Certificate of a Pharmaceutical Product (CPP)

Pharmaceutical exports require strict adherence to global regulatory frameworks, ensuring that medicines entering foreign markets are safe, effective, and compliant with international standards. Among the most essential documents for exporters is the Certificate of Pharmaceutical Product (CPP). Issued under the World Health Organization certification scheme, the CPP provides importing countries with assurance that a product is authorized for sale in the country of origin and manufactured according to recognized quality standards.

For businesses navigating international pharmaceutical trade, securing and properly authenticating a Certificate of Pharmaceutical Product is a critical step. CFG Apostille specializes in providing professional apostille and legalization services for CPPs, helping exporters meet foreign regulatory requirements with confidence and efficiency.

What is a Certificate of Pharmaceutical Product (CPP)?

A Certificate of Pharmaceutical Product is an official document that confirms a pharmaceutical product is authorized for sale in its country of origin and manufactured according to Good Manufacturing Practices (GMP). The World Health Organization introduced the CPP as part of its certification scheme to facilitate international trade in pharmaceuticals and ensure transparency in regulatory controls.

The CPP typically includes:

  • The product’s proprietary and generic names.
  • Information about the dosage form, composition, and active ingredients.
  • The name and address of the manufacturer.
  • Verification that the product is authorized for sale in the country of export.
  • Confirmation that the manufacturing site complies with GMP standards.

Importing countries rely on the CPP to assess whether a product meets the necessary quality, safety, and efficacy standards before granting marketing authorization.

Why is the Certificate of Pharmaceutical Product Important?

The Certificate of Pharmaceutical Product serves multiple critical purposes in the global pharmaceutical industry:

  • Market Authorization Abroad: Many foreign regulatory authorities require a CPP before they approve the sale of a new medicine within their jurisdiction.
  • Quality Assurance: It demonstrates that the product complies with internationally accepted GMP standards.
  • Regulatory Transparency: By including detailed information about the manufacturer and authorization status, the CPP provides confidence in the legitimacy of the product.
  • Customs Clearance: Proper documentation minimizes delays and ensures efficient importation processes.

Without a valid and authenticated CPP, pharmaceutical companies risk significant barriers to entering international markets.

Apostille and Legalization of a Certificate of Pharmaceutical Product

While the issuing authority provides the CPP, most countries require further validation through apostille or embassy legalization.

  • Apostille Authentication: For countries that are members of the Hague Apostille Convention, the apostille confirms the authenticity of the CPP, validating the signature and seal on the document.
  • Embassy Legalization: For Non-Participating Hague Convention Countries, the CPP requires consular or embassy legalization.

This authentication process ensures the CPP is recognized by foreign regulatory authorities, enabling exporters to avoid costly delays and rejections.

How CFG Apostille Supports Pharmaceutical Exporters

The process of authenticating a Certificate of Pharmaceutical Product can be complex and time-sensitive, particularly when dealing with multiple regulatory requirements across different countries. CFG Apostille provides specialized services to ensure that CPPs are processed accurately and efficiently.

Services Offered by CFG Apostille:

  • Apostille Authentication: Facilitating apostille certification for Hague Convention countries.
  • Embassy Legalization: Coordinating embassy or consular legalization for non-Hague Convention countries.
  • Expedited Processing: Fast-track services for businesses facing tight export deadlines.
  • Expert Guidance: Assistance in preparing and submitting documents correctly to minimize risks of rejection.
  • End-to-End Solutions: Managing the entire process from document submission to final delivery.

By entrusting this process to CFG Apostille, pharmaceutical exporters can focus on global operations while ensuring compliance with international documentation standards.

Secure Your Certificate of Pharmaceutical Product with CFG Apostille

For pharmaceutical companies seeking to expand into new markets, the Certificate of Pharmaceutical Product is a vital document that validates product legitimacy and manufacturing standards. To ensure international acceptance, it must be authenticated through apostille or embassy legalization.

CFG Apostille provides professional, reliable, and expedited services to authenticate your CPP, ensuring it is recognized globally. By partnering with CFG Apostille, pharmaceutical exporters can confidently navigate international requirements and achieve seamless access to foreign markets.

CFG documents received online

Simply upload your CFG digital file, you will receive by FedEx your document processed with an apostille.

Processing time

  • expedited service
  • No need to ship your document.
  • Billing is available.
  • Credit card payment is OK.
  • US Department of State fee is included.
  • No need for the US Dept. of State form.
  • Track your history and spending online.

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