Is COPP and FSC are same?

COPP stands for certificate of pharmaceutical products and FSC stands for free sale certificate.

Certificate of Pharmaceutical Product (COPP)

The COPP is the legal document that declares a certain manufacturing company is legally allowed to sell their pharmaceutical product in the country they are producing.  When registering a pharmaceutical product overseas, the government body in charge of approving the application will usually require a COPP to ensure that the product is being sold as a commercial finished product in the country that is producing it.

It is importing country’s regulatory body will ask for COPP, which will be issued by exporting country’s (country of origin’s) regulatory body.

Free Sales Certificate (FSC)

A Free Sales certificate is similar to a COPP where it enables a manufacturing company to list pharmaceutical products in which they can sell in the local market and internationally. A FSC, however can list multiple products at the same time.

At Royed Training, we have short 3 days orientation course on WHO-GMP Certification and COPP management. COPP requirements and how to manage COPP is also discussed in Executive Program in International Drug Regulatory Affairs (EPGIDRA) and PG Certification in Drug Biologic Medical Device Regulatory Affairs (PGDBMRA) course.