Understanding Export Requirements: The Importance of the CPP

When companies seek to export pharmaceutical products, they are often required to provide documentation demonstrating compliance with regulatory standards. This certification is managed through a Certificate of a Pharmaceutical Product (CPP) from the regulatory or health authority in the country of export for use by importing countries.

Regulatory planning and support to provide CPPs for countries where the finished medicinal product is meant to be registered and marketed is very important since the competitiveness of a product on a market is also determined by the time it is first available.

Dealing with all mandatory and requested certificates such as CPPs can hugely increase the workload, particularly when a company operates internationally.

What is a CPP used for?

The CPP is a confidential document required for exporting drug products. The certificate is issued in the format recommended by the World Health Organization (WHO) and is internationally recognized by national regulatory authorities to establish the status of a pharmaceutical product and of the applicant in the exporting country, where the product is nationally registered.

The CPP is specific for a single product only, since manufacturing arrangements and approved information for different dosage forms and different strengths can vary. In most cases, the CPP is also specific to one country of import. Some issuing countries, such as Italy, permit a CPP to be requested for an unlimited number of countries under certain conditions.

The certificate issued by the exporting country should be incorporated into a product licence application in the importing country. This applies when the concerned product is under consideration for a product licence that will authorize its importation and sale, or when administrative action is required to renew, extend, vary, or review such a licence.

The CPP is of huge strategic importance since local health authorities in importing countries might delay or reject an application when a CPP is not available.

Once issued, the CPP is transmitted to the requesting authority through the applicant and, when applicable, the agent in the importing country.

What is included in a CPP?

Among other information, the certificates include:

• Information on whether the product is sold in the exporting country
• Product name and dosage form
• Complete qualitative and quantitative composition
• Product Information for health professionals (SmPC) and for the public (patient information leaflets) as approved in the exporting country
• Details of the manufacturing site(s)

In the absence of any specific agreement, each certificate is prepared exclusively in the working language(s) of the certifying authority. The applicant is responsible for providing any notarized translation that may be required by the requesting authority.

The certifying authority is responsible for assuring the authenticity of the certified data.

Every effort must be made by the applicant to ensure that certificates and all annexed documentation are compliant with the version of the product license applicable on the date of issue