COPP (Certificate of pharmaceutical product), The Central Drugs Standard Control Organization (CDSCO), which is the national drugs regulatory authority, regulates the import and export of the drugs in the country, through the port offices located in different parts of the country.
The WHO GMP certificate is mandatory in most global markets for pharmaceutical companies to be able to sell medicines. The manufacturer of an exporting country must be licensed by the regulatory authority of that country and comply with the WHO GMP guidelines
The certificate of pharmaceutical product (CPP or CoPP) is a certificate issued in the format recommended by the World Health Organization (WHO). The application for grant of WHO GMP Certificate of Pharmaceutical Product shall be made to respective zonal/sub zonal officers as per the requirement. The COPP will be issued by zonal/sub zonal officers on behalf of Drugs Controller General (India) after inspection and satisfactory clearance by CDSCO officers as per WHO – GMP guidelines. It is valid for 3 years from the date of issue and companies can apply for renewal after that.
The Certificate of Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorisation) or renewal (prolongation) of registration, with the scope of commercialisation or distribution in that country. Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as prerequisite of registration or importation.
In the presence of such certificate of pharmaceutical product, WHO recommends to national authorities to ensure that analytical methods can be confirmed by the national laboratory, to review and if necessary to adapt product information as per local labelling requirements, and to assess bioequivalence and stability data if necessary.
However, regulatory practices often vary in importing countries. Thus, in addition to certificate of pharmaceutical product, assessment of application dossiers to support drug registrations, with different levels and complexity of requirements are considered necessary to satisfy full assurance on the appropriate quality of drugs.
The content of CPP consists of the following main data:
- Exporting (certifying) country
- Importing (requesting) country
- Name, dosage (pharmaceutical) form and composition of the product [active ingredient(s) and amount(s) per unit dose]
- Information on registration (licensing) and marketing (presence on the market) status of the product in the exporting country
- Number of product license (including license holder details, license holder’s involvement in manufacturing if any) and date of issue, if applicable
- Appended summary of technical basis on which the product has been licensed (if required by the issuing authority)
- Appended current product information
- Details on the applicant for the CPP
- If marketing authorisation is lacking in the exporting country, information about reasons
When applicable, information if the manufacturing site is periodically inspected by certifying authority and if the manufacturing site complies with Good manufacturing practice (GMP) as recommended by WHO.
Although issuing authorities claim that their certificate of pharmaceutical product conform to WHO format (a statement to confirm whether or not the document is issued in the format recommended by WHO should be included in the certificate), their format and content may vary from one issuing country to another. Also, some authorities do not issue CPP if the respective drug is not licensed in the exporting country (e.g. Italy). In this last case, a Certificate of Exportation is issued instead, with a format and content similar to those of CPP.