Abstract

CERTIFICATE OF PHARMACEUTICAL PRODUCT (COPP)

Sumanji Bala* and Jayashree B. Gaja

ABSTRACT

This review gives the brief description of COPP which is required for import of medication’s provide relevant standard of safety, quality and efficacy to allow marketing strategy, rigours testing and inspection by regulatory authorities in the exporting country. The certificate of pharmaceutical product was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing the time to market through reliance on a prior trusted analysis. The certificate is needed when the product tends that it is intended for registration or its renewal (licensing, authorization or prolongation) by the importing country, with the scope that the product are distributed or commercialized in that country. The review also provides the basics of COPP, procedure to obtained COPP, requirement for COPP, types advantage of COPP.

Keywords: COPP Certificate of Pharmaceutical product, Regulatory requirement, Import.