The certificate of pharmaceutical product is a certificate issued in the format recommended by the World Health Organization, which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. It is issued for a single product, because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary.
Scope
The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration or renewal 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 CPP, 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 CPP, 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.
Content and format
The content of CPP consists of the following main data:
When applicable, information if the manufacturing site is periodically inspected by certifying authority and if the manufacturing site complies with Good Manufacturing Practice as recommended by WHO. Although issuing authorities claim that their CPP conform to WHO format, their format and content may vary from an issuing country to another. Also, some authorities do not issue CPP if the respective drug is not licensed in the exporting country. In this last case, a Certificate of Exportation is issued instead, with a format and content similar to those of CPP.
Special considerations in importing countries
Most competent authorities in importing countries require CPP to be issued by the country of origin. Also, even though this certificate is released in its original form, addressed to a specific importing country and stamped with the seal of issuing authority on each page, many authorities in importing countries may unnecessarily request authentication of such a document in the form of legalisation by their embassy in the exporting country or by apostillation.
