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A Certificate of Pharmaceutical Product (CPP) is a document issued by a country’s Regulatory authority at the request of a product owner/ sponsor to support the registration process of a pharmaceutical product of another Regulatory authority. The CPP helps waive off full dossier evaluation as it confirms the quality, safety, and efficacy, thereby facilitating the Regulatory review process.

CPP is a required component of the dossier submission to ANVISA, the Brazilian Regulatory authority, since it summarizes all essential data such as the quality, safety, and efficacy of the pharmaceutical product. It is required for new product registration, certain variations, and renewals of pharmaceutical products. The CPP is anticipated to benefit all parties, including Regulatory Agencies, patients, and pharmaceutical businesses in Brazil, by improving product internationalization and decreasing time to market by limiting duplicative evaluations by relying on previous trustworthy analysis. The CPP is to be submitted electronically (e-CPP) to the ANVISA to obtain marketing authorization for pharmaceutical products in Brazil. 

The CPP Confirms:

  • Regulatory authority approval is based on a full evaluation of the product’s quality, safety, and efficacy
  • the product is manufactured under GMP conditions
  • the product is marketed in the CPP-issuing country, and therefore, well-defined quality criteria of the CPP lead to its worldwide acceptance

Therefore, the Certificate of Pharmaceutical Product (CPP) is one of the important documents that a foreign manufacturer needs to submit while entering the Brazilian market. A CPP not only ensures approval for your product but also guarantees fast market entry. Our on-ground team of Brazilian Regulatory experts helps you with the end-to-end registration process of your product and strategizes your market entry into Brazil with a minimum TAT.

To know more about Freyr’s capabilities and competencies in the Regulatory process of product registration in Brazil, consult Freyr today!