Giulia Corsi -

The Certificate of Pharmaceutical Product (CPP) is a document issued by a country’s regulatory authority at the request of a product MAH to support the registration process of a pharmaceutical product of another regulatory authority in a different country.


The CPP confirms:


  • the regulatory approval was based on a full evaluation of the product’s quality, safety and efficacy;
  • the product is manufactured under good manufacturing practices (GMP); and/or
  • the registration and marketing status of the product in the certifying country



Therefore, the CPP is one of the important documents that a MAH needs to submit while entering the Extra – EU market. A CPP not only ensures approval for the product but also guarantees fast market entry.


When a company wishes to submit a CPP application to AIFA, it is crucial to know whether or not the medicinal product in question has been assigned the Italian MA numbers (AIC numbers), since the approval and submission process is different.


Once the submission and evaluation by AIFA has been completed, the CPP is issued in the form of a digitally signed documentation and then should be legalized.


Our Regulatory Pharma net team can support your company in all regulatory steps (document preparation, submission, contact with the regulatory authority and legalization process at embassies).

Comments are closed for this post.