What Is a CoPP, and When Does an Exporter Need One?

A Certificate of Pharmaceutical Product (CoPP) is a WHO-format certificate issued by a manufacturer's home-country regulator, confirming that a specific product is approved for sale there and that it's manufactured in accordance with GMP. Destination-country regulators use it as part of the dossier for registering an imported product — it's essentially the exporting country vouching for the product and the plant that made it.

CoPPs carry real validity windows and issuance timelines that vary by regulator, and a manufacturer exporting to several markets ends up tracking several CoPPs — each with its own expiry — alongside the rest of the export paperwork (CoAs, WHO-GMP certificates, shipping documents). Losing track of one expiry is a common way a shipment ends up held at customs.