A Certificate of Pharmaceutical Product (CPP) is a document issued by an exporting country's regulatory authority under the voluntary WHO Certification Scheme. It confirms the regulatory and manufacturing status of a pharmaceutical product in the exporting country. It does not, by itself, prove that a particular vial in your shipment is genuine.
Key Takeaways
- The CPP is the main document of the WHO Certification Scheme, a voluntary agreement on the quality of pharmaceutical products moving in international commerce.
- It is issued by a regulator or designated authority, not by a distributor.
- It is product-level evidence; batch-level assurance is a separate document in the scheme.
- Some importing countries require it by law, others do not. Always check your local rules.
- A CPP complements, but never replaces, lot verification and cold chain checks.
What is a Certificate of Pharmaceutical Product?
A CPP is the primary document of the WHO Certification Scheme, which WHO describes as an international voluntary agreement giving participating countries assurance about the quality of pharmaceutical products moving in international commerce.
The scheme was established in the 1960s and is regarded as one of the first regulatory reliance tools, meaning an importing regulator can lean on the exporting regulator's assessment instead of repeating it. WHO's scheme page lists three model documents: the certificate of a pharmaceutical product, a batch certificate of a pharmaceutical product, and a statement of licensing status of pharmaceutical products.
Who issues a CPP, and who can rely on it?
The exporting country's regulatory authority, or an authority it designates, issues the CPP. A manufacturer, wholesaler or clinic cannot issue one.
That matters for buyers. If a supplier forwards a document that looks like a CPP, the issuing authority is the party that can confirm it. WHO states that an importing country with doubts can request a copy from the certifying authority. WHO also notes that certificates from different national authorities may differ in format and occasionally in wording, so layout differences alone are not proof of a problem.
What does a CPP prove, and what does it not prove?
A CPP supports product-level questions; it does not answer vial-level questions. Use the table below to separate the two.
| Question you need answered | CPP | Other evidence to request |
|---|---|---|
| Is the product authorised in the exporting country, and by whom? | Yes, this is its core purpose | Licensing status statement, if relevant |
| Is the manufacturing status documented? | Addressed by the certificate | Manufacturer details on the label and in the dossier |
| Does this specific batch meet its release requirements? | No | Batch certificate; lot number cross-check with the manufacturer |
| Was the shipment kept within its labelled storage range? | No | Temperature logger data and shipping records |
| Is the seller a legitimate, traceable supplier? | No | Company registration, invoices, references |
For the supplier-side paperwork in full, see our guide to documents to request from wholesale injectables suppliers, and for physical checks see how to verify authentic botulinum toxin.
Do importing countries always require a CPP?
No. The scheme is voluntary, but WHO observes that CPP requirements are often written into national law, so some regulators must request it even when they could assess a product without it.
WHO also says countries with strong assessment capacity, products made under oversight of WHO-listed authorities, or products covered by mutual recognition agreements generally do not need it. In practice, the answer for your clinic or distribution business depends on your national regulator and import licence conditions. Ask them directly, or consult a licensed regulatory adviser, rather than relying on a supplier's assumption.
Does the same document apply to fillers and skin boosters?
Not necessarily. The CPP is designed for pharmaceutical products, such as botulinum toxins like Dysport. Many HA fillers and PN or PDRN skin boosters, for example Rejuran Healer or Kiara Reju, may sit in a different regulatory category depending on the market.
Where a product is regulated as a medical device, exporting authorities may issue other documents, such as a certificate of free sale. For instance, the UK points medical device exporters to MHRA for such certificates, while the content and scope are defined by that authority. Ask the supplier which document corresponds to each product's regulatory category in the destination market, and confirm with your regulator.
What are electronic CPPs?
An electronic CPP (eCPP) is a digitally issued version of the certificate. WHO strongly encourages digital processes, including electronic signatures, and says issuing authorities should build secure, authentic and traceable systems.
WHO also advises that receiving authorities should have in-house tools to verify electronic certificates, and it opposes extra steps such as consular authentication, which it says add cost and delay without improving reliability. If a supplier sends a PDF certificate, ask how it can be verified with the issuing authority.
How should a clinic or distributor use a CPP in supplier due diligence?
Treat the CPP as one layer in a multi-document check, not as a green light.
- Match the product name, manufacturer and presentation on the certificate to the product you are ordering.
- Confirm the issuing authority and, if in doubt, ask it to confirm the document.
- Request batch-level documentation where it exists, and cross-check lot numbers on delivery.
- Review cold chain records; see our botulinum toxin cold chain checklist.
- Confirm your own import licence and local rules before ordering.
Frequently Asked Questions
Is a Certificate of Pharmaceutical Product legally required to import botulinum toxin?
It depends on the importing country. The WHO Certification Scheme is voluntary, but WHO notes that CPP requirements are often written into national law, so some regulators must request one. Confirm current requirements with your national regulator or a licensed customs and regulatory adviser before ordering.
Who issues a CPP?
The CPP is issued by the exporting country's regulatory authority or a designated certificate-issuing authority, not by a distributor or reseller. If you doubt a document, WHO's scheme page says the importing side can request a copy from the certifying authority.
Does a CPP prove that a specific vial is genuine?
No. A CPP addresses the product's regulatory and manufacturing status. The WHO scheme includes a separate model batch certificate for batch-level assurance. Vial-level checks, such as packaging, lot numbers and supplier traceability, remain the buyer's responsibility.
Do dermal fillers and skin boosters have a CPP?
Not necessarily. The CPP is designed for pharmaceutical products. Many fillers and skin boosters are regulated as medical devices in some jurisdictions, where other export documents may apply. Ask the supplier which document matches each product's regulatory category.
What is an electronic CPP?
An electronic CPP (eCPP) is a digitally issued certificate, often with an electronic signature. WHO encourages digital processes, but notes that issuing systems must be secure and traceable and receiving authorities need tools to verify them.
Conclusion
A CPP is a useful, regulator-issued layer of evidence about a product's regulatory standing, but it works best alongside batch documentation, lot checks and cold chain records. If you are a licensed clinic or distributor and want to review the documentation available for specific products, you can contact HolyPath through our inquiry page.
References
- WHO: Certification Scheme on the quality of pharmaceutical products moving in international commerce
- DIA Global Forum (October 2024): Efficient Regulatory Reliance: The WHO Certification Scheme for CPP
- GOV.UK: Apply for an export certificate
This article is for informational purposes for licensed medical professionals and distributors. It is not medical advice. Treatments should be performed only by qualified practitioners in accordance with local regulations.