, when it is needed, and how it is issued in India. It also covers the related documents that are often confused with it.

Where the COPP comes from

The COPP belongs to the WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The scheme is voluntary. It has operated since 1969, when the World Health Assembly adopted resolution WHA22.50, and has been amended several times since. The current implementation guidelines were published in 2021 as Annex 9 of WHO Technical Report Series No. 1033.

Under the scheme, a certifying authority in the exporting country issues the certificate, and a requesting authority in the importing country uses it. WHO publishes a model certificate and urges participating authorities to use it without deleting sections. The guidelines say a certificate with deleted sections is no longer considered a COPP. Certificates should not carry the WHO logo, but should state that they follow the format WHO recommends.

What the certificate states

Each COPP covers a single product, because manufacturing arrangements and approved information can differ between dosage forms and strengths. The WHO model asks for:

• Product details. The name and dosage form, and the active ingredients with their amounts per unit dose. Full composition is preferred but depends on the marketing authorisation holder's agreement.
• Marketing status in the exporting country. If the product is authorised, the certificate gives the authorisation number and date and the holder. If not, it states why, using set answers: not required, not requested, under consideration, refused, or withdrawn for commercial or sanitary reasons.
• Manufacturing sites and activities. Each site with its role, such as manufacture, quality control, batch release or packaging.
• Inspections and GMP. Whether the authority inspects the site periodically, when it last did, and whether the site conforms to WHO good manufacturing practice.
• Issuer details. The certifying authority, the authorised signatory, the date and stamp or electronic signature, and an optional validity period.

When you need one

The WHO guidelines describe two main uses. The first is when an importing regulator is considering a marketing authorisation for the product. The second is when that authorisation is being renewed, extended or varied. In practice a COPP also appears in other places:

• Special and named-patient imports. Several country guides on this site list a COPP, or proof of registration in the country of origin, among the documents for unregistered medicines, including Nigeria and Kenya.
• Tenders. Procurement agencies often ask for a COPP or a statement of licensing status when screening bids. See WHO prequalification and donor-funded tenders.
• Supplier qualification. Hospitals and importers use it to confirm the manufacturing site behind a product. See How to verify a medicine supplier.

Related documents that are not a COPP

WHO's guidelines note that the statement of licensing status and the batch release certificate are connected with the scheme but are not part of it. The model batch certificate, by contrast, is part of the scheme and is described in Pharma export documents explained.

How a COPP is issued

1. The requirement is set. The importing regulator or tender asks for a COPP for a named product.
2. The applicant applies. The manufacturer or marketing authorisation holder applies to the certifying authority with product data such as the authorisation number, active ingredients, composition, sites, approved product information and packaging.
3. Consent applies. WHO guidance treats the certificate as confidential and says it may be issued only with the permission of the applicant or the marketing authorisation holder.
4. The authority issues it. WHO suggests a standard time frame, ideally 30 working days once the file is complete. Each certificate should name the requesting authority and be verifiable, for example through a secure electronic system.
5. The certificate is passed on. It travels through the applicant, and the local agent where relevant, to the requesting authority. If a translation is needed, the applicant provides it.

The COPP in India

In India, COPPs are granted through the Central Drugs Standard Control Organisation under the WHO-GMP certification scheme, with state licensing authorities taking part in the process. A CDSCO circular made the ONDLS online portal the only route for WHO-GMP (COPP) applications, with paper submissions ending on 15 August 2025. Applications are made by manufacturing units, so a supplier in India that trades rather than manufactures needs the manufacturer to apply.

A COPP can still be issued for a product made in India only for export. In that case the certificate uses the section for products not authorised by the certifying authority and states the reason. The WHO model lists examples such as a product developed for conditions not common in the exporting country, or a reformulated product.

Common problems with COPPs

• Wrong variant. Because each certificate covers one product, a COPP for a different strength or dosage form does not cover the item ordered.
• Contract manufacturing. When contractors make part of the product, WHO notes that the applicant should identify who is responsible for each stage. A certificate that names only the brand owner's site may not match the label.
• Outdated product information. WHO asks that certificates and annexes match the version of the marketing authorisation in force on the date of issue, so an older certificate may describe superseded information.
• Wrong requesting country. Each certificate should identify the requesting authority, so a copy prepared for one country may not be accepted in another.
• Missing explanatory notes. WHO says the explanatory notes are not certified but should always be attached to the certificate.

Checks a buyer can make

• The product name, strength, dosage form and pack match the order and the permit.
• The manufacturing site matches the certificate of analysis and the label.
• The issue date and any validity period are acceptable to the destination regulator.
• The requesting country is named, where the format includes it.
• The certificate states that it follows the WHO format and shows the issuing authority's contact details.

When in doubt, WHO guidance says the importing authority should verify the certificate directly with the certifying authority. Some authorities also ask for legalisation, even though WHO discourages notarisation, embassy legalisation and apostilles because they cause delay. CDSCO's own import registration guidance, for instance, asks foreign applicants for notarised, apostilled or embassy-attested copies. Checking the destination's rule early avoids weeks of delay later, and Avoiding falsified medicines explains why document checks matter.