Introduction

The Certificate of Pharmaceutical Product (COPP) is issued in the format recommended by the World Health Organization (WHO), establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.

It is often mentioned in the Electronic Common Technical Document (eCTD) and is issued for a single product, since manufacturing arrangements and approved information for different pharmaceutical dosage forms and strengths can differ.

A COPP certifies that the imported medication meets the necessary criteria for quality, safety, and efficacy to allow marketing in their (importing country) market after having undergone vigorous testing and inspection by the exporting country’s Regulatory Authorities.

It also shows that product is manufactured by following the guidelines and procedures of Good Manufacturing Practice (GMP), raising the level of quality as well as the safety of the product

Benefit

  1. To grow business in foreign country, necessary to obtain the COPP certificates by pharmaceutical company
  2. It enables to gain assurance on the QSE (quality, safety and efficacy) of the product.
  3. It obliges certifying authorities to disclose important information to the importing country.
  4. It facilitates patient access to quality medicines.

Expiration of COPP

  1. Certificate expires two years after the date of verification or as specified.
  2. After the certificate’s expiration date, a new COPP application has to be submitted.

Format of CERTIFICATE OF PHARMACEUTICAL PRODUCT (COPP)