Certificate of pharmaceutical product

The Certificate of a 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. 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: • 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 the reasons for this When applicable, information as to whether the manufacturing site is periodically inspected by certifying authority and whether the manufacturing site complies with Good Manufacturing Practice (GMP) as recommended by WHO. Although issuing authorities claim that their CPP 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 a CPP if the medicinal product concerned 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 a CPP. In order to avoid disruption of medicinal product availability due to the COVID-19 pandemic, starting with year 2000 stringent regulatory agencies (SRA) implemented the electronic CPP (eCPP). Conceived in the initial stages as a temporary solution in response to the pandemic, eCPP turned gradually into a standard, replacing the paper CPP. In addition to reducing paper waste, another advantage is the faster availability of such documents compared to their hard format. ==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 ("Abuse of scheme"). This practice continues in some importing countries also with the advent of eCPP. Therefore, the issuing SRA strongly recommend verification of eCPP using alternative ways, such as online (e.g., on EMA and FDA websites), using a QR code (FDA), checking of electronic signature validity (EMA) etc. ==References==