FDA Certificate of Pharmaceutical Product Apostille


The Certificate of Pharmaceutical Product (CPP) is a document from the U.S. Food and Drug Administration issued in the World Health Organization's (WHO) recommended format that establishes the status of the pharmaceutical product and the applicant for this certificate in the exporting country. It is frequently mentioned in conjunction with the electronic Common Technical Document (eCTD). Because manufacturing arrangements and authorized information for different pharmaceutical forms and strengths might change, a CPP is issued for a single product. Although the heavily controlled items are subject to bilateral or regional trade agreements, the CPP is addressed in World Trade Organization regulations. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has established criteria for this purpose, however it is unclear how health regulators in non-ICH nations work.


Scope

When a product is intended for registration (license, authorization) or renewal (prolongation) of registration with the scope of commercialization or distribution in that nation, the importing country requires a Certificate of a Pharmaceutical Product. WHO has proposed certification to assist smaller drug regulatory bodies or drug regulatory authorities in importing countries without sufficient quality assurance capabilities in assessing the quality of pharmaceutical goods as a requirement of registration or importation.


In the existence of a CPP, WHO advises national authorities to check that analytical techniques can be validated by a national laboratory, to examine and, if required, adjust product information to local labeling laws, and to assess bioequivalence and stability data.


Regulatory practices in importing nations, on the other hand, are frequently inconsistent. As a result, in addition to CPP, evaluation of application dossiers to support drug registrations, with varying degrees and complexity of criteria, is regarded required to ensure full assurance on drug quality.


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 authorization is lacking in the exporting country, information about reasons

Certificate of Pharmaceutical Product (CPP) Apostille or Consular Legalization

The majority of competent authorities in importing nations want CPP from the place of origin. Furthermore, even though this certificate is issued in its original form, addressed to a specific importing country, and stamped with the issuing authority's seal on each page, many authorities in importing countries may request authentication of such a document in the form of legalization by their embassy in the exporting country or by apostillation.


There is no margin for error with the authentication or apostille process. If mistakes are made, both your time and money will be wasted and you'll have to start all over again. If you want to look into outsourcing this part of preparing to studying abroad to someone with experience, please email me at jared@apostillellc.com or call 848-467-7740 to request my services or learn more.

8 views0 comments

Recent Posts

See All