The certificate of pharmaceutical product is an official document issued to a country, verifying that a specified pharmaceutical product will meet the regulatory requirements for necessary quality, safety, and efficacy standards. The COPP is another certification to satisfy the requirements from the Central Drugs Standard Control Organisation (CDSCO) of the Indian Medical Device Regulations. Registration of pharmaceutical products in foreign markets requires this important certificate because usually, full dossier evaluations are often waived, giving a guarantee to the country where such a product comes from.
The COPP summarizes essential information regarding the product, including the status of the product's licensing and compliance with GMP. This is commonly used for the new registration, variation, or renewal of products across countries. The format of the COPP accords with guidelines by the WHO, which promotes international acceptance. It also assists pharmaceutical companies by simplifying regulations when entering other markets. This makes the process of global trade of pharmaceuticals better and easier due to the streamlined documentation requirements as well as facilitating market access.